Randomized phase III study of gemcitabine plus S-1 (GS) versus S-1 versus gemcitabine (GEM) in unresectable advanced pancreatic cancer (PC) in Japan and Taiwan: GEST study.

Ioka, T.; Ikeda, Miki; Ohkawa, S.; Yanagimoto, H.; Fukutomi, Akira; Sugimori, Kazuya; Baba, Hideo; Yamao, Kenji; Shimamura, Tsuyoshi; Chen, J.; Mizumoto, Kazuhiro; Furuse, J.; Funakoshi, A.; Hatori, Takashi; Yamaguchi, Taketo; Egawa, Shinichi; Sato, Aya; Ōhashi, Y.; Cheng, Arthur C.K.; Okusaka, Takuji

doi:10.1200/jco.2011.29.15_suppl.4007

Cited by 33 publications

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“…At the data cut-off point (April 2011; median follow-up time for all randomized patients, 10.6 months), four patients in the GS arm and one patient in the S-1 arm were still receiving the protocol treatment. Among the other patients, the median number of cycles of GS given was 10 (range, 1-34; interquartile range, [3][4][5][6][7][8][9][10][11][12][13][14] and that of S-1 was 3 (range, 1-9; interquartile range, 1-4). At the data cut-off point, 95% (96 ⁄ 101) of the patients terminated the protocol treatment.…”

Section: Resultsmentioning

confidence: 99%

“…The dose and schedule of the GS arm was planned based on those adopted in the randomized phase III study of pancreatic carcinoma carried out in Japan and Taiwan. (12) For the GS arm, 1000 mg ⁄ m 2 gemcitabine was infused on days 1 and 8, and 30 mg ⁄ m , 100 mg ⁄ day for 1.25 ≤ BSA < 1.50 m 2 , and 120 mg ⁄ day for BSA ≥1.50 m 2 ) was given orally twice daily for 4 weeks, followed by a 2-week rest, repeated every 6 weeks.…”

Section: Methodsmentioning

confidence: 99%

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Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Morizane¹,

Okusaka²,

Mizusawa

et al. 2013

Cancer Science

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The oral fluoropyrimidine, S‐1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S‐1 (GS) (gemcitabine: 1000 mg/m2, day 1 and day 8; S‐1: 60 mg/m2, twice daily on days 1–14, repeated every 3 weeks); and S‐1 (80 mg/m2, days 1–28, given orally twice daily for 4 weeks, followed by a 2‐week rest, repeated every 6 weeks). The regimen with a higher 1‐year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S‐1 (n = 50) arms, the 1‐year survival was 52.9% (95% confidence interval, 38.5–65.5) and 40.0% (95% confidence interval, 26.5–53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S‐1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment‐related deaths occurred in the GS arm, all other grade 3/4 non‐hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Morizane¹,

Okusaka²,

Mizusawa

et al. 2013

Cancer Science

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“…Recently, the result of the GEST trial in pancreatic cancer showed a superior RR and a superior TTF in the combination arm. Despite this superiority, this concurrent strategy also failed to improve OS [21]. Our phase-II trial with its small sample size nevertheless suggests that the sequential strategy could be considered for the treatment of gastric cancer, along with other types of cancer, and that the sequential use of S-1 followed by paclitaxel (PTX) remains as an alternative for patients who are for some reason not indicated for the S-1/CDDP combination.…”

Section: Discussionmentioning

confidence: 99%

A randomized phase-II trial comparing sequential and concurrent paclitaxel with oral or parenteral fluorinated pyrimidines for advanced or metastatic gastric cancer

et al. 2012

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Background The purpose of this study was twofold: (1) to compare S-1 with infusional 5-fluorouracil (FU) to determine which would be a better partner of paclitaxel (PTX), and (2) to compare a concurrent strategy with a sequential one, the latter strategy being the one that is widely used in Japanese general practice. Methods The 161 eligible patients were randomized into four arms to receive the following regimens: A (sequential), intravenous 5-FU at 800 mg/m 2 for 5 days every 4 weeks followed by weekly PTX at 80 mg/m 2 ; B (sequential), S-1 at 80 mg/m 2 for 4 weeks and 2-week rest followed by PTX; C (concurrent), intravenous 5-FU at 600 mg/m 2 for 5 days and weekly PTX at 80 mg/m 2 every 4 weeks; and D (concurrent), S-1 for 14 days and PTX at 50 mg/m 2 on days 1 and 8 every 3 weeks. The primary endpoint was the overall survival (OS) rate at 10 months. Results The ten-month OS rates in arms A, B, C, and D were 63, 65, 61, and 73%, respectively. The OS was best in the concurrent S-1/PTX arm, with a mean survival time of 123Gastric Cancer (2012) 15:363-369 DOI 10.1007 15.4 months, but no significant difference was observed between the four arms. Response rates were higher in the concurrent arms than in the sequential arms. Conclusion Our study did not show sufficient prolongation of survival with the concurrent strategy to proceed to a phase-III trial; however, the sequential arms showed survival comparable to that in the concurrent arms, with less toxicity. In patients who are ineligible for cisplatin (CDDP), sequential treatment starting with S-1 and proceeding to PTX would be a good alternative strategy, considering quality of life (QOL) and the cost-benefits of an oral agent as first-line treatment.

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“…S-1 is an oral prodrug of 5-FU widely used in Japan (8). In a phase III trial (the GEST trial) announced by the American Society of Clinical Oncology in 2011, S-1 produced a favorable response and was not inferior to gemcitabine in terms of the overall survival of patients with unresectable pancreatic cancer (11). However, there is no appropriate drug for third-line chemotherapy following gemcitabine (plus cisplatin) and 5-FU for BTC.…”

Section: Discussionmentioning

confidence: 99%

Successful treatment of unresectable gallbladder cancer with low-dose paclitaxel as palliative chemotherapy after failure of gemcitabine and oral S-1: A case report

Tajima¹,

Ohta²,

Shinbashi³

et al. 2012

Oncology Letters

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Abstract.A 56-year-old female with metastatic gallbladder cancer involving the liver and stenosis of the hilar bile duct was treated with gemcitabine (1,000 mg/m 2 ) plus S-1 (60 mg/m 2 ). After 9 cycles of therapy, CT showed evidence of stable disease; however, the serum CEA level was increased. Therefore, the chemotherapy regimen was changed to weekly low-dose paclitaxel (60 mg/m 2 ). After 12 cycles of therapy, paclitaxel was reduced to 30 mg/m 2 as the patient developed neutropenia. The patient completed 32 cycles of therapy, and the tumor was reduced in size and marked improvement in bile duct stenosis was noted without any impairment in quality of life. The patient succumbed to the disease 25 months after treatment was initiated. Thus, in this case paclitaxel was more effective than gemcitabine plus S-1. Palliative chemotherapy with paclitaxel after failure of gemcitabine and 5-FU was well-tolerated; therefore, it may be an effective treatment for biliary tract cancer (BTC). A phase I study of palliative chemotherapy with weekly low-dose paclitaxel following gemcitabine (plus cisplatin) and 5-FU is currently in progress in patients with unresectable or recurrent BTC.

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Randomized phase III study of gemcitabine plus S-1 (GS) versus S-1 versus gemcitabine (GEM) in unresectable advanced pancreatic cancer (PC) in Japan and Taiwan: GEST study.

Cited by 33 publications

References 0 publications

Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

A randomized phase-II trial comparing sequential and concurrent paclitaxel with oral or parenteral fluorinated pyrimidines for advanced or metastatic gastric cancer

Successful treatment of unresectable gallbladder cancer with low-dose paclitaxel as palliative chemotherapy after failure of gemcitabine and oral S-1: A case report

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