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Paclitaxel and Docetaxel Show Encouraging Results in Patients With Advanced Gastric Cancer

Early-phase trials of paclitaxel and docetaxel, alone or in combination, and more recently the reported interim analysis of a phase 3 trial of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) have underscored the considerable activity taxanes demonstrate in the treatment of patients with advanced gastric cancer.

Monotherapy with either docetaxel or paclitaxel as front-line treatment of advanced gastric cancer, as well as in the second-line setting, has produced response rates of approximately 15% to 24%, according to a study cited in this review by Eric Van Cutsem, MD, PhD, University Hospital Gasthuisberg, Leuven, Belgium.

"It is the appreciable activity seen in these early phase II studies along with the lack of cross-resistance to other drugs and the nonoverlapping toxicities that led researchers to consider further development of the taxanes in combination with existing fluoropyrimidine-platinum regimens in advanced gastric cancer," the author writes.

In recent phase 2 trials, paclitaxel plus platinum or paclitaxel plus 5-FU yielded response rates of 22% to 65% and median survival periods of 10 months (range 6-14 months). The regimens were overall well tolerated. Myelosuppression was the most frequently reported adverse effect. Other adverse effects observed with combination regimens including paclitaxel are alopecia, myalgia, mucositis and neurotoxicity.

Intent-to-treat analysis of a phase 2 trial evaluating the efficacy of docetaxel plus cisplatin in patients with advanced gastric cancer showed 56% of patients responded to the treatment, 2 patients achieving a complete response. The median time to progression (TTP) was 6.6 months and the median overall survival (OS) was 9 months.

Docetaxel has also been studied in combination with 5-FU in a phase 2 trial where a 28% overall response rate was reported. The median survival time of 7.7 months was comparable to those found in other phase 2 studies.

In another phase 2 trial of docetaxel, cisplatin and 5-FU (TCP), both the overall response rate (43% vs. 28%) and the time to progression (5.9 months vs. 5.0 months) favoured TCP over docetaxel and cisplatin alone.

In a phase 3 trial of docetaxel, cisplatin, and 5-FU (DCF) compared to cisplatin plus 5-FU (CF) combination in the treatment of advanced gastric cancer, the interim analysis showed DCF was associated with a superior response rate and time to progression (P = .0008). In the same trial, DCF resulted in a greater rate of grade 3/4 neutropaenia, febrile neutropaenia and neutropaenic infection (84%, 16%, and 14%, respectively) compared with CF (60%, 6%, and 7%, respectively).

"These findings represent an important milestone in the treatment of patients with advanced gastric cancer," the author concludes.

Oncologist 2004;9 Suppl 2:9-15 "The treatment of advanced gastric cancer: new findings on the activity of the taxanes"

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