Abstract
Simple SummaryCancers of the biliary tract are rare but severe with high mortality rates. Randomised controlled trials suggest that chemotherapies such as gemcitabine and oxaliplatin (GemOx) may relieve symptoms and prolong life, but less is known on the efficacy and safety of such regimens in real life. The current paper assessed the real-world outcome of GemOx in all patients with advanced biliary tract cancer treated at any cancer centre in the South East Region of Sweden over a period of nine years. The median overall survival was nine months and time to disease progression five months. Prognostic factors such as performance status and gall bladder (rather than bile duct) localisation of the primary tumour were identified. Most patients received a lower dose of oxaliplatin than proposed by previous studies, which seemed feasible as few patients had severe adverse events. This study supports further use of GemOx as standard of care.Background: Gemcitabine and oxaliplatin (GemOx) is a standard combination regimen in advanced biliary tract cancer (BTC). There is limited evidence on its efficacy and safety in real life. Methods: A retrospective multicentre cohort study in the South East Region of Sweden, covering nine years (2011–2020) and three hospitals where GemOx was treatment of choice, was designed. Clinicopathological prognostic parameters were explored. Results: One hundred and twenty-one patients with advanced BTC were identified. Median overall and progression-free survival (OS and PFS) were 8.9 (95% CI = 7.2–10.6) and 5.3 (95% CI = 3.8–6.7) months. Performance status according to Eastern Cooperative Oncology Group (PS according to ECOG) 1–2 and primary gallbladder carcinoma were independent predictors for poor OS. PS and derived neutrophil/lymphocyte ratio were predictive for PFS. The most common severe type of myelosuppresion was grade 3 neutropenia that was recorded in 8%. Fifty-three (43.8%) experienced at least one episode of unplanned hospitalisation. One hundred and seventeen (97%) received oxaliplatin with lower dosage than was utilized in previous phase III trials (80–85 vs. 100 mg/m2) and a majority received further dose reductions of oxaliplatin and/or gemcitabine. Conclusion: The outcome of GemOx in advanced BTC appears comparable in controlled trials and real-world contexts. A lower dose of oxaliplatin seems more tolerable without compromising the outcome.
Highlights
Biliary tract cancer (BTC) is an entity comprising a group of rare types of cancers with high mortality rates, including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma (Klatskin tumour), extrahepatic cholangiocarcinoma and gallbladder carcinoma [1]
A majority of patients (n = 101, 84%) had the diagnosis verified with histology or cytology
While the outcomes closely mirror what was previously reported in the phase III trial by Sharma et al [10], which compared GemOx to GemCis in patients with gallbladder cancer and reported mOS of 9 and 8.3 months in the GemOx and GemCis arms, respectively, the outcomes appear slightly worse than the corresponding results of the ‘Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer’ (BINGO) trial [14], where survival in the GemOx comparator arm was 12.4 months
Summary
Biliary tract cancer (BTC) is an entity comprising a group of rare types of cancers with high mortality rates, including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma (Klatskin tumour), extrahepatic cholangiocarcinoma (distal biliary tract carcinoma) and gallbladder carcinoma [1]. The worldwide age standardized incidence rate (per 100,000) is 0.9 for men and 1.4 for women [3]. The median 5-year survival varies between 10 and 40%, which is highly dependent on the location of the primary tumour, the disease stage at diagnosis and access/eligibility for multimodal treatment in terms of surgery and/or chemotherapy [4,5]. The majority of patients with BTC have locally advanced and/or metastatic disease at the time of diagnosis, both of which preclude curative intent surgery. Over the last twenty years, gemcitabine (Gem) has been a cornerstone in palliative systemic treatment of advanced BTC, either alone or in combination with platinum compounds [6,7]. Gemcitabine and oxaliplatin (GemOx) is a standard combination regimen in advanced biliary tract cancer (BTC). There is limited evidence on its efficacy and safety in real life
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