Phase II study of S-1 in patients with advanced biliary tract cancer

Ueno, Hideki; Okusaka, Takuji; Ikeda, Masafumi; Takezako, Yoriko; Morizane, Chigusa

doi:10.1038/sj.bjc.6602208

Cited by 135 publications

(102 citation statements)

References 31 publications

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“…Traditionally, 5-fluorouracil-based chemotherapy regimen has been used as an adjuvant therapy for biliary tract malignancies including GB cancer [6,9,20,21]. Recently, gemcitabine-, capecitabine, or S-1-based regimens have been tried, and several studies have demonstrated somewhat promising results from GB cancer [22][23][24][25][26]. However, few comparative analyses of treatments between detailed TNM stages of GB cancer have been reported.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant chemoradiation therapy in gallbladder cancer

Cho

Kim

Park

et al. 2010

Journal of Surgical Oncology

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Background and Objectives: Gallbladder cancer is a relatively uncommon gastrointestinal malgnancy. Indications for adjuvant chemoradiation therapy after surgical resection have not yet been determined. We aimed this study to elucidate the effectiveness of adjuvant chemoradiation therapy according to TNM stage for gallbladder cancer. Methods: Between March 2001 and March 2009, 100 patients with gallbladder cancer underwent surgical resection. We divided the patients according to TNM stage, and subdivided further according to whether adjuvant chemoradiation therapy was added or not. The clinicopathologic factors, recurrence and survival were retrospectively analyzed. Results: Patients with gallbladder cancer at T2N0M0, T2N1M0, T3N0M0, and T3N1M0 stages were enrolled in this study. Among the four stages, the two lymph node-negative stages (T2N0M0 and T3N0M0) did not show any gain in survival by adding adjuvant chemoradiation therapy. Conversely, the remaining lymph node-positive stages (T2N1M0 and T3N1M0) showed gain in disease-free survival, and the lymph node-positive T2 stage (T2N1M0) showed gain in disease-specific survival. In patients with lymph node-positive T2/T3 GB cancers, adjuvant chemoradiation therapy was an independent prognostic factor for survival. Conclusions: Adjuvant chemoradiation therapy is recommended for lymph node-positive T2/T3 gallbladder cancer following surgical resection.

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Section: Discussionmentioning

confidence: 99%

Adjuvant chemoradiation therapy in gallbladder cancer

Cho

Kim

Park

et al. 2010

Journal of Surgical Oncology

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“…A low level of DPD and TS activity, and a high level of OPRT activity enhance the antitumor effect of S-1 [51] . A phase Ⅱ study of S-1 in biliary tract cancer has shown promising results with a response rate of 21%-35% [27,28] , and S-1 can be expected to have a good effect on gallbladder cancer. In T2 GBCa, ss mas cancers showed a high rate of recurrence, regardless of the radical surgical approach.…”

Section: Discussionmentioning

confidence: 99%

“…S-1 is an oral anticancer drug that contains two biochemical modulators, 5-chloro-2,4-dihydroxypridine and potassium oxonate, which improve the tumor-selective toxicity of 5-fluorouracil (5-FU) [26] . A phase Ⅱ study of S-1 has shown promising results with response rates ranging from 21% to 35% in biliary tract cancer [27,28] .…”

Section: Introductionmentioning

confidence: 99%

Rational therapeutic strategy for T2 gallbladder carcinoma based on tumor spread

Kohya

Kono²,

Miyazaki

2010

WJG

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AIM:To evaluate the adequacy of surgical treatment of T2 gallbladder carcinoma (GBCa) according to tumor spread in the subserosal layer. METHODS:A series of 84 patients with GBCa were treated at Saga University Hospital, Japan between April 1989 and October 2008. The tumor stage was graded according to the TNM staging for GBCa from the American Joint Committee on Cancer Manual 6th edition. Tumor staging revealed 30 patients with T2 tumors. T2 GBCa was divided into three groups histologically by the extent of tumor spread in the subserosal layer, using a score of ss minimum (ss min), ss medium (ss med) or ss massive (ss mas). RESULTS:For ss min GBCa, there was no positive pathological factor and patient survival was satisfactory with simple cholecystectomy, with or without extra-hepatic bile duct resection. For ss med GBCa, some pathological factors, h-inf (hepatic infiltration), ly (lymphatic invasion) and n (lymph node metastasis), were positive. For ss mas GBCa, there was a high incidence of positive pathological factors. The patient group with extra-hepatic bile duct resection with D2 lymph node dissection (BDR with D2) and those with S4a5 hepatectomy had significantly better survival rates. CONCLUSION:We suggest that radical surgery is not necessary for ss min GBCa, and partial hepatectomy and BDR are necessary for both ss med and ss mas GBCa.

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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

237

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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Phase II study of S-1 in patients with advanced biliary tract cancer

Cited by 135 publications

References 31 publications

Adjuvant chemoradiation therapy in gallbladder cancer

Adjuvant chemoradiation therapy in gallbladder cancer

Rational therapeutic strategy for T2 gallbladder carcinoma based on tumor spread

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

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Phase II study of S-1 in patients with advanced biliary tract cancer

Cited by 135 publications

References 31 publications

Adjuvant chemoradiation therapy in gallbladder cancer

Adjuvant chemoradiation therapy in gallbladder cancer

Rational therapeutic strategy for T2 gallbladder carcinoma based on tumor spread

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

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