Panitumumab and cetuximab are standards of treatment for chemotherapy-refractory, wild-type KRAS exon 2 mCRC patients. There are limited data on efficacy of these drugs in everyday practice on national level.
Patients enrolled into nationwide Panitumumab/Cetuximab Reimbursement-Access Program ongoing in Polish cancer centres. All reported patients were included to analyses from April 2012 to December 2015. Key inclusion criteria to the program: mCRC, refractory to chemotherapy (5FU, oxaliplatin, irinotecan), wild-type KRAS exon 2 tumour status, measurable disease, ECOG performance status 0-2. Inclusion and exclusion criteria were the same for panitumumab and cetuximab therapy in all centres. Pre-planned, uniform schedule of efficacy assessment (every 12 weeks) was applied from start of therapy in all centres. Individual patients data concerning efficacy outcome measures were entered prospectively via electronic system into databases of public, national payer - National Health Fund (NFZ). We performed retrospective analysis using Kaplan-Meier method to assess overall survival (OS) and progression-free survival (PFS). Objective response rate (ORR) was also reported.
As of April 2012, 2425 patients were enrolled into the program in 62 cancer centres (1527 patients received panitumumab and 898 received cetuximab). Median follow-up was 17.9 months for panitumumab and 25.3 months for cetuximab. Median OS was 9.9 months (95% CI 9.4-10.5) with panitumumab and 10.2 months with cetuximab (95% CI 9.5-10.9). There was no OS significant difference between groups (p = 0.09). Median PFS was 5.6 months (95% CI 5.5-5.7) with panitumumab (n = 1124) and 5.2 months (95% CI 4.9-5.4) with cetuximab (n = 619). There was no PFS difference between groups (p = 0.16). ORR was 16% in panitumumab and 13% in cetuximab group.
Panitumumab and Cetuximab provide similar efficacy outcomes in everyday practice in one health care system. Reimbursement, centralized drug-access programs may serve as a source of data for survival analysis on national level.
Clinical trial identification
Legal entity responsible for the study
Military Institute of Medicine, Warsaw National Health Fund, Poland
M. Swierkowski: Consulting role with Pfizer. C. Szczylik: Consulting role with Bayer, Pfizer, Ipsen. All other authors have declared no conflicts of interest.