Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer

Vermorken, Jan B.; Mesı́a, Ricard; Rivera, Fernando; Remenár, Éva; Kawecki, Andrzej; Rottey, Sylvie; Erfán, József; Zabolotnyy, D.; Kienzer, H.; Cupissol, Didier; Peyrade, Fréd́eric; Benasso, Marco; Vynnychenko, I.; Raucourt, D. De; Bokemeyer, Carsten; Schueler, Armin; Amellal, Nadia; Hitt, Ricardo

doi:10.1056/nejmoa0802656

Cited by 3,184 publications

(2,680 citation statements)

References 15 publications

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“…Specifically, there were only two grade 4 adverse events described, both clinically insignificant lymphopenia. This number compares very favorably with prior studies, in which grade 4 adverse event rates ranged typically from 30% to 50% for chemotherapy doublets and triplets administered once every 21 days [4], [8], [12], [13]. Our adverse event (AE) data are consistent with another report of weekly docetaxel and cisplatin in this setting [14].…”

supporting

confidence: 86%

“…Although the field is evolving with the development of immunotherapies and targeted therapies, we assert that regimens such as TPC could be considered instead of the EXTREME regimens in future development of definitive trials likely to involve combinations of immunotherapy and chemotherapy in this patient population [1], [2], [3], [4], [5], [6], [7], [8]. …”

Section: Discussionmentioning

confidence: 99%

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Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

et al. 2018

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Lessons Learned. Chemotherapy for recurrent, metastatic squamous cell carcinoma of the head and neck need not be known for extreme toxicity.The weekly regimen studied here has been demonstrated to be tolerable and effective.Background.The objective of this study was to establish the response rate, progression‐free survival (PFS) and overall survival (OS), and safety profile of weekly docetaxel, platinum, and cetuximab (TPC) in patients with relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN).Materials and Methods.Twenty‐nine patients with metastatic or recurrent SCCHN with an Eastern Cooperative Oncology Group (ECOG) performance status <3 were enrolled in an institutional review board‐approved phase II trial. This study permitted prior chemoradiation, radiation, and/or surgery, provided that 3 months had elapsed since the end of the potentially curative treatment. Patients received cisplatin 30 mg/m2 or carboplatin area under the curve (AUC) 2, docetaxel 30 mg/m2, and cetuximab 250 mg/m2 weekly for 3 weeks, followed by a break during the fourth week, for a 28‐day cycle. Planned intrapatient dose modifications were based on individual toxicity.Results.Twenty‐seven patients received TPC and were evaluable for response and toxicity. Rates of complete response (CR), partial response (PR), and confirmed PR were 3%, 52%, and 30%, respectively. The overall objective response rate was 56%. Estimated median PFS and OS were 4.8 and 14.7 months, respectively. The rates of grade 3 and 4 worst‐grade adverse events (AEs) per patient were 85% and 7%, respectively. Dose density through cycle 4 was preserved for all patients; however, treatment beyond cycle 6 with the TPC regimen proved unfeasible.Conclusion.Weekly docetaxel, cisplatin, and cetuximab is an effective regimen for patients with metastatic or recurrent SCCHN. Response rates, PFS, and OS compare favorably with other combination chemotherapy treatments. Grade 4 toxicity rates observed in this study were substantially lower than those described with regimens using less frequent, higher‐dose chemotherapy schedules.

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supporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

et al. 2018

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“…Systemic chemotherapy or targeted therapy administered concomitantly with radiotherapy for head-and-neck cancer increases efficacy and improves survival (25,26), and such therapy might also improve the efficacy of BNCT. We have, therefore, initiated a prospective clinical trial where cetuximab, a monoclonal antibody directed at the epidermal growth factor receptor, is given immediately after BNCT (ClinicalTrials.gov identifier NCT00927147).…”

Section: Discussionmentioning

confidence: 99%

Boron Neutron Capture Therapy in the Treatment of Locally Recurred Head-and-Neck Cancer: Final Analysis of a Phase I/II Trial

Kankaanranta

Seppälä

Koivunoro

et al. 2012

International Journal of Radiation Oncology*Biology*Physics

213

182

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“…N=44. As shown above, the EXTREME trial [5] is the first study to demonstrate superior overall survival for combination chemotherapy. However, this three medication regimen incorporating C225 has not been routinely accepted by most oncologists.…”

Section: Accepted Articlementioning

confidence: 95%

“…Lapatinib is an orally administered agent that inhibits both HER1 (EGFR) and HER2; it is FDA approved in combination with capecitabine for the treatment of HER2 overexpressing metastatic breast cancer [5,6]. HER2 is an orphan receptor-it lacks a ligand-binding domain; it dimerizes with other members of the Erb family, including EGFR (ErbB1/HER1) leading to downstream signaling [7].…”

Section: Accepted Articlementioning

confidence: 99%

Capecitabine and lapatinib for the first‐line treatment of metastatic/recurrent head and neck squamous cell carcinoma

Weiss

Bagley

Hwang

et al. 2016

Cancer

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Funding: GSK (subsequently Novartis) funded this study. There are no NIH grants related to this work.COI: RBC has served as a consultant to GSK. CJL has served as a consultant to Novartis. The remaining authors report no COIs directly related to this work. Précis:Patients with first line recurrent/metastatic head and neck cancer were treated with the all-oral regimen capecitabine and lapatinib. mPFS was 4.2 months and mOS was 10.7 months. Keywords: head and neck neoplasms, capecitabine, lapatinib Page 2 of 72 CancerThis article is protected by copyright. All rights reserved. Accepted Article Abstract:Background: Combination of cisplatin, 5FU and cetuximab is a standard treatment for recurrent/metastatic head and neck cancer with a high rate of toxicity.Identifying less toxic, equally effective regimens is imperative. We therefore investigated first-line treatment with an all-oral regimen of capecitabine and lapatinib.Materials and Methods: Patients were required to have incurable head and neck cancer of any primary site other than nasopharynx, PS0-2, and no prior exposure to capecitabine or lapatinib. Subjects were treated with capecitabine 1000mg/m 2 BID and lapatinib 1250mg daily. Capecitabine was administered for 14 of 21 days for 4 cycles. Lapatinib was administered daily until progression. The primary outcome was overall survival (OS).Results: 44 subjects were accrued between 11/13/2009 and 4/29/2014. Patients with PS0 were 38.6% of the sample, PS1 52.3%, and PS2 9.1%. 81.8% were male and the median age was 62 years. Prior attempts at curative treatment with chemotherapy had been utilized in 68.2% of patients (platinum used in 55.8%).There was no grade 5 toxicity. The most common adverse events were diarrhea (18.2% G3) and rash (13.6% G3). The primary objective was met; OS was 10.7 months (90% CI 8.7 to 12.9). Overall response rate was 25% (90% CI: 15%-38%).PFS was 4.2 months (90% CI 3.6 to 5.1). Results were not substantially different when subdivided by p16 status. Only two patients were positive for HER2 by IHC.Conclusions: The study met its primary objective of survival comparable to the EXTREME regimen and toxicity of this all-oral regimen was tolerable. Page 3 of 72 CancerThis article is protected by copyright. All rights reserved. Accepted Article Introduction:Recurrent/metastatic head and neck squamous cell cancer (R/M HNSCC) remains incurable in the vast majority of cases. Cisplatin-containing regimens have been the standard treatment platform for more than 2 decades. The most recent advance was the addition of cetuximab to a cis-or carboplatin-containing regimen, which increased overall survival from 7.4 to 10.1 months compared to chemotherapy alone [1]. The EXTREME regimen represented the first significant breakthrough in the treatment of R/M HNSCC, but it came at a price. Adverse events in both arms of the EXTREME trial were significant; 76% of patients receiving 5FU and platinum experienced grade 3-4 adverse events, and 82% of patients receiving cisplatin, 5FU, and cetuximab experienced grade 3...

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Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer

Cited by 3,184 publications

References 15 publications

Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck

Boron Neutron Capture Therapy in the Treatment of Locally Recurred Head-and-Neck Cancer: Final Analysis of a Phase I/II Trial

Capecitabine and lapatinib for the first‐line treatment of metastatic/recurrent head and neck squamous cell carcinoma

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