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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.

ABSTRACT: BACKGROUND:Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC. METHODS:In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score. RESULTS:Fourhundred seventy patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (-?2.13 vs. non-responders +?1.15, p?=?0.048), and even more for the best post-baseline assessment (-?7.82 vs. non-responders -?1.97, p?=?0.0005). The VAS for pain (-?16.37 vs. non-responders -?8.89, p?=?0.001) and swallowing of solid food (-?16.67 vs. non-responders -?5.06, p?=?0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p?=?0.0009). CONCLUSION:In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC. TRIAL REGISTRATION:ClinicalTrials.gov, NCT00122460 . Registered 22 Juli 2005.

SUBMITTER: Hecht M

PROVIDER: S-EPMC7526421 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.

Hecht Markus M Hahn Dennis D Wolber Philipp P Hautmann Matthias G MG Reichert Dietmar D Weniger Steffi S Belka Claus C Bergmann Tobias T Göhler Thomas T Welslau Manfred M Große-Thie Christina C Guntinas-Lichius Orlando O von der Grün Jens J Balermpas Panagiotis P Orlowski Katrin K Messinger Diethelm D Stenzel Karsten G KG Fietkau Rainer R

BMC cancer 20200929 1

<h4>Background</h4>Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC.<h4>Methods</h4>In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetu ...[more]

PMID: 32993574

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Project description: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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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.

Publications

Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.

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