Cancer Res Treat.  2009 Dec;41(4):196-204.

Docetaxel versus Paclitaxel Combined with 5-FU and Leucovorin in Advanced Gastric Cancer: Combined Analysis of Two Phase II Trials

• Chon HJ
• Rha SY
• Im CK
• Kim C
• Hong MH
• Kim HR
• An JR
• Noh SH
• Chung HC
• Jeung HC

Abstract

PURPOSE
This is an ad hoc analysis of two phase II studies which compared the efficacy and safety of two taxanes (paclitaxel and docetaxel) combined with 5-fluorouracil (5-FU) and leucovorin (LV) in advanced gastric cancer. MATERIALS AND METHODS: Patients with advanced gastric adenocarcinoma who were untreated or had only received first-line chemotherapy, were treated with either paclitaxel (PFL; 175 mg/m2) or docetaxel (DFL; 75 mg/m2) on day 1, followed by a bolus of LV (20 mg/m2 days 1~3) and a 24-hour infusion of 5-FU (1,000 mg/m2 days 1~3) every 3 weeks. The primary endpoint was overall response rate (ORR) and the secondary endpoint included survival and toxicity. RESULTS: Sixty-six patients received DFL (first-line [n=38]; and second-line [n=28]) and 60 patients received PFL (first-line [n=37]; and second-line [n=23]). The ORRs were not significantly different between the 2 groups (DFL, 26%; PFL, 38%). With a median follow-up of 9.5 months, the progression free survival was 5.2 months (95% confidence interval [CI], 4.2~6.5 months) for DFL and 3.3 months (95% CI, 1.3~5.5 months) for PFL (p=0.17). The overall survival was also comparable between the patients who received DFL and PFL (10.0 months [95% CI, 7.2~12.5 months] and 13.9 months [95% CI, 10.9~19.2 months], respectively; p=0.37). The most frequent grade 3~4 adverse event was neutropenia (DFL, 71%; PFL, 62%). DFL and PFL had different non-hematologic toxicities; specifically, grade > or =3 mucositis (5%) and diarrhea (3%) were common in DFL, while nausea/vomiting (15%) and peripheral neuropathy (5%) were common in PFL. CONCLUSION: Thus, the two taxanes had similar efficacy in the treatment of advanced gastric cancer, but different toxicity profiles. Prospective comparative studies are required to further clarify the role of taxanes in the treatment of advanced gastric cancer.

Keyword

Docetaxel; Paclitaxel; Stomach neoplasms

MeSH Terms

Adenocarcinoma
Diarrhea
Disease-Free Survival
Fluorouracil
Follow-Up Studies
Humans
Leucovorin
Mucositis
Neutropenia
Paclitaxel
Peripheral Nervous System Diseases
Prospective Studies
Stomach Neoplasms
Taxoids
Fluorouracil
Leucovorin
Paclitaxel
Taxoids

Figure

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  Fig. 1 Survival curves of all patients. (A) Progression free survival (PFS), (B) overall survival (OS).

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  Fig. 2 Survival curves according to previous treatment. (A) Progression free survival of first-line treatment, (B) overall survival of first-line treatment, (C) progression free survival of second-line treatment, (D) overall survival of second-line treatment.

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