期刊
ORAL ONCOLOGY
卷 115, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.oraloncology.2021.105192
关键词
Cetuximab; Head and neck cancer; Palbociclib; Squamous cell carcinoma
资金
- Pfizer
- Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, USA
- National Cancer Institute Cancer Center Support Grant [P30 CA91842]
The study examined whether palbociclib and cetuximab prolonged overall survival compared to placebo and cetuximab. The results showed that there was no significant difference in median overall survival between the two groups, with median OS of 9.7 months and 7.8 months in the palbociclib group and placebo group respectively.
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 platinumresistant, cetuximab-na?ve, human papillomavirus-unrelated recurrent/metastatic head and neck squamouscell 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).
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