Comparison of efficacy and tolerability of gemcitabine and gemcitabine plus nab-paclitaxel in 2nd line therapy for pancreatic cancer. Experience of one center

Background. First-line therapy for advanced pancreatic cancer often involves combination regimens, including gemcitabine plus nab-paclitaxel (GEM-NAB), whereas the optimal treatment strategy in the second-line setting remains a subject of debate.

Aim. To compare efficacy and tolerability of gemcitabine (GEM) monotherapy and GEM-NAB combination as second-line treatment for pancreatic cancer.

Materials and methods. This retrospective single-center study was conducted in patients with pancreatic adenocarcinoma receiving second-line chemotherapy with one of two regimens: GEM monotherapy or the GEM-NAB combination. The primary endpoint was overall survival. Secondary endpoints included progression-free survival, objective response rate, disease control rate, and safety.

Results. A total of 118 patients were included: 57 received GEM and 61 received GEM-NAB. The groups were comparable in baseline clinical and demographic characteristics. Median follow-up was 9 months. Median OS was 5.9 months (95 % confidence interval (CI) 3.8–8.0) in the GEM group and 6.4 months (95 % CI 4.5–8.3) in the GEM-NAB group (p = 0.772). Median progression-free survival was 3.3 months (95 % CI 2.8–3.8) and 4.7 months (95 % CI 3.6–5.8), respectively (p = 0.079). Objective response rate was 15.8 % and 28.6 %, respectively (p = 0.127). The incidence of grade III–IV adverse events was comparable between the groups. In multivariate analysis, ECOG status ≥ 2, liver metastases, and decreased hemoglobin level were identified as independent predictors of poor survival.

Conclusion. Gemcitabine plus nab-paclitaxel combination as 2^nd line therapy did not demonstrate statistically significant improvement in overall survival compared with gemcitabine monotherapy and showed a comparable safety profile.