TY - JOUR
T1 - 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
T2 - A double-blind, randomized, phase 2 trial
AU - Adkins, Douglas R.
AU - Lin, Jin Ching
AU - Sacco, Assuntina
AU - Ley, Jessica
AU - Oppelt, Peter
AU - Vanchenko, Vyacheslay
AU - Komashko, Nataliia
AU - Yen, Chia Jui
AU - Wise-Draper, Trisha
AU - Lopez-Picazo Gonzalez, Jose
AU - Radulovic, Sinisa
AU - Shen, Qi
AU - Thurm, Holger
AU - Martini, Jean François
AU - Hoffman, Justin
AU - Huang, Xin
AU - Melichar, Bohuslav
AU - Tahara, Makoto
N1 - Funding Information:
We thank the participating patients and their families. We would also like to thank Chetan Deshpande, PhD, for his support with the biomarker analyses for this study and Kenneth Kern, MD, for his contributions to data interpretation. This study was sponsored by Pfizer. We recognize the support of the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, USA. The Siteman Cancer Center is supported in part by National Cancer Institute Cancer Center Support Grant #P30 CA91842. Editorial support was provided by Anny Wu, PharmD, of ICON plc (North Wales, PA, USA), and was funded by Pfizer.
Funding Information:
This work was supported by Pfizer Inc in the form of: salaries for authors QS, HT, J-FM, JH and XH; study design; data collection; and data analysis. The interpretation of the data, the content of the manuscript, and the decision to publish were at the discretion of the authors. DA confirms that he had full access to all the data in the study and final responsibility for the decision to submit for publication.
Funding Information:
We thank the participating patients and their families. We would also like to thank Chetan Deshpande, PhD, for his support with the biomarker analyses for this study and Kenneth Kern, MD, for his contributions to data interpretation. This study was sponsored by Pfizer. We recognize the support of the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, USA. The Siteman Cancer Center is supported in part by National Cancer Institute Cancer Center Support Grant #P30 CA91842. Editorial support was provided by Anny Wu, PharmD, of ICON plc (North Wales, PA, USA), and was funded by Pfizer. This work was supported by Pfizer Inc in the form of: salaries for authors QS, HT, J-FM, JH and XH; study design; data collection; and data analysis. The interpretation of the data, the content of the manuscript, and the decision to publish were at the discretion of the authors. DA confirms that he had full access to all the data in the study and final responsibility for the decision to submit for publication. Upon request, and subject to certain criteria, conditions and exceptions (seehttps://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programmes that have been terminated (i.e. development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
Publisher Copyright:
© 2021
PY - 2021/4
Y1 - 2021/4
N2 - 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).
AB - 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).
KW - Cetuximab
KW - Head and neck cancer
KW - Palbociclib
KW - Squamous cell carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85100472072&partnerID=8YFLogxK
U2 - 10.1016/j.oraloncology.2021.105192
DO - 10.1016/j.oraloncology.2021.105192
M3 - Article
C2 - 33571736
AN - SCOPUS:85100472072
SN - 1368-8375
VL - 115
JO - Oral Oncology
JF - Oral Oncology
M1 - 105192
ER -