A randomized Phase III trial of adjuvant S-1 therapy vs. observation alone in resected biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1202, ASCOT)

Nakachi, Kohei; Konishi, Masaru; Ikeda, Masafumi; Mizusawa, Junki; Eba, Junko; Okusaka, Takuji; Ishii, Hiroshi; Fukuda, Haruhiko; Furuse, Junji; Hepatobiliary,

doi:10.1093/jjco/hyy004

Cited by 82 publications

(57 citation statements)

References 11 publications

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“…Results of the Japan Clinical Oncology Group 1202 study comparing adjuvant S-1 to surveillance in resected biliary tract cancer might also add information about the role of fluoropyrimidines in this setting. 41 There is also a need for future research that focuses on high-risk patient subgroups and reports results for specific biliary tract subsites and/or specific molecular alterations. The Expert Panel members will continue to assess the currency of these recommendations and consider the need to update this guideline on an annual basis.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline

Shroff

Kennedy

Bachini

et al. 2019

JCO

350

240

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PURPOSE To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with resected biliary tract cancer.METHODS ASCO convened an Expert Panel to conduct a systematic review of the literature on adjuvant therapy for resected biliary tract cancer and provide recommended care options for this patient population.RESULTS Three phase III randomized controlled trials, one phase II trial, and 16 retrospective studies met the inclusion criteria.RECOMMENDATIONS Based on evidence from a phase III randomized controlled trial, patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy for a duration of 6 months. The dosing used in this trial is described in the qualifying statements, while it should be noted that the dose of capecitabine may also be determined by institutional and regional practices. Patients with extrahepatic cholangiocarcinoma or gallbladder cancer and a microscopically positive surgical resection margin (R1 resection) may be offered chemoradiation therapy. A shared decision-making approach is recommended, considering the risk of harm and potential for benefit associated with radiation therapy for patients with extrahepatic cholangiocarcinoma or gallbladder cancer. Additional information is available at www.asco.org/ gastrointestinal-cancer-guidelines.

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Section: Discussionmentioning

confidence: 99%

Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline

Shroff

Kennedy

Bachini

et al. 2019

JCO

350

240

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“…Adjuvant chemotherapy with oral administration of S-1 after hepatectomy for biliary tract cancer improved prognostic outcomes compare to gemcitabine at phase II study (KHBO1208). Now, ASCOT study (adjuvant S-1 versus surgery alone, phase III study) has been ongoing for resected biliary tract cancer since 2013 [18]. We explained to him and his family that there was no clear evidence of adjuvant chemotherapy in multiple and resected biliary tract cancer, and it is limited in case series [19].…”

Section: Discussionmentioning

confidence: 99%

Multiple cholangiocarcinomas in the intrahepatic and extrahepatic biliary tree due to dichloromethane exposure: a case report

et al. 2020

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Background: An outbreak of cholangiocarcinoma in Japan has led to widespread concern among workers in printing plants. In March 2013, the Japanese Ministry of Health, Labour and Welfare, confirmed a causal relationship between cholangiocarcinoma and long-term exposure to dichloromethane (DCM) and 1,2-dichloropropane (DCP), which were widely used in printing plants. We herein report a rare case of successful radical resection of multiple cholangiocarcinomas in the intrahepatic and extrahepatic bile ducts caused by past exposure to DCM. Case presentation: A 54-year-old man developed brown urine 22 years after his last exposure to DCP and DCM. He had an 11-year history of working at a printing plant from the age of 21 to 31 years and dealt with organic solvents during his employment. Enhanced computed tomography revealed a thickened distal bile duct wall with upstream biliary dilatation and multiple intrahepatic cholangiocarcinomas located in liver segments III, VI, and VIII. Biopsy of the distal bile duct wall revealed adenocarcinoma, and a diagnosis of distal cholangiocarcinoma was made. Tumor marker levels were within the reference range (carcinoembryonic antigen, 3.3 ng/mL; carbohydrate antigen 19-9, 25.4 U/mL; SPAN-1, 13 U/mL; and DUPAN-2, 33 U/mL). The multiple intrahepatic and extrahepatic bile duct cancers were treated by subtotal stomach-preserving pancreatoduodenectomy and partial hepatectomy of segments III, VI, and VIII. Pathological examination of the surgical specimens revealed multiple cholangiocarcinomas with well-differentiated adenocarcinoma in the biliary tree. The patient was still alive without recurrence 17 months after the operation. Conclusions: We experienced a rare case of multiple cholangiocarcinomas in the intrahepatic and extrahepatic bile ducts that developed 22 years after the patient's last exposure to DCP and DCM. Long-term and careful follow-up is required for workers with an occupational history of exposure to organic solvents because of the risk of development of cholangiocarcinoma.

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“…The ASCOT trial is evaluating the e cacy of 6-month administration of S-1 postoperatively for patients with bile duct cancer. (14) . However, the duration was decided according to the adjuvant therapy regimen for pancreatic cancer.…”

Section: Discussionmentioning

confidence: 99%

“…(13) Moreover, in Japan, the e cacy of 6-month administration of S-1 for postoperative BTC is currently being investigated in the large-scale phase ASCOT trial. (14) Thus, S-1 is expected to become a standard treatment in adjuvant therapy for resected BTC.…”

Section: Introductionmentioning

confidence: 99%

A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01)

Itano¹,

Takemura

Kishida

et al. 2020

Preprint

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Background: Although surgery is the definitive curative treatment for biliary tract cancer (BTC), outcomes after surgery alone have not been satisfactory. Adjuvant therapy with S-1 may improve survival in patients with BTC. This study examined the safety and efficacy of 1 year adjuvant S-1 therapy for BTC in a multi-institutional trial. Methods: The inclusion criteria were as follows: histologically proven BTC, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, R0 or R1 surgery performed, cancer classified as Stage IB to III. Within 10 weeks post-surgery, a 42-day cycle of treatment with S-1 (80 mg/m2/day orally twice daily on days 1–28 of each cycle) was initiated and continued up to 1 year post surgery. The primary endpoint was adjuvant therapy completion rate. The secondary endpoints were toxicities, disease-free survival (DFS), and overall survival (OS).Results: Forty-six patients met the inclusion criteria of whom 19 had extrahepatic cholangiocarcinoma, 10 had gallbladder carcinoma, 9 had ampullary carcinoma, and 8 had intrahepatic cholangiocarcinoma. Overall, 25 patients completed adjuvant chemotherapy, with a 54.3% completion rate while the completion rate without recurrence during the 1 year administration was 62.5%. Seven patients (15%) experienced adverse events (grade 3/4). The median number of courses administered was 7.5. Thirteen patients needed dose reduction or temporary therapy withdrawal. OS and DFS rates at 1/2 years were 91.2/80.0% and 84.3/77.2%, respectively. Among patients who were administered more than 3 courses of S-1, only one patient discontinued because of adverse events.Conclusions: One-year administration of adjuvant S-1 therapy for resected BTC was feasible and may be a promising treatment for those with resected BTC. Now, a randomized trial to determine the optimal duration of S-1 is ongoing.Trial registration: UMIN-CTR, UMIN000009029. Registered 5 October 2012-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347)

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A randomized Phase III trial of adjuvant S-1 therapy vs. observation alone in resected biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1202, ASCOT)

Cited by 82 publications

References 11 publications

Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline

Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline

Multiple cholangiocarcinomas in the intrahepatic and extrahepatic biliary tree due to dichloromethane exposure: a case report

A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01)

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