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Efficacy of Capecitabine Plus Irinotecan vs Irinotecan Monotherapy as Second-line Treatment in Patients With Advanced Gallbladder Cancer

医学 伊立替康 卡培他滨 内科学 胆囊癌 肿瘤科 胆囊 癌症 结直肠癌
作者
Anant Ramaswamy,Vikas Ostwal,Atul Sharma,Prabhat Bhargava,Sujay Srinivas,Mahesh Goel,Shraddha Patkar,Sarika Mandavkar,Poonam Jadhav,Manali Parulekar,Amitkumar Choudhari,Sudeep Gupta
出处
期刊:JAMA Oncology [American Medical Association]
卷期号:7 (3): 436-436 被引量:27
标识
DOI:10.1001/jamaoncol.2020.6166
摘要

Importance

There is therapeutic uncertainty regarding use of combination or single-agent chemotherapy in the treatment of patients with gallbladder cancer who experience disease progression after first-line chemotherapy.

Objective

To compare the efficacy of capecitabine plus irinotecan (CAPIRI) vs irinotecan (IRI) alone in patients with advanced gallbladder cancer (GBC) who have disease progression after gemcitabine-based first-line treatment.

Design, Setting, and Participants

The GB-SELECT trial was a multicenter, open-label, phase 2, randomized clinical trial of CAPIRI vs IRI alone for treatment of gallbladder cancer in patients who had disease progression after prior gemcitabine-based chemotherapy.The study was carried out in 2 tertiary care institutions in India. Patients aged between 18 and 70 years with histopathologic diagnosis of adenocarcinoma gallbladder, advanced or metastatic disease, previous treatment with gemcitabine-based chemotherapy, adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between August 2018 and January 2020. The data were analyzed for this report with cutoff on May 19, 2020.

Interventions

Patients were randomized 1:1 to receive capecitabine, 1700 mg/m2per day, on days 1 to 14 plus intravenous irinotecan, 200 mg/m2, on day 1 or intravenous irinotecan, 240 mg/m2, on day 1, in 21-day cycles until disease progression or unacceptable toxic effects.

Main Outcomes and Measures

The primary end point was overall survival (OS) at 6 months. The secondary end points were progression-free survival and quality of life.

Results

A total of 98 patients were randomized, 49 in each arm, with median (range) age of 51 (29-70) years, with 60 (61%) being women. In the CAPIRI vs IRI arms, the number of deaths at 6 months, 6-month OS, and median OS were 35, 34, 38.4% (95% CI, 24.2%-52.6%) and 5.16 (95% CI, 4.26-6.06) months vs 34, 29, 54.2% (95% CI, 39.4%-69.0%) and 6.28 (95% CI, 4.25-8.30) months, respectively, with a hazard ratio of 1.02 (95% CI, 0.64-1.49,P = .93). There were no chemotherapy-related deaths but more patients required dose modification in CAPIRI compared with the IRI arm (13 [27%] vs 4 [9%], respectively,P = .03).

Conclusions and Relevance

There was no significant difference in OS between treatment with capecitabine plus irinotecan or irinotecan alone among previously treated patients with gallbladder cancer. Single-agent irinotecan should be the preferred treatment option for such patients.

Trial Registration

CTRI/2017/10/010112
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