A Multicenter Randomized Phase II Study of Docetaxel vs. Docetaxel Plus Cisplatin vs. Docetaxel Plus S-1 as Second-Line Chemotherapy in Metastatic Gastric Cancer Patients Who Had Progressed after Cisplatin Plus Either S-1 or Capecitabine
Cancer Research and Treatment 2017년 49권 3호 p.706 ~ p.716
이근욱(Lee Keun-Wook) - Seoul National University Bundang Hospital Department of Internal Medicine
김범준(Kim Bum-Jun) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology
김미정(Kim Mi-Jung) - National Cancer Center Center for Gastric Cancer
한혜숙(Han Hye-Sook) - Chungbuk National University College of Medicine Department of Internal Medicine
김진원(Kim Jin-Won) - Seoul National University Bundang Hospital Department of Internal Medicine
박영이(Park Young-Iee) - National Cancer Center Center for Gastric Cancer
박숙련(Park Sook-Ryun) - National Cancer Center Center for Gastric Cancer
Abstract
Purpose: This study evaluated the re-challenge of S-1 or cisplatin in combination with docetaxel in metastatic gastric cancer (MGC) that had progressed on a cisplatin plus either S-1 or capecitabine regimen.
Materials and Methods: Patients with progressive disease after first-line cisplatin plus S-1 or capecitabine were randomized to receive 3-week cycles of docetaxel 75 mg/m2 intravenously (IV) on D1 (D), docetaxel 60 mg/m2 IV plus cisplatin 60 mg/m² IV on D1 (DC), or docetaxel 60 mg/m2 IV D1 plus oral S-1 30 mg/m2 twice a day on D1-14 (DS).
Results: Seventy-two patients were randomized to the D (n=23), DC (n=24), or DS (n=25) group. The confirmed response rate was 4.3% (95% confidence interval [CI], 0% to 12.6%), 4.3% (95% CI, 0% to 12.6%), and 8.7% (95% CI, 0% to 20.2%) for the D, DC, and DS groups, respectively. Compared to the D arm, the DS arm had a better progression-free survival (2.7 months vs. 1.3 months, p=0.034) without any deterioration in safety or quality of life, whereas the DC arm had a similar progression-free survival (1.8 months vs. 1.3 months, p=0.804) and poorer overall survival (5.6 months vs. 10.0 months, p=0.035).
Conclusion: A re-challenge with S-1, but not cisplatin, in combination with docetaxel has potential anticancer benefits over docetaxel alone in MGC with progression after prior cisplatin plus S-1 or capecitabine.
키워드
Stomach neoplasms, Antineoplastic agents, Docetaxel, Tegafur-gimeracil-oteracil, Cisplatin
KMID :
0939920170490030706
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유효성결과(Recomendation)
The addition of S-1, but not cisplatin, to docetaxel as a second-line treatment resulted in better efficacy in terms of the PFS compared to docetaxel alone, without clinically significant impairment of safety or QoL aspects, in MGC patients after progression on first-line S-1 or capecitabine plus cisplatin.