Nishimura Goshi, Taguchi Takahide, Takahashi Masahiro, Shiono Osamu, Komatsu Masanori, Sano Daisuke, Yabuki Kenichiro, Arai Yasuhiro, Takahashi Hideaki, Hata Masaharu, Oridate Nobuhiko
Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
Department of Otorhinolaryngology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Cancer Chemother Pharmacol. 2016 Jun;77(6):1315-9. doi: 10.1007/s00280-016-3052-4. Epub 2016 May 6.
Although locally advanced head and neck squamous cell carcinoma (HNSCC) can be effectively treated using chemoradiotherapy (CRT) with docetaxel (DTX), and cisplatin (CDDP) plus 5-fluorouracil (TPF-CRT), severe adverse events (especially neutropenia) can limit treatment adherence. Therefore, we evaluated the safety and efficacy of a new chemotherapy regimen that consisted of DTX and CDDP plus cetuximab (Cmab) with concurrent radiotherapy.
Bio-chemoradiotherapy (B-CRT) using DTX, CDDP, and Cmab was administrated to patients with locally advanced HNSCC, and its safety and efficacy were evaluated.
Interim analysis of nine patients revealed severe neutropenia in five patients (56 %) and leukopenia in seven patients (78 %); hence, the study was terminated. One patient experienced disease-free survival using only B-CRT.
Neutropenia was equally severe for B-CRT, compared to TPF-CRT. Based on the limited sample size, it is impossible to conclude that B-CRT has non-inferior efficacy, compared to TPF-CRT.
尽管局部晚期头颈部鳞状细胞癌（HNSCC）可通过多西他赛（DTX）、顺铂（CDDP）加5-氟尿嘧啶的放化疗（CRT）（TPF-CRT）得到有效治疗，但严重不良事件（尤其是中性粒细胞减少）会限制治疗依从性。因此，我们评估了一种由DTX、CDDP加西妥昔单抗（Cmab）并联合放疗组成的新化疗方案的安全性和疗效。
对局部晚期HNSCC患者采用DTX、CDDP和Cmab进行生物放化疗（B-CRT），并评估其安全性和疗效。
对9例患者的中期分析显示，5例患者（56%）出现严重中性粒细胞减少，7例患者（78%）出现白细胞减少；因此，研究终止。1例患者仅通过B-CRT实现了无病生存。
与TPF-CRT相比，B-CRT的中性粒细胞减少同样严重。基于有限的样本量，无法得出与TPF-CRT相比B-CRT具有非劣效疗效的结论。
