Safety and feasibility of every‐other‐week maintenance cetuximab after first‐line chemotherapy in patients with recurrent or metastatic head and neck squamous cell cancer

Bossi, Paolo; Kornek, Gabriela; Lanzetta, Gaetano; Rozzi, Antonio; Füreder, Thorsten; Locati, Laura D.; Licitra, Lisa

doi:10.1002/hed.23170

Cited by 19 publications

(14 citation statements)

References 15 publications

(38 reference statements)

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“…It has been proven previously in colorectal cancer and head and neck cancer patients that weekly cetuximab and biweekly cetuximab is equally effective with respect to target regulation, pharmacokinetics and pharmacodynamic parameters2021. Additionally, it has been shown in prostate cancer patients that docetaxel biweekly is as effective as docetaxel triweekly, but much better tolerated22.…”

Section: Discussionmentioning

confidence: 99%

Docetaxel plus cetuximab biweekly is an active regimen for the first-line treatment of patients with recurrent/metastatic head and neck cancer

Posch

Fuchs

Kornek

et al. 2016

Sci Rep

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For patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (SCCHN) limited therapeutic options exist. Only a subset of patients is suitable for combination chemotherapy regimens. Biweekly docetaxel plus cetuximab might be an alternative option. Thus, we performed this retrospective analysis in unselected patients in order to investigate the efficacy and safety of this regimen. Thirty-one patients receiving off protocol docetaxel (50 mg/m2) plus cetuximab (500 mg/m2) biweekly were included. Data collection included baseline demographic, response rate (ORR), disease control rate (DCR), overall survival (OS), progression free survival (PFS) as well as toxicity. OS and PFS were 8.3 months (95% CI 4.8–11.8) and 4.0 months (95% CI 1.0–7.0), respectively. Three (9.7%) patients achieved a complete response and one patient (3.2%) a partial response. The DCR was 41.9% and we observed an ORR of 12.9%. The one-year survival rate was 25.8%. The therapy was well tolerated and the most common grade 3/4 adverse events were neutropenia (19.4%), hypomagnesaemia (12.9%) and acne-like rash (9.7%). Biweekly cetuximab/docetaxel is an effective regimen and well tolerated in R/M SCCHN patients not suitable for platinum doublet treatment. Further evaluation of this regimen in prospective clinical trials is warranted.

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Section: Discussionmentioning

confidence: 99%

Docetaxel plus cetuximab biweekly is an active regimen for the first-line treatment of patients with recurrent/metastatic head and neck cancer

Posch

Fuchs

Kornek

et al. 2016

Sci Rep

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“…Median PFS and OS were 8 and 11 months, respectively, which are also in line with findings for cetuximab plus platinum-based CT in clinical trials (9, 11, 56). Similarly, in a retrospective study of 31 patients with R/M SCCHN, cetuximab plus CT followed by maintenance with biweekly cetuximab led to a stable disease rate of 52%, partial response rate of 39%, and complete response rate of 9% (59). Furthermore, there is evidence that maintenance therapy until PD with cetuximab as a single agent following the EXTREME regimen is also well-tolerated with a good compliance (relative dose intensity = 82%) (53, 59).…”

Section: First-line Treatment Options In R/m Scchnmentioning

confidence: 98%

“…Similarly, in a retrospective study of 31 patients with R/M SCCHN, cetuximab plus CT followed by maintenance with biweekly cetuximab led to a stable disease rate of 52%, partial response rate of 39%, and complete response rate of 9% (59). Furthermore, there is evidence that maintenance therapy until PD with cetuximab as a single agent following the EXTREME regimen is also well-tolerated with a good compliance (relative dose intensity = 82%) (53, 59). Indeed, in the EXTREME trial, the frequency of severe skin reactions in the cetuximab-containing arm decreased from 9 to 5% during the cetuximab maintenance phase (median treatment duration = 29.9 weeks) (60).…”

Section: First-line Treatment Options In R/m Scchnmentioning

confidence: 98%

Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

et al. 2017

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The major development of the past decade in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) was the introduction of cetuximab in combination with platinum plus 5-fluorouracil chemotherapy (CT), followed by maintenance cetuximab (the “EXTREME” regimen). This regimen is supported by a phase 3 randomized trial and subsequent observational studies, and it confers well-documented survival benefits, with median survival ranging between approximately 10 and 14 months, overall response rates between 36 and 44%, and disease control rates of over 80%. Furthermore, as indicated by patient-reported outcome measures, the addition of cetuximab to platinum-based CT leads to a significant reduction in pain and problems with social eating and speech. Conversely, until very recently, there has been a lack of evidence-based second-line treatment options, and the therapies that have been available have shown low response rates and poor survival outcomes. Presently, a promising new treatment option in R/M SCCHN has emerged: immune checkpoint inhibitors (ICIs), which have demonstrated favorable results in second-line clinical trials. Nivolumab and pembrolizumab are the first two ICIs that were approved by the US Food and Drug Administration. We note that the trials that showed benefit with ICIs included not only patients who previously received ≥1 platinum-based regimens for R/M SCCHN but also patients who experienced recurrence within 6 months after combined modality therapy with a platinum agent for locally advanced disease. In this review, we outline the available clinical and observational evidence for the EXTREME regimen and the initial results from clinical trials for ICIs in patients with R/M SCCHN. We propose that these treatment options can be integrated into a new continuum of care paradigm, with first-line EXTREME regimen followed by second-line ICIs. A number of ongoing clinical trials are comparing regimens with ICIs, alone and in combination with other ICIs or CT, with the EXTREME regimen for first-line treatment of R/M SCCHN. As we eagerly await the results of these trials, the EXTREME regimen remains the standard of care for the first-line treatment of R/M SCCHN.

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“…Most common adverse events were grade 3 or 4 febrile neutropenia (5.7%), skin rash (3.8%), or mucositis (3.8%). Bossi et al [36] evaluated cisplatin, 5-FU, and CTX as first-line treatment followed by CTX maintenance every other week. While maintenance patients developed skin rash (grade 3, 16%; grade 2, 23%), fatigue (grade 3, 3%; grade 2, 16%), diarrhea (grade 3, 7%; grade 2, 13%), hypomagnesaemia (grade 4, 3%; grade 3, 3%; grade 2, 19%), and mucositis (grade 3, 3%; grade 2, 23%), the study showed that CTX maintenance was well tolerated.…”

Section: Resultsmentioning

confidence: 99%

Advanced Squamous Cell Carcinoma of the Head and Neck: The Current Role of Cetuximab

Granados-García

Aguilar-Ponce²,

Maldonado-Magos³

et al. 2016

ORL

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We review clinical trials of squamous cell carcinoma of the head and neck (SCCHN) to address the current and potential uses of cetuximab (CTX). PubMed was reviewed to identify papers published between 2010 and 2016. The search terms used were “cetuximab” and “head and neck cancer.” A total of 634 articles were identified. Phase II or III studies with CTX in patients with advanced SCCHN without treatment or with recurrent/metastatic tumors were selected. Forty-six registries were obtained. Information was critically reviewed and relevant information presented. As definitive treatment of advanced squamous cells carcinomas and as palliative treatment of recurrent/metastatic disease, CTX alone or associated with chemotherapy and/or radiotherapy is an alternative to chemoradiotherapy because of its distinct and favorable toxicity profile.

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Safety and feasibility of every‐other‐week maintenance cetuximab after first‐line chemotherapy in patients with recurrent or metastatic head and neck squamous cell cancer

Cited by 19 publications

References 15 publications

Docetaxel plus cetuximab biweekly is an active regimen for the first-line treatment of patients with recurrent/metastatic head and neck cancer

Docetaxel plus cetuximab biweekly is an active regimen for the first-line treatment of patients with recurrent/metastatic head and neck cancer

Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Advanced Squamous Cell Carcinoma of the Head and Neck: The Current Role of Cetuximab

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