Randomised phase II study with cetuximab in combination with 5-FU and cisplatin or carboplatin versus cetuximab in combination with paclitaxel and carboplatin for treatment of patients with relapsed or metastatic squamous cell carcinoma of the head and neck (CETMET trial).

Friesland, Signe; Tsakonas, Georgios; Kristensen, Claus Andrup; Moren, Maria Herlestam Calero; Haugen, Hedda; Söderstrom, Karin; Specht, Lena

doi:10.1200/jco.2018.36.15_suppl.6032

Cited by 16 publications

(11 citation statements)

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“…The effects of carcinogen were also not mentioned in the Chinese and Korean population. The results of these studies are summarized in Table 6 ( Adkins et al, 2018 ; Bossi et al, 2017 ; De Mello et al., 2014 ; Friesland et al., 2018 ; Guigay et al, 2016 ; Guigay et al, 2012 ; Guigay et al, 2019 ; Guo et al., 2015 ; Tahara et al, 2016 ; Vermorken et al, 2008 ).…”

Section: Discussionmentioning

confidence: 99%

“…The addition of cetuximab to platinum-based chemotherapy with fluorouracil (platinum-fluorouracil) improved the overall response rates, median progression-free survival (PFS), and overall survival (OS) compared with chemotherapy alone. Another combination of cetuximab with chemotherapy agents such as taxane also demonstrated substantial benefits ( Adkins et al, 2018 ; Friesland et al., 2018 ; Guigay et al, 2019 ). However, most of these clinical trials were conducted in Western countries with fewer patients with primary oral cavity cancer; data regarding the effect of carcinogens such as betel nuts on outcome are very limited.…”

Section: Introductionmentioning

confidence: 99%

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Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study

Wang

Liu

et al. 2020

PeerJ

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Background This study aimed to analyze the clinical outcomes associated with patients with recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) who received cetuximab-based chemotherapy in a real-world clinical setting. Methods Clinical data were extracted from RM HNSCC patients diagnosed between 2016 and 2019. Kaplan–Meier survival estimates and Cox proportional hazards model were used for survival analyses. Results Of 106 RM HNSCC patients (mean age = 55.1 years), 38.7% exhibited recurrent disease and 61.3% had metastatic disease. The majority of patients showed a habit of addictive substance use, including alcohol (67.0%), betel nuts (71.7%), or tobacco (74.5%). The primary tumor sites included the oral cavity (64.1%), hypopharynx (19.8%), and oropharynx (16.0%). The median number of cetuximab cycles for the 106 patients was 11 (2–24). The disease control rate (DCR) was 48.1%, and the overall response rate (ORR) was 28.3%. The median progression-free survival (PFS) and overall survival (OS) were 5.0 and 9.23 months, respectively. Patients treated with more than 11 cycles of cetuximab exhibited a longer median PFS and median OS than did patients treated with less than 11 cycles (median PFS: 7.0 vs. 3.0 months, p < 0.001; OS: 12.43 vs. 4.46 months, p = 0.001). Patients without previous concurrent chemoradiotherapy (CRT) had a better median PFS than did those with previous CRT (6.0 vs. 4.0 months, p = 0.046). Multivariable analysis revealed that perineural invasion and fewer cycles of cetuximab (<11 cycles) were independent risk factors associated with disease progression. In addition, the reduction in treatment cycles of cetuximab and advanced lymph node metastasis were independent prognostic factors predicting poorer overall survival. Conclusion Our study provides important real-world data regarding cetuximab-containing treatment in RM HNSCC. Consistent administration of cetuximab could be associated with more favorable outcomes in RM HNSCC in endemic carcinogen exposure areas.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study

Wang

Liu

et al. 2020

PeerJ

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“…The effects of carcinogen were also not mentioned in the Chinese and Korean population. The results of these studies are summarized in Table 6 (Adkins et al 2018;Bossi et al 2017;De Mello et al 2014;Friesland et al 2018;Guigay et al 2016;Guigay et al 2012;Guigay et al 2019;Guo et al 2014;Tahara et al 2016;Vermorken et al 2008).…”

Section: Discussionmentioning

confidence: 99%

“…Cetuximab, an IgG1 chimeric monoclonal antibody targeting EGFR, was one of the first-line treatments for RM HNSCC patients with low programmed death ligand 1 (PD-L1) expression (Burtness et al 2019;Vermorken et al 2008).The addition of cetuximab to platinum-based chemotherapy with fluorouracil (platinum-fluorouracil) improved the overall response rates, median progression-free survival (PFS), and overall survival (OS) compared with chemotherapy alone. Another combination of cetuximab with chemotherapy agents such as taxane also demonstrated substantial benefits (Adkins et al 2018;Friesland et al 2018;Guigay et al 2019).…”

Section: Introductionmentioning

confidence: 99%

Peer Review #2 of "Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study (v0.1)"

2020

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Background. This study aimed to analyze the clinical outcomes associated with patients with recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) who received cetuximab-based chemotherapy in a real-world clinical setting. Methods. Clinical data were extracted from RM HNSCC patients diagnosed between 2016 and 2019. Kaplan-Meier survival estimates and Cox proportional hazards model were used for survival analyses. Results. Of 106 RM HNSCC patients (mean age = 55.1 years), 38.7% exhibited recurrent disease and 61.3% had metastatic disease. The majority of patients showed a habit of addictive substance use, including alcohol (67.0%), betel nuts (71.7%), or tobacco (74.5%). The primary tumor sites included the oral cavity (64.1%), hypopharynx (<19.8%), and oropharynx (16.0%). The median number of cetuximab cycles for the 106 patients was 11 (2-24). The disease control rate (DCR) was 48.1%, and the overall response rate (ORR) was 28.3%. The median progression-free survival (PFS) and overall survival (OS) were 5.0 and 9.23 months, respectively. Patients treated with more than 11 cycles of cetuximab exhibited a longer median PFS and median OS than did patients treated with less than 11 cycles (median PFS: 7.0 vs. 3.0 months, p < 0.001; OS: 12.43 vs. 4.46 months, p = 0.001). Patients without previous concurrent chemoradiotherapy (CRT) had a better median PFS than did those with previous CRT (6.0 vs. 4.0 months, p = 0.046). Multivariable analysis revealed that perineural invasion and fewer cycles of cetuximab (<11 cycles) were independent risk factors associated with disease progression.

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“…The uorouracil substitution by a taxane seeks to take advantage of the potential immunogenic and proapoptotic synergy between cetuximab and docetaxel or paclitaxel 12,13 . Cetuximab, platinum, and taxane-based schedules were associated with promising survival results and cytoreductive properties in clinical studies [14][15][16][17][18] . In this context, TPExtreme was the rst large, phase 3, randomized trial comparing the TPEx regimen (cetuximab, taxane, and platinum) with the EXTREME schema at rst-line setting 19 .…”

Section: Introductionmentioning

confidence: 99%

Cisplatin, Docetaxel and Cetuximab (TPEx) as First-line Treatment for Patients With Recurrent or Metastatic Head and Neck Cancer: A Multicenter Real-World Study

Falco

Leiva

Blanco

et al. 2020

Preprint

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BACKGROUNDThe association of platinum, taxanes, and cetuximab has proven to be an effective and safe strategy for head and neck cancer treatment. Here we present a multi-institutional real-world experience of the TPEx schema as first-line therapy in advanced squamous cell carcinoma of the head and neck (SCCHN).METHODS This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx regimen at five medical centers in Argentina between January 1, 2017, and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab, followed by cetuximab maintenance. Clinical outcomes and toxicity profiles were evaluated. RESULTSTwenty-four patients were included. Median age at diagnosis was 58 years (range 36-77). The majority of patients (83.3%) received at least four chemotherapy cycles in the initial part. In the included group, overall response rate was 62.5%, and three patients achieved a complete response (12.5%). The median time to response was 2.4 months (95% CI 1.3-3.5). With a median follow-up of 12.7 months (95% CI 8.8-16.6), the median progression-free survival was 6.9 months (95% CI: 6.5-7.3), and the overall survival rate at 12 months was 82.4%. Two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3-4 toxicities.CONCLUSIONSTPEx was an adequately tolerated regimen in our population. Median progression-free survival and overall response rates were consistent with recent reports in clinical trials evaluating this treatment combination.

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Randomised phase II study with cetuximab in combination with 5-FU and cisplatin or carboplatin versus cetuximab in combination with paclitaxel and carboplatin for treatment of patients with relapsed or metastatic squamous cell carcinoma of the head and neck (CETMET trial).

Cited by 16 publications

References 0 publications

Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study

Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study

Peer Review #2 of "Consistent administration of cetuximab is associated with favorable outcomes in recurrent/metastatic head and neck squamous cell carcinoma in an endemic carcinogen exposure area: a retrospective observational study (v0.1)"

Cisplatin, Docetaxel and Cetuximab (TPEx) as First-line Treatment for Patients With Recurrent or Metastatic Head and Neck Cancer: A Multicenter Real-World Study

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