A randomized, phase 2 study of cetuximab plus cisplatin with or without paclitaxel for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Bossi, Paolo; Miceli, Rosalba; Locati, Laura D.; Ferrari, Daris; Vecchio, Stefania; Moretti, G; Denaro, Nerina; Caponigro, Francesco; Airoldi, Mario; Moro, Cecilia; Vaccher, Emanuela; Sponghini, Andrea Pietro; Caldara, A.; Rinaldi, Gaetana; Ferraú, Francesco; Nolè, Franco; Vullo, Salvatore Lo; Tettamanzi, Francesca; Hollander, Lital; Licitra, Lisa

doi:10.1093/annonc/mdx439

Cited by 64 publications

(47 citation statements)

References 26 publications

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“…So, combination of the three agents Platin, Paclitaxel and Cetuximab could be of great interest. Indeed, a randomized phase II study in first-line reported 51.7% responses with Cisplatin-Paclitaxel-Cetuximab and an OS of 11 months [ 22 ]. Similarly, another phase II study combining Cisplatin Docetaxel and Cetuximab in first-line showed 44.4% responses and OS of 14 months [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

Carboplatin in combination with weekly Paclitaxel as first-line therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma unfit to EXTREME schedule

et al. 2018

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The standard first-line treatment in recurrent/metastatic head and neck squamous cell carcinoma combines Cisplatin, 5 Fluorouracil and Cetuximab, but many patients aren’t eligible. We retrospectively evaluated the efficacy and the tolerability of Carboplatin and Paclitaxel in this indication, mostly in patients unfit to Cisplatin.Paclitaxel (80mg/m2) was administered at day 1, 8 and 15 and Carboplatin area under the curve 5 at day 1, repeated every 28 days, for 6 cycles. Carboplatin could be administered at area under the curve 2 at day 1, 8 and 15.117 patients received this association at our institution, 94 of those were ineligible to cisplatin due to severe comorbidities, age >70years or Performance status >1.The overall response rate was 40%. The median progression free survival for patients ineligible to Cisplatin was 4.4 months [95% CI; 3.4; 5.0] and the median overall survival was 8 months [95% CI; 5.4–10.7].The most frequent toxicities were hematologic, with 94 grade ≥ 3, mostly in patients who received monthly Carboplatin.Our study shows Carboplatin and Paclitaxel in first-line in recurrent/metastatic head and neck squamous cell carcinoma appear efficient for patients ineligible to Cisplatin and safe when both drugs are weekly administered.

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Section: Discussionmentioning

confidence: 99%

Carboplatin in combination with weekly Paclitaxel as first-line therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma unfit to EXTREME schedule

et al. 2018

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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%

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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“…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%

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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A randomized, phase 2 study of cetuximab plus cisplatin with or without paclitaxel for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Abstract: EudraCT# 2011-002564-24.

Cited by 64 publications

References 26 publications

Carboplatin in combination with weekly Paclitaxel as first-line therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma unfit to EXTREME schedule

Carboplatin in combination with weekly Paclitaxel as first-line therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma unfit to EXTREME schedule

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)"

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