Publications
Detailed Information
Phase I trial of palbociclib, a selective cyclin dependent kinase 4/6 inhibitor, in combination with cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Michel, Loren | - |
dc.contributor.author | Ley, Jessica | - |
dc.contributor.author | Wildes, Tanya M. | - |
dc.contributor.author | Schaffer, Andras | - |
dc.contributor.author | Robinson, Anthony | - |
dc.contributor.author | Chun, Se-Eun | - |
dc.contributor.author | Lee, Wooin | - |
dc.contributor.author | Lewis, James, Jr. | - |
dc.contributor.author | Trinkaus, Kathryn | - |
dc.contributor.author | Adkins, Douglas | - |
dc.date.accessioned | 2023-04-18T06:25:00Z | - |
dc.date.available | 2023-04-18T06:25:00Z | - |
dc.date.created | 2017-11-15 | - |
dc.date.issued | 2016-07 | - |
dc.identifier.citation | Oral Oncology, Vol.58, pp.41-48 | - |
dc.identifier.issn | 1368-8375 | - |
dc.identifier.uri | https://hdl.handle.net/10371/190105 | - |
dc.description.abstract | Objectives: To test the safety of the CDK4/6 inhibitor palbociclib with cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Materials and Methods: A phase I trial using 3+3 design was performed to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of palbociclib with standard dose weekly cetuximab. Palbociclib was administered orally days 1-21 every 28 days: dose level 1 (100 mg/d) and 2 (125 mg/d; approved monotherapy dose). Pharmacokinetic assessments were performed on cycle 2, day 15. Cyclin D1, p16(INK4a), and Rb protein expression were measured on pre-treatment tumor. Tumor response was assessed using RECIST1.1. Results: Nine patients (five p16(INK4a) negative; four positive) were enrolled across dose levels 1 (n = 3) and 2 (n = 6) and none experienced a DLT. A MTD of palbociclib was not reached. Myelosuppression was the most common adverse event. Six of nine patients had cetuximab-resistant and 4/9 had platin-resistant disease. Disease control (DC) occurred in 89%, including partial response (PR) in two (22%) and stable disease in six (67%) patients. PRs occurred in p16(INK4a) negative HNSCC. Five patients (56%) had measurable decreases in tumor target lesions. In cetuximab-resistant HNSCC, best tumor response was PR in 1 and DC in 5 and median TTP was 112 days (range: 28-168). In platin-resistant HNSCC, best tumor response: PR in 1, DC in 3 and median TTP was 112 days (range: 28-112). The C-max and AUC(0-24h) appeared comparable in patients receiving 125 vs 100 mg dose of palbociclib. Conclusion: This trial, the first to evaluate a CDK4/6 inhibitor in HNSCC, determined that palbociclib 125 mg/day on days 1-21 every 28 days with cetuximab was safe. Tumor responses were observed, even in cetuximab- or platin-resistant disease. (C) 2016 Elsevier Ltd. All rights reserved. | - |
dc.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | Phase I trial of palbociclib, a selective cyclin dependent kinase 4/6 inhibitor, in combination with cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.oraloncology.2016.05.011 | - |
dc.citation.journaltitle | Oral Oncology | - |
dc.identifier.wosid | 000377935500012 | - |
dc.identifier.scopusid | 2-s2.0-84971224773 | - |
dc.citation.endpage | 48 | - |
dc.citation.startpage | 41 | - |
dc.citation.volume | 58 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Lee, Wooin | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | PLATINUM-BASED CHEMOTHERAPY | - |
dc.subject.keywordPlus | HUMAN-PAPILLOMAVIRUS | - |
dc.subject.keywordPlus | GENE-EXPRESSION | - |
dc.subject.keywordPlus | PLUS CETUXIMAB | - |
dc.subject.keywordPlus | D1 EXPRESSION | - |
dc.subject.keywordPlus | PD 0332991 | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | GROWTH | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | SCHEDULE | - |
dc.subject.keywordAuthor | Phase I | - |
dc.subject.keywordAuthor | Palbociclib | - |
dc.subject.keywordAuthor | Cetuximab | - |
dc.subject.keywordAuthor | Head and neck cancer | - |
dc.subject.keywordAuthor | Squamous cell carcinoma | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.