Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea
Choong-kun Lee , Minkyu Jung , Seok Yun Kang , Bong-Seog Kim , Ki Hyang Kim , Kyung Hee Lee , Moon Hee Lee , Dong Bok Shin , Dae Young Zang , Ji Yeong Ahn , Hyoung-Il Kim , Woo Jin Hyung , Sung Hoon Noh , Hyo Song Kim , Hyun Cheol Chung , Sun Young Rha
Background: Even among completely resected gastric cancer patients treated with adjuvant chemotherapy, stage III patients show bad prognosis and somewhat better treatment option is needed. Docetaxel or cisplatin each added to S1 monotherapy showed survival benefits in advanced gastric cancer. Methods: We conducted randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S1 plus cisplatin (SP) in stage III gastric cancer patients. Gastric cancer patients (AJCC 7th stage III) who had had curative D2 gastrectomy were randomized 1:1 to receive adjuvant chemotherapy of eight 3 week cycles of DS (S-1 70mg/m2/day on day 1-14 plus docetaxel 35mg/m2 on day 1, and day 8) or SP (S-1 70mg/m2/day on day 1-14 plus cisplatin 60mg/m2on day 1). The primary endpoint was 3-year disease-free survival (3Y-DFS). Secondary endpoints include overall survival (OS) and safety. (NCT01283217) Results: As a result of early closure due to slow accrual, 153 patients of planned 290 patients were randomly assigned (75 patients to DS and 78 patients to SP) from 8 institutions for 31 months. The median follow up duration was 15.8 months (range, 0.8 to 36.2 months). There was no difference in DFS (HR, 1.088; 95% CI, 0.589 to 2.01; p=0.787) or OS (HR, 1.621; 95% CI, 0.707 to 3.720; p=0.254) between DS and SP. Most common grade 3 or 4 adverse event was neutropenia (42.7% among DS group and 38.5% among SP group, p=0.351). SP group suffered more grade 3 or 4 anemia (1.3% vs. 11.5%, p=0.037), where grade 3 or 4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common among DS group. Conclusions: Although the trial closed prematurely and had short follow up duration, S-1 plus cisplatin or docetaxel is an effective and tolerable option for patients with stage III advanced gastric cancer patients. Clinical trial information: NCT01283217.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Toru Imai
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Anant Ramaswamy
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Takahiro Tsushima
2020 ASCO Virtual Scientific Program
First Author: Alberto F. Sobrero