Cancer Res Treat.  2007 Jun;39(2):49-53.

Phase II Study of Docetaxel and Cisplatin as First-line Chemotherapy in Patients with Recurrent or Metastatic Gastric Cancer

• Kim KH
• Jeung KJ
• Kim HJ
• Bae SB
• Kim CK
• Lee NS
• Lee KT
• Park SK
• Won JH
• Hong DS
• Park HS

Abstract

PURPOSE: Palliative chemotherapy for patients with recurrent or metastatic gastric cancer has been shown to have a survival benefit. Docetaxel monotherapy has achieved appreciable results for treating gastric cancer. We investigated the clinical efficacy and feasibility of a docetaxel and cisplatin combination regimen for patients suffering with recurrent or metastatic gastric cancer.
MATERIALS AND METHODS
Patients with histologically proven, bidimensionally measurable lesions of recurrent or metastatic gastric cancer, and they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and no prior palliative chemotherapy were eligible for this study. The combination chemotherapy regimen consisted of docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 on day 1, and this was repeated every 3 weeks until disease progression.
RESULTS
32 patients were enrolled from 2002 to 2005. The objective response rate was 31.3% (95% confidenceinterval (CI): 14.2~48.2%) with no CR. The disease control rate was 59.4%. At a median follow up of 38.9 months, the median overall survival was 7.4 months (95% CI: 6.3~8.5). The median time to progression was 4.7 months (95% CI: 3.1~6.3). During a total of 106 cycles, grade 3 or 4 hematological toxicities were observed as follows: neutropenia (39 of 106 cycles) and anemia (3 of 106 cycles). The grade 3 or 4 non-hematological toxicities included anorexia (18.9%) and nausea/vomiting (21.7%).
CONCLUSION
Docetaxel and cisplatin combination chemotherapy showed promising anti-tumor activity and this was well tolerated as a first-line treatment for patients with recurrent or metastatic gastric cancer. Further large, randomized phase III studies are warranted.

Keyword

Docetaxel; Cisplatin; Stomach neoplasms

MeSH Terms

Anemia
Anorexia
Cisplatin*
Disease Progression
Drug Therapy*
Drug Therapy, Combination
Follow-Up Studies
Humans
Neutropenia
Stomach Neoplasms*
Cisplatin

Figure

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  Fig. 1 Overall survival curve by the Kaplan-Meier method. The median OS was 7.4 months (95% CI: 6.3~8.5).

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  Fig. 2 Time to progression curve by the Kaplen-Meier method. The median TTP was 4.7 months (95% CI: 3.1~6.3).

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