Annals of Oncology 15:955-959, 2004
© 2004 European Society for Medical Oncology
Original Paper |
A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer
Received 22 December 2003; revised 8 February 2004; accepted 17 February 2004Background:
To evaluate the activity and toxicity of docetaxel in patients with metastatic esophageal cancer.
Patients and methods:
Eligible patients had histologically confirmed carcinoma of the esophagus with measurable metastatic sites according to Response Evaluation Criteria in Solid Tumors (RECIST). Patients were either chemotherapy-naïve or previously treated with one regimen of chemotherapy. Docetaxel 70 mg/m2 was administered intravenously over 1–2 h, every 21 days.
Results:
Of 52 patients enrolled in this study, three were excluded because they did not receive docetaxel due to worsening condition after enrollment. Thirty-six patients had received prior platinum-based chemotherapy. The majority of patients (94%) had squamous cell carcinoma. Ten of 49 evaluable patients [20%; 95% confidence interval (CI) 10–34%] showed a partial response. Of the 10 partial responses, six patients had received prior platinum-based chemotherapy. Grade 3 or 4 neutropenia was noted in 43 of 49 patients (88%), and nine of 49 patients (18%) developed febrile neutropenia. Twenty-eight of 49 patients (57%) required lenograstim. Grade 3 anorexia and fatigue occurred in nine (18%) and six (12%) patients, respectively. Median survival time was 8.1 months (95% CI 6.6–11.3) and the 1-year survival rate was 35% (95% CI 21–48%).
Conclusions:
Docetaxel as a single agent is effective in esophageal cancer, but careful management of neutropenia is needed.
1 Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo; 2 Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa; 3 Department of Medical Oncology, Cancer Institute Hospital, Tokyo; 4 Department of Internal Medicine, National Shikoku Cancer Center Hospital, Matsuyama; 5 Department of Surgery, Kurume University School of Medicine, Kurume; 6 Department of Surgery, Hiroshima City Asa Hospital, Hiroshima; 7 Aventis Pharma Ltd, Tokyo, Japan
Key words: docetaxel, esophageal cancer, phase II study, RECIST, single agent
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