Abstract 5853
Background
The EXTREME regimen (cetuximab + PBT ≤ 6 cycles followed by cetuximab-alone maintenance until progressive disease [PD]) was the first treatment in 30 years to significantly improve disease control and overall survival (OS) vs PBT in patients (pts) with first-line (1L) R/M SCCHN (median progression-free survival [PFS], 5.6 vs 3.3 months; median OS, 10.1 vs 7.4 months). ENCORE is a multinational, observational, prospective, open-label study investigating the real-world treatment practices, efficacy, and safety of the EXTREME regimen in 1L R/M SCCHN. The primary objective was to characterize the ways the 1L R/M treatment regimen is administered in SCCHN.
Methods
This study (EMR 062202-566) enrolled 225 pts with previously untreated R/M SCCHN from Italy, France, Portugal, Russia, Algeria, and South Africa, who were planned to receive 1L treatment with cetuximab + PBT.
Results
221 pts were evaluable. Median age was 64 years, 76% were male, and 85% had an ECOG performance status of 0 or 1. 51% of patients had recurrent disease, 9% had recurrent and metastatic disease, and 40% had metastasis at first presentation. 40% of patients received cisplatin, and 59% received carboplatin. Only 54% of patients received 5-fluorouracil (5-FU). 14% had previously received cetuximab as part of their concomitant treatment, and 12% had PD < 6 months since the last platinum dose in the locally advanced setting. 206 pts (93%) were planned to receive cetuximab maintenance until PD, and 97 of the 202 pts with known stop date (48%) received cetuximab maintenance. Median PFS was 6.5 months (95% CI, 5.4–7.6), and median OS was 10.2 months (95% CI, 8.5–12.6). Serious adverse events occurred in 36% of pts, with 5% related to cetuximab.
Conclusions
The ENCORE trial showed, in an international real-world setting, OS and PFS with 1L cetuximab + PBT that were comparable to what was observed in the randomized, phase 3 EXTREME study. Notably, the EXTREME regimen was feasible in an unselected population and was adapted in a substantial proportion of patients, with almost half of them not receiving 5-FU. Final data will be presented at the congress.
Clinical trial identification
Trial Protocol Number: EMR 062202-566.
Legal entity responsible for the study
Merck KGaA.
Funding
Merck KGaA.
Editorial Acknowledgement
Medical writing support was provided by ClinicalThinking, and was funded by Merck KGaA, Darmstadt, Germany.
Disclosure
C. Le Tourneau: Honoraria: MSD, Bristol-Myers Squibb, Roche, Amgen, Novartis, Merck Serono, Nanobiotix. All other authors have declared no conflicts of interest.