Abstract
Clinical outcomes of chemotherapy for patients with advanced pancreatic adenocarcinoma in a real-world setting might differ from outcomes in randomized clinical trials (RCTs). Here we show in a single-institution cohort of 595 patients that median overall survival (OS) of patients who received gemcitabine alone (n = 185; 6.6 months (95% CI; 5.5–7.7)) was the same as in pivotal RCTs. Gemcitabine/capecitabine (n = 60; 10.6 months (95% CI; 7.8–13.3)) and gemcitabine/nab-paclitaxel (n = 66; 9.8 months (95% CI; 7.9–11.8)) resulted in a longer median OS and fluorouracil/oxaliplatin/irinotecan (n = 31, 9.9 months (95% CI; 8.1–11.7)) resulted in a shorter median OS than previously reported. Fluorouracil/oxaliplatin (n = 35, 5.8 months (95% CI; 4.5–7)) and best supportive care (n = 206, 1.8 months (95% CI; 1.5–2.1)) could not be benchmarked against any RCTs. The degree of protocol adherence explained differences between real-world outcomes and the respective RCTs, while exposure to second-line treatments did not.
Highlights
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer-related death in the European Union [1]
We found that most patients who received 5-FU/oxaliplatin had relapsed after previous surgery and adjuvant chemotherapy and that the group treated with 5-FU/oxaliplatin/irinotecan had the highest proportion of patients who underwent exploration
Chemotherapy for patients with advanced pancreatic cancer in a clinical real-world cohort can achieve survival benefits similar to those described in randomized clinical trials (RCTs)
Summary
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer-related death in the European Union [1]. It is estimated to become the second most deadly cancer by 2030 because of an increasing incidence and a lack of the major improvements in prevention, early detection, and treatment seen in other common malignancies [2]. Monotherapy with gemcitabine is generally well-tolerated, even by patients with reduced performance status. It alleviates disease symptoms but only marginally improves survival outcomes [3,4]. The combination of gemcitabine with erlotinib is associated with a small, but statistically significant, improvement in OS over gemcitabine alone, but excess adverse events and high costs have limited its use in clinical practice [8]
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