Institut za onkologiju i radiologiju Srbije / Institute for Oncology and Radiology of Serbia
Published February 8, 2021 | Version v.1
Project deliverable Restricted

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

Creators

  • 1. Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA. Electronic address: dadkins@wustl.edu.
  • 2. Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan
  • 3. Infusion Center, University of California San Diego Moores Cancer Center, La Jolla, CA, USA.
  • 4. Division of Medical Oncology and Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
  • 5. Department of Microsurgery of Otolaryngology Organs, Ivano-Frankivsk Regional Clinical Hospital, Ukraine
  • 6. Division of Haemtology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • 7. Division of Hematology Oncology, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA
  • 8. Department of Oncology, Clínica Universidad de Navarra, Pamplona, Spain.
  • 9. Department of Experimental Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
  • 10. Global Product Development-Oncology, Pfizer Inc, New York City, NY, USA.
  • 11. Department of Oncology, Lekarska fakulta Univerzity Palackeho a Fakultni nemocnice, Olomouc, Czech Republic.
  • 12. Head and Neck Oncology Division, Japanese National Cancer Center, Chiba, Japan

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 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%).

Notes

Funding: Pfizer Inc (NCT02499120) ClinicalTrials.gov/NCT02499120 This work was supported by the Ministry of Education, Science and Technological Development, Republic of Serbia (contracts No 451-03-9/ 2021-14/200161, 451-03-9/2021-14/200043 and 451-03-9/2021-14/ 200023). The authors wish to thank Dr. Vladimir Dobriˇci´c and Mrs. Biljana Mihailovi´c (Department of Pharmaceutical Chemistry, University of Belgrade - Faculty of Pharmacy) for their technical assistance regarding drug loading procedure.

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Is part of
0928-4931 (ISSN)
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33571736 (PMID)