Real-World Evidence on Palliative Gemcitabine and Oxaliplatin (GemOx) Combination Chemotherapy in Advanced Biliary Tract Cancer

Abstract

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.

Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real‐world data

“…Concerning ECOG PS, our results are not surprising, since ECOG PS >0 is a well‐known negative prognostic factor in this setting. Indeed, ECOG PS has been previously shown to be a prognostic factor in retrospective analyses on heterogeneous cohorts of patients, including patients receiving first‐line treatment with cisplatin and gemcitabine 26 . The prognostic role of NLR in our analysis is consistent with previous evidence, and it is of particular interest since it may pave the way for an as‐yet unexplored line of research focused on biomarkers of response to immunotherapy in advanced BTC.…”

“…Indeed, ECOG PS has been previously shown to be a prognostic factor in retrospective analyses on heterogeneous cohorts of patients, including patients receiving first-line treatment with cisplatin and gemcitabine. 26 The prognostic role of NLR in our analysis is consistent with previous evidence, and it is of particular interest since it may pave the way for an as-yet unexplored line of research focused on biomarkers of response to immunotherapy in advanced BTC. NLR has been previously highlighted to have a prognostic role in patients with several solid malignancies receiving systemic treatment, mainly ICIs.…”

Efficacy and safety of a triple combination of atezolizumab, bevacizumab plus GEMOX for advanced biliary tract cancer: a multicenter, single-arm, retrospective study

“…And biliary drainage was performed first to ensure the safety of the regimen if jaundice exists. 20 , 21 Then patients who accepted the combination therapy of atezolizumab and bevacizumab plus GEMOX and had at least one measurable lesion per mRECIST and RECIST v1.1 were enrolled in this study, while those who had received previous therapies or other regimens were excluded.…”

Gemcitabine plus Oxaliplatin (GEMOX) combined with Atezolizumab and Bevacizumab for Advanced Biliary Tract Cancer: A Preliminary Observational Study

“…Patients received a combination of atezolizumab, bevacizumab, and gemcitabine plus oxaliplatin (GEMOX). And biliary drainage was performed rst to ensure the safety of the regimen if the jaundice exists (17,18) . Speci cally, each treatment cycle lasted for 6 weeks; atezolizumab plus bevacizumab was administered every 3 weeks, and gemcitabine plus oxaliplatin was administered every 2 weeks.…”