Abstract | OBJECTIVES: MATERIALS AND METHODS: We performed a multicenter phase 2 trial. Key eligibility requirements included measurable HPV-related OPSCC that progressed on a cetuximab-containing regimen. Palbociclib 125 mg po was administered on Days 1-21 of 28 day cycles, with weekly cetuximab. The primary endpoint was objective response (RECIST1.1). The study design had a probability of 0.70 of accepting the alternative hypothesis (ORR ≥ 20%) and rejecting the null hypothesis (ORR ≤ 5%). Two or more tumor responses among 24 patients were needed to accept the alternative hypothesis. RESULTS: Twenty-four patients enrolled. The median interval from prior cetuximab to study enrollment was 0.7 months (IQR 0.2-6.1). Disease progression on a platinum agent occurred in 23 patients (96%). An objective response occurred in one patient (ORR 4%). The duration of response was 4 months. Stable disease with ≥ 10% decrease in target lesions occurred in 2 patients (8%). Median follow-up was 8.9 (IQR 3.7-16.8) months. The median progression-free survival was 1.9 months (95% CI 1.8-2.1) and the median overall survival was 17.1 months (95%CI: 5.8-21.5). CONCLUSION: The trial did not meet its primary endpoint. Further investigation of palbociclib and cetuximab in cetuximab-resistant HPV-related OPSCC is not warranted.
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Authors | Peter Oppelt, Jessica C Ley, Francis Worden, Kevin Palka, Ronald Maggiore, Jingxia Liu, Douglas Adkins |
Journal | Oral oncology
(Oral Oncol)
Vol. 114
Pg. 105164
(03 2021)
ISSN: 1879-0593 [Electronic] England |
PMID | 33465681
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 Elsevier Ltd. All rights reserved. |
Chemical References |
- Piperazines
- Pyridines
- palbociclib
- Cetuximab
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Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(pharmacology, therapeutic use)
- Carcinoma, Squamous Cell
(drug therapy)
- Cetuximab
(pharmacology, therapeutic use)
- Female
- Humans
- Male
- Middle Aged
- Oropharyngeal Neoplasms
(drug therapy)
- Piperazines
(pharmacology, therapeutic use)
- Pyridines
(pharmacology, therapeutic use)
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