scholarly journals Neither Neoadjuvant nor Adjuvant Therapy Increases Survival After Biliary Tract Cancer Resection with Wide Negative Margins

2012 ◽  
Vol 16 (9) ◽  
pp. 1666-1671 ◽  
Author(s):  
Evan S. Glazer ◽  
Ping Liu ◽  
Eddie K. Abdalla ◽  
Jean-Nicolas Vauthey ◽  
Steven A. Curley
Keyword(s):  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Cancer Resection ◽  
Tract Cancer

scholarly journals 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)

2020 ◽  
Author(s):  
Osamu Itano ◽  
Yusuke Takemura ◽  
Norihiro Kishida ◽  
Eiji Tamagawa ◽  
Hiroharu Shinozaki ◽  
...  
Keyword(s):  
Adjuvant Therapy ◽  
Adverse Events ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Disease Free Survival ◽  
Completion Rate ◽  
Inclusion Criteria ◽  
Tract Cancer ◽  
Post Surgery ◽  
One Year

Abstract 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, 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: Overall, 46 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 temporal 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 S-1 more than 3 courses, only one case discontinued due to 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)

scholarly journals Adjuvant and neoadjuvant therapy for biliary tract cancer: a review of clinical trials

2020 ◽  
Vol 50 (12) ◽  
pp. 1353-1363 ◽  
Author(s):  
Satoshi Nara ◽  
Minoru Esaki ◽  
Daisuke Ban ◽  
Takeshi Takamoto ◽  
Kazuaki Shimada ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Bile Duct ◽  
Adjuvant Therapy ◽  
Neoadjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Tract Cancer ◽  
Adjuvant And Neoadjuvant Therapy ◽  
Duct Cancer

Abstract Cancer originating in the biliary tract can be classified as bile duct cancer (cholangiocarcinoma), gallbladder cancer, or ampullary cancer. Bile duct cancer is further divided to intrahepatic, perihilar and distal bile duct subtypes according to the anatomical location of the tumor. The biological characteristics of each tumor are heterogeneous. However, because of the rarity of each disease, the efficacy of new drugs has been tested in groups of patients with different biliary tract cancers. In patients with metastatic or recurrent biliary tract cancer, recent randomized clinical trials revealed the non-inferiority of gemcitabine + S-1 and the superiority of gemcitabine + cisplatin + S-1 compared with gemcitabine + cisplatin in terms of overall survival, thereby establishing a new standard treatment. In the field of adjuvant therapy for biliary tract cancer, the British BILCAP (capecitabine compared with observation in resected biliary tract cancer) study revealed longer median overall survival in the capecitabine group than in the observation group in the per-protocol analysis (but not in the intention-to-treat analysis), bringing a shift toward postoperative management. Several other studies of adjuvant therapy are ongoing, and they may lead to reforms in treatment strategy for resectable biliary tract cancer in the future. The use of neoadjuvant therapy for biliary tract cancer is in its infancy, but it is expected to overcome the limitations of adjuvant therapy for this malignancy. In this review, we summarized the evidence available from clinical trials of adjuvant and neoadjuvant therapy for biliary tract cancer and described ongoing clinical trials.

scholarly journals P-0144 Adjuvant Therapy and Prognostic Factors for Biliary Tract Cancer Intrahepatic Cholangiocarcinoma: Single-Center Experience

2012 ◽  
Vol 23 ◽  
pp. iv72
Author(s):  
Joaquina Martinez-Galan ◽  
Javier Garcia Garcia ◽  
Karim Muffa K-Granero ◽  
José Antonio Ortega ◽  
Beatriz Gonzalez-Astorga ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Intrahepatic Cholangiocarcinoma ◽  
Biliary Tract Cancer ◽  
Single Center ◽  
Tract Cancer ◽  
Single Center Experience

Adjuvant Therapy in the Treatment of Biliary Tract Cancer: A Systematic Review and Meta-Analysis

2012 ◽  
Vol 30 (16) ◽  
pp. 1934-1940 ◽  
Author(s):  
Anne M. Horgan ◽  
Eitan Amir ◽  
Thomas Walter ◽  
Jennifer J. Knox
Keyword(s):  
Systematic Review ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Meta Analysis ◽  
Random Effect ◽  
Published Data ◽  
Curative Intent ◽  
Tract Cancer ◽  
The Impact

PurposeThe benefit of adjuvant therapy (AT) for biliary tract cancer (BTC) is unclear, with conflicting results from nonrandomized studies. We report a systematic review and meta-analysis to determine the impact of AT on survival.MethodsStudies published between 1960 and November 2010, which evaluated adjuvant chemotherapy (CT), radiotherapy (RT), or both (CRT) compared with curative-intent surgery alone for resected BTC were included. Only tumors of the gallbladder and bile ducts were assessed. Published data were extracted and computed into odds ratios (ORs) for death at 5 years. Subgroup analyses of benefit based on lymph node (LN) or resection margin positivity (R1) were prespecified. Data were weighted by generic inverse variance and pooled using random-effect modeling.ResultsTwenty studies involving 6,712 patients were analyzed. There was a nonsignificant improvement in overall survival with any AT compared with surgery alone (pooled OR, 0.74; P = .06). There was no difference between gallbladder and bile duct tumors (P = .68). The association was significant when the two registry analyses were excluded. Those receiving CT or CRT derived statistically greater benefit than RT alone (OR, 0.39, 0.61, and 0.98, respectively; P = .02). The greatest benefit for AT was in those with LN-positive disease (OR, 0.49; P = .004) and R1 disease (OR, 0.36; P = .002).ConclusionThis analysis supports AT for BTC. Prospective randomized trials are needed to provide better rationale for this commonly used strategy. On the basis of our data, such trials could involve two active comparators rather than a no-treatment arm among patients with LN-positive or R1 disease.

Adjuvant therapy for resected biliary tract cancer: a review

2016 ◽  
Vol 5 (5) ◽  
pp. 64-64 ◽  
Author(s):  
Mark K. Doherty ◽  
Jennifer J. Knox
Keyword(s):  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Tract Cancer

Systematic review with network meta-analysis: adjuvant therapy for resected biliary tract cancer

2014 ◽  
Vol 40 (7) ◽  
pp. 759-770 ◽  
Author(s):  
G.-Q. Zhu ◽  
K.-Q. Shi ◽  
J. You ◽  
H. Zou ◽  
Y.-Q. Lin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Meta Analysis ◽  
Tract Cancer

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

2019 ◽  
Vol 37 (12) ◽  
pp. 1015-1027 ◽  
Author(s):  
Rachna T. Shroff ◽  
Erin B. Kennedy ◽  
Melinda Bachini ◽  
Tanios Bekaii-Saab ◽  
Christopher Crane ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Clinical Practice Guideline ◽  
Biliary Tract Cancer ◽  
Phase Iii ◽  
Extrahepatic Cholangiocarcinoma ◽  
Tract Cancer ◽  
Randomized Controlled

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 .

scholarly journals Adjuvant Therapy for Resectable Biliary Tract Cancer: A Bayesian Network Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Xiuqiong Chen ◽  
Fanqiao Meng ◽  
Hua Xiong ◽  
Yanmei Zou
Keyword(s):  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Postoperative Recurrence ◽  
Positive Lymph Node ◽  
High Rate ◽  
Therapeutic Interventions ◽  
Free Survival ◽  
Tract Cancer ◽  
Comprehensive Search

Background: Selecting proper postoperative adjuvant therapy is of great importance for prolonging overall survival (OS) of patients with biliary tract cancer (BTC). OS is commonly affected by high rate of postoperative recurrence and metastasis.Purpose: The present study aimed to identify the optimal adjuvant therapy for BTC patients.Method: A comprehensive search was carried out on Pubmed, Web of science, and Embase databases to acquire articles regarding BTC therapy approaches. Subsequently, the hazard ratio (HR) and its 95% confidence intervals (CIs) were applied to evaluate the efficacy of different adjuvant therapy regimens. The GemTc (GemTc.0.8-2) and R (R.3.6.0) software were employed to perform statistical analyses.Result: Data from 22 articles, including 14,646 patients, were quantitatively analyzed. The results showed that in terms of 5-year OS, gemcitabine (GEM) was considered as the optimal adjuvant therapy for BTC compared with chemoradiotherapy (CRT; HR = 0.59; 95% CI = 0.34-0.97), observation (OB; HR = 0.49; 95% CI = 0.33-0.73), and radiotherapy (RT; HR = 0.40; 95% CI = 0.22-0.71). Additionally, 5-fluorouracil (5-FU) exhibited improved efficacy compared with RT (HR = 0.52; 95% CI = 0.29-0.91) and OB (HR = 0.63; 95% CI = 0.43-0.92). When the efficacy of 5-FU was compared with that of GEM, the results showed that 5-FU (HR = 1.29) was more effective than GEM. Furthermore, CRT and RT prolonged positive resection margin (R+)-OS (HR = 0.69; 95% CI = 0.49-1.00) and positive lymph node-(N+)-OS (HR = 0.22; 95% CI = 0.074-0.66) in BTC patients. In terms of median recurrence-free survival (RFS) and 1-year OS, the differences were not statistically significant among different therapeutic interventions.Conclusion: The present study suggested that GEM could be used as a first-line adjuvant therapy for resected BTC patients. Additionally, CRT could be the optimal treatment approach for R+ and N+ patients.

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