Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial.

Abstract

OBJECTIVE:

The aim of the present study was to confirm the efficacy and tolerability of docetaxel 75 mg/m(2) in a population of Korean patients with advanced gastric cancer.

METHODS:

Patients with metastatic or locally recurrent gastric cancer received docetaxel 75 mg/m(2) by intravenous infusion every 3 weeks. Objective response rate was the primary endpoint.

RESULTS:

Forty-five patients were enrolled. Most showed adenocarcinomas of the gastric antrum and/or body of the stomach. All showed metastases and two-thirds retained the primary tumour. Forty-four patients received at least one docetaxel infusion ('treated' population), with 40 patients evaluable for response. A total of 159 cycles (median three cycles) were administered, with mean duration of treatment 10.9 weeks. The objective response rate in the treated population was 15.9% (17.5% in the per protocol population), with stable disease in 25.0% of patients and progressive disease in 50.0%. Grade 3-4 neutropenia occurred in 36 (81.8%) patients and 36.1% of cycles. However, febrile neutropenia occurred in only two (4.5%) patients and 1.3% of cycles. Grade 3 anorexia, experienced by two patients (4.5%) and during 1.9% of cycles, was the most frequent non-haematological adverse event possibly or probably related to docetaxel. No grade 4 non-haematological events occurred.

CONCLUSION:

This study suggests that docetaxel 75 mg/m(2) is active in metastatic or locally recurrent adenocarcinoma with a low incidence of grade 3-4 adverse events. Docetaxel warrants further study in combination regimens for advanced gastric cancer.

• Authors: Yung-Jue Bang, Won Ki Kang, Yoon-Koo Kang, Hugh Chul Kim, Christian Jacques, Emmanuel Zuber, Byzance Daglish, Yvane Boudraa, Won Seog Kim, Dae Seog Heo, Noe Kyeong Kim
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 32 Issue 7 Pg. 248-54 (Jul 2002) ISSN: 0368-2811 [Print] England
• PMID: 12324575 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Taxoids
• Docetaxel
• Paclitaxel

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Docetaxel
• Drug Administration Schedule
• Drug Evaluation
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Neutropenia (chemically induced)
• Paclitaxel (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Stomach Neoplasms (drug therapy)
• Taxoids