Adjuvant Gemcitabine Plus S-1 Chemotherapy Improves Survival After Aggressive Surgical Resection for Advanced Biliary Carcinoma

Murakami, Yoshiaki; Uemura, Kenichiro; Sudo, Takeshi; Hayashidani, Yasuo; Hashimoto, Yasushi; Nakamura, Hiroyuki; Nakashima, Akira; Sueda, Taijiro

doi:10.1097/sla.0b013e3181b0fc8b

Cited by 105 publications

(104 citation statements)

References 51 publications

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“…In pancrea to duodenectomy for pancreatic cancer, the CONKO-001 and JSAP-02 trials revealed that dose modification was frequently necessary for completion [15,16]. In BTC, Murakami et al presented gemcitabine-based adjuvant chemotherapy, however, all patients could not complete the protocol, even for biweekly 700 mg/m 2 gemcitabinebased chemotherapy [14]. Clinically, several omittances are necessary in the usual 4-weekly protocol of gemcitabine after BTC surgery, and it become like the 3-weekly protocol.…”

Section: Discussionmentioning

confidence: 99%

“…And, there have been several reports of gemcitabine-based adjuvant chemo therapy following major hepatic to mine for BTC or pancrea to duodenectomy for pancreatic cancer, which have suggested that dose modification is often necessary or that the usual 4-weekly protocol could not be, or was not applied [14][15][16]. Because of the morbidity, liver dysfunction, and low performance status (PS) after BTC surgery (major hepatectomy/pancreatoduodenectomy), it would seem difficult to complete the usual 4-weekly protocol, and frequent pauses during the adjuvant during therapy would be necessary.…”

Section: Comparison Of 4-weekly Vs 3-weekly Gemcitabine As Adjuvant Cmentioning

confidence: 99%

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Comparison of 4-Weekly vs 3-Weekly Gemcitabine as Adjuvant Chemotherapy Following Curative Resection for Biliary Tract Cancer: A Prospective Randomized Controlled Trial

Kobayashi¹,

Miyamoto²,

Shimizu³

et al. 2011

JCT

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Background: Surgery for biliary tract cancer, including pancreatoduodenectomy and major hepatectomy, is too aggressive and does not allow postoperative gemcitabine to be administered by the usual dosage protocol. We hypothesized that the feasibility of 3-weekly protocol (days 1 and 8, every 3 weeks) of adjuvant gemcitabine therapy may be superior to the usual 4-weekly protocol (days 1, 8, and 15 every 4 weeks). Method: We compared the outcomes of 6 cycles of the 4-weekly protocol and 9 cycles of the 3-weekly protocol in a prospective randomized setting. The primary endpoint was the completion rate, and the secondary endpoints were the adverse events and the recurrence-free survival rate. Results: Totally, 27 patients were enrolled. The protocol could be completed without any omittances and/or dose modifications in two patients (14%) of the 4-weekly protocol, and three patients (23%) of the 3-weekly protocol (p = 0.8099); grade 3/4 neutropenia occurred in almost all the remaining (70%) patients. The relative dose intensity was 72% in the 4-weekly protocol and 78% in the 3-weekly protocol. There was no significant difference in the recurrence-free survival rate. Conclusion: The 3-weekly protocol did not yield superior completion, adverse events or recurrence-free survival rates as compared to the 4-week protocol. Trial Registration: UMIN-CTR, UMIN000001020.

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Section: Discussionmentioning

confidence: 99%

Section: Comparison Of 4-weekly Vs 3-weekly Gemcitabine As Adjuvant Cmentioning

confidence: 99%

Comparison of 4-Weekly vs 3-Weekly Gemcitabine as Adjuvant Chemotherapy Following Curative Resection for Biliary Tract Cancer: A Prospective Randomized Controlled Trial

Kobayashi¹,

Miyamoto²,

Shimizu³

et al. 2011

JCT

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“…Takada et al demonstrated that patients with GBC receiving adjuvant therapy consisting of mitomycin C and 5-FU after surgery had an improved overall survival (22). Some have recommended adjuvant chemotherapy and chemoradiotherapy after surgery for biliary carcinoma, as shown in Table III (21,24,(33)(34)(35)(36)(37)(38)(39)(40)(41)(42). However, the results of adjuvant external-beam radiation therapy with concurrent 5-FU treatment were unsatisfactory, with a 5-year survival rate of less than 40% (38)(39)(40)(41)(42).…”

Section: Discussionmentioning

confidence: 99%

“…With the exception of periampullary carcinoma, only one randomized control trial has demonstrated the efficacy of the combination adjuvant therapy of mitomycin C and 5-FU for GBC (22). Most recently, a retrospective study on adjuvant therapy with gemcitabine plus S-1 chemotherapy after aggressive surgery significantly improved prognosis, with 57% survival at 5 years after surgery (23,24).…”

mentioning

confidence: 99%

Effect of Adjuvant Gemcitabine Combined with Low-dose 5-Fluorouracil and Cisplatin Chemotherapy for Advanced Biliary Carcinoma

Morine

Shimada

Ikemoto

et al. 2017

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Abstract. Background Biliary carcinoma, which includes intrahepatic cholangiocarcinoma (IHCC), hilar cholangiocarcinoma (HC) and gallbladder carcinoma (GBC), may be a relatively uncommon malignancy in Western countries, but is one of the most lethal digestive tract tumours because of metastasis or invasion of the tumour directly into adjacent organs at diagnosis. In Japan, the incidence of biliary carcinoma has markedly increased over the past several decades. Vital statistics in 2013 in Japan showed that biliary carcinoma was the sixth leading cause of carcinoma deaths with an incidence of over 22 per 100,000 and a mortality rate of ~15 per 100,000 (1). Complete surgical resection provides the only chance of survival. Many surgeons have advocated aggressive surgery, including major hepatectomy, extended lymph node (LN) dissection and combined vascular resection for improving surgical outcomes (2-8). However, despite aggressive liver surgery, the prognosis after surgery remains unsatisfactory, with 5-year survival rates of 19-35% for HC (5-8), 32-53% for GBC (9-11) and 23-29% for IHCC (12)(13)(14). Moreover, several investigators have indicated that LN metastasis, intrahepatic metastasis and positive surgical margins in the bile duct are poor prognostic factors (12-15). Even with aggressive surgical resection, tumour relapse frequently occurs immediately after surgery, particularly in patients with poor prognostic factors. Nevertheless, no standard treatment before or after surgery has been established, even in patients with biliary carcinoma with high risk factors of recurrence. Therefore, a multidisciplinary strategy including adjuvant therapy is desirable before or after surgery, at least for those patients with poor prognostic factors.For unresectable biliary carcinoma, gemcitabine alone has been regarded as the key antitumour agent (17); recently, gemcitabine combined with cisplatin became the new standard regimen based on the results of the ABC-02 trial (18). In Japan, several investigators have reported the efficacy of gemcitabine plus S-1, an oral anticancer drug consisting of tegafur as a prodrug of 5-fluorouracil (5-FU), 5-chloro-2,4-dihydroxypyridine and potassium oxonate, in advanced biliary carcinoma (18-21). However, adjuvant treatment after surgery has shown little impact on this malignancy, and combinations of effective chemotherapeutic agents and regimens have not been established. With the exception of periampullary carcinoma, only one randomized control trial has demonstrated the efficacy of the combination adjuvant therapy of mitomycin C and 5-FU for 6421

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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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Adjuvant Gemcitabine Plus S-1 Chemotherapy Improves Survival After Aggressive Surgical Resection for Advanced Biliary Carcinoma

Abstract: Adjuvant gemcitabine plus S-1 chemotherapy may be one of several factors contributing to improved outcomes after aggressive surgical resection of advanced biliary carcinoma in recent years.

Cited by 105 publications

References 51 publications

Comparison of 4-Weekly vs 3-Weekly Gemcitabine as Adjuvant Chemotherapy Following Curative Resection for Biliary Tract Cancer: A Prospective Randomized Controlled Trial

Comparison of 4-Weekly vs 3-Weekly Gemcitabine as Adjuvant Chemotherapy Following Curative Resection for Biliary Tract Cancer: A Prospective Randomized Controlled Trial

Effect of Adjuvant Gemcitabine Combined with Low-dose 5-Fluorouracil and Cisplatin Chemotherapy for Advanced Biliary Carcinoma

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

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