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Phase II Study of Docetaxel and Cisplatin Chemotherapy in 5-Fluorouracil/Cisplatin Pretreated Esophageal Cancer

Shim, Hyun-Jeong MD, PhD*; Cho, Sang-Hee MD, PhD*; Hwang, Jun-Eul MD*; Bae, Woo-Kyun MD*; Song, Sang-Yun MD; Cho, Sung-Bum MD, PhD*; Lee, Wan-Sik MD, PhD*; Joo, Young-Eun MD, PhD*; Na, Kook-Joo MD, PhD; Chung, Ik-Joo MD, PhD*‡

American Journal of Clinical Oncology: December 2010 - Volume 33 - Issue 6 - p 624-628
doi: 10.1097/COC.0b013e3181bead92
Original Article: Thoracic

Background: This study was performed to determine the feasibility and safety of salvage chemotherapy, using docetaxel and cisplatin in 5-fluorouracil (5-FU) and cisplatin-pretreated esophageal cancer.

Methods: Patients with metastatic or recurrent esophageal squamous cell carcinoma that had previously been treated with 5-FU and cisplatin chemotherapy or chemoradiotherapy were eligible for this study. Docetaxel (70 mg/m2) and cisplatin (75 mg/m2) were given as a 1-hour intravenous infusion on day 1, and the treatment was repeated every 3 weeks.

Results: Thirty-eight male patients were enrolled, and 35 patients were available for evaluation. The median age was 64.5 years; Eastern Cooperative Oncology Group performance status was 0/1/2 = 2/18/18. The median and total numbers of cycles delivered were 3.5 (range, 1–9 cycles) and 162, respectively. One patient (2.6%) achieved complete response, 12 (31.6%) achieved partial response, 12 (31.6%) had stable disease, and 10 (26.3%) had progressive disease. The overall response rate was 34.2% (95% confidence interval, 19.6–51.3). The median progression-free survival and overall survival times were 4.5 ± 1.3 months (95% CI, 4.1–4.9) and 7.4 ± 0.4 months (95% CI, 7.3–7.5), respectively. The main hematological toxicities greater than grade 3 were neutropenia and leucopenia in 20 (52.6%) and 18 patients (47.3%), respectively. Nonhematological toxicities greater than grade 3 included asthenia in 12 patients (31.6%), nausea in 7 patients (18.4%), and peripheral neuropathy in 6 patients (15.8%).

Conclusions: Chemotherapy with docetaxel and cisplatin was an effective and feasible treatment following treatment with 5-FU and cisplatin, and would be considered as a salvage option for patients with refractory esophageal cancer.

From the Departments of *Internal medicine and †Chest Surgery, and ‡The Brain Korea 21 Project, Center for Biomedical Human Resources, Chonnam National University Medical School, Gwangju, Korea.

Reprints: Ik-Joo Chung, MD, PhD, Department of Internal Medicine, Chonnam National University Hwasun Hospital, 160 Ilsim-ri, Hwasun-eup, Hwasun-gun, Jeollanamdo, Korea. E-mail ijchung@chonnam.ac.kr.

© 2010 Lippincott Williams & Wilkins, Inc.