Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan Surgery for Recurrent Pancreatic Ductal Adenocarcinoma 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) Chemotherapy for cholangiocarcinoma: An update.
Background : A British r and omised study of gemcitabine plus cisplatin ( GC ) combination showed promising results in biliary tract cancer ( BTC ) patients . In our study , we evaluated the efficacy and safety of this combination compared with gemcitabine alone ( G ) in Japanese BTC patients . Methods : Overall , 84 advanced BTC patients were r and omised to either cisplatin 25 mg m−2 plus gemcitabine 1000 mg m−2 on days 1 , 8 of a 21-day cycle ( GC-arm ) , or single-agent gemcitabine 1000 mg m−2 on days 1 , 8 and 15 of a 28-day cycle ( G-arm ) . Treatments were repeated for at least 12 weeks until disease progression or unacceptable toxicity occurred , up to a maximum of 48 weeks . Results : A total of 83 patients were included in the analysis . For the GC and G-arms , respectively , the 1-year survival rate was 39.0 vs 31.0 % , median survival time 11.2 vs 7.7 months , median progression-free survival time 5.8 vs 3.7 months and overall response rate 19.5 vs 11.9 % . The most common grade 3 or 4 toxicities ( GC-arm/G-arm ) were neutropenia ( 56.1%/38.1 % ) , thrombocytopenia ( 39.0%/7.1 % ) , leukopenia ( 29.3%/19.0 % ) , haemoglobin decrease ( 36.6%/16.7 % ) and γ-GTP increase ( 29.3%/35.7 % ) . Conclusions : Gemcitabine plus cisplatin combination therapy was found to be effective and well tolerated , suggesting that it could also be a st and ard regimen for Japanese patients Objective : This study evaluates the outcome of patients who underwent surgery for recurrent pancreatic cancer . Summary Background Data : Recurrence of pancreatic ductal adenocarcinoma occurs in up to 80 % of pancreatic cancer patients within 2 years of a potential curative resection because , in most cases , occult ( local and /or distant ) micrometastases are present at the time of the initial resection . Methods : Thirty patients were operated for recurrent pancreatic cancer between October 2001 and April 2005 . Median time between the initial resection and recurrence was 12.0 months . While 15 patients were resected , 15 patients either underwent palliative bypass or only exploration . Prospect ively recorded data were analyzed retrospectively . Survival analysis was performed using Kaplan-Meier estimation and log-rank test . Results : The overall median survival of patients with recurrent disease was 29.0 months . After the first reresection/exploration for recurrent disease , the median survival was 11.4 months . There was a tendency of increased median survival in the group of patients undergoing resection ( 17.0 months ) compared with the bypass/exploration group ( 9.4 months ) , although this difference was not significant ( P = 0.084 ) . In addition , patients with a prolonged interval ( > 9 months ) from resection to recurrence were more likely to benefit from reresection compared with patients with recurrence within 9 months ( median survival 17.0 vs. 7.4 months ; P = 0.004 ) . The in-hospital morbidity and mortality rate of resected patients was 20 % and 6.7 % compared with 13.3 % and 0 % of patients who underwent only exploration/palliative bypass . Conclusion : Resection for recurrent pancreatic cancer can be carried out safely . Further studies are required to address the question whether a subgroup of patients might actually benefit from this procedure 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 st and ard regimen . This r and omized phase II trial was design ed 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 r and omized . 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 ) Cholangiocarcinomas ( bile duct cancers ) are a heterogeneous group of malignancies arising from the epithelial cells of the intrahepatic , perihilar and extrahepatic bile ducts . Patients diagnosed with cholangiocarcinoma must be evaluated by a multidisciplinary team and be treated with individualized management . First of all , it is very important to define the potential resectability of the tumor because surgery is the main therapeutic option for these patients . Overall , cholangiocarcinomas have a very poor prognosis . The 5-year survival rate is 5%-10 % . In cases with a potentially curative surgery , 5-year survival rates of 25%-30 % are reported . Therefore , it is necessary to increase the cure rate from surgery , exploring the survival benefit of any adjuvant strategy . It is difficult to clarify the role of adjuvant treatment in localized and locally advanced cholangiocarcinomas . There are limited data and the role of adjuvant chemotherapy/chemoradiation in patients with resected biliary tract cancer is poorly defined . The most relevant studies in the adjuvant setting are one from Japan , the well known ESPAC-3 and BILCAP from the United Kingdom and a meta- analysis . We show the results of these trials . According to medical oncology guidelines , postoperative adjuvant therapy is widely recommended for all patients with intrahepatic or extrahepatic cholangiocarcinoma who have microscopically positive resection margins , as well as for those with a complete resection but node-positive disease . Clinical trials are ongoing . The locally advanced cholangiocarcinoma setting includes a heterogeneous mix of patients : ( 1 ) patients who have had surgery but with macroscopic residual disease ; ( 2 ) patients with locally recurrent disease after potentially curative treatment ; and ( 3 ) patients with locally unresectable disease at presentation . In these patients , surgery is not an option and chemoradiation therapy can prolong overall survival and provide control of symptoms due to local tumor effects . Nowadays , no neoadjuvant therapy can be considered a st and ard approach for the treatment of patients with cholangiocarcinoma . There are promising results and r and omized trials are needed in patients with a metastatic cholangiocarcinoma . In systemic therapy , no single drug or combination has consistently increased median survival beyond the expected 8 - 12 mo . It is always recommended that patients enrol in clinical trials . Clinical trials have shown that the more st and ard chemotherapy for a first line regimen of gemcitabine plus cisplatin ( or oxaliplatin as a potentially better tolerated agent ) is superior to gemcitabine alone . Leucovorin-modulated 5-fluorouracil , capecitabine monotherapy or single agent gemcitabine are reasonable options for patients with a borderline performance status . After progression in patients with an adequate performance status , active regimens that could be considered include gemcitabine plus capecitabine , or erlotinib plus bevacizumab , for second line treatment
Background For recurrent biliary tract cancer , chemotherapy is the st and ard treatment .
However , the efficacy of surgery is unknown .
Here , the prognostic benefit of surgery for recurrent biliary tract cancer was investigated .