MICC Research Newsletter 2020 Vol 2 Iss 1 (1)

MICC
Max Institute of
Cancer Care
Jan-Apr 2020, Vol 2, Issue 1
India's Leading
Cancer Care Institute

Table of Content
Editorial
In the news
Interview
Showcasing Research in Breast DMG
• Clinical Trial 1
• Clinical Trial 2
• Critical Analysis of Recent Clinical Trial
Showcasing Research in Haematology DMG
• Critical Analysis of Recent Clinical Trial
• Summary of recent work from MICC Saket
• Ongoing DNB Thesis from MICC Saket
DNB Thesis
Studies currently ongoing
Research Team Contact List
01
02
03
06
11
14
17
20

Page 1
MICC Newsletter
Editorial
Dear Friends,
Max Institute of Cancer Care (MICC) has started its journey a decade ago with just 20 odd
oncologists and two facilities. Today, it has over 80 oncologists handling more than 10,000
oncology in-patients annually across its 10 facilities in Delhi-NCR and Northern India, with a
growth rate of 32% Year on Year (YoY) since its beginning.
MICC centres are among the few centres in India where Disease Management Group (DMG)
based practice has been established to give focused attention by multi-disciplinary teams right
from diagnosis to management by sites of cancer.
Hospital-based cancer registry programme is being run in collaboration with National Cancer
Registry Programme (NCRP) at most MICC hubs. MICC also runs patient support group activities
under “Nidarr Hamesha” where cancer awareness and management activities are done with
patients and public participation at various centres.
With a large pool of patients’ follow-up data, clinical and translational research opportunities,
MICC is making use of knowledge for understanding, preventing, diagnosing and treating cancer.
Last year, MICC clinical teams published over 50 scientific articles in reputed
national/international medical journals.
MICC has the opportunity to forge a new paradigm
in research that involves academia, government,
industry and patient support groups. MICC research
newsletter is our endeavour to give an insight into
various academic and research activities for
collaboration opportunities available. The
newsletter made its humble start in 2019 and three
issues were published in the same year. With the
growth in clinical work and capacity, we have
decided to have a small expansion in the editorial
team to be able to provide a broader perspective.
Now we are introducing a new look to the
newsletter by adding a section on In the News, an
Interview with a leading expert, and DMG specific
research content besides our regular features.
We look forward and appreciate your valuable
feedback.
Best regards,
Editorial Team
Kanika Batra Modi, Shefali Sardana, Deepak Arora,
Waseem Abbas, Ramandeep Arora, Shailender Rathore

Page 2
MICC Newsletter
In the News
International Collaboration for Research Methods Development in Oncology (CReDO)
Workshop 2020
CReDO (https://tmc.gov.in/credo/) is an intensive oncology
research protocol development workshop modelled on
similar workshops held in the United States (the AACR/ASCO
Workshop on Methods in Clinical Cancer Research, Vail),
Europe (AACR-EORTC-ESMO Workshop on Methods in
Clinical Cancer Research) and Australia (the ACORD Protocol
Development Workshop). Details on the format, eligibility
and application process are discussed further below in the
interview with the convenor of CReDO, Dr Priya Rangnatha.
Dr Kanika Batra Modi was selected from MICC for the
ReDO workshop from 1 st - 7 th March 2020. Her proposal is on randomised control trial on the role of
Enhanced Recovery After Surgery (ERAS) programme in advanced ovarian malignancy.
Research Awards
Dr Ramandeep received SUSRUTA Award for his exemplary
performance towards Research and Innovation from Max Healthcare.
MICC Saket and Mohali (as part of NCG) Submitted Grant Proposal to the National
Biopharma Mission for National Oncology Clinical Trial Network
MICC Saket and Mohali submitted grant proposal under the umbrella of the NCG to The National
Biopharma Mission (NBM). The NBM is an Industry-Academia Collaborative Mission for accelerating early
development for biopharmaceuticals. Funded by Department of Biotechnology (DBT), their work is
implemented through Biotechnology Industry Research Assistance Council (BIRAC).
Clinical trials are currently an important bottleneck in the product development process as companies and
institutions usually have to go through an ad hoc process of finding sites with access to the required
population that meet internationally accepted clinical and ethical standards. To solve this bottleneck, NBM
will support the establishment of clinical trial networks and strengthen clinical trial capacity in the
country. Max Healthcare (MICC Saket and Mohali) along with other NCG centres led by Tata Memorial
Hospital collaborated to create such a network for oncology. We submitted in November 2019 and have
had initial acceptance. We had a site visit in Saket in February 2020 and are awaiting a decision.

Page 3
MICC Newsletter
ICRC ICMR submissions
Dr Ramandeep Singh Arora submitted ad-hoc project request to the newly formed Indian Cancer Research
Consortium (ICRC) ICMR on 17 th January 2020. The study title is ‘Patterns of End-of-Life Care in Children
with Cancer in India - A Multicentre Retrospective Study’.
NCRP News
With MICC being a reputed partner of NCRP, two more centres of the MICC family have been successfully
registered for the registry program including MICC Lajpat Nagar and MICC Mohali. Another centre,
Gurugram is in the pipeline and has started the registration process.
Interview
Interviewee: Dr Priya Ranganathan
Professor of Anaesthesiology, Tata Memorial Centre, Mumbai
Convener CReDO (International Collaboration for Research Methods Development in
Oncology) Workshop
Interviewer: Ramandeep Arora
Q- What is the CReDO Workshop and what gap does it fill?
A- For the last 10-15 years, three major Oncology research protocol development workshops have
happened across the world including USA, Europe, Australia. Several researchers from India have attended
the one-week Australia workshop (ACORD) to convert a concept into protocol (Clinical Investigation Plan).
However, only few people were able to participate due to limited number of positions and cost
considerations.. This made us think about the possibility of replicating a similar workshop in India.
CReDO trains researchers in various aspects of research methods and helps them to convert research
concepts into full fledge protocols. We felt that this gap should be filled in India. Although there are
several didactic courses on clinical research methods but none of them are comparative..
Q- Who are targeted for this workshop and who will benefit most from it?
A- The workshop is targeted at anyone working in the field of oncology; this includes not only mainstream
oncologists but also anyone who is in an allied branch e.g. Pathologists, Radiologists, Anaesthesiologists,
Palliative Care Physicians working in the field of oncology. With respect to criteria for application, the
workshop is open to anybody who is an academic researcher or anyone mentoring researchers in the field

Page 4
MICC Newsletter
of oncology. The workshop has maximum impact on the early and mid-level researcher who most likely will
be a faculty in an academic research setting and guiding his/her fellow.
It would be good to have some understanding and experience of research before participating in an intense
workshop like this. To help with this, we have also started conducting pre-workshop webinars for selected
participants so that they are better prepared to attend the workshop.
Q- My research is mostly basic science or epidemiological or psychosocial. Can I apply?
A- Yes, the candidates from other fields related to oncology are also likely to benefit from the workshop.
We ensure that the protocols we select for the workshop are not only hardcore clinical trials but also those
dealing with early phase trials, qualitative research, palliative research, quality of life research, community
research etc., so that participants are exposed to different types of research.
Q- What are the logistic specifics of the workshop? When and where is it held? What
is the deadline for applying?
A- The workshop is scheduled once a year usually in the end-February or early-March. It is a six day
residential training program from Sunday to Friday. The training location is Lonavala and the workshop fees
includes transport to/from Mumbai to Lonavala, accommodation, food for participants during the
workshop, and access to course material. Applications for the workshop are through an online process
which usually opens in July and closes in September. We take two months to send applications for National
and International peer review so each application is reviewed by at least two experts who score them and
then we assimilate all scores and finalise applicants by November. The application is competitive; last year
we received 166 applications and finalised 64 participants.
Q- I know people who applied last year but were not selected. What would increase
my chances of getting selected for the workshop?
A– Each application is rated on the following points:
1. Quality of the research concept: Scientific validity, innovativeness, appropriateness of study design
2. Enthusiasm/Commitment demonstrated in the Statement of Purpose. What are the participant's reasons
for attending this workshop? Does the participant show commitment to continuing research in future?
3. Letter of Support: Has the supervisor /institute undertaken to support the proposed research study?
4. Impact of the workshop on the participant and the institute: Does the participant appear inclined to an
academic research career?
5. Given the participant current position, is the training likely to benefit the participant institute? So it is
not just the research concept but also the potential impact on the institute that is considered while
selecting a candidate.
We send the reviewers comments to those applicants who are not selected so that they can work on
improving their applications and re-apply in subsequent years.

Page 5
MICC Newsletter
Q- Since CReDO was started, has it made an impact in India?
A– A total of 5 CReDO workshops have been conducted until now and around 250 people have been
trained. We send follow-up questionnaires to participants after the course to enquire about their progress
and to motivate them to carry out their projects.
The biggest challenge is that participants go back fully charged with their protocols but many of them do
not get adequate support and funding after the workshop. We are trying to address these problems in two
ways.
First, some of the protocols developed at CReDO are considered for funding by the National Cancer Grid of
India (NCG). Second, we have the NCG Contract Research Organisation (CRO) to help with trial logistics. In
addition, we are working on setting up an academic Clinical Trials Unit (CTU) to help with study design and
planning. Several studies developed at the previous CReDO workshops are now full-fledged multi-centric
trials with NCG funding and support.
Q- What are the fees for the workshop? Can an applicant apply for any scholarship or
subsidy?
A- The course fee at present for academic participants from LMICs is Rs. 10,000, which includes transport
to/from Mumbai to Lonavala, accommodation and food for participants during the workshop, and access to
course material. This is a heavily subsidised fee, since the actual cost per participant is almost twenty times
higher. CReDO is a non-profit venture; we want to encourage participants from all regions and do not want
the fee to be a limiting factor. This has been possible by support from several organisations which fund us
directly or indirectly namely, the Tata Trust, Tata Memorial Centre, National Cancer Institute, USA, King’s
College London, American Society of Clinical Oncology and the Indian Council of Medical Research.

Page 6
MICC Newsletter
Showcasing Research in Breast DMG
Clinical Trial 1:
Title: A phase III, multicentre, randomised, double-blind, placebo-controlled study of XXX (Anti-PD-L1
Antibody) in combination with paclitaxel compared with placebo with Paclitaxel for patients with
previously untreated inoperable locally advanced or metastatic triple negative breast cancer.
Centres and Local PI: Max Patparganj and Dr Meenu Walia
Study Objectives: Evaluation of the efficacy, safety, and pharmacokinetics (Pk) of atezolizumab plus
paclitaxel compared with placebo plus paclitaxel in patients with inoperable locally advanced or metastatic
Triple-negative adenocarcinoma of the breast (TNBC) who have not received prior systemic therapy for
these conditions.
Primary
Objective
Secondary
Objectives
Exploratory
Objectives
Biomarker
• Progression Free Survival
(PFS)
• Overall Survival (OS)
• 12-month and 18-month
OS rates
• Health-related Quality of
Life (HRQoL)
• 12-month PFS rate
• Objective Response Rate
(ORR)
• Duration of objective
Response (DoR)
• Clinical Benefit Rate (CBR)
• Safety
• Pk
• Immunogenicity
• Second line PFS (PFS2)
• EORTC QLQ-C30 and
QLQ-BR23
• Global Health
Status/HRQoL scale
• European Quality of Life 5
Dimension (EQ-5D)
• Functional Assessment of
Cancer Therapy – General
(FACT-G)
• Potential effects of
Anti-therapeutic
Antibodies (ATAs)
• Activity and safety of
XXX according to
Programmed Death−
ligand 1 (PD-L1)
status
Study Design:
Multicentre double-blind randomised phase III trial
Paclitaxel 90 mg/m 2 d1, 8,
15 + placebo d1 & 15
Metastatic or unresectable
locally advanced TNBC
N=495
R
1:2
Cycles repeated q28d
Paclitaxel 90 mg/m 2 d1, 8,
15 + atezo 840 mg d1 & 15
Treat to PD,
unacceptable toxicity or
withdrawal of consent

Page 7
MICC Newsletter
FPI: ~ September 2017
Key inclusion criteria:
• No prior chemotherapy or
targeted therapy in the
advanced setting
• Previous eBC treatment
completed ≥12 months
before randomisation
• Eligible for taxane
monotherapy
• Measurable disease
• ECOG PS 0/1
LPI: ~ October 2018
Primary endpoint:
• PFS
Secondary endpoints:
• OS (Key)
• 12- & 18-months OS rate
• 12-month PFS rate
• ORR, DoR, CBR
• Safety
• Translational research
Primary analysis: Q1 2019
Stractification factors:
• Prior taxane (yes/no)
• Tumour PD-L1 IHC Status
(0 vs 1/2/3)
• Liver metastases (yes/no)
• Geographical region
Clinical Trial 2:
Title: A phase III randomised controlled trial of single injection depot XXX prior to surgery in women with
high-risk operable breast cancer (Proluton Trial)
Centres and Local PI: Max Saket - Dr Harit Chaturvedi, Max Patparganj - Dr Geeta Kadayaprath
Study Design:
Trial Schema
Inj Hydroxy
Progesterone 500 mg IM
(Day -5 to -14)
High-risk OBC*
N = 960
R Surgery Adj Rx
Control
Stractification
Menopausal
Status (Pre, Peri, Post)
Tumour Size cm
(<=2,2.1-5, >5)
Institute
*High-risk OBC defined by clinical or radiological node positivity and/or T2/T3 tumours

Page 8
MICC Newsletter
Eligibility Criteria’s:
• Inclusion Criteria
– Unilateral operable breast cancer
– Clinical/Radiological N+, or T2/T3 tumours
– Female aged >=18 years
• Exclusion
– Previous history of excision biopsy of the primary tumour
– History of other epithelial/ mesenchymal malignant tumours except BCC/SCC of skin
Critical Analysis of Recent Clinical Trial
Revisiting adjuvant ovarian suppression in premenopausal breast cancer patient
Dr Waseem Abbas
Consultant - Medical Oncology
Max Super Speciality Hospital, Shalimar Bagh
In postmenopausal women, better results are seen with AI compared to tamoxifen; can the same results be
seen in premenopausal women? In young, premenopausal women more recurrences occur during the first 5
years of treatment. These young premenopausal women require aggressive management.
In SOFT and TEXT, the clinical parameters on which women, who did not require adjuvant chemotherapy
and were considered low-risk, were selected remains unclear. The selection criteria defining low-risk were
not published. Presumably, the parameters must have been elderly, small breast primary, well differentiated,
lymph node negative, ER, PR Positive, and Her2 Neu negative. Either, gene expression profile can be used to
select such patients with low-risk. These patients did very well in the updated analysis by Francis et al. [1]
Tamoxifen% Tamoxifen Exemestene
plus OFS% plus OFS%
Overall survival 98.8 97.9 97.7
RFS 97.8 97.8 99.3
Table 1
RFS=Recurrence Free Survival; OFS=Ovarian Function Suppression

Page 9
MICC Newsletter
What should be used, OFS plus tamoxifen or OFS plus exemestene?
In the updated analysis by Francise et al. [1] OFS plus tamoxifen resulted in 2.1% benefit in distant events
but survival benefit was 4.3%, whereas OFS plus exemestene resulted in 4.5% reduction in distant events
but only 2.1% reduction in death at 8 years. Could it be by chance or is it because in SOFT, patients with
permanent ovarian suppression were excluded but not in TEXT, where patients entered in study before
chemotherapy was started. According to TEXT, permanent ovarian failure was because of chemotherapy and
not because of OFS, and as known, exemestene works better with non-functioning ovaries, and will work
better where ovarian suppression is induced by chemotherapy and not from OFS alone. This is a good
hypothesis as far as reduction in distant recurrences is concerned, but does not explain only 2.1%
reduction in death in OFS plus exemestene arm, compared to 4.35% in OFS plus Tamoxifen arm.
OFS plus Tamoxifen
OFS plus Exemestene
Reduction in 8-year distant events 2.1% (to 17.9% from 4.5% (HR=0.74)
20%, HR=0.84)
Reduction in death 4.3% (to 10.6% from 2.1% (HR=0.79)
14.9%, HR=0.59)
HR=Hazard Ratio, OFS=Ovarian Function Suppression
Table 2
A major concern is, in updated analysis by Prudence et al, [1] there is only 2.1% reduction in death in
exemestene arm compared to 4% in tamoxifen arm. The observation noted earlier was, ABCSG12 patients
who expressed on-treatment FSH levels greater than the trial population, had significantly worse distant
metastasis–free survival. The recovery in FSH level has been ascribed to feedback through inhibin.
Comparatively less attention has been paid to the FSH increase, because it was inconsequential, but this is
far from the case. Much discussion has happened on measuring the Estradiol, Luteinizing Hormone (LH) and
FSH Levels. Many questions still remain unanswered. Should they be checked weekly, monthly, or quarterly,
as it is difficult to predict the estrogen escape or rebound phenomenon? At what time of the day should
the levels be measured? Should we check levels of both FSH and Estradiol or only Estradiol? It is difficult to
predict when and on which day of the month Estradiol levels will be high in body? How does one proceed
when Estradiol levels are raised? Should we stop OFS and switch to exemestene?
In 2016 Regan et al. [2] showed that not every high-risk group benefits from ovarian function suppression.
Patients less than 35 years of age, grade 3 tumours and patients with 4 or more than 4 nodes derive the
highest benefit, up to 15% in recurrence-free interval. These are the patients who should be started on
hormonal therapy plus OFS. In intermediate-risk patients, benefit is only 5%, which is definitely a huge
benefit, but at the cost of side effects. In TEXT and SOFT, there were 30% grade 3 and 4 side effects which
amount to poor quality of life. In SOFT, 20% of patients stopped ovarian function suppression early, and the
assigned oral hormonal therapy was stopped in 28% of patients on exemestane plus ovarian function
suppression. With many documented side effects, one has to maintain a balance between benefits and side
effects.

Page 10
MICC Newsletter
In updated analysis by Francis et al, [2] better survival benefit was seen with OFS plus tamoxifen than OFS
plus exemestane, but disease-free survival was better with OFS plus exemestene. OS is a better end point.
Should tamoxifen be preferred over exemestane? Further analysis in future, especially for OS from TEXT and
SOFT, will shed light on the same.
References
1. Francis PA, Pagani O, Fleming GF, et al. Tailoring Adjuvant Endocrine therapy for Premenopausal Breast Cancer. N Engl J Med.
2018;379:122-37.
2. Regan MM, Francis PA, Pagani O, et al. Absolute benefit of adjuvant endocrine therapies for premenopausal women with
hormone receptor–positive, human epidermal growth factor receptor 2–negative early breast cancer: TEXT and SOFT trials. J
ClinOncol. 2016; 34:2221-31.

Page 11
MICC Newsletter
Showcasing Research in Haematology DMG
Critical Analysis of Recent Clinical Trial
Dr Preethi Jeyaraman
Associate Consultant - Medical Oncology
Max Smart Super Speciality Hospital, Saket
Randomised Trial of Lenalidomide versus Observation in Smoldering
Multiple Myeloma
Lonial S, Jacobus S, Fonseca R, et al. J Clin Oncol. 2020 Apr 10;38(11):1126-1137.
Purpose
Observation is the current standard of care for smoldering multiple myeloma. We hypothesised that early
intervention with lenalidomide could delay progression to symptomatic multiple myeloma.
Methods
We conducted a randomised trial that assessed the efficacy of single-agent lenalidomide compared with
observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was
administered orally at a dose of 25 mg on Day 1 to 21 of a 28-cycle. The primary end point was
progression-free survival, with disease progression requiring the development of end-organ damage
attributable to multiple myeloma and biochemical Progression.
Results
182 patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm.
Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39 - 61%) of patients
in the lenalidomide arm with no response in the observation arm. Progression-free survival was
significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62;
P = .002). 1-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm
versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two
in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI,
0.08 - 2.53). Grade 3 or 4 non-haematologic adverse events occured in 25 patients (28%) on lenalidomide.
Conclusion
Early intervention with lenalidomide in smolderig multiple myeloma significantly delays progression to
symptomatic multiple myeloma and the development of end-organ damage.
Standard of care for smoldering multiple myeloma so far has been under observation. In a recent Mayo
Clinic study (2018), smoldering myeloma patients were risk stratified using 3 variables. Bone marrow
plasma cell percentage > 20%, M-protein > 2 g/dL, and serum free light chain ratio (involved to uninvolved)
>20 at diagnosis. Patients with none of the three risk factors were classified as low-risk with a median

Page 12
MICC Newsletter
time to progression (TTP) of 110 months. Patients with one risk factor were classified as intermediate-risk
with TTP of 68 months. High-risk patients (≥2 of the three risk factors) had a relatively short TTP of 29
months. A randomised control trial from Spanish Myeloma Group demonstrated improved outcomes with
lenalidomide and dexamethasone in patients with smoldering myeloma. However, study results could not
be extrapolated due to study design issues. As the study used a combination therapy, specific role of
lenalidomide could not be assessed. PET CT and MRI were not used at diagnosis to rule out bone disease of
symptomatic multiple myeloma and lack of generalised availability of multiparametric flow cytometry
criteria used to define high-risk SMM in the trial. These shortcomings have been overcome in a recent
randomised control study by Lonial S, et al (JCO Oct 2019). Single agent lenalidomide (25 mg) was
compared with observation in 182 patients of intermediate and high-risk smoldering myeloma. PFS was
significantly longer with lenalidomide compared with observation arm (hazard ratio, 0.28; 95% CI, 0.12 -
0.62; P = .002). 3-year PFS was 91% for the lenalidomide arm versus 66% for the observation arm. Grade 3
or 4 haematological and non-haematologic adverse events occurred in 41% patients on lenalidomide. This
study may represent a paradigm shift in the approach of therapy of myeloma with emphasis on prevention
of end organ damage which by itself is an important goal considering the longevity of these patients with
the availability of newer multiple therapeutic options. However, prolonged use of lenalidomide has been
associated with poor stem cell mobilisation for autologous stem cell transplant. To overcome this, patients
in the study were encouraged to mobilise stem cells after 4-6 cycles of therapy following which
cryopreservation was done. This is of special importance as autologous stem cell transplant helps in
prolonging PFS in myeloma patients. Lack of universal availability of cryopreservation may limit the
practical use of lenalidomide in smoldering myeloma patients.
Summary of recent work from MICC Saket
Adequate Engraftment with Lower Haematopoietic Stem Cell Dose
By Dr Preethi Jayaraman and Dr Rahul Naithani (Haematocon 2019, New Delhi)
Background
Adequate haematopoietic stem cell dose is required to proceed with Autologous Stem Cell Transplant
(ASCT).
Methods
This is a retrospective analysis of 108 patients with multiple myeloma or lymphoma who underwent ASCT
with non-cryopreserved stem cells at our centre. Data was compared for patients who received a stem cell
dose less than 2x106/kg with those who received higher dose.
Results
The HSC dose harvested in lesser dose group was 1.76x106 cells/kg (1.22 to 1.97x106 cells/kg). Mean CD34
dose of the whole group was 4.96+4.2x106 cells/kg. Neutrophil engraftment was similar in both groups
(11.7 days vs 11.1 days) (p=0.58). Similarly, platelet engraftment occurred in 13.3 vs 11.5 days in both
groups (p=0.65). Hospital stay was similar in both groups. There was no significant difference in the
incidence of proven bacterial infections between the 2 groups. There was no TRM in lower dose group.
Conclusion
ASCT can be safely performed even with lower HSC dose in non-cryopreserved setting.

Page 13
MICC Newsletter
Assessment of bone marrow involvement with 2-fluorine-18-fluoro-2-deoxy-d-glucose
(FDG) positron emission tomography with patients of lymphoma and its correlation with
bone marrow aspiration and bone marrow biopsy
Dr Suhas Kirti Singla
MBBS MD Medicine DNB
Senior Resident - Max Institute of Cancer Care
Bone Marrow Involvement (BMI) is an important prognostic factor in lymphoma, resulting in upstaging of
disease, more chances of cytopenias during the treatment and poor stem cell yield for bone marrow
transplant and its incidence varies in various populations and subtypes of lymphoma with an approximate
incidence being 10% in Hodgkins Lymphoma (HL) and 23% in non-Hodgkin’s Lymphoma. Trephine needle
biopsy had been a gold standard for defining BMI but 2 most important factors making it unsatisfactory
diagnostic test includes: missing of the focal lesions and pain associated with the invasive nature of
procedure. We assessed the concordance between bone marrow biopsy and whole-body PET CT in detecting
bone marrow involvement so that patients can evade the pain and be diagnosed at the same time.
Research question:
Whether bone marrow involvement as defined by 2-fluorine-18-fluoro-2-deoxy-D-glucose (FDG) Positron
Emission Tomography (PET) with Computed Tomography (CT) in patients of lymphoma correlates with bone
marrow involvement on bone marrow aspiration and bone marrow biopsy?
We are doing a prospective study at Max Super Speciality Hospital, Saket, New Delhi, in patients who are
≥18 years of age and are newly diagnosed cases of lymphoma.
We have so far collected data of 75 newly diagnosed cases after exhaustive history taking, examination &
investigations.
Data collected would be statistically analysed and will be assessed for incidence of bone marrow
involvement in patients with lymphoma at presentation and concordance between bone marrow biopsy
and PET CT in detecting bone marrow involvement.

Page 14
MICC Newsletter
DNB Thesis
The following thesis are being conducted by DNB students of medical, surgical and radiation oncology
across MICC hubs.
Dept
DMG
Topic
MAX PATPARGANJ
MAX SAKET
Candidate Name
Guide and Co-Guide
Medical Multiple Safety and clinical outcomes of
checkpoint inhibitor immunotherapy as
post first-line therapy in various solid
organ malignancies – an observation
non-interventional study
Dr Lima Arya Guide – Dr Meenu Walia
Medical Breast To study the prevalence of androgen
receptor positivity in cases of breast
cancer and its co-relation with various
clinico-pathological parameters
Dr Muveen Kumar Guide-Dr Meenu Walia
Co-Guide-Dr Rooma
Ambastha, Dr Rajat Saha,
Dr Deepak Sundriyal,
Dr Geeta Kadyapath
Medical Thoracic Prevalence of PD L1 positivity in lung
carcinoma in Indian scenario and
clinico-pathological correlation of PD L1
expression in lung carcinoma
Dr Minakshi Roy Guide-Dr Meenu Walia
Co-Guide-Dr Rajat Saha,
Dr Praveen Pandey
Surgical Urology A prospective evaluation of different
nephrometry scores in relations to
perioperative outcome of robotic
partial nephrectomy for renal masses
Dr Sunny Khanna Guide-Dr Harit Chaturvedi
Co-Guide-Dr Gagan
Gautam, Dr Puneet
Ahluwalia, Dr Vivek
Saxena
Surgical Thoracic A prospective, single centre,
double-blind, observational study to
determine efficacy of MRI in
preoperative local staging of soft tissue
sarcoma
Dr Surendra Singh Guide-Dr Harit Chaturvedi
Co-Guide-Dr Akshay
Tiwari, Dr Gyaneesh
Aggarwal, Dr Anuj
Khurana
Surgical Breast Expression and clinical significance of
androgen receptor in triple negative
breast cancer
Dr Hozefa Guide-Dr. Harit Chaturvedi
Co-guide-Dr Geeta
Kadyaprath, Dr Shubham
Jain, Dr Urmi Mukherjee,
Dr Amit Verma
Surgical Breast A retrospective study to determine the
predictor of pathological complete
response to neoadjuvant chemotherapy
in patients of breast cancer
Dr Siddhant Singh Guide-Dr Harit Chaturvedi
Co-Guide-Dr Aditi
Chaturvedi, Dr Shubham
Jain, Dr Nitesh Rohatgi,
Dr Devavrat Arya
Surgical Urology A retrospective study to determine the
predictor of pathological response to
neoadjuvant long course chemotherapy
in patients of rectal cancer
Dr Anuj Kumar Guide-Dr Harit Chaturvedi
Co-Guide-Dr Manish Jain
Year
2019
2018
2019
2018
2018
2019
2019
2019

Page 15
MICC Newsletter
Dept
DMG
Topic
Candidate Name
Guide and Co-Guide
Radiation GI Evaluation of dose volume parameters
in patients undergoing Stereotactic
Ablative Body Radiotherapy (SABR) for
primary and metastatic liver tumours
Dr Jeevi Mona
Priyadharshni
Guide-Dr Anil Kumar
Anand
Co-Guide-Dr Ruchi
Rustogi, Dr Anil Kumar
Bansal
Radiation GI The outcomes and morbidities
associated with trimodality
treatment,in patients with carcinomas
middle and lower third of the
oesophagus-a single instituition
restrospective study
Dr Arthi Elango Guide-Dr Anand
Co-Guide- Dr Charu,
Dr Bharat Dua,
Mr Malhotra
Radiation Urology Evaluation of treatment outcomes and
toxicities in patients of locally
advanced carcinoma rectum treated
with preoperative chemoradiation by
IMRT/VMAT technique followed by
surgery
Dr Ajay Kumar
Chaubey
Guide-Dr AK Anand
Co-Guide- Dr Urmi
Mukherjee, Dr Rajendra
Kumar
Radiation Thoracic A prospective study to access tumour
volume changes and its dosimetric
implications in Non Small Cell Lung
Cancer (NSCLC) on treatment with
definitive radiation or chemoradiation
Dr Gowtham
Manimaran
Guide-Dr Charu Garg
Co-Guide- Dr AK Anand,
Dr Vikas Choudhary,
Dr AK Bansal,
Dr Malhotra
Year
2019
2019
2018
2019
Surgical
Gynaecology
+ GI
Perioperative outcome analysis after
cytoreductive surgery and
hyperthermic intraperitoneal
chemotherapy in peritoneal
carcinomatosis: A prospective study
Dr Vineet Goel
Guide-Dr Harit Chaturvedi
Co-Guide-
Dr Amish Chaudhary,
Dr Satyam Taneja,
Dr Neeraj Goel,
Dr Ankur Bahl
2017
Medical
Gynaecology
+ GI
Epidemiology and clinicopathologic
profile of malignant epithelial ovarian
tumours
Dr Abhishek
Guide-Dr. Sandeep Batra
Co-Guide- Dr Devavrat
Arya, Dr Alok Gupta,
Dr Amish Chaudhary
2017
Medical Thoracic An observational study of outcome of
Folfox based chemotherapy in patients
with advanced pancreatobiliary cancers
presenting with hyperbilirubinemia
Dr Sanjeev Guide-Dr Sandeep Batra
Co-Guide- Dr Nitesh
Rohatgi, Dr Ankur Bahl,
Dr Satyam Taneja
Medical Thoracic To determine the clinico-pathological
profile and treatment outcomes of
stage IV lung cancer patients treated at
tertiary cancer centre in India
Dr Gunjan Guide-Dr Sandeep Batra
Co-Guide- Dr Nitesh
Rohatgi, Dr Alok Gupta
Medical Haematology Assessment of bone marrow
involvement with FDG positron
emission tomography with patients of
lymphoma and its correlation with
bone marrow aspiration and bone
marrow biopsy
Dr Suhas Guide-Dr Sandeep Batra
Co-Guide- Dr Rahul
Naithani, Dr Pankaj
Dougall
2017
2018
2018

Page 16
MICC Newsletter
Dept
DMG
Topic
MAX SHALIMAR BAGH
Candidate Name
Guide and Co-Guide
Medical Haematology Prognostic and predictive factors for Dr Mayank Guide- Dr Ranga Rao
the development of chemotherapy
induced anaemia in cancer patients, a
prospective study from a cancer
centre in India
Co-Guide- Dr Waseem
Abbas
Medical Breast A prospective study of quality of life Dr Prateek Patil Guide- Dr Ranga Rao
and toxicity in patients of breast
Co-Guide-Dr Waseem
cancer on dose dense regimen
Abbas
Radiation
Head and
Neck
Quality of life assessment in head &
neck cancer patients undergoing
radiotherapy with or without
concurrent chemotherapy treatment–
a prospective; non-randomised study
Dr Nitika Joshi
Guide-Dr Arun Kumar
Goel, Co-guide-
Dr Vaishali Zamre,
Dr Dinesh Singh,
Dr Gopal Sharma
Radiation Breast Prospective dosimetric comparison of
intensity modulated radiation therapy
versus three dimensional conformal
radiation therapy in post-operative
breast cancer patients undergoing
hypofractionated radiotherapy
Dr Swati Singh Guide-Dr Dinesh Singh,
co-Guide-Dr Rashi
Agrawal,
Mr S Balasubramanian
Radiation
Head and
Neck
MAX VAISHALI
Correlation of health related quality
of life with dose to dysphagia
aspiration related structures in head &
neck cancer patients treated with
intensity modulated radiotherapy
Dr Shreebha Hari
Guide-Dr Gagan Saini,
Co-Guide-
Dr Prekshi Chaudhary,
Dr Sowrabh Kumar Arora,
Dr Vikas Goswami,
Mr S Balasubramanian
Radiation Breast A prospective observational study to
compare the dose received by cardiac
structure in post-operative left sided
breast cancer treated by intensity
modulated radiotherapy versus three
dimensional conformal radiotherapy
Dr Soumita
Majumdar
Guide-Dr Dinesh Singh
Radiation Breast A prospective study of quality of life
in breast cancer patients undergoing
radiation therapy
Dr Sahil
Guide-
Dr Prekshi Chaudhray
Co-Guide- Dr Arun
Kumar Goel, Dr Gopal
Sharma
Radiation Breast An observational study of setup error
assessment in planar kV image guided
radiation therapy versus cone beam
CT image-guided radiation therapy in
breast cancer patients undergoing
treatment with external beam
radiation
Dr Himanshu
Joshi
Guide- Dr Dinesh Singh
Co-Guide-Dr Meenu
Walia, Dr Rashi Agrawal,
Dr Vaishali Zamre, Mr S
Balasubramanian
Medical Breast A prospective cross sectional study of
quality of life of female breast cancer
survivor
Dr Vishal
Chaudhary
Guide-Dr Arun Kumar
Goel
Co-Guide-Dr Vaishali
Zamre, Dr Dinesh Singh,
Dr Gopal sharma
Year
2019
2018
2017
2017
2018
2019
2019
2019
2019

Page 17
MICC Newsletter
Ongoing Clinical Studies
DMG
Study
MAX PATPARGANJ
P.I.
Update
Update
Breast ML28714: An Indian multicentric open label prospective phase
IV study to evaluate safety and efficacy of XXX in HER2
positive, node positive or high-risk node negative breast cancer
as part of a treatment regimen consisting of Doxorubicin,
Cyclophosphamide, with either Docetaxel or paclitaxel or
Docetaxel and carboplatin.
Dr M Walia Total subjects enrolled 30
Breast COMPLEEMENT-1: An open label, multicentre, phase III b study
to assess the safety and efficacy of XXX (LEE011) in
combination with XXX for the treatment of men and
pre/postmenopausal women with hormone receptor(HR+)
HER2-negative(HER2-) advanced Breast Cancer (aBC) with no
prior hormonal therapy for advanced disease
Dr M Walia Total subjects enrolled 04
Breast
Randomised controlled trial to assess blockade of voltage gates
sodium channels during surgery in operable breast cancer
Dr G
Kadayaprath
Total subjects enrolled 102
Breast
A Phase III randomised controlled study of Inj XXXXXXX
(Hydroxyprogesterone caproate) as single dose preoperative
therapy in patients with high-risk operable breast cancer
Dr G
Kadayaprath
Total subjects enrolled 6
Multiple
NCDIR/NCRP Hospital Based Cancer Registry
Dr G
Kadayaprath
Total subjects enrolled 10311
Multiple
Patterns of care and survival studies in Cancer Cervix, Breast
and Head & Neck Cancer
Dr G
Kadayaprath
Total subjects enrolled 986
Paediatric The Indian Childhood Cancer Survivorship Study (C2S study) Dr P Jain Total subjects enrolled 15
After treatment completion registry of childhood cancers:
Multicentre study
Paediatric Indian Haemophagocytic Lymphohistiocytosis Registry (I-HLH): Dr P Jain Total subjects enrolled 1
Establishment of a nationwide prospective web-based registry
for patients diagnosed with HLH
Paediatric New-Accessing Childhood Cancer Services in India (ACCESS Dr P Jain Total subjects enrolled 8
INDIA)
Breast
MAX SAKET
A phase III randomised controlled study of Inj XXXXXXX
(Hydroxyprogesterone caproate) as single dose preoperative
therapy in patients with high-risk operable breast cancer
Dr Harit
Chaturvedi
Study enrollment target 720,
Total subjects enrolled 11
Multiple NCDIR/NCRP Hospital Based Cancer Registry
Dr A Anand Total subjects enrolled 23338
Multiple Patterns of care and survival studies in Cancer Cervix, Breast Dr A Anand Total subjects enrolled 1424
and Head & Neck Cancer
Multiple
Add Aspirin: A phase III, double-blind, placebo-controlled,
randomised trial assessing the effects of aspirin on disease
recurrence and survival after primary therapy in common non
metastatic solid tumours
Dr Harit
Chaturvedi
Total subjects enrolled 07

Page 18
MICC Newsletter
DMG
Study
P.I.
Update
Paediatric The Indian Childhood Cancer Survivorship Study (C2S study) Dr R Arora Total subjects enrolled 53
After treatment completion registry of childhood cancers:
Multicentre study
Paediatric Indian Haemophagocytic Lymphohistiocytosis Registry (I-HLH): Dr R Arora Total subjects enrolled 1
Establishment of a nationwide prospective web-based registry
for patients diagnosed with HLH
Paediatric Prospective Collaborative Study for Relapsed / Refractory Dr R Arora Total subjects enrolled 0
Hodgkin Lymphoma - InPOG-HL-17-02
Paediatric New-Accessing Childhood Cancer Services in India (ACCESS Dr R Arora Total subjects enrolled 6
INDIA)
MAX SHALIMAR BAGH
Multiple
XXXXXXX: A prospective, multicentre, observational data taken
registry study to monitor the routine clinical use of XXXXX
(Rituximab 100mg/500mg concentrate for solution for infusion)
In Indian patients
Dr Waseem
Abbas
Total subjects enrolled 10
Breast
ML 29662: “A multicentre, open-label, single arm, phase IV
study of Trastuzumab Emtansine in Indian patients with HER2
positive unresectable locally advanced or metastatic breast
cancer who have received prior treatment with trastuzumab &
taxane”
Dr Waseem
Abbas
Total subjects enrolled 11
Breast
MO39196: A phase III, multicentre, randomised, double-blind,
placebo-controlled study of Atezolizumab (anti-PD-L1
antibody) in combination with paclitaxel compared with
placebo with paclitaxel for patients with previously untreated,
inoperable locally advanced or metastatic Triple Negative Breast
Cancer"
Dr Waseem
Abbas
Total subjects enrolled 02
Multiple NCDIR/NCRP Hospital Based Cancer Registry
Dr R Rao Total subjects enrolled 3890
MAX VAISHALI
Multiple NCDIR/NCRP Hospital Based Cancer Registry
Dr S Garg Total subjects enrolled 2160
Paediatric
New-Accessing Childhood Cancer Services in India (ACCESS
INDIA)
Dr Rashi
Agarwal
Total subjects enrolled 01
MAX SMART
Paediatric Indian Haemophagocytic Lymphohistiocytosis Registry (I-HLH): Dr C Singha Total subjects enrolled 0
Establishment of a nationwide prospective web-based registry
for patients diagnosed with HLH
MAX LAJPAT NAGAR
Paediatric New-NCDIR/NCRP Hospital Based Cancer Registry
Dr PK Julka Total subjects enrolled 0
MAX MOHALI
Thoracic
CONCORDANCE “An observational, multicentre, prospective
study to evaluate concordance of detecting EGFR mutation by
circulating tumour free DNA versus tissues biopsy in NSCLC”
Dr Gautam
Goyal
Total subjects enrolled 04

Page 19
MICC Newsletter
DMG
Gynaecology
Study
New- An Indian multicentric open label prospective post
marketing surveillance study of bevacizumab in the frontline
management of advanced/metastatic epithelial ovarian cancer,
fallopian tube cancer or primary peritoneal cancer in real-life
clinical practicet
P.I.
Dr Gautam
Goyal
Update
Total subjects enrolled 0
Thoracic
New- A randomised, double-blind, multicentre, multinational
comparative clinical study to compare the efficacy and safety
of XXXXXXX against innovator Bevacizumab in patients with
unresectable, locally advanced, recurrent or metastatic non
squamous non-small cell lung cancer
Dr Gautam
Goyal
Total subjects enrolled 0
Gastro-
Oesophageal
New- A two arm randomised open label phase II clinical trial to
assess the efficacy of Gemcitabine-Cisplatin or Capecitabine
and concurrent chemoradiation in operated stage II & III GB
Cancer (GECCOR-GB)
MAX BHATINDA
MAX DEHRADUN
Dr Gautam
Goyal
Total subjects enrolled 0
Paediatric New- Accessing Childhood Cancer Services in India (ACCESS Dr Sachin Total subjects enrolled 1
INDIA)
Gupta
Paediatric New- Accessing Childhood Cancer Services in India (ACCESS Dr Manjinder Total subjects enrolled 0
INDIA)
Sandhu
Paediatric New- Accessing Childhood Cancer Services in India (ACCESS Dr Vimal Total subjects enrolled 0
INDIA)
Pandita

Page 20
MICC Newsletter
Research Team Contact List
Location
Name of staff
Title
email ID
Phone number
Roles
CENTRAL TEAM
Pan Max
Rajesh Saxena
DGM
rajesh.saxena@maxhealthcare.com
9818474003
Clinical
Operation Leader
Pan Max
Saroj Sabath
DGM
saroj.kumar@maxhealthcare.com
9999325464
Regulatory
(IEC+ISC)
and Legal
Coordinator
Max Hospital,
Saket
Max Hospital,
Patparganj
Ratnam Shukla
Savera Gulati
CRC
CRC
ratnam.shukla@maxhealthcare.com
savera.gulati@maxhealthcare.com
7985184630
8368520427
Oncology + other
therapeutics
clinical trials
Oncology + other
therapeutics
clinical trials
Max Hospital,
Shalimar Bagh
Anjali Aggarwal
CRC
anjali.aggarwal@maxhealthcare.com
9560708797
Oncology + other
therapeutics
clinical trials
Max Hospital,
Mohali
Ambika Sharma
CRC
ambika.sharma@maxhealthcare.com
8566041317
Oncology + other
therapeutics
clinical trials
Location Name of staff Title email ID Phone number Roles
MICC TEAM
Pan Max
Shailender
Rathore
Clinical Research
Manager
shailender.rathore@maxhealthcare.com
8800940056
Clinical
operation
leader
Max Hospital,
Saket
Max Hospital,
Saket
Max Hospital,
Saket
Max Hospital, Saket
Max Hospital, Saket
Max Hospital,
Patparganj
Max Hospital,
Patparganj
Max Hospital,
Patparganj
Max Hospital,
Patparganj
Arun Adhana
Kamlesh Kumari
Ankit
Naseem
Sristi Rai
Suryadev
Farhan Siddiqui
Aarif Khan
Shakti Srivastava
Data Entry
Executive/
Manager
CRC
Data Entry
Operator
Social Worker
CRC
Data Entry
Operator
Social Worker
Departmental
Coordinator
Departmental
Coordinator
arun.adhana@maxhealthcare.com
kamlesh.kumari@maxhealthcare.com
ankit.kumar2@maxhealthcare.com
naseem.khan@maxhealthcare.com
sristiraj@gmail.com
sandylohia7@gmail.com
fazsid1@gmail.com
arif@maxhealthcare.com
shaktishri.max@gmail.com
9953155333
9711035866
8447278856
9268882718
8102734585
9899346000
9953676292
8700242790
9839515336
NCRP
NCRP+
Clinical trials
NCRP
NCRP
Clinical trials
NCRP
NCRP
NCRP
Clinical trials

www.maxhealthcare.in
/MaxHealthcare
/MaxHospitalsIndia