A multicenter phase II trial of paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy in patients with unresectable locally advanced squamous cell carcinoma of the head and neck

Cancer Medicine

卷:9

Shogo Nomura¹  Yuri Ueda²  Susumu Okano²  Makoto Tahara²  Tomohiro Enokida²  Takao Fujisawa²  Jun Taguchi³  Yasushi Shimizu³  Kenji Okami⁴  Koji Ebisumoto⁴  Daisuke Maki⁴  Takenori Ogawa⁵  Akira Ohkoshi⁵  Ayako Nakanome⁵  Akihiro Homma⁶  Shujiro Minami⁷  Atsushi Motegi⁸ 

[1] Biostatistics Division Center for Research Administration and Support National Cancer Center Chiba Japan;

[2] Department of Head and Neck Medical Oncology National Cancer Center Hospital East Chiba Japan;

[3] Department of Medical Oncology Hokkaido University Hospital Sapporo Japan;

[4] Department of Otolaryngology – Head Neck Surgery Tokai University Kanagawa Japan;

[5] Department of Otolaryngology – Head and Neck Surgery Tohoku University School of Medicine Miyagi Japan;

[6] Department of Otolaryngology, Head & Neck Surgery Hokkaido University Graduate School of Medicine Sapporo Japan;

[7] Department of Otorhinolaryngology National Hospital Organization Tokyo Medical Center Tokyo Japan;

[8] Division of Radiation Oncology and Particle Therapy National Cancer Center Hospital East Chiba Japan;

关键词: carboplatin;    cetuximab;    chemoradiotherapy;    induction chemotherapy;    paclitaxel;    unresectable locally advanced squamous cell carcinoma of the head and neck;   

DOI  :  10.1002/cam4.2852

来源: DOAJ

【 摘 要 】

Abstract Background Induction chemotherapy (IC) in locally advanced squamous cell carcinoma of the head and neck (LA‐SCCHN) often compromises compliance with subsequent chemoradiotherapy (CRT), which negatively affects outcomes. Here, we assessed the combination of paclitaxel (PTX), carboplatin (CBDCA), and cetuximab (Cmab) as IC for unresectable LA‐SCCHN. Methods Induction chemotherapy consisted of weekly CBDCA area under the plasma concentration‐time curve = 1.5, PTX 80 mg/m2 and Cmab with an initial dose of 400 mg/m2 followed by 250 mg/m2 for 8 weeks. Following IC, CDDP (20 mg/m2, 4 days × 3 cycles) and concurrent radiotherapy (70 Gy/35 fr) were started. Primary endpoint was the proportion of CRT completion (%CRT completion). PCE was planned to be deemed effective if the Bayesian posterior probability (PP), defined as the probability that %CRT completion was larger than the threshold value of 65%, exceeded 84%. Results Thirty‐five patients were enrolled. Cases were hypopharynx/oropharynx/larynx in 17/17/1 patients, all at Stage IV. Of 35 patients, 34 (97%) completed IC and 32 received CRT and met the criteria of full analysis set (FAS). In FAS, the %CRT completion was 96.9%, and PP was 99.9%, exceeding the prespecified boundary of 84%. Mean cumulative dose and relative to dose intensity of CDDP in CRT was 232.5 mg/m2 and 100%, respectively. Response rate was 88.6% by IC and 93.8% in the CRT phase. Three year overall survival was 83.5%. Main grade 3 toxicities included neutropenia (11.4%) and skin rash (5.7%) during IC; and oral mucositis (31.3%) and neutropenia (12.5%) during CRT. No grade 4 toxicity or treatment‐related death was seen. Conclusions PCE as IC was feasible, with promising efficacy and no effect on compliance with subsequent CRT in unresectable LA‐SCCHN.

【 授权许可】

Unknown