Homma Akihiro, Shirato Hiroki, Furuta Yasushi, Nishioka Takeshi, Oridate Nobuhiko, Tsuchiya Kazuhiko, Nagahashi Tatsumi, Aoyama Hidefumi, Inuyama Yukio, Fukuda Satoshi
Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Kita 15, Nishi 7, Kitaku, Sapporo 060-8638, Japan.
Cancer J. 2004 Sep-Oct;10(5):326-32. doi: 10.1097/00130404-200409000-00010.
This randomized, phase II study aimed to compare concomitant chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin as a treatment for squamous cell carcinoma of the head and neck.
One hundred nineteen patients with moderate- to advanced-stage disease were eligible for the study. Fifty-three patients had stage II disease, 28 had stage III, and the remaining 38 had stage IV disease. Primary tumor sites included the larynx (N = 63), oropharynx (N = 30), hypopharynx (N = 23), and oral cavity (N = 3). Each patient received either a weekly carboplatin dose (100 mg/m(2)) in one arm or daily cisplatin (4 mg/m(2)) in the other arm for the initial 4 weeks of radiotherapy. The radiotherapy dose of 65 Gy was given in 26 fractions over 45 days, dependent on a good tumor response at 40 Gy. For ty-nine (81.7%) of 60 patients treated with carboplatin and 41 (69.5%) of 59 patients treated with cisplatin received the full dose of radiotherapy. Surgical-resection was optionally used for the remaining patients.
The median follow-up time was 63 months. The local control rate at 5 years was 56.2% for the carboplatin-treated arm and 35.5% for the cisplatin-treated arm, respectively. The 5-year overall survival rate did not significantly differ between treatments: 71.4% for carboplatin and 66.0% for cisplatin. Hematologic toxicity was more frequent in the carboplatin-treated arm. No difference was observed in surgical complications or in radiation-related adverse effects.
These findings suggest that weekly carboplatin treatment is preferable to daily low-dose cisplatin. This could be because the total dose of cisplatin was too low to be effective.
本随机II期研究旨在比较每周使用卡铂或每日使用低剂量顺铂同步放化疗对头颈部鳞状细胞癌的治疗效果。
119例中晚期疾病患者符合研究条件。53例为II期疾病，28例为III期，其余38例为IV期疾病。原发肿瘤部位包括喉（n = 63）、口咽（n = 30）、下咽（n = 23）和口腔（n = 3）。一组患者在放疗的最初4周内每周接受一次卡铂剂量（100 mg/m²），另一组患者每天接受顺铂（4 mg/m²）。放疗剂量为65 Gy，分26次在45天内给予，具体取决于40 Gy时的肿瘤反应情况。接受卡铂治疗的60例患者中有59例（81.7%）、接受顺铂治疗的59例患者中有41例（69.5%）接受了全剂量放疗。其余患者可选择手术切除。
中位随访时间为63个月。卡铂治疗组和顺铂治疗组的5年局部控制率分别为56.2%和35.5%。两种治疗方法的5年总生存率无显著差异：卡铂治疗组为71.4%，顺铂治疗组为66.0%。卡铂治疗组血液学毒性更常见。手术并发症或放疗相关不良反应方面未观察到差异。
这些结果表明，每周卡铂治疗优于每日低剂量顺铂治疗。这可能是因为顺铂的总剂量过低而无效。
