Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic gastric cancer.

Abstract

PURPOSE:

Docetaxel, as a single agent, has demonstrated activity in patients with advanced gastric cancer and cisplatin has shown lack of overlapping toxicities with docetaxel. Therefore, we conducted a phase II study to assess the efficacy and the toxicity of a combination regimen of docetaxel plus cisplatin in patients with advanced gastric cancer who have never been treated with palliative chemotherapy.

METHODS:

Ninety-two patients with metastatic gastric cancer were enrolled from April 2000 to March 2004. Patients with histologically confirmed gastric adenocarcinoma, at least one bi-dimensionally measurable lesion, no prior palliative chemotherapy and at least 6 months from the end of adjuvant chemotherapy were eligible for study entry. Docetaxel 75 mg/m(2 )and cisplatin 75 mg/m(2) were given on day 1. The cycle was repeated every 3 weeks. The objective response was evaluated after three cycles of chemotherapy. Toxicity was assessed according to the National Cancer Institute common toxicity criteria scale version 2.0.

RESULTS:

In total, 401 cycles were administered, with a median of 5 cycles per patient (range 1-9 cycles). The median age was 56 years (range 31-76). Eighty-six patients were evaluable for treatment response. The objective response rate was 43.5% (95% CI, 33.4-53.6) with one complete response and 39 partial responses. Twenty patients (21.7%) had stable disease and 26 patients (28.3%) had a progression. The median time to progression was 7.0 months (95% CI, 5.0-9.0) and the median overall survival was 11.5 months (95% CI, 9.5-13.4). The chemotherapy was generally well tolerated and the most common grade 3-4 toxicities were neutropenia (17.4%), nausea/vomiting (13.0%) and diarrhea (7.6%).

CONCLUSION:

The combination chemotherapy of docetaxel with cisplatin in advanced gastric cancer was tolerable for most patients and showed a promising antitumor activity as a first-line therapy.

• Authors: Keon Woo Park, Jin Seok Ahn, Young Suk Park, Jeeyun Lee, Jung Hoon Kang, Joon Oh Park, Ho Yeong Lim, Young-Hyuck Im, Won Ki Kang, Keunchil Park, Soon Il Lee
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 59 Issue 1 Pg. 17-21 (Jan 2007) ISSN: 0344-5704 [Print] Germany
• PMID: 16721549 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents
• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel
• Cisplatin

Topics

• Adenocarcinoma (drug therapy, pathology)
• Adult
• Aged
• Antineoplastic Agents (administration & dosage)
• Antineoplastic Agents, Phytogenic (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Cisplatin (administration & dosage)
• Diarrhea (chemically induced)
• Disease Progression
• Docetaxel
• Female
• Humans
• Male
• Middle Aged
• Nausea (chemically induced)
• Neoplasm Metastasis (pathology)
• Neutropenia (chemically induced)
• Palliative Care
• Stomach Neoplasms (drug therapy, pathology)
• Taxoids (administration & dosage)
• Vomiting (chemically induced)