Triplet chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced squamous cell carcinoma of the esophagus: phase I/II trial results
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Toshiyasu Ojima1, Masaki Nakamura1, Mikihito Nakamori1, Masahiro Katsuda1, Keiji Hayata1, Junya Kitadani1, Shimpei Maruoka1, Toshio Shimokawa2 and Hiroki Yamaue1
1Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan
2Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan
Hiroki Yamaue, email: [email protected]
Keywords: squamous cell carcinoma; esophageal cancer; docetaxel; cisplatin; S-1
Received: December 06, 2018 Accepted: January 03, 2019 Published: January 25, 2019
Background: Although triplet regimen of docetaxel, cisplatin, and 5-FU (DCF) reportedly yields high response rates for metastatic squamous cell carcinoma of the esophagus (SCCE), it has severe toxicity. In our previous phase II trial, grade 3/4 toxicities of neutropenia occurred in 68.8% of the patients. Development of chemotherapeutic regimen that does not impair quality of life of the patients with metastatic SCCE is therefore needed. A novel chemotherapeutic regimen combining docetaxel, cisplatin, and alternate-day administration of S-1 (modified DCS) may be associated with reduction of severe adverse effects.
Methods: This study is a single center phase I/II trial of chemotherapy using modified DCS regimen for patients with recurrent/unresectable SCCE. The phase I trial adopts a ‘3 + 3 patient cohort’, dose-escalating study design. In the phase II trial, the primary endpoint is evaluation of the overall response rate (ORR). Secondary endpoints are evaluation of drug-related toxicity, overall survival (OS), and progression-free survival (PFS).
Results: In the phase I trial, the recommended dose for docetaxel, cisplatin, and S-1 were 40 mg/m2 (day 1), 50 mg/m2 (day 1), and 80 mg/m2/day, respectively. In the phase II trial (n = 50), the ORR was 54 %. The median OS and PFS were 10 and 4 months, respectively. Grade 3/4 adverse events included neutropenia (26%), leukopenia (14%), anorexia (10%) and febrile neutropenia (6%).
Conclusion: The modified DCS therapy for patients with advanced SCCE is feasible and safe in both chemotherapeutic and perioperative periods.
Registration number: UMIN000016364.
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