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- Title
A phase I study of docetaxel/oxaliplatin/S-1 (DOS) combination neoadjuvant chemotherapy for patients with locally advanced adenocarcinoma of the esophagogastric junction.
- Authors
Hosoda, Kei; Azuma, Mizutomo; Katada, Chikatoshi; Ishido, Kenji; Niihara, Masahiro; Ushiku, Hideki; Sakuraya, Mikiko; Washio, Marie; Wada, Takuya; Watanabe, Akinori; Harada, Hiroki; Tanabe, Satoshi; Koizumi, Wasaburo; Yamashita, Keishi; Hiki, Naoki
- Abstract
Background: The optimal dose of each drug used in the docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy remains to be clarified for the Japanese population. The purpose of this study was to determine a recommended dose for a combination neoadjuvant DOS chemotherapy for Japanese patients with locally advanced adenocarcinoma of the esophagogastric junction (AEG). Methods: Patients with cT3 or more advanced AEG without distant metastasis were eligible for this study. The planned dosages of docetaxel (mg/m2, day 1), oxaliplatin (mg/m2, day 1), and S-1 (mg/day, days 1–14) were: 50/100/80–120 at level 1, and 60/100/80–120 at level 2, respectively. The treatment cycle was repeated every 3 weeks, and patients were assessed for response to the treatment after 2 and 3 cycles. This study was registered in the UMIN Clinical Trial Registry (UMIN 000022210). Results: We enrolled 12 patients with locally advanced AEG in this study. At dose level 1, one of the six patients experienced dose-limiting toxicity (DLT) of grade 3 diarrhea and grade 3 febrile neutropenia. Two of the next six patients also experienced DLT of need for more than 2-week delay of the start of the second cycle due to adverse events at dose level 2. Based on these results, level 2 was considered the recommended dose for this regimen. Conclusion: Recommended doses of docetaxel (mg/m2), oxaliplatin (mg/m2), and S-1 (mg/day) were 60/100/80–120. This chemotherapy scheme showed good preliminary efficacy with acceptable toxicity warranting a further phase II trial to investigate the efficacy of this regimen.
- Subjects
ESOPHAGOGASTRIC junction; COMBINATION drug therapy; CLINICAL trial registries; FEBRILE neutropenia; ADENOCARCINOMA
- Publication
International Journal of Clinical Oncology, 2020, Vol 25, Issue 6, p1090
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-020-01638-5