TY - JOUR
T1 - Phase II trial of combination treatment with paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CSPOR-HN02)
AU - Tahara, Makoto
AU - Kiyota, N.
AU - Yokota, T.
AU - Hasegawa, Y.
AU - Muro, K.
AU - Takahashi, S.
AU - Onoe, T.
AU - Homma, A.
AU - Taguchi, J.
AU - Suzuki, M.
AU - Minato, K.
AU - Yane, K.
AU - Ueda, S.
AU - Hara, H.
AU - Saijo, K.
AU - Yamanaka, T.
N1 - Funding Information:
MT reports personal fees from Merck serono, during the conduct of the study; grants and personal fees from MSD, Bayer, Eisai, Pfizer, Astra Zeneca, Ono Pharmaceutical and Bristol-Myers Squibb, personal fees from Otsuka, grants from Boehringer Ingelheim, Novartis and NanoCarrier, outside the submitted work. NK reports honoraria from Merck Serono during the conduct of the study; grants from research funding from Ono Pharmaceutical, and Astra Zeneca, and honoraria from Ono Pharmaceutical, Bristol-Meyers Squibb, Astra Zeneca, Eisai and Bayer, outside the submitted work. TY reports grants and personal fees from Merck Serono, during the conduct of the study; personal fees from Merck Serono and AstraZeneca, grants from MSD and Pfizer, grants and personal fees from Bristol-Myers Squibb and Ono Pharmaceutical, outside the submitted work. KM reports personal fees from Merck Serono, during the conduct of the study; personal fees from Chugai, Taiho, Takeda, Yakult, Eli Lilly, grants from MSD, Daiichi Sankyo, Kyowa Hakko Kirin, Shionogi, Gilead Sciences and Ono Pharmaceutical, outside the submitted work. ST reports grants and personal fees from MERCK Serono, during the conduct of the study; grants and personal fees from MSD, Daiichi-Sankyo, Novartis, Eisai, Bayer, Chugai, Bristol-Myers Squibb, and Ono Pharmaceutical, outside the submitted work. HH reports grants from AstraZeneca, Daiichi Sankyo, Dainippon Sumitomo Pharma, Lilly, Merck Serono, MSD, Ono Pharmaceutical, Taiho, Chugai, Boehringer Ingelheim, Eisai and LSK BioPharma, outside the submitted work. KMi reports grants from Ono Pharmaceutical, AstraZeneca, Taiho Pharmaceutical, and Bristol Myers Squibb, outside the submitted work. KS reports grants from Merck Serono during the conduct of the study; grants from Taiho, Chugai, Novartis, Bristol-Myers Squibb, Bayer, Ono Pharmaceutical, Daiichi Sankyo, Eisai, outside the submitted work. TY reports grants and personal fees from Takeda, grants and personal fees from Taiho, personal fees from Boehringer-Ingelheim, personal fees from Chugai, outside the submitted work. All remaining authors have declared no conflicts of interest.
Funding Information:
This study was partially funded by the Comprehensive Support Project of the Public Health Research Foundation (CSPOR), with support from Merck Serono Co., Ltd. (Japan), an affiliate of Merck KGaA, Darmstadt, Germany. The grand number was not applied.
Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Background: The standard of care for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is combination treatment with platinum, 5-FU and cetuximab (PFE). However, this regimen requires hospitalization to ensure proper hydration and continuous infusion of 5-FU, and causes severe nausea and anorexia. We evaluated the efficacy and safety of paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with R/M SCCHN. Patients and methods: Eligibility criteria included recurrent and/or metastatic, histologically proven SCC of the oropharynx, oral cavity, hypopharynx or larynx; PS 0-1; adequate organ function; no suitable local therapy for R/M SCCHN; and no prior systemic chemotherapy for R/M SCCHN. Chemotherapy consisted of paclitaxel 100 mg/m2 on days 1, 8; carboplatin area under the blood concentration-time curve 2.5 on days 1, 8, repeated every 3 weeks for up to 6 cycles; and cetuximab at an initial dose of 400 mg/m2, followed by 250 mg/m2 weekly until disease progression or unacceptable toxicities. Primary end point was overall response rate. Secondary end points were safety, treatment completion rate, progression-free survival, overall survival, and clinical benefit rate. Planned sample size was 45 patients. Results: Forty-seven subjects were accrued from July 2013 to October 2014. Of 45 evaluable, 40 were male; median age was 63 years; Eastern Cooperative Oncology Group Performance Status was 0/1 in 23/22 cases; site was the hypopharynx/ oropharynx/oral cavity/larynx in 17/11/10/7 cases; and 36/9 cases were smokers/nonsmokers, respectively. Overall response rate, the primary end point, was 40%. Median overall survival was 14.7 months and progression-free survival was 5.2 months. Grade 3/4 adverse events included neutropenia (68%), skin reaction (15%), fatigue (9%) and febrile neutropenia (9%). A potentially treatment-related death occurred in one patient with intestinal pneumonia. Conclusions: The PCE regimen shows promising activity with acceptable toxicity in the outpatient clinic. Further studies are needed to compare PCE with PFE in this population.
AB - Background: The standard of care for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is combination treatment with platinum, 5-FU and cetuximab (PFE). However, this regimen requires hospitalization to ensure proper hydration and continuous infusion of 5-FU, and causes severe nausea and anorexia. We evaluated the efficacy and safety of paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with R/M SCCHN. Patients and methods: Eligibility criteria included recurrent and/or metastatic, histologically proven SCC of the oropharynx, oral cavity, hypopharynx or larynx; PS 0-1; adequate organ function; no suitable local therapy for R/M SCCHN; and no prior systemic chemotherapy for R/M SCCHN. Chemotherapy consisted of paclitaxel 100 mg/m2 on days 1, 8; carboplatin area under the blood concentration-time curve 2.5 on days 1, 8, repeated every 3 weeks for up to 6 cycles; and cetuximab at an initial dose of 400 mg/m2, followed by 250 mg/m2 weekly until disease progression or unacceptable toxicities. Primary end point was overall response rate. Secondary end points were safety, treatment completion rate, progression-free survival, overall survival, and clinical benefit rate. Planned sample size was 45 patients. Results: Forty-seven subjects were accrued from July 2013 to October 2014. Of 45 evaluable, 40 were male; median age was 63 years; Eastern Cooperative Oncology Group Performance Status was 0/1 in 23/22 cases; site was the hypopharynx/ oropharynx/oral cavity/larynx in 17/11/10/7 cases; and 36/9 cases were smokers/nonsmokers, respectively. Overall response rate, the primary end point, was 40%. Median overall survival was 14.7 months and progression-free survival was 5.2 months. Grade 3/4 adverse events included neutropenia (68%), skin reaction (15%), fatigue (9%) and febrile neutropenia (9%). A potentially treatment-related death occurred in one patient with intestinal pneumonia. Conclusions: The PCE regimen shows promising activity with acceptable toxicity in the outpatient clinic. Further studies are needed to compare PCE with PFE in this population.
KW - Carboplatin
KW - Cetuximab
KW - Paclitaxel
KW - Squamous cell carcinoma of the head and neck
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U2 - 10.1093/annonc/mdy040
DO - 10.1093/annonc/mdy040
M3 - Article
C2 - 29408977
AN - SCOPUS:85046696316
VL - 29
SP - 1004
EP - 1009
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 4
ER -