Chan A T, Teo P M, Leung T W, Leung S F, Lee W Y, Yeo W, Choi P H, Johnson P J
Department of Clinical Oncology, Prince of Wales Hospital, Shatin, Hong Kong.
Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):569-77. doi: 10.1016/0360-3016(95)00218-N.
A prospective randomized trial was conducted to compare chemoradiotherapy against radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma.
Eighty-two patients with histologically proven nasopharyngeal carcinoma who had either Ho's N3 staging or any N stage with a nodal diameter of > or = 4 cm were entered. Seventy-seven patients were evaluated for tumor response and survival. The patients were randomized to receive two cycles of cisplatin 100 mg/m2 Day 1,5-fluorouracil 1000 mg/m2 24-h infusion Days 2, 3, and 4 before radical radiotherapy, and four cycles of postradiotherapy chemotherapy (37 patients) or radiotherapy alone (40 patients). All patients received radical radiotherapy to the nasopharynx and neck. The nasopharynx and upper neck were treated to 66 Gy by conventional fractionation and the lower neck to 58 Gy. Booster radiotherapy (7.5 Gy/two fractions/week) was given to any residual nodes after standard radiotherapy.
The patient characteristics, including staging, were similar in both arms. The overall response rate to neoadjuvant chemotherapy was 81% (19% complete response, 62% partial response). The rates of radiotherapy for boosting parapharyngeal disease or residual lymph nodes were not significantly different in the two arms. The overall complete response rate to chemoradiotherapy was 100%, and to radiotherapy alone, 95%. Toxicities in the chemoradiotherapy arm were mainly myelosuppression, nephrotoxicity, and nausea and vomiting. The degree of mucositis was not significantly different in the two arms. There was no treatment-related death. The median follow up was 28.5 months. The 2-year overall survival was 80% in the chemoradiotherapy arm and 80.5% in the radiotherapy arm. The 2-year disease-free survival was 68% in the chemoradiotherapy arm and 72% in the radiotherapy arm, without significant difference between the two arms. The locoregional relapse rate, distant metastatic rate, and median time to relapse were also not significantly different between the two arms.
Despite promising tumor response rates from Phase II trials, this prospective randomized trial has demonstrated no benefit from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma.
开展一项前瞻性随机试验，比较同步放化疗与单纯放疗在治疗局部晚期鼻咽癌中的效果。
纳入82例经组织学证实为鼻咽癌且符合以下条件之一的患者：何氏N3分期，或任何N分期且淋巴结直径≥4 cm。77例患者接受了肿瘤反应评估和生存分析。患者被随机分为两组，一组在根治性放疗前接受两个周期化疗，具体方案为第1天给予顺铂100 mg/m²，第2、3、4天给予5-氟尿嘧啶1000 mg/m²持续24小时静脉滴注，放疗后再接受四个周期化疗（37例患者）；另一组仅接受放疗（40例患者）。所有患者均接受鼻咽部和颈部的根治性放疗。鼻咽部和上颈部采用常规分割照射至66 Gy，下颈部照射至58 Gy。对标准放疗后仍有残留淋巴结的患者给予缩野放疗（7.5 Gy，分两次，每周一次）。
两组患者的特征，包括分期，相似。新辅助化疗的总体缓解率为81%（完全缓解率19%，部分缓解率62%）。两组在针对咽旁病变或残留淋巴结进行缩野放疗的比例上无显著差异。同步放化疗的总体完全缓解率为100%，单纯放疗为95%。同步放化疗组的毒性主要为骨髓抑制、肾毒性以及恶心和呕吐。两组的黏膜炎程度无显著差异。无治疗相关死亡。中位随访时间为28.5个月。同步放化疗组的2年总生存率为80%，单纯放疗组为80.5%。同步放化疗组的2年无病生存率为68%，单纯放疗组为72%，两组之间无显著差异。两组的局部区域复发率、远处转移率以及复发的中位时间也无显著差异。
尽管II期试验显示出有前景的肿瘤缓解率，但这项前瞻性随机试验表明，在治疗局部晚期鼻咽癌时，同步放化疗联合辅助化疗并无益处。
