Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India
PURPOSEBiliary tract cancers (BTCs) are usually diagnosed in advanced stages, where treatment options are either palliative chemotherapy and/or best supportive care. The breakthrough results of the TOPAZ-1 trial demonstrated a 24% decrease in risk of death at 2 years with the addition of durvalumab...
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American Society of Clinical Oncology
2024-12-01
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| Series: | JCO Global Oncology |
| Online Access: | https://ascopubs.org/doi/10.1200/GO.24.00216 |
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| author | Vamshi Krishna Muddu Anjali Shah Anupa John Abhishek Raj Ankur Bahl Senthil J. Rajappa Thirumalairaj Raja Joydeep Ghosh Viraj Lavingia Amish Vora Prabhat Bhargava Anant Ramaswamy Arif Khan Atul Sharma Mehak Trikha Aditya Dhanawat Avinash Bonda Indraja Siripurapu Manoj Mahajan Nitesh Rohatgi Mosale Venkatesha Chandrakant Himanshu Gujarathi Manan Vora Sumankumar Ankathi Vikas S. Ostwal |
| author_facet | Vamshi Krishna Muddu Anjali Shah Anupa John Abhishek Raj Ankur Bahl Senthil J. Rajappa Thirumalairaj Raja Joydeep Ghosh Viraj Lavingia Amish Vora Prabhat Bhargava Anant Ramaswamy Arif Khan Atul Sharma Mehak Trikha Aditya Dhanawat Avinash Bonda Indraja Siripurapu Manoj Mahajan Nitesh Rohatgi Mosale Venkatesha Chandrakant Himanshu Gujarathi Manan Vora Sumankumar Ankathi Vikas S. Ostwal |
| author_sort | Vamshi Krishna Muddu |
| collection | DOAJ |
| description | PURPOSEBiliary tract cancers (BTCs) are usually diagnosed in advanced stages, where treatment options are either palliative chemotherapy and/or best supportive care. The breakthrough results of the TOPAZ-1 trial demonstrated a 24% decrease in risk of death at 2 years with the addition of durvalumab to chemotherapy.MATERIALS AND METHODSThis was a multicenter retrospective cohort study conducted across 14 institutions in India. All the patients were diagnosed with advanced BTCs. The primary objective was to assess median overall survival (mOS) with the use of durvalumab in combination with chemotherapy backbone. The patient details, treatment details, laboratory results, and outcome parameters were recorded from the prospectively collected databases.RESULTSA total of 148 patients were included with a median age of 57.5 years; 36 (24.3%) patients had borderline Eastern Cooperative Oncology Group performance status ≥2. The most common subtype was gall bladder cancer (GBC), seen in 94 patients (63.5%); 126 (85.1%) patients presented with de novo metastases. At a median follow-up of 6.8 months (95% CI, 5.9 to 7.8), the estimated mOS for the entire cohort was 12 months (95% CI, 7.8 to 16.3) and median progression-free survival was 8.2 months (95% CI, 7.1 to 9.4) with objective response achieved in 44 (29.7%) patients, and the estimated 2-year OS being 25%. Immune-related grade 3/4 adverse events were reported in 11 (7.4%) patients. In multivariate analysis, age <60 years (P = .001) and standard dose of durvalumab (P < .001) were found to have improved OS compared with age >60 years and low dose of durvalumab.CONCLUSIONTo our knowledge, these real-world data provide the first evidence in Indian context of the efficacy and safety of durvalumab plus chemotherapy in patients with advanced/metastatic BTCs especially in GBC. |
| format | Article |
| id | doaj-art-5e1cae9054f54403ab5431925579c484 |
| institution | OA Journals |
| issn | 2687-8941 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | American Society of Clinical Oncology |
| record_format | Article |
| series | JCO Global Oncology |
| spelling | doaj-art-5e1cae9054f54403ab5431925579c4842025-08-20T02:19:37ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412024-12-011010.1200/GO.24.00216Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From IndiaVamshi Krishna Muddu0Anjali Shah1Anupa John2Abhishek Raj3Ankur Bahl4Senthil J. Rajappa5Thirumalairaj Raja6Joydeep Ghosh7Viraj Lavingia8Amish Vora9Prabhat Bhargava10Anant Ramaswamy11Arif Khan12Atul Sharma13Mehak Trikha14Aditya Dhanawat15Avinash Bonda16Indraja Siripurapu17Manoj Mahajan18Nitesh Rohatgi19Mosale Venkatesha Chandrakant20Himanshu Gujarathi21Manan Vora22Sumankumar Ankathi23Vikas S. Ostwal24Department of Medical Oncology and Hematology, Institute of Oncology, AIG Hospitals, Hyderabad, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, Sarvodaya Hospital, Faridabad, IndiaDepartment of Medical Oncology, Fortis Memorial Hospital, Gurgaon, IndiaDepartment of Medical Oncology, Basavatarakam Indo American Cancer Hospital & RI, Hyderabad, IndiaDepartment of Medical Oncology, Apollo Cancer Hospital, Chennai, IndiaDepartment of Medical Oncology, Apollo Cancer Center, Kolkata, IndiaDepartment of GI Medical Oncology, Shalby Hospital, Ahmedabad, IndiaHope Cancer Centre, New Delhi, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology and Hematology, Institute of Oncology, AIG Hospitals, Hyderabad, IndiaDepartment of Medical Oncology, Max Superspeciality Hospital, Delhi, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, AIG Hospitals, Hyderabad, IndiaDepartment of Medical Oncology, AIG Hospitals, Hyderabad, IndiaDepartment of Medical Oncology, Pacific Medical College, Udaipur, IndiaDepartment of Medical Oncology, Fortis Memorial Hospital, Gurgaon, IndiaDepartment of Medical Oncology, Narayana Superspeciality Hospital, Howrah and R N Tagore Hospital, Kolkata, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaDepartment of Interventional Radiology, Tata Memorial Centre, Homi Bhabha National Institute HBNI, Mumbai, IndiaDepartment of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, IndiaPURPOSEBiliary tract cancers (BTCs) are usually diagnosed in advanced stages, where treatment options are either palliative chemotherapy and/or best supportive care. The breakthrough results of the TOPAZ-1 trial demonstrated a 24% decrease in risk of death at 2 years with the addition of durvalumab to chemotherapy.MATERIALS AND METHODSThis was a multicenter retrospective cohort study conducted across 14 institutions in India. All the patients were diagnosed with advanced BTCs. The primary objective was to assess median overall survival (mOS) with the use of durvalumab in combination with chemotherapy backbone. The patient details, treatment details, laboratory results, and outcome parameters were recorded from the prospectively collected databases.RESULTSA total of 148 patients were included with a median age of 57.5 years; 36 (24.3%) patients had borderline Eastern Cooperative Oncology Group performance status ≥2. The most common subtype was gall bladder cancer (GBC), seen in 94 patients (63.5%); 126 (85.1%) patients presented with de novo metastases. At a median follow-up of 6.8 months (95% CI, 5.9 to 7.8), the estimated mOS for the entire cohort was 12 months (95% CI, 7.8 to 16.3) and median progression-free survival was 8.2 months (95% CI, 7.1 to 9.4) with objective response achieved in 44 (29.7%) patients, and the estimated 2-year OS being 25%. Immune-related grade 3/4 adverse events were reported in 11 (7.4%) patients. In multivariate analysis, age <60 years (P = .001) and standard dose of durvalumab (P < .001) were found to have improved OS compared with age >60 years and low dose of durvalumab.CONCLUSIONTo our knowledge, these real-world data provide the first evidence in Indian context of the efficacy and safety of durvalumab plus chemotherapy in patients with advanced/metastatic BTCs especially in GBC.https://ascopubs.org/doi/10.1200/GO.24.00216 |
| spellingShingle | Vamshi Krishna Muddu Anjali Shah Anupa John Abhishek Raj Ankur Bahl Senthil J. Rajappa Thirumalairaj Raja Joydeep Ghosh Viraj Lavingia Amish Vora Prabhat Bhargava Anant Ramaswamy Arif Khan Atul Sharma Mehak Trikha Aditya Dhanawat Avinash Bonda Indraja Siripurapu Manoj Mahajan Nitesh Rohatgi Mosale Venkatesha Chandrakant Himanshu Gujarathi Manan Vora Sumankumar Ankathi Vikas S. Ostwal Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India JCO Global Oncology |
| title | Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India |
| title_full | Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India |
| title_fullStr | Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India |
| title_full_unstemmed | Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India |
| title_short | Gemcitabine Cisplatin and Durvalumab Experience in Advanced Biliary Tract Cancers: A Real-World, Multicentric Data From India |
| title_sort | gemcitabine cisplatin and durvalumab experience in advanced biliary tract cancers a real world multicentric data from india |
| url | https://ascopubs.org/doi/10.1200/GO.24.00216 |
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