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• W2803294407 abstract "Gallbladder cancer demonstrates strong epidemiological variation across regions with up to 10–20 fold difference in incidence and mortality.1Torre L.A. Siegel R.L. Islami F. Bray F. Jemal A. Worldwide burden of and trends in mortality from gallbladder and other biliary tract cancers.Clin Gastroenterol Hepatol – Off Clin Pract J Am Gastroenterol Assoc. 2018; 16: 427-437PubMed Scopus (56) Google Scholar Despite its decline over the past decades it seems to be on the increase again in some countries, including among women in the UK and Netherlands and men in Germany.1Torre L.A. Siegel R.L. Islami F. Bray F. Jemal A. Worldwide burden of and trends in mortality from gallbladder and other biliary tract cancers.Clin Gastroenterol Hepatol – Off Clin Pract J Am Gastroenterol Assoc. 2018; 16: 427-437PubMed Scopus (56) Google Scholar The reason for this change is uncertain although both lifestyle changes and the epidemic of metabolic syndrome and increasing obesity are likely associated. Gallbladder cancer often presents at an advanced stage and has an overall dismal prognosis. In its anatomical relation and in a biological sense, gallbladder cancer is both a close neighbour and a biological cousin to pancreatic ductal adenocarcinoma. They share late presentation due to subtle symptoms, usually unfavourable biology with early perineural infiltration and distant metastatic spread and, lack of response to most available adjunct therapies. Resectability is typically limited to <15–20% of all patients. Many patients are elderly and poor operative candidates, thus making the subgroup of patients amenable to surgery small. As a consequence, few centres have a large volume of experience and it becomes hard to run clinical trials in gallbladder cancer particularly surgical trials. Unsurprisingly, high-level evidence is virtually non-existent in surgery for gallbladder cancer and, evidence is at best weak considering adjunctive oncological therapy based on all biliary tract cancers.2Ghidini M. Tomasello G. Botticelli A. Barni S. Zabbialini G. Seghezzi S. et al.Adjuvant chemotherapy for resected biliary tract cancers: a systematic review and meta-analysis.HPB. 2017; 19: 741-748Abstract Full Text Full Text PDF Scopus (38) Google Scholar Notably, while sharing a common biliary anatomical relationship, it has become increasingly clear that cancers of the gallbladder are biologically and molecularly distinct from other intra- and extra-hepatic biliary tract cancers.3Valle J.W. Lamarca A. Goyal L. Barriuso J. Zhu A.X. New horizons for precision medicine in biliary tract cancers.Canc Discov. 2017; 7: 943-962Crossref PubMed Scopus (316) Google Scholar For example, the prevalence of TP53 mutation is higher in gallbladder cancers compared with cholangiocarcinomas but KRAS mutations somewhat lower than the prevalence found in intra- and extrahepatic cholangiocarcinomas.3Valle J.W. Lamarca A. Goyal L. Barriuso J. Zhu A.X. New horizons for precision medicine in biliary tract cancers.Canc Discov. 2017; 7: 943-962Crossref PubMed Scopus (316) Google Scholar Such mutational differences suggest biological variations exist with implications for treatment. This nuance has not been fully appreciated in previous studies of biliary tract cancers (grouping gallbladder cancers and bile duct cancer into one entity) and needs to be better addressed in future trial design. Presentation with jaundice and advanced disease (e.g. stage IV) is usually a sign of unresectable disease and poor prognosis. Exceptions exist in some rare, small series showing a somewhat longer overall survival in strictly selected patients for extended surgery.4Kang M.J. Song Y. Jang J.Y. Han I.W. Kim S.W. Role of radical surgery in patients with stage IV gallbladder cancer.HPB. 2012; 14: 805-811Abstract Full Text Full Text PDF Scopus (17) Google Scholar, 5Birnbaum D.J. Vigano L. Ferrero A. Langella S. Russolillo N. Capussotti L. Locally advanced gallbladder cancer: which patients benefit from resection?.Eur J Surg Oncol. 2014; 40: 1008-1015Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar Extended surgery including resection of large liver volumes, extrahepatic bile ducts and multiorgan resections may be considered in a few selected patients only, but the chance of good long-term outcome is limited in most patients with advanced disease. Trials to address this patient group would be highly challenging and would require multicentre collaboration to recruit sufficient patient numbers. One trial question that needs to be addressed is the role of neoadjuvant chemotherapy to foster better surgical selection of patients with locally advanced disease at presentation, as this is now based on selected, small series.6Kobayashi S. Tomokuni A. Gotoh K. Takahashi H. Akita H. Marubashi S. et al.A retrospective analysis of the clinical effects of neoadjuvant combination therapy with full-dose gemcitabine and radiation therapy in patients with biliary tract cancer.Eur J Surg Oncol. 2017; 43: 763-771Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar, 7Creasy J.M. Goldman D.A. Dudeja V. Lowery M.A. Cercek A. Balachandran V.P. et al.Systemic chemotherapy combined with resection for locally advanced gallbladder carcinoma: surgical and survival outcomes.J Am Coll Surg. 2017; 224: 906-916Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar A considerable number of gallbladder cancers are discovered incidentally after laparoscopic cholecystectomy, of which a subset of patients has a much better prognosis. This is usually due to a cancer that presents at an early T-stage (e.g. T1a). Gallbladder cancer that invades the muscular layer (T1b) already demonstrates negative prognostic features and a poorer survival. Thus, the consensus of a radical cholecystectomy and lymphadenectomy is proposed for all fit patients with ≥T1b gallbladder cancers.8Aloia T.A. Jarufe N. Javle M. Maithel S.K. Roa J.C. Adsay V. et al.Gallbladder cancer: expert consensus statement.HPB. 2015; 17: 681-690Abstract Full Text Full Text PDF Scopus (256) Google Scholar The argument for this stems largely from observational studies showing poor outcome of cholecystectomy alone in a subset of patients with early gallbladder cancer.9Hari D.M. Howard J.H. Leung A.M. Chui C.G. Sim M.S. Bilchik A.J. A 21-year analysis of stage I gallbladder carcinoma: is cholecystectomy alone adequate?.HPB. 2013; 15: 40-48Abstract Full Text Full Text PDF Scopus (56) Google Scholar However, it is shown that when residual disease or node metastases are found on the second resection, it is not translated into a survival benefit.10Watson H. Dasari B. Wyatt J. Hidalgo E. Prasad R. Lodge P. et al.Does a second resection provide a survival benefit in patients diagnosed with incidental T1b/T2 gallbladder cancer following cholecystectomy?.HPB. 2017; 19: 104-107Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar It may thus be that residual disease merely upstages the patient with no return on survival despite additional extensive surgery. Furthermore, the lag-time from initial cholecystectomy, to diagnosis of cancer in the specimen, to eventual referral for further treatment may take several weeks and sometimes months. How this lag-time influences decision-making and even risk for residual disease is not well known. To what extent further surgery represents true chance for cure or merely works as a staging procedure is an open-ended question. The balance of risk and benefit needs to be better addressed to improve decision-making for the individual patient. There is considerable variation in the literature as to what constitutes a ‘radical cholecystectomy’ and an ‘appropriate lymphadenectomy’. Variations range from a rim of liver in the gallbladder fossa to formal resection of segments 4B and 5. In some instances, a right hemihepatectomy and even more extended, multiorgan resections are performed. Notably, a high risk of residual disease is already present in more than one-third of patients with well-differentiated T1b/T2 cancers, and almost 90% in poorly differentiated T3 cancer.11Creasy J.M. Goldman D.A. Gonen M. Dudeja V. Askan G. Basturk O. et al.Predicting residual disease in incidental gallbladder cancer: risk stratification for modified treatment strategies.J Gastrointest Surg. 2017; 21: 1254-1261Crossref PubMed Scopus (19) Google Scholar Presence of residual disease has a strong influence on overall survival. Thus, with the variation in outcomes reported between largely retrospective, monocentric studies one can only conclude that there is a high likelihood for both over- and under-treatment of patients at the moment. It would appear that multicentre, collaborative efforts are warranted in order to arrive at more robust and valid answers for patients with gallbladder cancer. Both surgery and use of adjuvant therapy seems to be variable with many centres having a standard default approach to patients with gallbladder cancer. Thus, the actual role of a second resection and the type of resection involved is judgement-based with no clear-cut data to translate into survival benefits. The knowledge gap becomes an obstacle to an informed and balanced conversation with patients when discussing risk and benefits of further surgery. Many patients present in their 7th or 8th decade, and age largely determines the choice of further extensive surgery or adjuvant treatment and influences overall survival estimates when large databases are used to compare treatments. Adjuvant therapy is underused in patients with gallbladder cancer.12Mitin T. Enestvedt C.K. Jemal A. Sineshaw H.M. Limited use of adjuvant therapy in patients with resected gallbladder cancer despite a strong association with survival.J Natl Cancer Inst. 2018; 2017: 109 (7)https://doi.org/10.1093/jnci/djw324Crossref Scopus (33) Google Scholar Adjuvant chemotherapy is also variable with poor evidence for the regimens available and additionally blurred by adding radiotherapy, as preferred in some centres. Gemcitabine and cisplatin was previously considered the combination of choice, however, studies are based on result from advanced biliary tract cancers from which less than a third were gallbladder cancer and only a minority underwent curative resection. Data from the BILCAP trial (NCT00363584) presented at ASCO in 2017 favoured capecitabine over placebo as the drug of choice for adjuvant therapy in resectable biliary tract cancers. While gallbladder cancers were included in the BILCAP trial, there is uncertainty as to how capecitabine will perform in the subgroup of patients with resectable gallbladder cancer compared to other intra- and extrahepatic cholangiocarcinomas. Difficulty in interpretation of the subgroup may be related to statistical power in subgroups, but also to biological differences per se. A more precise approach is needed.3Valle J.W. Lamarca A. Goyal L. Barriuso J. Zhu A.X. New horizons for precision medicine in biliary tract cancers.Canc Discov. 2017; 7: 943-962Crossref PubMed Scopus (316) Google Scholar In 2012, the World Cancer Fund estimated more than 178,000 new cases of gallbladder cancer worldwide, of which two-thirds occurred in low- and middle income countries. In the UK, some 1000 new patients are diagnosed with gallbladder cancer each year and in the US, the number is less than 5000 new cases per year with a similar estimated number in all of Europe. Gallbladder cancer is a global disease that affects thousands of patients each year, yet few patients are offered treatment. A global effort is needed to close the research gaps and improve knowledge. This can best be done through initiatives across borders and with large-scale collaboration to ensure accrual, speed, validity and generalizability of results. None declared." @default.
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• W2803294407 title "Research gaps and unanswered questions in gallbladder cancer" @default.
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