Second-line systemic therapy for metastatic pancreatic ductal adenocarcinoma: a real-world analysis of the SLOVPAC registry

Czech version

Authors: A. Savka ¹; M. Hrnčár ¹; J. Vidulin ²; S. Pöršök ³; M. Kráčalíková ³; M. Streško ⁴; D. Šafčák ⁵; V. Ušáková ⁶; M. Miškovičová ⁷; R. Podoba ⁸; M. Fremal ⁹; I. Kecskés ¹⁰; J. Lešková ¹¹; P. Demo ¹²; L. Rušinová ¹³
Authors‘ workplace: Onkologická klinika SZU a FNsP F. D. Roosevelta Banská Bystrica ¹; Oddelenie onkológie, FN Trenčín ²; II. onkologická klinika LF UK a Národného onkologického ústavu, Bratislava ³; Oddelenie onkológie, FN Trnava ⁴; Oddelenie klinickej onkológie, Východoslovenský onkologický ústav, a. s., Košice ⁵; I. onkologická klinika LF UK a Onkologického ústavu sv. Alžbety, Bratislava ⁶; Oddelenie onkológie, FN Nitra ⁷; Klinika klinickej a radiačnej onkológie, ÚVN SNP Ružomberok – FN ⁸; Oddelenie klinickej onkológie, UNsP Milosrdní bratia, Bratislava ⁹; Onkologické centrum, UN Martin ¹⁰; Oddelenie klinickej onkológie, FN J. A. Reimana Prešov ¹¹; Oddelenie klinickej onkológie, FNsP Nové Zámky ¹²; Onkologické centrum, NsP Štefana Kukuru Michalovce ¹³
Published in: Gastroent Hepatol 2026; 80(5): 375-383
Category: Gastrointestinal Oncology: Original Article
doi: https://doi.org/10.48095/ccgh2026375

Overview

Introduction: Pancreatic ductal adenocarcinoma is among the malignancies with the poorest prognosis in contemporary clinical oncology. Despite the expansion of systemic therapy to include more intensive combination regimens, the clinical benefit of treatment for metastatic disease remains limited, particularly in subsequent treatment lines. Second-line treatment represents a specifically selected clinical situation in which the feasibility of treatment is conditioned by prior therapeutic exposure, residual toxicity, performance status, nutritional and inflammatory profiles, and the availability of individual regimens.

Objective: The objective of the analysis was to evaluate the actual implementation of second-line systemic therapy in patients with metastatic pancreatic cancer in the SLOVPAC registry, to characterize the therapeutic sequences used, and to identify clinical and laboratory factors associated with survival.

Methods: The analysis included patients from the Slovak SLOVPAC registry who continued with second-line treatment following first-line systemic therapy. Overall survival from the start of second-line treatment was the primary endpoint. Secondary endpoints included progression-free survival (PFS) from the start of second-line treatment, the distribution of treatment regimens, and the prognostic significance of performance status, APNI, the Glasgow Prognostic Score, C-reactive protein, the neutrophil-to-lymphocyte ratio, SIRI, and SII. The sequential interval, defined as the time from documented progression in first-line treatment to progression or death during second-line treatment, was also analyzed exploratorily. Survival was analyzed using the Kaplan-Meier method, and differences between groups were assessed using the log-rank test. For variables with more than two categories, exploratory pairwise comparisons were also performed.

Results: Overall survival from the start of second-line treatment was evaluable in 246 patients. A total of 116 deaths were recorded. The median overall survival was 9.13 months. The median PFS from the start of second-line therapy to progression or death was 3.45 months (95% CI 2.98–3.92). The median sequential interval, defined as the time from progression in the first-line treatment to progression or death in the second-line treatment, was 4.30 months (95% CI 3.87–4.73). The treatment distribution was significantly unbalanced, with liposomal irinotecan in combination with fluorouracil and leucovorin being the dominant second-line regimen. A global comparison of overall survival by second-line regimen did not reveal a statistically significant difference; however, given the imbalance in the treatment groups, this result cannot be interpreted as evidence of comparable efficacy among the regimens. ECOG performance status was significantly associated with overall survival. Among the nutritional and inflammatory parameters, low APNI, an unfavorable Glasgow prognostic score, CRP > 10 mg/L, NLR ≥ 3, NLR ≥ 5, and SIRI ≥ 2.3 were associated with shorter overall survival. Conversely, NLR ≥ 2.5, SII ≥ 900, and sex did not show a significant association with overall survival.

Conclusion: A secondary analysis of the SLOVPAC registry shows that subsequent systemic treatment of metastatic pancreatic cancer represents a highly selected and heterogeneous situation in real-world clinical practice. The results support the importance of a comprehensive patient assessment prior to second-line treatment, including performance status, systemic inflammation, nutritional status, prior treatment, and the availability of individual regimens. SLOVPAC represents a complementary source of real-world data that can contribute to a more rational interpretation of treatment sequences in the national healthcare setting.

Keywords:

Pancreatic cancer – second-line therapy – liposomal irinotecan – SLOVPAC

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