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Training program for DEO

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HCC
REPORT
2022

https://www.hemecancer.org/
 MESSAGE FROM DIRECTOR

Hematological cancers are one of the most curable cancers

if diagnosed early and treated appropriately. The delivery of
treatment in our country has several limitations which
include but are not limited to resource constraints, lack of
expertise and knowledge to deliver therapy. While India has
highly skilled professionals in the medical and basic science
institutes and numerous institutions that are on par with
international peers, these are often limited to major cities and
are inaccessible to the poor. The overall number of trained educated health workers
is very low in proportion to the country’s population. It is widely recognized that
there is significant under diagnosis of hematological cancers in India and of those
diagnosed, a substantial proportion of patients do not receive standard of care
therapy. Many of the issues have never been systematically evaluated due to the
lack of large well-annotated registry data. Also, treatment strategies and algorithms
are often based on studies and data generated in high-income countries, usually in
the setting of a clinical trial, with a different health care delivery system which may
not necessarily be applicable in India.
Hematology Cancer Consortium is a multi-center collaborative academic
organization established with the aim to improve knowledge, standardized
treatment protocols, and cost-effective approaches to management based on locally
generated data.
We began with 12 leading Cancer Centers as our institutional partner and we
currently have 17 partners. We have established a collaborative database for acute
leukemia’s and lymphoma’s and have started conducting prospective investigator-
initiated studies.
We are grateful to the donors and our institutional partners for their support.

DR. VIKRAM MATHEWS

DIRECTOR,
HEMATOLOGY CANCER CONSORTIUM

REPORT 2022
 WHO ARE WE

OUR
Hematology Cancer Consortium (HCC) is a multi center collaborative
organisation established to fulfil the long felt need of good quality,
cooperative group data in hematological malignancies in India.
PERFOR M A
Our Goals
N C E
Aggregate clinical data to support care outcomes of
hematological malignancies
Develop evidence based, locally relevant treatment protocols and
guidelines
Run investigator initiated prospective collaborative clinical trials
addressing regionally relevant questions and evaluating cost
effective treatment strategies
Continuous education to improve awareness and enhance
knowledge of therapeutic options for standardization of care in
hematological cancers

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 HCC REGISTRY

One of the goals of Hematology Cancer

Consortium is to aggregate clinical data to support
care outcomes of hematological malignancies.

The below graph summarizes the total data recorded across all the
centers till September 2022 with center-wise distribution and
yearly progression.

Acute Myeloid Leukemia: 22 centers across the country recorded

4831 patients' information.

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 HCC REGISTRY

Acute Lymphocytic Leukemia: 20 centers across the country recorded

3827 patients' information.

Acute Promyelocytic Leukemia: 22 centers across the country recorded

511 patients' information.

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 HCC REGISTRY

Chronic Myeloid Leukemia: 22 centers across the country recorded

1930 patients' information.

Lymphoma: 20 centers across the country recorded 5177 patients'

information.

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 RESEARCH

Title: Induction Related Mortality Score in Acute Myeloid Leukemia:

Prospective Validation Study

Title: Evaluation of the safety and efficacy of generic low-dose Dasatinib

for frontline therapy in chronic phase chronic myeloid leukemia - A
multi-center phase II single arm study

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 RESEARCH

Title: COVID-19 with Hematological Cancers Registry of India (CHCRI)

Title: Epidemiology and treatment outcomes of patients older than 55

years of age with Acute Myeloid Leukemia in India

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 RESEARCH

Title: Care of patients with Acute Myeloid Leukemia during COVID in

India

Title: Outcomes and prognostic factors in patients with Burkitt’s

lymphoma: real world data

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 UPCOMING RESEARCH

Title: Phase III open labeled randomized controlled study to evaluate the
optimal dose of all-trans retinoic acid in the treatment of low and
intermediate risk acute promyelocytic leukemia

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 EDUCATION & TRAINING

WEBINAR SERIES: APRIL - DECEMBER 2022

TOPIC: LEVERAGING T-CELL ENGAGING IMMUNOTHERAPY FOR THE TREATMENT OF
ACUTE LYMPHOBLASTIC LEUKEMIA
IN ASSOCIATION WITH
SOCIETY OF HEMATOLOGIC ONCOLOGY (SOHO) AND
PHYSICIANS' EDUCATION RESOURCE® (PER®)

SPEAKERS

Elias Jabbor, MD Nikita Mehra, MD, DM

MD Anderson Cancer Center,Houston, TX, USA Cancer Institute (WIA),Adyar, Chennai, India

Hagop M Kantarjian, MD Prasanth Ganesan, MD, DM

MD Anderson Cancer Center,Houston, TX, USA JIPMER, Puducherry, India

In addition to this HCC has conducted webinars on various topics

Topic Speaker(s)

Common challenges in management of

Multiple speakers
hematological malignancies in COVID era

Current Evidence in Management of CLL & Dr. Nitin Jain, MD Associate Professor Department of
Future Direction Leukemia MD Anderson Cancer Center Houston, TX

What can our chromosomes tell us? Relevance

Dr.Nancy Beryl Janet. A Lecturer, Department of
of cytogenetic assessment in hematological
Haematology CMC, Vellore
malignancies

A Primer on Molecular Testing in Dr. Madhavi Maddali, MD, DNB, Assistant Professor,
Haematology & MRD in AML Department of Haematology CMC, Vellore

Overview of Cytomorphology in
Brig Tathagata Chatterjee, COL S Venkatesan
Hematological Malignancies

REPORT 2022
 EDUCATION & TRAINING

Cont..

Topic Speaker(s)

Immunophenotyping: Basic Interpretation for Dr. Prashant Tembhare, Hematopathology Laboratory,

a Clinician ACTREC, Tata Memorial Center

ASH 2020 Update Multiple Speakers

How to evaluate flow and interpret flow Dr. Prashant Tembhare, Hematopathology Laboratory,
cytometry based MRD ACTREC, Tata Memorial Center

Dr. Nitin Jain, MD Associate Professor Department of

What's new in CLL - ASH 2020 Updates
Leukemia MD Anderson Cancer Center Houston, TX

Prof Ritu Gupta, Professor & Officer-In-Charge,

How I Define High- Risk CLL
Laboratory Oncology, AIIMS, New Delhi

How I Treat CLL Dr. Pankaj Malhotra, PGI, Chandigarh

COVID Vaccination and Hematological Dr. Priya Sampathkumar, MD, Division of Infectious
Cancers Disease, Mayo Clinic

SOP'S FOR CONDUCTING MULTICENTER TRIALS

Standard Operating Procedures (SOP) for conducting a multicenter trial have
been developed and are available on the HCC website.
SOP 1 How to screen a study for a multicenter trial
SOP 2 Screening a site for eligibility
SOP 3 Site initiation checklist
SOP 4 Monitoring the trial
SOP 5 How to respond to the monitoring report from the CRO
SOP 6 Approach to establish authorship in a multicentric clinical trial

REPORT 2022
 TRAINING PROGRAM FOR
DEO
HCC conducted training programs for our Data Entry Operators in collaboration
with the BIRAC, CDMC & NCG teams.
BIRAC team conducted 12 training programs on various topics.

ICMR Guidelines Clinical Trial Monitoring Source Documents

Essential Documents ICH GCP guideline E6 R2 Investigator responsibilities

Root Cause Analysis (RCA) and

Investigational Product
Sponsor Responsibilities Corrective and Preventive Actions
Management
(CAPA)

Safety Reporting in CTs Audits Audit and Inspection

DEOs also attended the “Clinical Research Methodology - CRM 2021" workshop
organized by Tata Memorial Center in the month of October 2021. Topics were:

Generating a Research Question PubMed Search Phases of Clinical Trials

Protocol/Aims/Objectives/
Randomization Study Designs
Methods

Why Statistics, p-value, Errors, Measures Of Association - Odds

Which Stats test where?
Sample size and Standard Error Ratio And Relative Risk

Diagnostic tests ICD and IC Process Survival analysis

Meta-Analysis Electronic Data Base and SPSS Making a CRF

Referencing styles Medical Writing- Publication and posters

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 TRAINING PROGRAM FOR
DEO

A special workshop for DEO’s was conducted on 6th & 7th August 2021.

We conducted DEO training program on 27th and 28th May 2022 in

collaboration with the CDMC team.

Training program recordings are now available on the HCC website.

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 NURSING WEBINAR

HCC nurses group had initiated an education program to enhance

knowledge. Webinars are held on the last Tuesday of every month.

Topic Speaker

CVAD- PICC Insertion care & Ms. Sheelpa N Raskar, Sr. Nurse Department of CVAD,
maintenance Tata Memorial Hospital, Mumbai

Role of immunotherapy in cancer Mrs. Abijah Princy B, Nurse Manager, Hemato- Oncology
treatment Nursing Department, CMC Vellore

Mrs. Sangeetha Samuel, Deputy Nursing Superintendent /

Transforming nursing practice:
Assistant Professor, Christian Medical College & Hospital,
Nursing Research
Ludhiana

Nursing management of side effects

Mrs. Reena Nair, ANS, Tata Memorial Hospital, Mumbai
of chemotherapy

Clinical transfusion practices for Ms. Manisha U G, Staff Nurse, ACTREC, Tata Memorial
nurses Center, Navi Mumbai

Dr. Venkatraman Radhakrishnan, Professor & In-charge

How to write a research proposal
Medical Oncology, Cancer Institute (W.I.A)

Role of car t - cell therapy in Mrs. Abijah Princy B, Nurse Manager, Department of
hematological malignancies Hematology, CMC Vellore

Ms. Josephine Suganya AMC, Apheresis Nurse, Hemato-

Role of nurses in apheresis
Oncology Nursing Department, CMC Vellore

Recognition and management of early

Ms. Mita Roychowdhury, Clinical Nurse Specialist, Bone
complication in allogenic HSCT:
Marrow Transplant Unit, TMC, Kolkata
Nursing Perspective

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 NURSING WEBINAR

Cont..

Topic Speaker

Capt Monika, BSC nursing, Diploma in oncology

nursing and
Childhood and Young All Sticking to
Lt Gunjan Rawat, BSC (hons) nursing,
Protocol - A Nursing Perspective
Hematology daycare and BMT, Command Hospital,
Kolkata

Role of Nurses in Bone Marrow Ms. Sindhu S, BMT Incharge, Malabar Cancer Center,
Transplant Thalassery, Kannur, Kerala

PICC, Insertion, Care and Ms. Jyothi Vidya, Senior Registered Nurse, HCGMSR
Maintenance Cancer Hospital, Bangalore

Common Investigations in Hemato-

Ms. Preethi S, Nursing Officer, JIPMER, Puducherry
Oncology (BMT)

Extravasation it's Prevention and Ms. Surya Sukumaran, Senior Nurse Educator, Rajiv
Management Gandhi Cancer Institute and Research Center, Delhi

Palliative Nursing Improving Quality Ms. Rekha Kuchekar, Palliative Care Nurse, TMH,
of Life of Oncology Patients Mumbai

Webinar recordings are available on our website:

http://hemecancer.org/
Register as a member to access recordings:
http://hemecancer.org/webinar-recording.php

REPORT 2022
 PUBLICATIONS

Outcomes in adolescent and young adult acute

lymphoblastic leukaemia: a report from the Indian Acute
Leukaemia Research Database (INwARD) of the
Hematology Cancer Consortium (HCC)

British Journal of Haematology

https://www.hemecancer.org/pdf/bjh.17268.pdf
DOI: 10.1111/bjh.17268

Hematological Cancer Consortium: Multi-Center Acute

Myeloid Leukemia Registry Data from India

Blood 2018; 132 (Supplement 1): 4006.

https://doi.org/10.1182/blood-2018-99-116853

Outcomes of patients with hematologic malignancies and

COVID-19 from the Hematologic Cancer Registry of India

Blood Cancer Journal

https://doi.org/10.1038/s41408-021-00599-w

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 ABSTRACTS

ABSTRACTS SELECTED BY ASH FOR POSTER PRESENTATION

Aby Abraham, MD, DM, Hasmukh Jain, MD, DM, Jina Bhattacharyya,MD, DM,
Dubashi Biswajit, MD, DNB, DM, Jayachandran PK, MD,MRCP, DM, Dinesh
Bhurani, MD, DM, FRCPA, Stalin Chowdary Bala,MBBS, MD, DM, DNB, Suman
Pramanik, MD, Santhosh Devadas, Uday Prakash Kulkarni, MD, DM, Manju
Sengar, MD, DM, RayazAhmed, MD, DM, Thenmozhi Mani, PhD, Damodar Das,
MD,Parathan Karunakaran, MD, DM, Sadashivudu Gundeti, MD DM, Rasmi
Pallasseri, Nikhil Patkar, MD, Manjunath Nookala, MD and Poonkuzhali
Balasubramanian, MSc, PhD
Department of Haematology, Christian Medical College, Vellore, India;
Adult Hematolymphoid Disease Management Group, Department ofMedical
Oncology, Tata Memorial Centre, Mumbai, India;
Department ofMedical Oncology, Tata Memorial Centre, Mumbai, India;
Homi BhabhaNational Institute, Mumbai, India;
Department of Clinical Hematology,Gauhati Medical College & Hospital,
Guwahati, India;
Department ofMedical Oncology, Jawaharlal Institute of Postgraduate Medical
Education& Research (JIPMER), Puducherry, India;
Department of MedicalOncology, Cancer Institute (WIA), Chennai, India;
Department of Hemato-Oncology & BMT, Rajiv Gandhi Cancer Institute and
Research Centre, NewDelhi, Madhya Pradesh, India;
Department of Medical Oncology, Nizam'sInstitute of Medical Sciences,
Hyderabad, India;
Army Hospital (Research& Referral), New Delhi, India;
Department of Medical Oncology, MSRamaiah Memorial Hospital, Bengaluru,
IND;
Department of MedicalOncology, Tata Memorial Centre, Mumbai, Maharashtra,
India;
Department of Hemato-Oncology & BMT, Rajiv Gandhi Cancer Instituteand
Research Centre, New Delhi, India;
Department of Biostatistics,

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 ABSTRACTS

ABSTRACT ID#: 169777

Christian Medical College, Vellore, India;
Department of Haematology,Guwahati Medical College, Guwahati, India;
Nizam's Institute of MedicalSciences, Hyderabad, India;
Department of Oncology, MS RamaiahMedical College, Bengaluru, India;
Hematopathology Laboratory, TataMemorial Centre, Mumbai, India;
Haematopathology Laboratory, TataMemorial Hospital, Tata Memorial Centre,
Affi liated to Homi BhabhaNational Institute, Navi Mumbai, India;
Hematopathology Laboratory,ACTREC, Tata Memorial Centre, Navi Mumbai,
India;
ClinicalPharmacology, Advanced Centre for treatment research and education
incancer, Panvel, India;
Christian Medical College, Vellore, IND
Background- A lower dose of Dasatinib has been shown to have excellent results in CML in CP, even better
than standard doses in a single-center study using the innovator drug (Naqvi et al, Cancer, January 2020). We
conducted a multicenter trial using a lower dose of generic Dasatinib (Invista, Dr. Reddy’s, Hyderabad, India)
to see the outcomes.

Methods- This is a phase II multi-center investigator initiated study conducted between October 2020 till
September 2021. Patients were enrolled from 9 centers across India. The inclusion criteria were CML in CP,
aged 18-60 years without any co-morbidities and another cancer. They were enrolled in the trial after a
written informed consent. Initial assessment included complete blood counts, bone marrow examination
including karyotype, FISH for t (9;22) and serum chemistries. They were given 50 mg daily of generic
Dasatinib. Blood counts were monitored once in 1-2 weeks for the fi rst 2 months and monthly thereafter.
Dasatinib drug levels and RQPCR was monitored at 3-, 6- and 12-month intervals. The response was defined
as per ELN 2020 criteria. The main outcome measure was CCyR (or equivalent molecular response </=1%) at
12months, the secondary outcome measures included MMR and EMR. Patients who did not tolerate or
progressed while on Dasatinib were switched to Imatinib or one of the other TKIs while those who failed at
6months were switched to standard dose Dasatinib.

Results- Out of the 207 patients who were screened, 90 patients were enrolled into the trial of which 70
(77.8%) were men. The median age was 36.5 years (29-50). The distribution of patients as per Sokal score and
ELTS were 35 (39.3%) for high, 44(49.4%)/37(41.6%) for intermediate and 10(11.2%)/17(19.1%) for low risk
respectively

With a median follow-up of 11(6,12) months, 80 (88.8%), 71 (78.8%) and 39(43.3%) patients completed 3,6 and
12 months of therapy and the results are available currently. Optimal response at 3, 6 and 12 months as per
ELN 2020 criteria was achieved by 44/80 (55%), 42/71 (59.1%) and 19/39(48.7%) patients.

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 ABSTRACTS

ABSTRACT ID#: 169777

EMR at 3 months was achieved by 44/80 (55 %) patients. CCyR was achieved by 42/71 (59.1%) at 6 months and
35/39 (89.7%) at 12 months. MMR was achieved by 17/71 (23.9%) and 19/39 (48.7%) patients respectively.

A total of 53 patients developed at least one adverse event. A total of 199adverse events were recorded, out of
which only 13 (6.5%) were of grade¾. The most common toxicity events were hematological (14),
gastrointestinal (55), headache (17) and cough (11). The most common grade ¾ toxicities were hematological
(8 events). There were 4 serious AEs during the trial-hematological (2), Ileus (1) and disseminated varicella
(1). Toxicities led to a dose reduction in 2 patients and interruption in 18 patients.

Discussion- This is the fist multicenter investigator initiated clinical trial involving nine centers from India
on Chronic myeloid Leukemia. This reflects the challenges involved in conducting multicenter study like
recruitment, patient compliance and default. The CCyR of 89.7% inpatients who have completed 12 months of
therapy appears promising. The toxicity is comparable to previous studies. The higher proportion of high and
intermediate risk patients in this cohort could probably account for the less than expected results compared
to previously published data with low dose Dasatinib.

Conclusion- At this interim analysis Dasatinib 50 mg appears to be promising with respect to responses but
with a caution considering the fact that the majority of patients had a higher disease load. We need to wait for
the fi nal results before Dasatinib 50 mg can be considered as standard of care.

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 ABSTRACTS

Manju Sengar, MD, DM , Anu Korula, MD, DM , Prasanth Ganesan, MD, DM , Akhil
Rajendra, MD , Hasmukh Jain, MD, DM , Prasanna Samuel, MSc, PhD ,
Jayachandran P K, MD, DM , Gaurav Prakash, MD, DM , M. Joseph John, MD, DM ,
Rasmi Palassery, MD , Chandran K. Nair, MD, DNB, DM , Tanuja Shet , Sushil
Selvarajan, MD, DM , Lingaraj Nayak, MD, DM , Parathan Karunakaran, MD, DM ,
Fouzia NA, DNB, DM , Om Prakash, MSc , Bhausaheb Bagal, MD, DM , Nikita Mehra,
MD, DM , Saranya Kumaran , Sridhar Epari , Jayshree Thorat, MD , Venkatraman
Radhakrishnan and Aby Abraham, MD, DM
Homibhaba National Institute, Mumbai, India, MUMBAI, India;
Department of Haematology, Christian Medical College, Vellore, India;
Department of Medical Oncology, Jawaharlal Institute of Postgraduate
Medical Education & Research (JIPMER), Puducherry, India; Department
of Medical Oncology, Tata Memorial Centre, Mumbai, Alabama, India;
Department of Medical Oncology, Tata Memorial Centre, Mumbai,
India; Department of Biostatistics, Christian Medical College, Vellore,
Vellore, India; Cancer Institute(WIA), Adyar, Chennai, India;
Department of Clinical Hematology and Medical Oncology,
Postgraduate Institute of Medical Education and Research, Chandigarh,
India; Department of Clinical Haematology and BMT, Christian Medical
College & Hospital, Ludhiana, India; Ramaiah Medical College and
Hospital, Ramaiah Medical College and Hospital, Bengaluru, OH, India;
Department of Clinical Hematology and Medical Oncology, Malabar
Cancer Centre, Thalassery, IND; Department of Pathology, Tata
Memorial Centre, Aaliated to Homi Bhabha National Institute, Mumbai,
India; Department of Haematology, Christian Medical College, Vellore,
Tamil Nadu, India; Department of Medical Oncology, Cancer Institute
(WIA), Chennai, India; Department of Biostatistics, Christian Medical
College, Vellore, India; Department of Medical Oncology, Tata
Memorial Centre, Mumbai, Maharashtra, India; CDMC, Christian
Medical College, Vellore, Vellore, India; Tata Memorial Hospital,
Mumbai, India; Adult Hematolymphoid Management Group, Tata
Memorial Hospital,Mumbai, Mumbai, Maharashtra, India; Department
of Haematology, Christian Medical College, Vellore, Vellore, Tamil Nadu, India

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 ABSTRACTS

ABSTRACT ID#: 165840

The treatment of BL/L has evolved on the principles of short-course, intensive, non-cross resistant,
alternating chemotherapy. These intensive high-dose methotrexate-based treatment regimens (CODOXM/
IVAC, Hyper-CVAD, BFM, LMB) have led to high response rates and cures in a significant proportion of
children and young adults. The addition of rituximab has led to overall survival benefit. There is limited data
that dose adjusted EPOCH-R provides a low intensity treatment option for patients who may not be able to
tolerate high-dose methotrexate-based regimens. Efficacy of these regimens in real-world, more so in an
LMIC setting need to be evaluated given the delays in seeking care, higher risk of treatment-related
complications including infections and antecedent treatment interruptions.

This retrospective multicentric study collected the data from eight member centers of Hematology Cancer
Consortium (www.hemecancer.org) using an electronic database, to analyze the clinical characteristics,
treatment patterns, outcomes and prognostic factors in adolescent and adult newly diagnosed Burkitt
lymphoma and leukemia diagnosed between 2012-2019 (including HIV positive). Patients who had received
more than 2 weeks of chemotherapy or steroids prior to presentation were excluded. The data included
demographic details, performance status (ECOG), HIV serology, bone marrow and CNS involvement, stage,
treatment type, use of rituximab, response to treatment, and treatment-related mortality as assessed by the
investigator of the respective centre. The primary objective was to evaluate event-free survival at 2 years.
Secondary objectives were to evaluate the overall survival, impact of the treatment protocol, use of rituximab,
stage, age, performance status, CNS involvement, and HIV positive status on the overall and event-free
survival.

A total of 312 patients were included in this study. Out of these 257 patients received treatment and were
analyzed for the outcome and prognostic factors. The treated and untreated cohorts differed in age [
median age 37 years (range-25-49 years) versus 42 years (range-32-51 years); with the untreated cohort being
older. Table 1 provides the baseline characteristics of the patients who received treatment. The HIV
positive patients (in treated cohort) had higher LDH [median - 967.5 (range, 509- 2355) vs 589 (311-1141),

p=0.003). A total of 100 (42%) patients received intensive and high-dose methotrexate-based chemotherapy,
81 (34%) patients received dose-adjusted EPOCH-based treatment whereas 56 (24%) received other low-
intensity or palliative chemotherapy. Patients with HIV were largely treated with a dose adjusted EPOCH-
based regimen (25/32 patients). Patients who received a high-dose methotrexate-based regimen were
younger than those who received dose-adjusted EPOCH and other lower intensity regimens (Mean age 29
years versus 42.4 and 43.9 years)

At the median follow-up of 36.5 months, the 2-year EFS was 61% and 2- year OS was 73%. There was no
significant difference in outcomes in HIV-positive and negative patients. On univariate analysis lack of use of
rituximab and use of protocols other than high-dose methotrexate and dose-adjusted EPOCH negatively

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 ABSTRACTS

ABSTRACT ID#: 165840

affected EFS and OS. Age had an adverse impact on the OS but not EFS whereas stage 2 or above had a
negative impact on EFS. On multivariate analysis use of regimens other than high-dose methotrexate-based
and dose-adjusted EPOCH was a negative prognostic factor for both EFS and OS. The HR favored high dose
methotrexate and dose-adjusted EPOCH-based regimen for both EFS and OS; HR- 0.42 (95% CI,0.22,0.77) and
0.27(95% CI,0.13-0.59), respectively. Use of rituximab was associated with better OS HR- 0.44(95% CI,0.21-
0.93) and a trend toward better EFS – HR-0.58 (95%CI, 0.31-1.07). The treatment-related mortality was 11.2%
(29/257) and high serum LDH was associated with higher mortality (p=0.003).

Treatment of adolescent and adult Burkitt lymphoma and leukemia with intensive regimens (high-dose
methotrexate-based) and dose adjusted EPOCH regimen resulted in similar survival. Dose-adjusted
EPOCH-based regimen was preferred in older patients. The use of rituximab in these patients adds to the
overall survival benefit.

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 ABSTRACTS

Chepsy C Philip, MD, MBBS, DM, Sushil Selvarajan, MBBS, MD, DM, Lingaraj
Nayak, MD, DM, Hasmukh Jain, MD, DM, Uday Prakash Kulkarni,MD, DM,
Prasanna Samuel, MSc, PhD, Narendra Agrawal, MD, DM, Smita Kayal, MD, DM
, Kundan Mishra, MD, DM, Pavitra D S, MD, SmitaDas, MBBS, MD, Jayachandran
PK, MD, MRCP, DM, Stalin ChowdaryBala, MBBS, MD, DM, DNB, Vineetha
Raghavan, MD, Mobin Paul, MBBS,MD, DM, Jagdeep Singh, MD, DM, Prashant
Mehta, MD, DM, SreerajVasudevan, DM, Swaratika Majumdar, MD, DM, Akshatha
Nayak, MDDM, Om Prakash, MSc, Marimuthu S, Akhil Rajendra, JayashreeThorat
, Bhausaheb Bagal, MD, DM, Aby Abraham, MD, DM, DineshBhurani, MD, DM,
FRCPA, Prasanth Ganesan, MD, DM, Manju Sengar,MD, DM and Vikram Mathews,
MD, DM
Regional Advanced Centre for (Stem Cell) Transplant, Hemato-
LymphoidOncology & Marrow Diseases, Believers Church Medical College
Hospital,Thiruvalla, India;
Department of Haematology, Christian Medical College,Vellore, India;
Adult hematolymphoid disease management group,Department of Medical
Oncology, Tata Memorial Centre, Mumbai, India;
Department of Biostatistics, Christian Medical College, Vellore, India;
Department of Hemato-Oncology & BMT, Rajiv Gandhi Cancer Institute
andResearch Centre, New Delhi, India;
Department of Medical Oncology,Jawaharlal Institute of Postgraduate Medical
Education & Research (JIPMER),Puducherry, India;
Department of Haematology, Army Hospital (Research &Referral), New Delhi,
India;
Christian Medical College & Hospital, Ludhiana,India;
Department of Clinical Haematology, Gauhati Medical College and Hospital,
Guwahati, India;
Department of Medical Oncology, CancerInstitute (WIA), Chennai, Tamilnadu,
India;
Department of MedicalOncology, Nizam's Institute of Medical Sciences,
Hyderabad, India;
Department of Clinical Hematology and Medical Oncology, Malabar
CancerCentre, Thalassery, India;
Clinical Haematology and Haemato-oncology,Rajagiri Hospital, ALUVA, India;

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 ABSTRACTS

ABSTRACT ID#: 165570

Medical Oncology, Dayanand MedicalCollege & Hospital, Ludhiana, India;
Department of Medical Oncology andBMT, Asian Institute of Medical Sciences,
Faridabad, Faridabad, IND;
Department of Medical Oncology and Haematology, Amala Institute ofMedical
Sciences, Thrissur, India;
Department of Medical Oncology,Ramaiah Medical College, Bengaluru, India;
Mazumdar Shaw MedicalCentre, Narayana Health City, Bengaluru, India
The coronavirus (COVID -19) pandemic posed critical challenges for public health, research, diagnosis, and
treatment globally. Beyond the existing challenges in the management of Acute Myeloid Leukemia (AML) in
India; we hypothesized that the COVID pandemic would lead to a collateral impact on the management of
AML in our setting. Identifying with this goal; we analyzed data utilizing the Indian Acute Leukemia research
database [INwARD] established in 2018 by the Hematology Cancer Consortium (HCC).

Retrospective analysis of data for adult AML collected from 17 member institutions through a central online
data management system was compared through two time periods: the pre-COVID period (1st January2018
through 31st March 2020) and the COVID pandemic period (1st April2020 through 31st August 2021). Survival
and follow-up data were analyzed as on 31st May 2022.

A total of 2998 patients, were registered (2003 in the pre-COVID period and995 during the COVID pandemic),
Fig 1. The average patient registrations per month were 74 ± 11 and 59 ± 19, P < 0.05 respectively. In
comparison, 978(28.7%) patients in the pre-COVID period and 612 (61.5%) patients during the COVID
pandemic received treatment. In those who underwent treatment during the pandemic; 357(58.5%) received
intensive (7+3 based) induction and 210 (34.4%) received hypomethylating agent-based therapy. They
included 165 (26.6%) patients who had concurrent infections needing antibiotics at presentation. 336(54.9%)
patients developed febrile neutropenia, with an organism isolated in the blood in 110 (32.7%) patients.
Fungal infection was noted in 126 (20.5%) patients; proven in 8(6.3%). There were 87 (14.4%) patients needing
admission to an intensive care unit. Inotrope was needed in 57 (9.3%) patients and mechanical ventilation for
38(6.2%) patients. 172 (28.1%) patients received further consolidation; with high (3g/m2) dose cytarabine in
127 (73.8%) of them. Additionally, 52 (8.5%)patients underwent a stem cell transplant.

In comparison to patients receiving treatment in the pre-COVID period; the demographic features, rates of
documented bloodstream infection, ICU stay, requirements for mechanical ventilation, and use of inotropes
were comparable to patients during the pandemic. However, we noted that the differences [pre-COVID vs
during the pandemic] in the use of hypomethylating agents [ 298 (30.4%) vs 210 (34.3%)], targeted drugs
[27(2.7%) vs 43 (7.0%)] febrile neutropenia [621 (63.5%) vs 336 (54.9%)], fungal infections [297 (30.3%) vs 126
(20.5%)], concurrent infection [325 (33.2%) vs165 (26.6%)] and use of central venous access [598 (61.1%) vs

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ABSTRACT ID#: 165570

310 (50.6%)]were statistically significant. Among patients who underwent transplants; the intensity of
conditioning, remission status, and GvHD were comparable.

The median overall survival (OS) following diagnosis was 549 days and the median event-free survival (EFS)
was 363 days for the entire cohort. The median overall survival (OS) during the pre-COVID period was 552
days and529 days during the pandemic (p = 0.952), Fig 2. The corresponding median EFS was 363 days and
364 days respectively (p = 0.679).

In our experience, although delivering care was challenging; the outcomes for patients who received
treatment for AML during the COVID pandemic was comparable with the pre-COVID period. Travel
disruption or patient reluctance to visit a hospital during the pandemic might have led to the reduction in
patient registrations, though a higher proportion of them received treatment. We hypothesize that the
universal embracing of general infection control policies targeting COVID-19 might have driven the observed
reduction of fungal and concurrent infection.

Our data suggest that continuing standard of care in treatment-emergent AML even during the pandemic is
feasible and intensive induction chemotherapy and transplant should still be offered for eligible patients.

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Smita Kayal, MD, DM, Hasmukh Jain, MD, DM, Lingaraj Nayak, MD,DM, Jayashree
Thorat, MD, DM, Jina Bhattacharyya, MD, DM, Damodar Das, MD, DNB, Sewali
Deka Talukdar, MD, Dinesh Bhurani,MD, DM, FRCPA, Rayaz Ahmed, MD, DM,
Narendra Agrawal, MD, DM, Dubashi Biswajit, MD, DNB, DM, Prasanth Ganesan,
MD, DM, Chandran K. Nair, MD, DNB, DM, Vineetha Raghavan, MD, Manuprasad A,
MD, DM, Uday Kulkarni, MD, DM, Sushil Selvarajan, MD, DM, Jayachandran PK,
MD, MRCP, DM, Parathan Karunakaran, MD, DM, Sadashivudu Gundeti, MD, DM,
Kundan Mishra, MD, MNAMS,DM, Sharat Damodar, MD, DM, Bharath Ram S,
MBBS, DNB, AtulSharma, MD, DM, Suvir Singh, MD, DM, M. Joseph John, MD, DM
,Gaurav Prakash, MD, DM, Smitha Carol Saldanha, MD, DM, Chepsy CPhilip, MD,
DM, Prashant Mehta, MD, DM, Thenmozhi Mani, PhD, Om Prakash, MSc,
Marimuthu S, Jeyaseelan Lakshmanan, PhD, Manju Sengar, MD, DM, Vikram
Mathews, MD, DM and Rajan Kapoor, MD, DM
Department of Medical Oncology, Jawaharlal Institute of PostgraduateMedical
Education & Research (JIPMER), Puducherry, India;
AdultHematolymphoid Disease Management Group, Department of
MedicalOncology, Tata Memorial Centre, Mumbai, India;
Department of ClinicalHematology, Gauhati Medical College & Hospital,
Guwahati, India;
Department of Hemato-Oncology & BMT, Rajiv Gandhi Cancer Instituteand
Research Centre, New Delhi, India;
Department of ClinicalHematology and Medical Oncology, Malabar Cancer
Centre, Thalassery,India;
Department of Haematology, Christian Medical College, Vellore,India;
Department of Medical Oncology, Cancer Institute (WIA), Chennai India;
Department of Medical Oncology, Nizam's Institute of MedicalSciences,
Hyderabad, India;
Department of Haematology, Army Hospital(Research & Referral), New Delhi,
India;
Department of Hematology,Mazumdar Shaw Medical Center, Narayana Health
City, Bangalore, India;
Department of Medical Oncology, Dr. B.R.A. IRCH, All India Institute of Medical
Sciences (AIIMS), New Delhi, India;

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ABSTRACT ID#: 169001

Department of ClinicalHaematology, Dayanand Medical College and Hospital,
Ludhiana, India;
Department of Clinical Haematology and BMT, Christian Medical College&
Hospital, Ludhiana, India;
Department of Clinical Hematology andMedical Oncology, Postgraduate Institute
of Medical Education andResearch, Chandigarh, India;
Department of Medical Oncology, KidwaiMemorial Institute of Oncology,
Bengaluru, India;
Department of ClinicalHematology, Believers Church Medical College Hospital,
Tiruvalla, India;
Department of Medical Oncology and BMT, Asian Institute of MedicalSciences,
Faridabad, India;
Department of Biostatistics, ChristianMedical College, Vellore, India
Treatment of Acute Myeloid Leukemia (AML) should be initiated at the earliest to improve outcomes. The
standard induction regimen (3+7) is associated with significant risk of induction mortality, especially in
resource limited settings. Hence there is a need to develop risk prediction model for our patient cohorts.
Treatment related mortality (TRM) scoring systems developed and used in developed country, mostly for the
elderly, may not be directly applicable to population of young adults in developing countries, many of whom
have poor general condition and infections at baseline. We developed a multivariate model of induction
mortality score in 2019, from a retrospective AML cohort of the Indian acute leukemia research database
[INwARD] established by the Hematology Cancer Consortium (HCC). In the present study we have validated
the approach and recalibrated the induction mortality score on a multicenter prospective cohort.

Prospective data for adult AML, for a period of 20 months, starting July2020 to February 2022, was received
from 17 member institutions in a central online data management system. Potential variables that would
predict mortality were selected based on clinical and statistical significance. Eleven variables relating to
baseline patient and disease characteristics (age, ECOG performance status, duration of symptoms in days,
albumin, creatinine, bilirubin, white cell count, platelet, hemoglobin, peripheral blood blast percentage, and
presence of infection requiring intravenous antibiotic within one week prior of starting induction), were
considered for the predictive model using machine learning (ML)algorithms: Logistic regression (LR),
Support Vector Machine (SVM) and eXtreme Gradient Boosting (XGB). Of the various ML algorithms, the best
model was chosen based on area under curve (AUC) from the training dataset and validity statistics from the
test dataset. We also used the same approach to predict intensive care unit (ICU) admission. R software was
used to analyze the data.

Of the 779 treated cases during the study period, 438 received intensive induction, ‘3+7’ being the most
common regimen in 80%. The median age of this cohort was 37 years (IQR 28, 46), male to female ratio 1.2.

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ABSTRACT ID#: 169001

European Leukemia Net (ELN) risk group was good in 31.3 % (n= 137),intermediate in 44% (n=192), high in
13.7% (n=60), and unknown in 11%(n=48). Complete remission was attained in 56.3%. Overall induction
mortality was 13.0%, ranging from 7.1% to 40% across different centers. Infection was the most common
cause of death in 52%. For predicting induction mortality using 11 covariates, SVM provided the best
threshold as 0.126, with an AUC of 94.71%, sensitivity (92.50%), and specificity(96.11%). A comparison of the
ML algorithms is shown in Fig 1 and statistics for the SVM model in Table 1. ICU admission was observed
in22.8%; a cut-off threshold of 0.231, with an AUC of 93.3% in the SVM model predicted ICU admission with
sensitivity of 93.15% and specificity of 89.7%.

Induction mortality prediction score developed in a retrospective cohort was effectively applied to
contemporary prospective data from major centers across the country, with diverse resources and patient
profiles. Thus, we have validated the machine learning approach of predicting induction mortality with
variables relevant to regional clinical settings including baseline infection. The SVM model predicted the risk
of both induction mortality as well as morbidity with high accuracy. An online calculator is being developed
to help clinicians use this score in regular practice for guiding treatment intensity as per an individual
patient’s risk and in directing appropriate resource utilization. Further, the approach of risk-adapted
induction intensity, especially for young adult AML, based on the score adjusted to center-specific prevalence
of mortality rates, is under consideration for a prospective clinical trial.

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Suvir Singh, Sharon Lionel, Hasmukh Jain, Akhil Rajendra, Lingaraj Nayak, Sushil
Selvarajan, Prasanna Samuel,Rayaz Ahmed, Narendra Aggarwal, Pavitra DS,
Poojitha Byreddy, M Joseph John, Kundan Mishra, Suman Kumar, Mobin Paul,
Latha K Abraham, Smita Kayal, Prashanth Ganesan, Chepsy C Philip, Damodar
Das, Sreeraj V, Prashant Mehta, Jayachandran PK, Vineetha Raghavan, Stalin
Chowdary Bala, Bharath Ram S, Swaratika Majumdar ,Om Prakash, Barath U,
Bhausaheb Bagal , Aby Abraham , Rajan Kapoor, Dinesh Bhurani , Manju Sengar,
Vikram Mathews
Dayanand Medical College and Hospital, Ludhiana
Christian Medical College, Vellore
Tata Memorial Hospital, Mumbai
Department of Biostatistics, CMC Vellore
Rajiv Gandhi Cancer Institute and Research Centre
Christian Medical College, Ludhiana
Army Hospital Research and Referral, Delhi
Rajagiri Hospital, Kochi
Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry
Believers Church Medical College Hospital, Thiruvalla
Guwahati Medical College, Assam
Amala Cancer Hospital and Research Centre, Thrissur
Asian Institute of Medical Sciences (AIMS), Faridabad
Cancer Institute Adyar, Chennai
Malabar Cancer Centre, Kerala
Nizam's Institute of Medical Sciences (NIMS), Hyderabad
Narayana Health Hospital, Bengaluru
Ramaiah Medical College and Hospitals (RMCH), Bengaluru
Despite significant advances in the treatment of acute myeloid leukemia (AML), outcomes in older patients
continue to be suboptimal, due to adverse disease characteristics and increasing prevalence of co-
morbidities. This challenge is further magnified in resource-limited settings where logistical and financial
barriers often preclude effective therapy. In addition, a significant number of patients do not undergo any
evaluation after diagnosis, resulting in very little real-world data on treatment outcomes in this cohort. We
present data on epidemiology and treatment patterns in older patients with AML from the Indian Acute
Leukemia Research Database [INwARD] established by Hematology Cancer Consortium (HCC).

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Retrospective data from 17 centres was collected to include patients older than 55 years diagnosed between
January 2018 and April 2021.. A lower age cut off of 55 years was used based on previous data indicating
physiologic characteristics comparable to a 65 year old individual in the West. No exclusion criteria were
specified. The primary objectives were to ascertain the proportion of patients receiving therapy and one-year
overall survival among treated patients. Patient status was assessed as on March 31, 2022.

A total of 733 patients (M:F=1.48) were included in this study, of which only 339(46%) patients underwent
further evaluation and treatment. The most common reasons for not initiating treatment were to begin
evaluation at another centre (37%) and financial constraints(13%).Among treated patients, the median age at
diagnosis was 63 years (IQR, 59-69), with 130(40.2%) having an ECOG performance score≥2 and 203(60.4%)
having at least one comorbidity. No differences in baseline attributes were noted among treated or untreated
patients.(Table 1)Of the 339 patients who received treatment, initial therapy comprised hypomethylating
agents (HMA) in 247 (72.8%) patients, standard or modified 7+3 regimen in 64 (18.8%) and other intensive
regimens in 2 (0.59%) patients. Infections requiring treatment were diagnosed in 117 (40.3%) patients, with 36
(13.79%) requiring intensive care. A second induction was required in 26 patients, of which 5(19%) received
intensive chemotherapy and 8 (30%) received HMA. Early mortality (within 60 days of diagnosis) was noted in
58(20.1%) out of 288 evaluable patients at this time point. Poor performance status at baseline was
significantly associated with early mortality(p=0.015) with no effect of age or associated co-morbidities.
Among patients who died within 60 days, a significantly higher white cell count was observed at baseline
(median, 20310 vs 7200/mm3,p=0.005).Complete remission (CR) was achieved in 24(36%) patients after
intensive chemotherapy. Among 146(59%) evaluable patients receiving HMA, 62(42%) achieved CR at any
time point after therapy. The probability of achieving CR significantly decreased with increasing age
(p=0.037). Allogeneic stem cell transplant was utilized for only 11 (3.2%) patients in the treated cohort.

After a median follow up of 5 months (IQR 1.4 to 14.6 months), 102 (32.2%) patients were lost to follow up and
only 72 (26%) had completed treatment. For survival analysis, patients lost to follow up were considered dead
at the date of last follow up. At the end of one year, probability of survival was 32.9%, (Figure 1) with the
median overall survival being190 days (95% CI, 143 to 236) in the treated cohort. Among 145 patients with
available data, the most common cause of death was progressive disease (52%), followed by infectious
complications(29%).
Our data highlights dual challenges of low rates of treatment initiation and significant treatment
discontinuation within one year in patients older than 55 years of age with AML in India. Poor disease biology
is also highlighted by low rates of CR irrespective of initial therapy and low probability of survival at one
year. Financial challenges emerge as major modifiable factors leading to incomplete treatment. This large
registry dataset indicates the need for more effective, affordable and safer treatment options for this group of
patients.

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Manju Sengar, MD, DM , Hasmukh Jain, MD, DM , Uday Prakash Kulkarni, MD ,

Vasu Babu Goli , Anu Korula, MD, DM , Prasanna Samuel, MSc, PhD , Sushil
Selvarajan, MBBS, MD, DM , Lingaraj Nayak, MD, DM , Aby Abraham, MD, DM , Om
Prakash, MSc , Fouzia N., DM , Saranya Kumaran , Jayashree Thorat, MD, DM ,
Bhausaheb Bagal, MD, DM , Poonkuzhali Balasubramanian, MSc, PhD , Dhanlaxmi
Shetty , Nikhil Patkar, MD , Biju George, MD, DM and Vikram Mathews, MD, DM
Department of Medical Oncology, Tata Memorial Centre Affliated to Homi Bhabha
National Institute, Mumbai, India; Department of Medical Oncology, Tata
Memorial Centre, Affliated to Homi Bhabha National Institute, Mumbai, India;
Department of Haematology, Christian Medical College, Vellore, India;
Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National
Institute, Mumbai, India; Department of Biostatistics, Christian Medical College,
Vellore, India; Medical Oncology, Tata Memorial Centre, Mumbai, India;
Department of Haematology, Christian Medical College, Vellore, Tamil Nadu,
India; Department of Biostatistics, Christian Medical College, Vellore, Vellore,
India; Department of Haematology, Christian Medical College, Washington, DC;
Christian Medical Vellore, Vellore, India; Department of Medical Oncology, Tata
Memorial Centre, Affliated to Homi Bhabha National Institute, Mumbai,
Maharashtra, India; Medical Oncology, Tata Memorial Centre, Mumbai,
Maharashtra, India; Cytohenetics, Tata Memorial Centre, Affliated to Homi
Bhabha National Institute, Navi Mumbai, India; Haematopathology Laboratory,
Tata Memorial Hospital, Tata Memorial Centre, Affliated to Homi Bhabha
National Institute, Navi Mumbai, India; Department of Haematology, Christian
Medical College, Vellore, Tamilnadu, India
Treatment outcomes of acute promyelocytic leukemia (APL) show variation between clinical trials and real-
world setting largely due to exclusion of patients who present with major bleeding, severe infections and
those who die within the first week. Use of differentiation agent-based therapy for low/intermediate risk
group (ATRA and ATO) and limiting anthracycline use to high-risk subgroup has reduced the treatment-
related mortality beyond first week. However, use of steroids for treatment of differentiation syndrome and
chemotherapy can still increase the risk of infections which can compromise the outcomes, particularly in a
setting with high incidence of multi-drug resistant organism and invasive fungal infections. There is a need to
identify the predictors of this mortality and ways to reduce it to improve the outcomes.

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ABSTRACT ID#: 167202

We analyzed the data for patients with newly diagnosed APL from two large tertiary care centers in India,
registered between 2013-2018 to evaluate the outcomes in all risk groups (as per Sanz score), mortality
within first 30-days and prognostic factors. Patients with low/intermediate risk were treated with ATRA and
ATO based therapy whereas the high-risk group received chemotherapy in addition to ATRA/ATO. We
recorded demographic variables, white blood cell count and platelet count at diagnosis, Sanz score, serum
albumin, serum creatinine, treatment administered, achievement of morphological complete remission post
induction and complete molecular remission post consolidation, relapse and death. The primary outcome was
event free survival (EFS) which counted lack of complete remission post induction, lack of complete
molecular remission post consolidation, relapse and death as event. The secondary outcomes were relapse-
free survival (RFS), overall survival (OS) and induction mortality (death within first 30 days) and assessment
of impact of baseline disease and host factors on the EFS, RFS, OS and induction mortality.

A total of 238 patients were included in this analysis. The median age was 34 years (range 2-72 years) with
male: female ratio of 1.5:1. At presentation the median WBC count was 6790 per cumm (range 300- 237,000per
cumm) and median platelet counts were 21000 per cumm (3000-266,000 per cumm). As per Sanz score – 12%
were low-risk, 48% were intermediate risk and 40% were high-risk. Median fibrinogen levels were 239 (range
36-883). A total of 231 patients received therapy. A total of 204 patients were assessed for response at the end
of induction and all but one patient achieved complete response (87.8% as per intention to treat). The rest
were not assessable due to death during induction (19) and loss to follow up (15). The induction mortality
was 8.2% (infections-6, coagulopathy-9, differentiation syndrome-2 and others-2).170/185(92%) patients
achieved post consolidation complete molecular remission. A total of 19 patients relapsed during the follow
up (bone marrow-14, CNS alone-2 and combined -3). The median time to relapse was 23.9 months (IQR 13.6-
42.9 months).

At a median follow up of 51.2 months,3-year EFS, RFS and OS were 79%,92% and 88%.

There was no statistically significant difference between low, intermediate and high-risk group for any of the
survival outcomes. Similarly, age, gender, fibrinogen and albumin at diagnosis did not have any adverse
impact. Baseline WBC of >40000/cumm and serum creatinine of >2 mg/dL at diagnosis adversely affected the
overall survival with HR of 3.22 (95% CI 1.42-7.29, p-0.005) and 11.9 (95% CI- 2.78-50.82)respectively. However,
the number of patients with raised creatinine were very small (n=4). These two factors had adverse impact
on induction mortality too (WBC>40,000 per cumm – HR -3.32, 95% CI- 1.31-8.42, p-0.012 serum creatinine >2
mg/dL- HR 14.69, 95% CI-3.36- 64.18, p<0.0001). The survival probabilities at 3, 4 and 5 years using 30-
day landmark analysis were 96%, indicating that there are very few deaths after the first 30 days of induction.
Fig 1 depicts the overall survival.

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ABSTRACT ID#: 167202

This retrospective analysis highlights that ATO+ATRA and minimal anthracycline based therapy has led to
similar outcomes in all risk groups and the present need to address induction mortality. High induction
mortality in patients with WBC >40,000/cum indicates the potential contribution of infections due to use of
steroids to treat differentiation and underlying coagulopathy or a different biology.

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ABSTRACTS SELECTED BY ASH FOR POSTER PRESENTATION_2018

Anu Korula, MD, DM , Jina Bhattacharyya, MD , Hasmukh Jain, MD , Rajan Kapoor,

MD, DM , Chepsy C Philip, MD , Maitreyee Bhattacharyya, DM , Nikita Mehra, MD,
DM , Smita Kayal, MD , Dinesh Bhurani, MD, DM, FRCPA , Linu Jacob, MD , Ranjit
Kumar Sahoo, MD, DM , Gaurav Prakash, MD, DM , Om Prakash, MSc , Thenmozhi
Mani, PhD , Jeyaseelan Lakshmanan, PhD , Biju George, DM , Bhausaheb Bagal,
MD, DM , Satyaranjan Das, MD , Venkatraman Radhakrishnan, MD, DM , Prasanth
Ganesan, MD, DM , Vikram Mathews, MD and Manju Sengar, MD, DM
Department of Haematology, Christian Medical College, Vellore, India
Department of Clinical Hematology, Guwahati Medical College & Hospital,
Guwahati, India
Adult Hematolymphoid Disease Management Group, Department of Medical
Oncology, Tata Memorial Center, Mumbai, India
Department of Haematology, Army Hospital (Research & Referral), New Delhi,
Department of Clinical Haematology, Christian Medical College & Hospital,
Ludhiana, India
Institute of Haematology &Transfusion Medicine (IHTM), Kolkata, India
Department of Medical Oncology, Cancer Institute (WIA), Chennai, India
Department of Medical Oncology, Regional Cancer Center, Jawaharlal Institute of
Postgraduate Medical Education & Research (JIPMER), Puducherry,
Department of Hemato-Oncology, Rajiv Gandhi Cancer Institute and Research
Centre, New Delhi, India
Department of Medical Oncology, Kidwai Cancer Institute, Bangalore, India
Department of Medical Oncology Institute of Rotary Cancer Hospital, All India
Institute of Medical Sciences, New Delhi, India
Department of Internal Medicine and Hematology, Postgraduate Institute of
Medical Education and Research, Chandigarh, India
Department of Biostatistics, Christian Medical College, Vellore, India
Department of Medical Oncology, Tata Memorial Centre, Navi Mumbai,
Maharashtra, India
Department of Haematology, Christian Medical College, Vellore, Tamil Nadu,
Adult Hematolymphoid Disease Management Group, Department of Medical
Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India

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ABSTRACT ID#: 1374

Significant strides have been made in the management of ALL and clinical outcomes have steadily improved
over the last few decades. Many of these advances involve intensification of therapy, allogeneic SCT, improved
molecular risk stratification and measurable residual disease (MRD) directed therapy. However in the
developing world and low middle income countries (LMIC) there are significant challenges in implementing
or access to such advances. Additionally, in the absence of large collaborative research groups in LMIC, as has
been developed in most developed economies, it is difficult to get a handle of the magnitude of the problem
and develop strategies to overcome them. The ‘Hematological Cancer Consortium’ is a collaborative group
from India currently comprising of twelve institutions spread across the country that have come together to
collaborate in the field of leukemia. As an initial exercise to establish denominators a retrospective data
analysis was undertaken (Indian acute leukemia research database [INwARD]). Here we present the
retrospective analysis of the acute lymphoblastic leukemia (ALL) data.

Retrospective data from January 2013 to December 2017 was collected from 7 large tertiary centers from
across the country. A central online data capture and management system was in place which was
independent of all the participating centers (Clinical Data Management Center [CDMC], Vellore, which is
compliant with standard ICH-GCP regulations). In this initial phase some centers contributed data offline to
the data management center. A total of 1631 patients were confirmed to have had a diagnosis of ALL in this
period of which it was noted that 1217 (75%) received definitive treatment (Fig 1 a). The majority of treated
cases were B ALL (73%) followed by T ALL (23%), MPAL was diagnosed in 11 cases (0.9%) (Fig 1b). Of the 1217
patients that received treatment a karyotype report was available in 81.6% (Fig 1c), while FISH/PCR data was
available in 703 (58%) of cases. The median age of the patients was 16 years (range: 1-76) and there were 70%
males. The age distribution of patients by each decade is illustrated in Fig 1d. Of the diagnosed cases 879
(54%) were ≤ 18 years of age. Following initial induction therapy 80% of patients achieved complete
hematological remission (CR) and there were 6.6% induction deaths. Only 37 (3%) received an allogeneic SCT
in CR1. The 5 year KM estimate for overall and event free survival for the entire cohort of patients that
received treatment was 80.4±2% and 57.1±3.8% respectively.

This retrospective data gives a snapshot of the status of treatment of ALL in India and illustrates the
challenges. A significant proportion of cases due to various constraints abandon therapy and a significant
proportion of treated cases do not have conventional karyotyping or molecular tests done prior to start of
therapy which would be considered a deviation from the standard of care in the developed world. This
collaborative group has the potential to evaluate and understand these challenges in greater depth over
subsequent prospective studies and develop strategies to overcome them.

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ABSTRACT ID#: 1374

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Rajan Kapoor, MD, DM , Hasmukh Jain, MD, DM , Anu Korula, MD, DM , Dinesh
Bhurani, MD, DM, FRCPA , Venkatraman Radhakrishnan, MD, DM , Chepsy C
Philip, MD , Jina Bhattacharyya, MD , Maitreyee Bhattacharyya, DM , Smita Kayal,
MD , Pankaj Malhotra, MD , Govind Babu, MD, DM , Lalit Kumar, MD DM , Om
Prakash, MSc , Ambily Nadaraj, MSc , Jeyaseelan Lakshmanan, PhD , Biju George,
DM , Poonkuzhali Balasubramanian, MSc , Bhausaheb Bagal, MD, DM ,
Satyaranjan Das, MD , Rayaz Ahmed, MD, DM , Prasanth Ganesan, MD, DM ,
Gaurav Prakash, MD, DM , Nikita Mehra, MD, DM , Manju Sengar, MD, DM and
Vikram Mathews, MD
Department of Haematology, Army Hospital R&R, New Delhi, India
Adult hematolymphoid disease management group, Department of Medical
Oncology, Tata Memorial Centre, Mumbai, India
Department of Haematology, Christian Medical College, Vellore, India
Department of Hemato-Oncology, Rajiv Gandhi Cancer Institute and Research
Centre, New Delhi, India
Department of Medical Oncology, Cancer Institute (WIA), Chennai, India
Department of Clinical Haematology, Christian Medical College & Hospital,
Ludhiana, India
Department of Clinical Hematology, Guwahati Medical College & Hospital,
Guwahati, India
Institute of Haematology &Transfusion Medicine (IHTM), Kolkata, India
Department of Medical Oncology, Regional Cancer Center, Jawaharlal Institute of
Postgraduate Medical Education & Research (JIPMER), Puducherry,
India
Department of Internal Medicine and Hematology, Postgraduate Institute of
Medical Education and Research, Chandigarh, India
Department of Medical Oncology, Kidwai Cancer Institute, Bangalore, India
Department of Medical Oncology, Institute of Rotary Cancer Hospital, All India
Institute of Medical Sciences, New Delhi, India
Department of Biostatistics, Christian Medical College, Vellore, India
Department of Haematology, Christian Medical College, Vellore, Tamil Nadu,
India

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ABSTRACT ID#: 4006

Multicenter large collaborative research groups have been the cornerstone for advances that have been made
in multiple disciplines in medicine. These collaborative groups are specifically useful in situation where no
single center based dataset is large enough to effectively address biological and clinical relevant questions
that could advance the field. Most such collaborative groups exist in the developed countries and have
contributed significantly to the development of the current standards of care in leukemia. The challenges in
the developing countries or low middle income countries (LMIC) are distinctly different and often algorithms
that have evolved in the developed world may not be applicable, relevant or accessible in the LMIC. It is
imperative that these challenges be addressed through large multicenter studies that are located within the
LMIC and appropriate local data driven solutions be implemented in response. The ‘Hematological Cancer
Consortium’ is a collaborative group from India currently compromising twelve institutions spread across the
country that have come together to collaborate in the field of leukemia. As an initial exercise, to establish
denominators a retrospective data analysis was undertaken (Indian acute leukemia research database
[INwARD]). Here we present the retrospective analysis of the acute myeloid leukemia (AML) data.

Retrospective data from January 2013 to December 2017 was collected from 10 large tertiary centers from
across the country (in one center data was available only from January 2017). A central online data capture
and management system was in place which was independent of all the participating centers (Clinical Data
Management Center [CDMC], Vellore, which is compliant with standard ICH-GCP regulations). In this initial
phase some centers contributed data offline to the data management center. A total of 3848 were confirmed to
have had a diagnosis of AML in this period of which it was noted that 1766 (46%) received definitive treatment
(Fig 1 a). The median age of the patients was 40 years (range: 0-89) and there were 59% males. The age
distribution of patients by each decade is illustrated in Fig 1b. 399 (10.4%) were ≤ 18 years). A sample for
karyotyping was sent in 2609 (68%) however of these an evaluable karyotype was noted in only 1477 (57%)
(Fig 1c), the reasons for lack of evaluable metaphases was not clear. A FLT3 and NPM1 mutation status was
evaluated in 1338 (35%) and 1401 (36%) respectively. Of the evaluated patients 20.6% and 21.9% had FLT3-ITD
and NPM1 mutated respectively (Fig 1d). Of the 1766 patients that were treated 858 (48.6%) received a
conventional 7/3 induction, 170 (9.6%) received hypomethylating agents while the rest received various
abbreviated dose regimens and a small proportion (2.8%) received high dose cytosine based regimens as
induction therapy. Antifungal prophylaxis was used by 82% of patients that received therapy. Of those that
received induction therapy there were 18% induction deaths and 12.9% subsequently received an allogeneic
SCT as part of their consolidation therapy (Fig 1a). The 5 year KM estimate for overall and event free survival
for the patient that received treatment was 56.2±2.6% and 33.8±2.4% respectively.

The data illustrates significant challenges and opportunities with the management of AML in India. A
significant proportion of cases do not receive definitive therapy nor do they have conventional tests such as
karyotyping or molecular tests done as part of the baseline diagnostic tests, various social and financial

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 ABSTRACTS

ABSTRACT ID#: 4006

constraints could contribute to these and these need to be evaluated in more detail. Strategies to increase
access to care and laboratory facilities along with an effort to reduce early induction deaths need relatively
urgent attention. The relatively young age of the cohort and large number of cases would allow us to address
relevant biological and clinically challenges effectively, in the future, in this cooperative setting.

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