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 2017³â 49±Ç 3È£ p.706 ~ p.716
À̱ٿí(Lee Keun-Wook) - Seoul National University Bundang Hospital Department of Internal Medicine
±è¹üÁØ(Kim Bum-Jun) - University of Ulsan College of Medicine Asan Medical Center Department of Oncology
±è¹ÌÁ¤(Kim Mi-Jung) - National Cancer Center Center for Gastric Cancer
ÇÑÇý¼÷(Han Hye-Sook) - Chungbuk National University College of Medicine Department of Internal Medicine
±èÁø¿ø(Kim Jin-Won) - Seoul National University Bundang Hospital Department of Internal Medicine
¹Ú¿µÀÌ(Park Young-Iee) - National Cancer Center Center for Gastric Cancer
¹Ú¼÷·Ã(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/m©÷ 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.
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Stomach neoplasms, Antineoplastic agents, Docetaxel, Tegafur-gimeracil-oteracil, Cisplatin
KMID :
0939920170490030706
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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.