Comparison of gemcitabine plus oxaliplatin versus gemcitabine plus nab‐paclitaxel as first‐line chemotherapy for advanced pancreatic adenocarcinoma: A single‐center retrospective analysis

Abstract Background Pancreatic cancer is mostly diagnosed in an advanced stage and treated with systemic therapy with palliative intent. Nowadays, the doublet chemotherapy of Gemcitabine and nab‐paclitaxel (Gem‐Nab) is one of the most frequently used regimens worldwide, but is not ubiquitarily available or reimbursed. Therefore, we compared the clinical efficacy of Gem‐Nab to a historical control of patients treated with gemcitabine and oxaliplatin (Gem‐Ox) at our tertiary cancer center, which was the standard treatment prior to the introduction of FOLFIRINOX. Methods This single‐center retrospective real world study includes 121 patients diagnosed with locally advanced or primary metastatic pancreatic adenocarcinoma who were treated with chemotherapy doublet, with either Gem‐Nab or Gem‐Ox in palliative first‐line. Survival rates were analyzed using the Kaplan–Meier method, and comparisons were made with log‐rank tests. Gem‐Ox was considered as standard first line therapy at our institution for patients who were deemed fit for doublet chemotherapy between the years 2006 to 2012. These patients were compared to a cohort of patients treated with the new standard first‐line therapy of Gem‐Nab between 2013 and 2020. Results A total of 554 patients with pancreatic cancer of all stages were screened, and 73 patients treated with Gem‐Nab and 48 patients treated with Gem‐Ox in the palliative first‐line setting were identified and included in this analysis. Patients receiving Gem‐Ox had a statistically significantly better performance score (ECOG PS) when compared to the Gem‐Nab group (Odds ratio (OR) 0.28, 95% CI 0.12–0.65, p = 0.005), more often suffered from locally advanced than metastatic disease (OR 3.10, 95% CI 1.27–7.91, p = 0.019) and were younger in age (OR 0.95, 95% CI 0.91–0.99, p = 0.013). Median overall survival (OS) of the whole study cohort was 10.3 months (95% CI 8.5–11.6). No statistically significant difference in OS could be observed between the Gem‐Nab and the Gem‐Ox cohort (median OS: 8.9 months (95% CI 6.4–13.5) versus 10.9 months (95% CI 9.5–13.87, p = 0.794, HR 1.27, 95% CI 0.85–1.91)). Median progression‐free survival (PFS) was 6.8 months in the entire cohort (95% CI 4.9–8.4). No statistically significant difference in PFS could be observed between the Gem‐Nab and the Gem‐Ox cohort (median PFS: 5.8 months (95% CI 4.3–8.2) versus 7.9 months (95% CI 5.4–9.5) p = 0.536, HR 1.11, 95% CI 0.74–1.67). Zero‐truncated negative binomial regressions on OS and PFS adjusting for gender, age, performance status (ECOG PS), and CA19‐9 levels yielded no significant difference between Gem‐Nab or Gem‐Ox. Conclusion From our analysis, we could evidence no difference in outcome parameters in this retrospective analysis despite the worse prognostic pattern for GemOX. Therefore, we suggest Gem‐Ox as potential first line treatment option for inoperable locally advanced or metastatic pancreatic cancer, especially if Gem‐Nab is not available

Feasibility of Continuous Monitoring of Endoscopy Performance and Adverse Events: A Single-Center Experience

Background: We integrated a standardized questionnaire focusing on adverse events and performance measures in gastrointestinal endoscopy as a mandatory component of the electronical medical record. Methods: This retrospective study was conducted using prospectively collected data on quality parameters and adverse events (AEPM) for all diagnostic and therapeutic endoscopic procedures at our center between 2018 and 2020. Results: A total of 7532 consecutive endoscopic procedures were performed in 5035 patients. The proportion of high-risk examinations and high-risk patients was 20% and 23%, respectively. Severe adverse events (AEs, n = 21) occurred in 0.3% of procedures and significantly more often in patients with an ASA score > II (0.6%, p n = 2). Following screening colonoscopy (n = 242), four endoscopists documented AEPM in more than 98% of the examinations. The cecal intubation rate was 97%, and the mean adenoma detection rate 60%. The quality of lavage was documented in 97% (rated as good in 70% and moderate in 24%). Conclusions: The risk of adverse events is significantly increased in patients with an ASA score > II, which should be considered when choosing treatment methods and precautionary measures. Continuous recording of AEPM can be effectively integrated into the clinical reporting process, enabling analysis of the data and feedback to be provided to endoscopists

Feasibility of Continuous Monitoring of Endoscopy Performance and Adverse Events: A Single-Center Experience

Background: We integrated a standardized questionnaire focusing on adverse events and performance measures in gastrointestinal endoscopy as a mandatory component of the electronical medical record. Methods: This retrospective study was conducted using prospectively collected data on quality parameters and adverse events (AEPM) for all diagnostic and therapeutic endoscopic procedures at our center between 2018 and 2020. Results: A total of 7532 consecutive endoscopic procedures were performed in 5035 patients. The proportion of high-risk examinations and high-risk patients was 20% and 23%, respectively. Severe adverse events (AEs, n = 21) occurred in 0.3% of procedures and significantly more often in patients with an ASA score > II (0.6%, p < 0.01). We observed no long-term morbidity after severe AEs. Mortality was 0.03% (n = 2). Following screening colonoscopy (n = 242), four endoscopists documented AEPM in more than 98% of the examinations. The cecal intubation rate was 97%, and the mean adenoma detection rate 60%. The quality of lavage was documented in 97% (rated as good in 70% and moderate in 24%). Conclusions: The risk of adverse events is significantly increased in patients with an ASA score > II, which should be considered when choosing treatment methods and precautionary measures. Continuous recording of AEPM can be effectively integrated into the clinical reporting process, enabling analysis of the data and feedback to be provided to endoscopists