Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer

Hironaka, Shuichi; Zenda, Sadamoto; Boku, Narikazu; Fukutomi, Akira; Yoshino, Takayuki; Onozawa, Yusuke

doi:10.1007/s10120-005-0351-6

Cited by 124 publications

(107 citation statements)

References 13 publications

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“…Neutropenia was one of the most frequently reported adverse events in both treatment arms, and the incidence in the PL ? PTX arm was within the range of that reported in other Japanese and Western trials with a similar paclitaxel dose and schedule [7,[11][12][13]. Neutropenia was commoner in the Japanese population, but this could be managed safely, as indicated by the longer median duration of therapy in the RAM ?…”

Section: Discussionsupporting

confidence: 67%

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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Background We evaluated the safety and efficacy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients previously treated for advanced gastric or gastroesophageal junction adenocarcinoma in Japanese and Western subgroups from the RAINBOW trial. Methods Patients received ramucirumab at 8 mg/kg or placebo (days 1 and 15) plus paclitaxel at 80 mg/m 2 (days 1, 8, and 15 of a 28-day cycle). End points were compared between treatment arms within Japanese (N = 140) and Western (N = 398) populations. Results The incidence of adverse events of grade 3 or higher was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 83.8 % vs 52.1 %; Western population, 79.1 % vs 61.9 %). Neutropenia was the commonest adverse event of grade 3 or higher, with a higher incidence for ramucirumab plus paclitaxel (Japanese population, 66.2 % vs 25.4 %; Western population, 32.1 % vs 14.7 %). The incidence of febrile neutropenia was low and was similar between treatment arms in both populations. The overall survival hazard ratio was 0.88 (95 % Conclusions Safety profiles of the ramucirumab plus paclitaxel arm were similar between populations, though there was a higher incidence of neutropenia in Japanese patients. Progression-free survival and objective response rate improvements were observed for ramucirumab plus paclitaxel in both populations. ClinicalTrials.gov identifier: NCT01170663This

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Section: Discussionsupporting

confidence: 67%

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

et al. 2015

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“…In previous phase II trials, weekly PAC administration was found to be active against GC with peritoneal metastasis (14,15). Moreover, it has been suggested that the regimen is feasible, safe and shows consistent activity against heavily treated GC in a second-line or further setting (12,20). neutropenia (14.9%), anemia (10%), leukopenia (4%), and anorexia (4%) were the most common grade 3/4 adverse events observed in this study, occurring less frequently than in previous reports.…”

Section: Discussionsupporting

confidence: 49%

“…Consequently, CPT-11 may be a key novel agent for the treatment of advanced GC in a second-line setting. On the other hand, the weekly administration of paclitaxel (PAC) for GC following the failure of prior chemotherapy has become standard practice in Japan, as it offers milder toxicities than a tri-weekly schedule but with equivalent activity (12,13). In previous phase II trials, it was found that PAC was active against GC with peritoneal metastasis that was refractory to regimens containing 5-FU (14,15).…”

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confidence: 99%

Availability of irinotecan in a second-line setting confers survival benefit to patients with advanced gastric cancer refractory to fluoropyrimidine-based regimens

et al. 2011

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Abstract.Optimal second-line chemotherapy may contribute to favorable survival in patients who receive first-line treatment for advanced gastric cancer. The aim of this retrospective study was to compare a second-line setting using irinotecan with paclitaxel in terms of survival benefit and safety. A total of 179 patients with recurrent or unresectable gastric cancer who had received prior chemotherapy with a fluoropyrimidine-based regimen were treated with irinotecan alone at 150 mg/m 2 on days 1 and 15 every 4 weeks (Cohort I) or weekly paclitaxel at 80 mg/m 2 on days 1, 8 and 15 every 4 weeks (Cohort P) between April, 2004 and March, 2009. Patient characteristics, overall response rate, disease control rate, progression-free survival, overall survival and safety were investigated. Of the 179 patients, 92 received irinotecan and 87 patients who were contraindicated for irinotecan received weekly paclitaxel. The overall response and disease control rates in Cohort I were 6.5 and 43.5%, respectively, as compared with 9.8 and 54.9%, respectively, in Cohort P. No variation was noted in median progression-free survival (Cohort I vs. P, 2.6 vs. 2.8 months; P=0.812), whereas median overall survival (Cohort I vs. P, 9.8 vs. 4.9 months; P<0.0001) differed significantly between the two cohorts. The most common grade 3/4 adverse events were neutropenia, leukopenia, anemia and anorexia, which were tolerable in each treatment cohort. Availability of irinotecan in a second-line setting confers a survival benefit to advanced gastric cancer patients in whom fluoropyrimidine-based firstline chemotherapy was unsuccessful.

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“…The recommended optimal dose of paclitaxel in Japan was determined to be 210 mg m À2 once every 3 weeks (Yamaguchi et al, 2002). Recently, good results have been obtained with a weekly regimen of paclitaxel in patients with ovarian cancer and gastric cancer (Fennelly et al, 1997;Arai et al, 2003;Hironaka et al, 2006). The use of weekly regimens of paclitaxel, used mainly as second-line chemotherapy, has increased in Japan because of milder haematological toxicity as compared with regimens administering paclitaxel once every 3 weeks.…”

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Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

et al. 2006

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Both paclitaxel and S-1 are effective against gastric cancer, but the optimal regimen for combined chemotherapy with these drugs remains unclear. This phase I/II study was designed to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicity (DLT), and objective response rate of paclitaxel in combination with S-1. S-1 was administered orally at a fixed dose of 80 mg m À2 day À1 from days 1 to 14 of a 28-day cycle. Paclitaxel was given intravenously on days 1, 8, and 15, starting with a dose of 40 mg m À2 day À1 . The dose was increased in a stepwise manner to 70 mg m À2 . Treatment was repeated every 4 weeks unless disease progression was confirmed. In the phase I portion, 17 patients were enrolled. The MTD of paclitaxel was estimated to be 70 mg m À2 because 40% of the patients given this dose level (two of five) had DLT. The RD was determined to be 60 mg m À2 . In the phase II portion, 24 patients, including five with assessable disease who received the RD in the phase I portion, were evaluated. The median number of treatment courses was six (range: 1 -17). The incidence of the worst-grade toxicity in patients given the RD was 28 and 8%, respectively. All toxic effects were manageable. The response rate was 54.1%, and the median survival time was 15.5 months. Our phase I/II trial showed that S-1 combined with paclitaxel is effective and well tolerated in patients with advanced gastric cancer.

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Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer

Abstract: Weekly paclitaxel seems to be active as second-line chemotherapy against metastatic and recurrent gastric cancer. Further study is needed to confirm the efficacy and safety of weekly paclitaxel.

Cited by 124 publications

References 13 publications

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer

Availability of irinotecan in a second-line setting confers survival benefit to patients with advanced gastric cancer refractory to fluoropyrimidine-based regimens

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

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