Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-na?ve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: A double-blind, randomized, phase 2 trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F21%3A73608756" target="_blank" >RIV/61989592:15110/21:73608756 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S1368837521000154?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S1368837521000154?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.oraloncology.2021.105192" target="_blank" >10.1016/j.oraloncology.2021.105192</a>
Alternative languages
Result language
angličtina
Original language name
Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-na?ve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: A double-blind, randomized, phase 2 trial
Original language description
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).
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
ORAL ONCOLOGY
ISSN
1368-8375
e-ISSN
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Volume of the periodical
115
Issue of the periodical within the volume
April 2021
Country of publishing house
GB - UNITED KINGDOM
Number of pages
8
Pages from-to
"'105192(1)'"-"'105192(8)'"
UT code for WoS article
000636451300014
EID of the result in the Scopus database
2-s2.0-85100472072