Kinetics of CA19-9 decline in a randomized phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracial/leucovorin (NALIRIFOX) or nab-paclitaxel plus gemcitabine (GEM+NABP) in patients who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas (NAPOLI 3).
Year: 2024
Type: conference-abstract
Abstract: 687 Background: The NAPOLI 3 study (NCT04083235, N = 770) reported that NALIRIFOX improved overall survival (OS) vs Gem+NabP with manageable toxicity in 1L treatment of metastatic pancreatic adenocarcinoma. We explored changes in CA19-9 levels and their potential associations with efficacy as an important tumor marker in pancreatic adenocarcinoma. Methods: In NAPOLI 3, CA19-9 was evaluated at baseline and every 8 weeks until patients discontinued study treatment. The detection limit of CA19-9 was 8000 kU/L in this study. The Cox proportional hazards regression and logistic regression were employed to investigate the relationship between CA19-9 decrease and OS, progression-free survival (PFS), and overall response rate (ORR). Results: Patients with evaluable CA19-9 (levels =< 8000) at baseline and additional measurements at weeks 8 and 16 were included in the analysis (NALIRIFOX, n = 179; Gem+NabP, n = 194). The median baseline CA19-9 level was 378.0 and 409.7 kU/L for the NALIRIFOX and Gem+NabP arms, respectively. Overall, patients with (vs without) any CA 19-9 decrease by week 16 had a higher ORR (59.9% vs 35.2%; p = 0.002), a longer median PFS (9.2 vs 6.2 months; p < 0.001) and a longer median OS (14.2 vs 8.7 months; p = 0.005), respectively in a pooled analysis of the treatments. In the NALIRIFOX arm, patients with any CA19-9 decrease by week 16 had a higher confirmed ORR of 65.1% compared with those without at 42.4% ( p < 0.001), a median PFS of 9.5 vs 7.1 months ( p < 0.001) and a median OS of 15.4 versus 8.4 months ( p = 0.004), respectively. In the Gem+NabP arm, patients with CA19-9 decrease by week 16 had a higher ORR of 55.5% compared with those without at 23.8% ( p = 0.012), a median PFS of 7.6 versus 5.8 months ( p < 0.001) and a median OS of 13.7 versus 11.9 months ( p = 0.235), respectively. Conclusions: CA19-9 decrease by week 16 has the potential to be an early prognostic factor for OS, PFS and ORR. The results should be interpreted with caution as a considerable percentage of patients were excluded due to non-evaluable CA19-9 that exceeded the lab detection limit of 8000 kU/L. Clinical trial information: NCT04083235 .
Source: Journal of Clinical Oncology
Authors: Sreenivasa R Chandana, Zev A. Wainberg, Davide Melisi, Teresa Macarulla, Roberto A. Pazo Cid, Christelle De La Fouchardiere, Andrew Peter Dean, Igor Kiss, Woo Jin Lee, Thorsten Goetze, Eric Van Cutsem, Andrew Scott Paulson, Tanios S. Bekaii-Saab, Shubham Pant, Richard Hubner, Zhimin Xiao, Jia Li, Fawzi Benzaghou, Eileen Mary O'Reilly
Institutions: University of California, Los Angeles, Azienda Ospedaliera Universitaria Integrata Verona, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Hospital Universitario Miguel Servet, Centre Léon Bérard, St John of God Subiaco Hospital, Masaryk Memorial Cancer Institute, National Cancer Center, National Cancer Center Hospital, Institute of Clinical Cancer Research, Krankenhaus Nordwest, KU Leuven, Texas Oncology, Mayo Clinic, Mayo Clinic in Arizona, Mayo Clinic Comprehensive Cancer Center (Arizona), The University of Texas MD Anderson Cancer Center, The Christie NHS Foundation Trust, Ipsen (United States), Memorial Sloan Kettering Cancer Center
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funder: Ipsen
OpenAlex ID: W4391096720