Trial reportOral oncology2021
Palbociclib and cetuximab in cetuximab-resistant human papillomavirus-related oropharynx squamous-cell carcinoma: A multicenter phase 2 trial.
Trial report in Oral oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 20 citations in OpenAlex.
- Review
- Exploring the Therapeutic Implications of Co-Targeting the EGFR and Spindle Assembly Checkpoint Pathways in Oral Cancer.Pharmaceutics · 2024Review
- ORAOV1, CCND1, and MIR548K Are the Driver Oncogenes of the 11q13 Amplicon in Squamous Cell Carcinoma.Molecular cancer research : MCR · 2024Article
- Combination Therapy as a Promising Way to Fight Oral Cancer.Pharmaceutics · 2023Review
- Proliferative exhausted CD8eLife · 2023Article
- Review
- Review
- Palbociclib-based high-throughput combination drug screening identifies synergistic therapeutic options in HPV-negative head and neck squamous cell carcinoma.BMC medicine · 2022Article
- Mechanisms of Cisplatin Resistance in HPV Negative Head and Neck Squamous Cell Carcinomas.Cells · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 1 country.
Funding
Abstract
objectivesWe previously reported that palbociclib, a selective CDK4/6 inhibitor, given with cetuximab, resulted in an objective response rate (ORR) of 19% in cetuximab-resistant human papillomavirus (HPV)-unrelated head and neck squamous-cell carcinoma (HNSCC). In this study, we aimed to determine the proportion of patients with cetuximab-resistant HPV-related oropharynx (OP)SCC who achieved an objective response to palbociclib and cetuximab. MATERIALS AND
methodsWe 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.
resultsTwenty-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).
conclusionThe 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.