Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Sasaki, Takashi; Isayama, Hiroyuki; Nakai, Yousuke; Ito, Yukiko; Kogure, Hirofumi; Togawa, Osamu; Toda, Nobuo; Yasuda, Ichiro; Hasebe, Osamu; Maetani, Iruru; Sasahira, Naoki; Hirano, Keisuke; Tsujino, Takeshi; Tada, Minoru; Omata, Masao

doi:10.1007/s00280-009-1115-5

Cited by 91 publications

(77 citation statements)

References 35 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%

“…In their reports, GS also showed promising response rates (30% and 34%, respectively) and median survival times (12.7 and 11.6 months, respectively). (10,11) Based on these observations, we planned the present randomized phase II trial. The aim of this study was to evaluate the safety and efficacy of the two regimens and to determine which regimen would be more promising as a test arm regimen in a subsequent phase III trial.…”

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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%

mentioning

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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“…S-1 is also approved according to the results of phase II trials [216,217]. In addition, the combination therapy of gemcitabine and S-1 shows benefits in several phase II studies [218][219][220][221] and a phase III study is now being conducted.…”

Section: Cq23: Is the Local Resection Or Papillectomy (Surgical Or Enmentioning

confidence: 99%

Clinical practice guidelines for the management of biliary tract cancers 2015: the 2^nd English edition

Miyazaki

Yoshitomi

Miyakawa³

et al. 2015

J Hepato Biliary Pancreat

234

165

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Background The Japanese Society of Hepato-Biliary-Pancreatic Surgery launched the clinical practice guidelines for the management of biliary tract and ampullary carcinomas in 2008. Novel treatment modalities and handling of clinical issues have been proposed after the publication. New approaches for editing clinical guidelines, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, also have been introduced for better and clearer grading of recommendations. Methods Clinical questions (CQs) were proposed in seven topics. Recommendation, grade of recommendation and statement for each CQ were discussed and finalized by evidencebased approach. Recommendation was graded to grade 1 (strong) and 2 (weak) according to the concept of GRADE system. Results The 29 CQs covered seven topics: (1) prophylactic treatment, (2) diagnosis, (3) biliary drainage, (4) surgical treatment, (5) chemotherapy, (6) radiation therapy, and (7) pathology. In 27 CQs, 19 recommendations were rated strong and 11 recommendations weak. Each CQ included the statement of how the recommendation was graded. Conclusions This guideline provides recommendation for important clinical aspects based on evidence. Future collaboration with cancer registry will be a key for assessment of the guidelines and establishment of new evidence. Free full-text articles and a mobile application of this guideline are available via

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“…Previously, the combination of GEM and 5-FU was shown to have a marked synergistic cytotoxic effect against pancreatic cancer cells (25). In addition, recent increasing evidence suggests that GEM and S-1 combination offers promising survival benefit with acceptable toxicity in patients with advanced biliary tract cancer (26,27) and nonsmall cell lung cancer (28,29) as well as advanced pancreatic cancer (10)(11)(12). Furthermore, GEM and S-1 have an indication for the treatment of pancreatic cancers regardless of pathogical types in Japan.…”

Section: Discussionmentioning

confidence: 99%

Poorly Differentiated Neuroendocrine Carcinoma of the Pancreas Responsive to Combination Therapy with Gemcitabine and S-1

et al. 2012

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Poorly differentiated neuroendocrine carcinoma is a very rare malignancy, but it is characterized by agressive histological features and a poor clinical prognosis. We report a 42-year-old man who had poorly differentiated neuroendocrine carcinoma of the pancreas with multiple liver metastases. We administrated combined chemotherapy with S-1 and gemcitabine. This treatment was efficacious and well tolerated, and then this patient obtained objective partial response for 7 months and survived for 13 months after the diagnosis. This case suggests that S-1 and gemcitabine combination produce beneficial responses for patients with this disease.

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Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Abstract: Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.

Cited by 91 publications

References 35 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)

Clinical practice guidelines for the management of biliary tract cancers 2015: the 2^nd English edition

Poorly Differentiated Neuroendocrine Carcinoma of the Pancreas Responsive to Combination Therapy with Gemcitabine and S-1

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Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer

Abstract: Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.

Cited by 91 publications

References 35 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)

Clinical practice guidelines for the management of biliary tract cancers 2015: the 2nd English edition

Poorly Differentiated Neuroendocrine Carcinoma of the Pancreas Responsive to Combination Therapy with Gemcitabine and S-1

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Clinical practice guidelines for the management of biliary tract cancers 2015: the 2^nd English edition