M Tahara1, N Kiyota2, T Yokota3, Y Hasegawa4, K Muro5, S Takahashi6, T Onoe7, A Homma8, J Taguchi9, M Suzuki10, K Minato11, K Yane12, S Ueda13, H Hara14, K Saijo15, T Yamanaka16. 1. Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Electronic address: matahara@east.ncc.go.jp. 2. Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan. 3. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan. 4. Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 5. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 6. Department of Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan. 7. Department of Medical Oncology, Hyogo Cancer Center, Akashi, Japan. 8. Department of Otolaryngology - Head and Neck Surger, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 9. Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan. 10. Department of Head and Neck Surgery, Japan. 11. Department of Pulmonary Medicine, Gunma Prefectural Cancer Center, Ota, Japan. 12. Department of Otolaryngology, Kindai University Nara Hospital, Ikoma, Japan. 13. Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan. 14. Department of Gastroenterology, Saitama Cancer Center Hospital, Saitama, Japan. 15. Department of Clinical Oncolog, Institute of Development Aging and Cancer, Tohoku University, Sendai, Japan. 16. Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.
Abstract
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. Registered clinical trial number: UMIN000010507.
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. Registered clinical trial number: UMIN000010507.
Authors: Glaucia Maria de Mendonça Fernandes; Vilson Serafim Junior; Ana Lívia Silva Galbiatti-Dias; Leticia Antunes Muniz Ferreira; Márcia Maria Urbanin Castanhole-Nunes; Rosa Sayoko Kawasaki-Oyama; José Victor Maniglia; Erika Cristina Pavarino; Eny Maria Goloni-Bertollo Journal: Am J Cancer Res Date: 2022-09-15 Impact factor: 5.942
Authors: Douglas Adkins; Jessica Ley; Omar Atiq; Steven Powell; William C Spanos; Mark Gitau; Caron Rigden; Kevin Palka; Jingxia Liu; Peter Oppelt Journal: Oral Oncol Date: 2021-02-03 Impact factor: 5.337