A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer

Nakajo, Akihiro; Hokita, Shuichi; Ishigami, Sumiya; Miyazono, Futoshi; Etoh, T; Hamanoue, Masahiro; Maenohara, Shigeho; Iwashita, Takuya; Komatsu, Hideaki; Satoh, Kiyoharu; Aridome, Kuniaki; Morita, Satoshi; Natsugoe, Shoji; Takiuchi, Hiroya; Nakano, Shota; Maehara, Yoshihiko; Sakamoto, Junichi; Aikou, Takashi

doi:10.1007/s00280-008-0693-y

Cited by 19 publications

(16 citation statements)

References 18 publications

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“…In Korean trial, the dose was Wnely adjusted compared with Japanese trials in which S-1 dose by body surface area (BSA) was roughly divided into three levels. The actual dose was nearly same in patients with BSA between 1.4-1.7 m 2 of two nations paclitaxel 50-60 mg/m 2 , weekly [6,7,9,13,17,20,23]. The most common dose limiting toxicities were grade 3 diarrhea or grade 4 neutropenia.…”

Section: Time (Weeks)mentioning

confidence: 95%

“…Paclitaxel has synergistic antitumor eVects with 5-Xuorouracil (5-FU) according to clinical trials as well as preclinical studies, and a diVerent spectrum of side eVects [12,18]. Several clinical trials of S-1 and paclitaxel combination therapy have been conducted in Japan [6,7,9,13,17,20,23]. The response rate has been reported to be 40-60% with the schedule of S-1 80 mg/m 2 for 14 days plus weekly paclitaxel 50-60 mg/m 2 on days 1 and 8.…”

Section: Introductionmentioning

confidence: 99%

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A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Lee

Kim

Chung

et al. 2008

Cancer Chemother Pharmacol

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Purpose This study was conducted to evaluate the safety and eYcacy of S-1 and paclitaxel combination therapy for patients with advanced gastric cancer. Methods Eligible patients had previously untreated advanced or relapsed gastric cancer with measurable lesion(s) and an ECOG PS of 0-2. Treatment consisted of S-1 35 mg/ m 2 p.o. b.i.d. on days 1-14 followed by a 7-day oV plus paclitaxel 70 mg/m 2 i.v. on days 1 and 8 of a 21-day cycle. Results Fifty-six patients (M/F = 37/19) were enrolled. The median age was 59 years. The median number of cycles administered was six (range 1-18). Out of the 53 patients evaluated, there was 1 (1.9%) CR, 20 (37.7%) conWrmed PRs, 5 (9.4%) unconWrmed PRs, 21 (39.6%) SDs, and 6 (11.3%) PDs. The objective tumor response was 39.6%. The median time to progression was 29 weeks. The median survival was 51 weeks. All 56 patients were assessed for treatment safety. The treatment was well tolerated with grade 3/4 neutropenia in 20%/13%, grade 3 febrile neutropenia in 7%, grade 2/3 diarrhea in 9%/4%, vomiting in 11%/0%, stomatitis in 4%/4%, and neuropathy in 4%/0% of patients. 123Conclusions S-1 and paclitaxel combination treatment is an eVective regimen with a favorable toxicity proWle in patients with advanced gastric cancer.

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Section: Time (Weeks)mentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Lee

Kim

Chung

et al. 2008

Cancer Chemother Pharmacol

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“…Many phase II studies have also been performed to investigate the safety profi le and effectiveness of weekly paclitaxel-containing combination therapies for advanced and metastatic gastric cancers (Table 4) [ [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61].…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

“…Studies of combinations with oral S-1 (tegafur, gimeracil, oteracil) have also been performed [47,49,[55][56][57][58][59]. In these trials, response rates ranged from 40% to 65% and MSTs ranged from 8.9 to 15.5 months.…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

Paclitaxel chemotherapy for the treatment of gastric cancer

2009

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cause of cancer mortality. Although the incidence of gastric cancer has been declining in most developed countries, esophago-gastric junctional tumor and tumor in the cardia has, conversely, been increasing [2] and these tumors still remain one of the biggest problems worldwide.The prognosis of patients with advanced (i.e., unresectable or metastatic) gastric cancer is very poor. The median survival time for such patients is 6 to 9 months [3]. For many years, various chemotherapeutic agents have been used in attempts to improve survival, progression free-survival, response rate, and quality of life in patients with advanced gastric cancer as well as to improve disease-free survival in patients in whom curative resection of the cancers has been performed. 5-Fluorouracil (5-FU) and cisplatin-based regimens have long been considered reference treatments. Commonly used regimens have included epirubicin, cisplatin, and continuous infusion of 5-FU; 5 days' infusion of 5-FU plus cisplatin every 4 weeks; a weekly infusion regimen of 5-FU/leucovorin (LV) over 24 h plus cisplatin every 2 weeks; and 5-FU bolus plus 22-h infusion of 5-FU on days 1 and 2, in combination with cisplatin every 2 weeks. The results with these regimens, together with other study results, suggested that combination regimens including fl uorinated pyrimidines, cisplatin, doxorubicin, epirubicin, and methotrexate, had better response rates than single agents. Although gastric cancer is a relatively chemosensitive disease, with response rates of 30% to 40%, these treatments have shown a modest but unsatisfactory increase in overall survival [4]. In this regard, chemotherapy in the advanced gastric cancer setting is limited by a low complete response rate, response durations that are shortlived, and considerable toxicities.Nevertheless, recently, the development of new chemotherapeutic and molecular targeting agents has opened the door to various clinical trials to fi nd novel therapeutic strategies to improve the outcome of Abstract A comprehensive review of phase I and phase II clinical trials of paclitaxel and paclitaxel-containing chemotherapy regimens for advanced gastric cancer was performed. Response rates, median progression-free survivals, and median overall survivals were examined, together with the treatment regimens and the numbers of patients registered in each trial. Although paclitaxel monotherapy produced considerable improvement in tumor response and prognosis, combination doublet or triplet chemotherapy with fl uoropyrimidines and/ or platinum compounds showed better results than the paclitaxel monotherapy. With regard to the schedule of paclitaxel administration, weekly injection seemed to show less toxicity and better results than administration every 3 weeks. Adjuvant therapies, chemoradiation therapies, and paclitaxel treatment for gastric ascites were also investigated and are discussed.

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“…Several clinical trials of S-1 and paclitaxel combination therapy have been conducted in Japan [28][29][30][31][32][33]. The response rate has been reported to be 40%-60% with the schedule of S-1 80 mg/m 2 for 14 days plus paclitaxel 50-60 mg/m 2 on days 1 and 8 or days 1 and 15.…”

Section: Introductionmentioning

confidence: 99%

Multicenter phase II study of weekly paclitaxel plus S-1 combination chemotherapy in patients with advanced gastric cancer

et al. 2010

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prognosis of advanced gastric cancer is still poor, chemotherapies were reported to improve the overall survival compared to the best supportive care in several studies [2][3][4]. Among the various active chemotherapeutic agents, cisplatin-based chemotherapy is the most commonly used worldwide. The V-325 study demonstrated that adding docetaxel (D) to a frequently used regimen of cisplatin and 5-fl uorouracil (CF) provided benefi ts with regard to overall survival, response rate, time to disease progression, clinical benefi t, and healthrelated quality of life [5]. Although the DCF regimen provides these advantages, it is accompanied by an increase in toxicity compared with the doublet regimen. The toxicity profi le of DCF is acceptable only with appropriately selected patients and comprehensive toxicity management strategies [6]. In this regard, the development of less toxic new combination chemotherapy has still been considered necessary to properly treat those patients with advanced gastric cancer.Paclitaxel, (Taxol; Bristol-Myers Squibb, Princeton, NJ, USA), which is derived from the bark of the Pacifi c yew, Taxus brevifolia, is one of the most active anticancer drugs for the treatment of solid tumors, effectively blocking cancer cells in the G2/M phase through the inhibition of microtubular depolymerization [7,8]. An administration schedule at doses of 175-225 mg/m 2 by intravenous infusion every 3 weeks has been widely accepted [9]. In addition, several phase II studies have shown that paclitaxel, alone or in combination with cisplatin or 5-fl uorouracil (5-FU), is also active against advanced gastric cancer [10-13]. However, a relatively high incidence of grade 3 or 4 neutropenia (14%-35%) is one of the major adverse effects.Paclitaxel is known to be a cell-cycle-specifi c agent, and in vitro experiments have suggested that prolonged Results. A total of 54 patients were registered. All of them had measurable disease and were determined to be eligible for the present study. Two complete responses and 23 partial responses were confi rmed, giving an overall response rate of 46.3%. At a fi nal follow up of 3 years, the median progressionfree survival and median overall survival were 6.0 and 14.3 months, respectively. Grade 3 neutropenia occurred in 14 patients, and grade 4 in 1 patient (total, 27.8%). The most serious nonhematological toxicity was diarrhea, where grade 3 occurred in 5 patients (9.3%). There were no treatmentrelated deaths. Conclusion. A combination of weekly paclitaxel plus S-1 was found to be well tolerated and effective in patients with advanced gastric cancer. Further investigation with comparative trials is needed for confi rmation.

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A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer

Abstract: A combination regimen of biweekly paclitaxel and oral S-1 was well tolerated and showed promising activity against unresectable and recurrent gastric cancer.

Cited by 19 publications

References 18 publications

A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Paclitaxel chemotherapy for the treatment of gastric cancer

Multicenter phase II study of weekly paclitaxel plus S-1 combination chemotherapy in patients with advanced gastric cancer

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