Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: A double-blind, randomized, phase 2 trial. (April 2021)

• Record Type: Journal Article
• Authors: Adkins, Douglas R.; Lin, Jin-Ching; Sacco, Assuntina; Ley, Jessica; Oppelt, Peter; Vanchenko, Vyacheslay; Komashko, Nataliia; Yen, Chia-Jui.; Wise-Draper, Trisha; Lopez-Picazo Gonzalez, Jose; Radulovic, Sinisa; Shen, Qi; Thurm, Holger; Martini, Jean-François; Hoffman, Justin; Huang, Xin; Melichar, Bohuslav; Tahara, Makoto
• Is Part Of: Oral oncology. Volume 115(2021)
• Publication Date: 2021-04
• Subjects: Cetuximab -- Head and neck cancer -- Palbociclib -- Squamous cell carcinoma; Mouth -- Cancer -- Periodicals; Mouth -- Tumors -- Periodicals; Mouth Diseases -- Periodicals; Mouth Neoplasms -- Periodicals; Bouche -- Cancer -- Périodiques; Bouche -- Tumeurs -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9943105
• DOI: 10.1016/j.oraloncology.2021.105192
• Languages: English
• ISSNs: 1368-8375

Abstract

Highlights: Median overall survival (OS) was 9.7 months with palbociclib (PAL)+cetuximab (CET). Median OS was 7.8 months with placebo (PBO)+CET (HR = 0.82, P = 80.18 vs PAL+CET). OS was longer than expected in the PBO+CET group. Treatment-related adverse events were more common in the PAL+CET group. Abstract: Objectives: This study examined whether palbociclib and cetuximab prolonged overall survival (OS) versus placebo and cetuximab. Materials and methods: In this double-blind, randomized, phase 2 trial (PALATINUS), patients with platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent/metastatic head and neck squamous-cell carcinoma received cetuximab and either palbociclib (arm A) or placebo (arm B). The primary endpoint was OS; 120 patients were required to have ≥80% power to detect a hazard ratio (HR) of 0.6 (median OS of 10 months in arm A and 6 months in arm B) using a one-sided, log-rank test ( P = 0.10). Results: 125 patients were randomized (arm A: 65, arm B: 60). Median follow-up was 15.9 months (IQR, 11.3–22.7). Median OS was 9.7 months in arm A and 7.8 months in arm B (HR, 0.82; 95% CI, 0.54–1.25; P = 0.18). Median progression-free survival was 3.9 months in arm A and 4.6 months in arm B (HR, 1.00; 95% CI, 0.67–1.5; P = 0.50). The most common treatment-related adverse events in arm A were rash (39 patients, 60.9%) and neutropenia (26, 40.6%; three febrile) and in arm B was rash (32, 53.3%). Conclusion: There was no significant difference in median OS with palbociclib and cetuximab versus placebo and cetuximab. Funding: Pfizer Inc (NCT02499120).