A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer.

Abstract

BACKGROUND:

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/m(2) 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.

• Authors: K Muro, T Hamaguchi, A Ohtsu, N Boku, K Chin, I Hyodo, H Fujita, W Takiyama, T Ohtsu
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 15 Issue 6 Pg. 955-9 (Jun 2004) ISSN: 0923-7534 [Print] England
• PMID: 15151954 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel

Topics

• Adenocarcinoma (drug therapy, secondary)
• Aged
• Antineoplastic Agents, Phytogenic (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, secondary)
• Docetaxel
• Esophageal Neoplasms (drug therapy, pathology)
• Female
• Humans
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Survival Analysis
• Taxoids (adverse effects, therapeutic use)
• Treatment Outcome