A phase II study of nedaplatin and 5-fluorouracil in metastatic squamous cell carcinoma of the esophagus: The Japan Clinical Oncology Group (JCOG) Trial (JCOG 9905-DI)
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This phase II study evaluated the efficacy and toxicity of combination chemotherapy with nedaplatin and 5-fluorouracil (5-FU) for metastatic esophageal squamous cell carcinoma.
Eligibility criteria included squamous cell carcinoma with organ metastasis, ECOG performance status (PS) 0–2, ≤ 75 years, measurable disease, and adequate organ function. Chemotherapy consisted of 5-FU (800 mg/m2/day) on days 1–5 and a 2-h infusion of nedaplatin (90 mg/m2) on day 1, repeated every 4 weeks. Therapy was continued until disease progression or intolerable adverse events. The primary end point was response rate. Secondary end points included overall survival, progression-free survival, and toxicities.
Forty-two patients (39 men, 3 women; median age 59 years; range 44–70 years) were enrolled. Twenty-one, 21, and 0 patients had PS 0, 1, and 2, respectively. 23, 6, 3, and 18 patients had a history of surgical resection, radiotherapy, adjuvant chemotherapy, and no therapy, respectively. Among the 38 eligible patients, 1 and 14 complete and partial responses were observed, respectively; the overall response rate was 39.5 % (90 % confidence interval: 26.1–54.1 %). The median survival time was 8.8 months. The one-year survival rate was 32.9 %. Grade 4 neutropenia and thrombocytopenia were observed in 7 and 2 % of 41 patients, respectively. Grade 3 nausea, diarrhea, and stomatitis were observed in 12, 2, and 2 %, respectively.
Combination therapy with nedaplatin and 5-FU is highly active and well tolerated in metastatic or recurrent esophageal squamous cell cancer and is therefore a chemotherapy option for esophageal squamous cell carcinoma.
KeywordsEsophageal squamous cell carcinoma Chemotherapy 5-FU Nedaplatin
We thank Ms. Makiko Shinogi and Ms. Hiromi Orita for collecting data. This study was supported by Grants-in-Aid for Cancer Research from the Ministry of Health, Labour, and Welfare of Japan.
This work conforms to the guidelines set forth in the Helsinki Declaration of 1975, as revised in 2000 (5), concerning Human and Animal Rights. We followed the policy concerning informed consent as shown on the following sites. http://www.springer.com/authors/journal+authors/helpdesk?SGWID=0-1723213-12-995756-0%3Cbr%20/%3E.
Conflict of interest
All authors declare that they have no conflicts of interest regarding this article.
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