Inohara Hidenori, Takenaka Yukinori, Yoshii Tadashi, Nakahara Susumu, Yamamoto Yoshifumi, Tomiyama Yoichiro, Seo Yuji, Isohashi Fumiaki, Suzuki Osamu, Yoshioka Yasuo, Sumida Iori, Ogawa Kazuhiko
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Faculty of Medicine, Suita, Osaka, Japan.
Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):934-41. doi: 10.1016/j.ijrobp.2014.12.032.
We investigated the efficacy and safety of weekly low-dose docetaxel and cisplatin therapy concurrent with conventionally fractionated radiation in patients with technically resectable stage III-IV squamous cell carcinoma of the head and neck.
Between March 2004 and October 2011, we enrolled 117 patients, of whom 116 were analyzable (43 had oropharyngeal cancer, 54 had hypopharyngeal cancer, and 19 had laryngeal cancer), and 85 (73%) had stage IV disease. Radiation consisted of 66 Gy in 33 fractions. Docetaxel, 10 mg/m(2), followed by cisplatin, 20 mg/m(2), administered on the same day were given once a week for 6 cycles. The primary endpoint was overall complete response (CR) rate after chemoradiation therapy. Human papillomavirus (HPV) DNA in oropharyngeal cancer was examined by PCR.
Of 116 patients, 82 (71%) completed treatment per protocol; 102 (88%) received the full radiation therapy dose; and 90 (78%) and 12 (10%) patients received 6 and 5 chemotherapy cycles, respectively. Overall CR rate was 71%. After median follow-up of 50.9 months (range: 15.6-113.9 months for surviving patients), 2-year and 4-year overall survival rates were 82% and 68%, respectively. Cumulative 2-year and 4-year local failure rates were 27% and 28%, respectively, whereas distant metastasis rates were 15% and 22%, respectively. HPV status in oropharyngeal cancer was not associated with treatment efficacy. Acute toxicity included grade 3 and 4 in-field mucositis in 73% and 5% of patients, respectively, whereas myelosuppression and renal injury were minimal. No patients died of toxicity. Feeding tube dependence in 8% and tracheostomy in 1% of patients were evident at 2 years postchemoradiation therapy in patients who survived without local treatment failure.
Local control and survival with this regimen were satisfactory. Although acute toxicity, such as mucositis, was common, late toxicity, such as laryngoesophageal dysfunction, was minimal. Therapy using weekly low-dose docetaxel and cisplatin concurrent with radiation warrants further evaluation.
我们研究了每周低剂量多西他赛和顺铂同步常规分割放疗对技术上可切除的Ⅲ-Ⅳ期头颈部鳞状细胞癌患者的疗效和安全性。
2004年3月至2011年10月，我们纳入了117例患者，其中116例可进行分析（43例为口咽癌，54例为下咽癌，19例为喉癌），85例（73%）为Ⅳ期疾病。放疗为33次分割，总剂量66 Gy。多西他赛10 mg/m²，随后顺铂20 mg/m²，于同一天给药，每周1次，共6个周期。主要终点为放化疗后的总体完全缓解（CR）率。通过聚合酶链反应检测口咽癌中的人乳头瘤病毒（HPV）DNA。
116例患者中，82例（71%）按方案完成治疗；102例（88%）接受了全量放疗；90例（78%）和12例（10%）患者分别接受了6个和5个化疗周期。总体CR率为71%。中位随访50.9个月（存活患者范围：15.6 - 113.9个月）后，2年和4年总生存率分别为82%和68%。2年和4年累积局部失败率分别为27%和28%，远处转移率分别为15%和22%。口咽癌的HPV状态与治疗疗效无关。急性毒性包括分别有73%和5%的患者出现3级和4级靶区黏膜炎，而骨髓抑制和肾损伤轻微。无患者死于毒性反应。在无局部治疗失败存活的患者中，放疗后2年有8%的患者依赖饲管，1%的患者行气管造口术。
该方案的局部控制和生存率令人满意。虽然黏膜炎等急性毒性常见，但喉食管功能障碍等晚期毒性轻微。每周低剂量多西他赛和顺铂同步放疗的治疗方案值得进一步评估。
