Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder
Objective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC). Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initia...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Thieme Medical and Scientific Publishers Pvt. Ltd.
2020-10-01
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| Series: | South Asian Journal of Cancer |
| Subjects: | |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1721216 |
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| author | Manish Sharma Vineet Talwar Udip Maheshwari Venkata Pradeep Babu Koyyala Varun Goel Sumit Goyal Prasanta Kumar Dash Ullas Batra Rajat Bajaj Abhishek Yadav Pankaj Goyal Dinesh Chandra Doval |
| author_facet | Manish Sharma Vineet Talwar Udip Maheshwari Venkata Pradeep Babu Koyyala Varun Goel Sumit Goyal Prasanta Kumar Dash Ullas Batra Rajat Bajaj Abhishek Yadav Pankaj Goyal Dinesh Chandra Doval |
| author_sort | Manish Sharma |
| collection | DOAJ |
| description | Objective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC).
Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initial six cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of the 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1 g/m2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was performed using the Kaplan–Meier method and comparisons by the log-rank test. A p-value < 0.05 was considered as statistically significant.
Results Of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1–6.3) in gemcitabine arm and 2.6 months (2.4–2.8) in observation arm, hazard ratio (HR) 0.196 (95% confidence interval [CI]: 0.1–0.39), p < 0.001. Median overall survival in gemcitabine arm was 12.4 months (9.15–15.6) as opposed to 9.9 months (8.29–11.5) in observation arm, HR 0.76 (95% CI: 0.43–1.35), p = 0.354. The grade 3 or 4 side effects in maintenance arm were transaminitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%), and febrile neutropenia (7.1%).
Conclusions Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increase PFS with minimal and manageable side effects. |
| first_indexed | 2024-12-17T03:37:20Z |
| format | Article |
| id | doaj.art-c3b1bbb73eac4f88bc4129c49d3e169b |
| institution | Directory Open Access Journal |
| issn | 2278-330X 2278-4306 |
| language | English |
| last_indexed | 2024-12-17T03:37:20Z |
| publishDate | 2020-10-01 |
| publisher | Thieme Medical and Scientific Publishers Pvt. Ltd. |
| record_format | Article |
| series | South Asian Journal of Cancer |
| spelling | doaj.art-c3b1bbb73eac4f88bc4129c49d3e169b2022-12-21T22:05:06ZengThieme Medical and Scientific Publishers Pvt. Ltd.South Asian Journal of Cancer2278-330X2278-43062020-10-01090420420810.1055/s-0040-1721216Role of Maintenance Gemcitabine in Advanced Carcinoma GallbladderManish Sharma0Vineet Talwar1Udip Maheshwari2Venkata Pradeep Babu Koyyala3Varun Goel4Sumit Goyal5Prasanta Kumar Dash6Ullas Batra7Rajat Bajaj8Abhishek Yadav9Pankaj Goyal10Dinesh Chandra Doval11Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Fortis Escorts Hospital, Faridabad, Haryana, IndiaDepartment of Medical Oncology, Fortis Escorts Hospitals, Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaDepartment of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, IndiaObjective The aim of this study is to investigate the effects of gemcitabine maintenance on progression-free survival (PFS) in patients with metastatic gallbladder cancer (GBC). Materials and Methods Sixty patients with unresectable or metastatic GBC having ongoing response to treatment with initial six cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of the 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1 g/m2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was performed using the Kaplan–Meier method and comparisons by the log-rank test. A p-value < 0.05 was considered as statistically significant. Results Of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1–6.3) in gemcitabine arm and 2.6 months (2.4–2.8) in observation arm, hazard ratio (HR) 0.196 (95% confidence interval [CI]: 0.1–0.39), p < 0.001. Median overall survival in gemcitabine arm was 12.4 months (9.15–15.6) as opposed to 9.9 months (8.29–11.5) in observation arm, HR 0.76 (95% CI: 0.43–1.35), p = 0.354. The grade 3 or 4 side effects in maintenance arm were transaminitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%), and febrile neutropenia (7.1%). Conclusions Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increase PFS with minimal and manageable side effects.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1721216gallbladder cancergemcitabinemaintenanceprogression-free survival |
| spellingShingle | Manish Sharma Vineet Talwar Udip Maheshwari Venkata Pradeep Babu Koyyala Varun Goel Sumit Goyal Prasanta Kumar Dash Ullas Batra Rajat Bajaj Abhishek Yadav Pankaj Goyal Dinesh Chandra Doval Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder South Asian Journal of Cancer gallbladder cancer gemcitabine maintenance progression-free survival |
| title | Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder |
| title_full | Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder |
| title_fullStr | Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder |
| title_full_unstemmed | Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder |
| title_short | Role of Maintenance Gemcitabine in Advanced Carcinoma Gallbladder |
| title_sort | role of maintenance gemcitabine in advanced carcinoma gallbladder |
| topic | gallbladder cancer gemcitabine maintenance progression-free survival |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1721216 |
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