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Research Papers:

Triplet chemotherapy with docetaxel, cisplatin and S-1 for unresectable advanced squamous cell carcinoma of the esophagus: phase I/II trial results

Toshiyasu Ojima, Masaki Nakamura, Mikihito Nakamori, Masahiro Katsuda, Keiji Hayata, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa and Hiroki Yamaue _

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Oncotarget. 2019; 10:847-855. https://doi.org/10.18632/oncotarget.26614

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Abstract

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

Correspondence to:

Hiroki Yamaue, email: yamaue-h@wakayama-med.ac.jp

Keywords: squamous cell carcinoma; esophageal cancer; docetaxel; cisplatin; S-1

Received: December 06, 2018     Accepted: January 03, 2019     Published: January 25, 2019

ABSTRACT

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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