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- Title
Phase I/II Trial of Chemotherapy with Docetaxel, Cisplatin, and S-1 for Unresectable Advanced Squamous Cell Carcinoma of the Esophagus.
- Authors
Ojima, Toshiyasu; Nakamura, Masaki; Nakamori, Mikihito; Katsuda, Masahiro; Hayata, Keiji; Maruoka, Shimpei; Shimokawa, Toshio; Yamaue, Hiroki
- Abstract
Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxicity of the DCF regimen, however, was clinically harmful. S-1, an oral anticancer drug, has been approved as a combination therapy for SCCE, and alternate-day regimen with S-1 has shown lower levels of toxicity. This prospective single-center phase I/II trial examines the efficacy and toxicity of a combination of docetaxel, cisplatin, and an alternate-day regimen of S-1 (modified DCS) for patients with metastatic SCCE. We use a two-stage design. Phase I is undertaken to determine the maximum tolerated dose and the recommended dose. The phase I trial adopts a three-patient cohort with escalating dose study design. In the phase II trial, the primary endpoint is the assessment of the overall response rate (Response Evaluation Criteria in Solid Tumors 1.1). The secondary endpoints are the evaluation of drug-related toxicity (National Cancer Institute Common Toxicity Criteria 4.0), overall survival, and progression-free survival. Fifty patients with metastatic SCCE participate in the phase II section. This study protocol is the first to test the effects of the modified DCS regimen for metastatic SCCE.
- Subjects
ANTINEOPLASTIC agents; COMBINATION drug therapy; CISPLATIN; CLINICAL trials; ESOPHAGEAL tumors; LONGITUDINAL method; METASTASIS; ORAL drug administration; SQUAMOUS cell carcinoma; SURVIVAL; TUMOR classification; DOCETAXEL; PROGNOSIS
- Publication
Oncology, 2018, Vol 95, Issue 2, p116
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000488861