Satheesh Chiradoni Thungappa

Healthcare Global Enterprises

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Shekar Patil

HCG Cancer Hospital

Radheshyam Naik

Healthcare Global Enterprises

Bruno Sangro

Clinica Universidad de Navarra

Masatoshi Kudo

Kindai University

ВВ

В. В. Бредер

National Medical Research Center of Cardiology

Stephen L. Chan

Chinese University of Hong Kong

B. S. Ajaikumar

Healthcare Global Enterprises

Ravi Thippeswamy

Healthcare Global Enterprises

Mithua Ghosh

HCG Cancer Hospital

Wattana Sukeepaisarnjaroen

Khon Kaen University

Cooperative Institutions

Healthcare Global Enterprises

HCG Cancer Hospital

HCG Cancer Centre

Strand Life Sciences (India)

Istituti di Ricovero e Cura a Carattere Scientifico

Inserm

Cancer Institute (WIA)

Harvard University

Dana-Farber Cancer Institute

The University of Texas MD Anderson Cancer Center

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Outcomes of Brentuximab Vedotin with or without Bendamustine and Nivolumab in Relapsed or Refractory Hodgkin’s Lymphoma: An Early Experience from Patient Access Programme in India

Advances in Hematology and Oncology Research (2024)

Jyothi Goutham Samrudhi Joshi Shekar Patil Satheesh Chiradoni Thungappa Ravi Thippeswamy

Hodgkin's lymphoma (HL) accounts for 30 % of all lymphomas. The primary therapy regimens ABVD or BEACOPP are frequently used for Hodgkin's lymphoma. Up to 40% of patients with advanced Hodgkin's Lymphoma (HL) experience a relapse after receiving their first therapy, despite current treatment protocols. Autologous Stem Cell Transplantation (ASCT) can produce long-lasting responses following an initial relapse in roughly 50% of patients with chemo-sensitive relapse. Patients included were both pediatric and adult with pathologically confirmed HL who have relapsed, refractory, or progressive disease after at least one line of treatment. Demographic and clinical data was collected along with details of treatment and responses to the treatment was observed. Safety assessments included evaluation of adverse events, routine hematology and serum chemistry tests. Data was analyzed in IBM SPSS Statistics V22.0. Descriptive statistics were performed, and categorical variables were expressed as percentages and continuous variables were expressed as mean. this series of 12 patients supports the potential clinical benefit of brentuximab vedotin as a therapeutic option for patients suffering relapse of HL with primary treatment and SCT, with equal response of <PR and >PR in 50% patients and a PFS of 8 months.

Brentuximab vedotin

Bendamustine

Refractory (planetary science)

10.33140/ahor.07.01.02

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P2.03b-064 Genomic Profiling in Non-Small Cell Lung Cancer: New Hope for Personalized Medicine

Journal of Thoracic Oncology (2017)

Satheesh Chiradoni Thungappa Shekar Patil H P Shashidhara Mithua Ghosh L Sheela

Personalized Medicine

10.1016/j.jtho.2016.11.1345

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Role of induction chemotherapy in locally advanced oropharyngeal carcinoma in Indian population.

Journal of Clinical Oncology (2024)

Vijay Moorthy Radheshyam Naik Srinivasa Bj Shekar Patil Satheesh Chiradoni Thungappa

e18026 Background: Head and neck cancer is the third most frequent cancer in Indian men, it is a growing public health problem. Given the numerous disparities in head and neck cancer biology, etiologic and demography between the developing world and the developed world, management guidelines should be based on Indian literature rather than western data. This study aims to define role of Induction chemotherapy in locally advanced oropharyngeal cancer In Indian population by comparing the outcomes which are Overall response rate (O.R.R), Progression free survival (P.F.S), overall survival (O.S) between patients who received Induction chemotherapy followed by CTRT vs CTRT. Methods: Patients who were registered for treatment between jan-2018 to dec-2022 who met the selection criteria were included for the study. Selection criteria: Patients who were diagnosed with Stage III OR IV (a & b, non-metastatic) oropharyngeal squamous cell carcinoma from age group of 20 to 70 who were HPV negative or unknown status were included for study. Total of 50 patients were chosen for the study after stringent selection criteria. Out of 50 ,23 patients received Induction chemotherapy and 27 patients received only CTRT. Results: Overall response rate was analysed using Interim PET CT after Induction chemotherapy and PET CT after 3 to 6 months of CTRT. Complete response and partial response is considered as ORR. It was observed that ORR in sequential therapy arm is 42% and only CTRT arm is 36%, however this is not statistically significant with p value of 0.54. Median PFS for CTRT arm is 8 months and median PFS for IC +CTRT arm is 12 months with p value = 0.97(>0.05) (Log rank test) which is not statistically significant. Median OS for CTRT is 60 months and IC+ CTRT is 18 months. The log rank test has been used for comparing the overall survival outcomes of both the groups , and thus the p-value obtained is 0.56(>0.05), which shows that there is no statistically significant difference in the survival outcome of the two groups. Conclusions: In conclusion, our study on induction chemotherapy in locally advanced head and neck cancer did not identify statistically significant differences in O.R.R, PFS and OS between the two treatment arms which is concordant with MACH- NC updated 2021 data. Several factors, including patient heterogeneity, sample size, treatment protocol, follow-up, duration, may have contributed to these results, it is essential to interpret these results in the context of the study's limitations. [Table: see text]

Induction chemotherapy

10.1200/jco.2024.42.16_suppl.e18026

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Plain language summary of the HIMALAYA study: tremelimumab and durvalumab for unresectable hepatocellular carcinoma (liver cancer)

Future Oncology (2023)

Ghassan K. Abou‐Alfa George Lau Masatoshi Kudo Stephen L. Chan Robin Kate Kelley

What is this summary about? This is a summary of results from a phase 3 clinical study called HIMALAYA. HIMALAYA looked at treatment with one dose of a medication called tremelimumab combined with multiple doses of a medication called durvalumab (the STRIDE regimen) or multiple doses of durvalumab alone. These treatments were compared with a medication called sorafenib in participants with unresectable hepatocellular carcinoma (HCC). HCC is a type of liver cancer that is difficult to treat because it is often diagnosed when it is unresectable, meaning it can no longer be removed with surgery. Sorafenib has been the main treatment for unresectable HCC since 2007. However, people who take sorafenib may experience side effects that can reduce their quality of life, so alternative medicines are being trialed. Tremelimumab and durvalumab are types of drugs called immunotherapies, and they both work in different ways to help the body's immune system fight cancer. What were the results of the study? Participants who took STRIDE lived longer than participants who took sorafenib, whilst participants who took durvalumab alone lived a similar length of time as participants who took sorafenib. Participants who took STRIDE or durvalumab had a lower relative risk of experiencing worsening in their quality of life than participants who took sorafenib. The side effects that participants who received STRIDE or durvalumab experienced were expected for these types of treatments and could mostly be managed. What do the results of the study mean? Overall, STRIDE is more effective than sorafenib for people with unresectable HCC.

Durvalumab

Tremelimumab

Regimen

10.2217/fon-2023-0486

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Landscape of clinically actionable mutations in breast cancer ‘A cohort study’

Translational Oncology (2020)

Mithua Ghosh Radheshyam Naik S.M. Lingaraju Sridhar Papaiah Susheela Shekar Patil

Breast cancer (BC) is a heterogeneous disease. Numerous chemotherapeutic agents are available for early stage or advanced/metastatic breast cancer to provide maximum benefit with minimum side effects. However, the clinical outcome of patients with the same clinical and pathological characteristics and treated with similar treatments may show major differences and a vast majority of patients still develop treatment resistance and eventually succumb to disease. It remains an unmet need to identify specific molecular defects, new biomarkers to enable clinicians to adopt individualized treatment for every patient in terms of endocrine, chemotherapy or targeted therapy which will improve clinical outcomes in BC. Our study aimed to identify frequent hotspot mutation profile in BC by targeted deep sequencing in cancer-related genes using Illumina Truseq amplicon/Swift Accel-Amplicon panel and MiSeq technology in an IRB-approved prospective study in a CLIA compliant laboratory. All the cases had pathology review for stage, histological type, hormonal status and Ki-67. Data was processed using Strand NGS™. Mutations identified in the tumor were assessed for 'actionability' i.e. response to therapy and impact on prognosis.

Targeted Therapy

Amplicon

10.1016/j.tranon.2020.100877

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Citations (6)

Table of Contents

Annals of Oncology (2023)

A. E. Rosenberg Everett E. Vokes Zeid Kuzbari Chaitanya Bandlamudi Chey Loveday

Table (database)

10.1016/s0923-7534(23)00053-4

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Survival outcomes of metaplastic breast carcinoma: An Indian tertiary care center data.

Journal of Clinical Oncology (2020)

Lalnun Puii Vinu Sarathy Lalram Sangi Beulah Elsa Thomas Samuel Luke Koramati

e12579 Background: Metaplastic breast carcinoma is a rare histological subtype that has basal like characteristics and is reported to have a poorer prognosis than no specific type/ductal carcinoma (ductal/NST). We aimed to investigate clinicopathological features and outcome from a single institution based registry. Methods: Clinical records of breast cancer patients treated during 2012-2019 were screened and 31 cases of metaplastic breast carcinoma were found. Descriptive analysis was done for patients’ demographics and clinicopathological features. Kaplan Meier method was used to assess survival outcomes. Results: The incidence of metaplastic breast cancer was 0.5% (31/6180) in our study out of which the most common histopathological differentiation was squamous (45.16%). The second most common was sarcomatoid histology (32.25%), followed by chondroid (9.68%) and mixed histology (12.9%). The median age at diagnosis was 60 years ranging from 28 to 82 years. 64.15% of patients were post-menopausal. At presentation, three (9.67%) patients had metastatic disease while the rest were diagnosed with early (51.61%) and locally advanced cancers (38.72%). Triple negative cancers (ER/PR/Her2 negative) constituted the vast majority with 22 cases (80.6%) while hormone receptor positive (ER/PR positive, Her-2 negative) and Her-2 neu positive (ER/PR negative) made up the rest with three patients (9.67%) each group respectively. The median overall survival was found to be 39 months (95% CI 25.46 - 52.53). Conclusions: After a thorough search in PubMed and Google Scholar, we could not find a larger case series from India with clinical outcomes for metaplastic breast carcinoma. Our results suggest that metaplastic breast carcinoma is a heterogenous disease. Outcomes of metaplastic breast carcinoma are relatively worse when compared with literature for triple negative breast cancer and breast cancer in general. Further biological understanding may offer valuable insights for newer targets and therapeutic approaches to metaplastic breast cancer.

Metaplastic Carcinoma

Histology

Not Otherwise Specified

Sarcomatoid Carcinoma

10.1200/jco.2020.38.15_suppl.e12579

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Translational relevance of androgen receptor immunohistochemistry scoring systems for data harmonization in triple negative breast cancer (TNBC).

Journal of Clinical Oncology (2020)

Suhail Sayeed Mufti Bhanu Prakash Lalkota Tejaswini BN Hrishi Varayathu Vinu Sarathy

1078 Background: Androgen receptor (AR) expressing triple negative breast cancer (TNBC) is a sub-set of TNBC with an evolving prognostic and predictive behaviour. AR immunohistochemical threshold for positivity has not been standardized and a wide range of cut-offs have been used across studies ( > 0% to 75%). In this study we explored AR immunohistochemistry thresholds in relation to disease free survival (DFS) and clinical outcomes in non-metastatic TNBC using the Allred and H-Score systems. Increasing interest in AR as a therapeutic target for TNBC and the use of digital tissue image analysis makes it important to standardize AR immunohistochemistry reporting. Methods: 100 FFPE (formalin-fixed paraffin-embedded) tumour blocks were retrieved for non-metastatic TNBCs diagnosed between January 2015 and May 2017 and immunostained using AR441 (IgG1) mouse monoclonal antibody. Clinical follow-up ranged from 59 to 31 months and DFS was calculated. Cut-off scores were explored using Evaluate Cutpoints ( R maxstat package) and X-tile software. The score with maximum split in DFS (based on log-rank statistics and lowest p-value) was chosen as the cut-off. Descriptive and survival statistics was performed. Results: The median age was 51 (SD 11.262; range 28 to 82) years. Using Evaluate Cutpoints ≥3 was found as the threshold for AR by Allred Score. 36% cases were AR positive using Allred score (HR 0.508; CI 0.234 - 1.11; p-value 0.08). Using Evaluate Cutpoints ≥30 was found as the threshold for AR by H-Score (HR 0.624, CI 0.306 - 1.27; p-value 0.19). 35% cases were AR positive using H-Score. X-tile analysis also found the cut-offs as ≥3 and ≥30 for Allred and H-Score respectively (p < 0.05). A significant correlation was seen between the two scoring systems (Pearson Correlation 0.935; p < 0.01). A significantly higher number of grade III TNBCs were AR negative (n = 55/76) compared to grade II (n = 9/24) (p = 0.002). Cut-off for Ki67 was 75 (HR 1.61, CI 0.85-3.04, p-value 0.141) with a significantly higher number of AR negatives in the Ki67≥75 group (21/26; p < 0.05). The overall median DFS was 51.9 months. There was no significant difference in DFS for the AR negative (median: 47.4 months; mean: 39.39 months) and AR positive (Median survival not reached; mean: 41.3 months) groups(p = 0.23). Conclusions: AR immunohistochemistry cut-offs using the Allred (≥3) and H-Score (≥30) are close to the ones used for ER/PR immunohistochemistry as per ASCO/CAP guidelines, making a strong case for universal application of these systems for harmonization of AR data.

Triple-negative breast cancer

Clinical Significance

10.1200/jco.2020.38.15_suppl.1078

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Identification of clinically actionable biomarkers in an Indian cancer cohort using comprehensive genomic profiling (CGP): An institutional experience.

Journal of Clinical Oncology (2023)

Mithua Ghosh Gautam Balaram Sheela ML Krishna Murti Cr Shekar Patil

e15166 Background: CGP through Next-Generation Sequencing (NGS) has substituted single-gene testing to identify more druggable gene aberrations. The simultaneous detection of broad spectrum predictive biomarkers and molecular signatures including tumor mutational burden (TMB), microsatellite instability (MSI) burden, somatic BRCA, homologous recombination repair genes (HRR) and RNA variants by CGP provides a more cost efficient and tissue-preserving approach than serial single-biomarker analyses. Methods: 750 biopsy proven patients of various cancer spectrum at HCG cancer center were consented and profiled using Illumina TruSight Oncology 500 (TSO500) assay that interrogates 523 cancer-related genes on NextSeq in an IRB-approved prospective study. The findings were discussed in molecular tumor board (MTB) and recommendations from treating physicians were documented in patient records for change in clinical management and follow up. Results: A total of 1291 genomic alterations were detected in 750 cases (mean 1.7 mutations/sample). CGP identified genetic alterations with therapeutic and prognostic implications in 77% patients (Tier I- 34%, Tier II-64%, Tier III-14%). CGP revealed higher number of druggable genes (47%) than small panels (14%).Tumor agnostic markers for immunotherapy (IO) were observed in 20% of the current cohort, based on which IO was initiated and are on follow up. In 20% of the cohort, HRR pathway alterations including s BRCA (7%) were detected providing an option to treat with platinum or PARP inhibitors. Other significant alterations like EGFR, RAS/RAF, ERBB2, PIK3CA, cKIT, PDGFRA, ARID1A, ARID2, POLE, and FGFR were found. RNA sequencing yielded 54 RNA alterations (38 translocations and 16 splice variants). Androgen receptor splice variants were observed in 50% prostate carcinoma patients for whom taxane therapy was initiated. Other frequent fusions detected were: TMPRSS-ERG, RPS6KB1-VMP1, EML4-ALK, NTRK, PDGFRA and EWSR. Conclusions: CGP reports actionable and prognostic genetic alterations in 77% of patients who could potentially benefit by tumor-matched targeted and immunotherapy. Post MDT patients were assigned to approved therapies (5-80%) or change in clinical management (5-25%) based on the cancer type (Table). 25% patients were enrolled for investigator initiated clinical trials and are on follow up for clinical outcome and analysis of independent prognostic and therapeutic value of novel biomarkers in a larger cohort of Indian patient. [Table: see text]

Druggability

Microsatellite Instability

PDGFRA

ARID1A

Olaparib

10.1200/jco.2023.41.16_suppl.e15166

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P1.01-94 Phase I Trial to Establish Maximum Tolerated Dose Safety and Pharmacokinetic Profile of Oral Paclitaxel

Journal of Thoracic Oncology (2018)

Satheesh Chiradoni Thungappa Rashmi Rajappa I. Sreevallika Shirish S. Alurkar Sameer Patel

10.1016/j.jtho.2018.08.650

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