Symonds R P, Habeshaw T, Reed N S, Paul J, Pyper E, Yosef H, Davis J, Hunter R, Davidson S E, Stewart A, Cowie V, Sarkar T
Beatson Oncology Centre, Western Infirmary, Glasgow, UK.
Eur J Cancer. 2000 May;36(8):994-1001. doi: 10.1016/s0959-8049(00)00034-4.
204 eligible patients were entered into a multicentre randomised trial of neo-adjuvant chemotherapy prior to radical radiotherapy. The aim of this study was to assess whether there was any survival advantage in patients undergoing chemotherapy and radiotherapy compared with those given radiotherapy alone. Patients were aged up to 70 years, performance status 0-1/2, with bulky stage IIb, stage III or stage IVa squamous or adenosquamous carcinoma. Three cycles of methotrexate 100 mg/m2 and cisplatin 50 mg/m2 were given at 2-weekly intervals before radical radiotherapy. 104 eligible patients received the combination treatment and 100 radiotherapy only. The two arms of the study were well balanced for tumour and patient characteristics. The response rate to chemotherapy was 49%, 33% of patients in the radiotherapy (XRT) alone arm and 45% of the combination arm were clinically free of tumour at the end of treatment. The median follow-up for surviving patients is 5.4 years (range: 11 months-8 years) and 84% have been followed-up for more than 4 years. 134 patients have died (68 XRT only, 66 combined arm). The median survival RT alone was 111 weeks (95% confidence interval (CI) 72-151 weeks), combination arm 125 weeks (95% CI 79-170 weeks). The estimated death ratio is 0.79 (P = 0.19, 95% CI 0.56-1.12). The estimated 3-year survival is 40% (95% CI 30-50%) RT only compared with 47% (95% CI 37-57%) in the combination arm. Acute and late toxicity of radiotherapy was not increased by the addition of chemotherapy.
204名符合条件的患者进入了一项在根治性放疗前进行新辅助化疗的多中心随机试验。本研究的目的是评估接受化疗和放疗的患者与仅接受放疗的患者相比是否有生存优势。患者年龄在70岁以下，体能状态为0-1/2，患有体积较大的IIb期、III期或IVa期鳞状或腺鳞癌。在根治性放疗前，每2周给予三个周期的甲氨蝶呤100mg/m²和顺铂50mg/m²。104名符合条件的患者接受了联合治疗，100名患者仅接受放疗。研究的两组在肿瘤和患者特征方面平衡良好。化疗的缓解率为49%，仅接受放疗（XRT）组的33%患者和联合治疗组的45%患者在治疗结束时临床上无肿瘤。存活患者的中位随访时间为5.4年（范围：11个月-8年），84%的患者随访时间超过4年。134名患者死亡（仅接受放疗组68例，联合治疗组66例）。仅接受放疗组的中位生存期为111周（95%置信区间（CI）72-151周），联合治疗组为125周（95%CI 79-170周）。估计死亡率为0.79（P = 0.19，95%CI 0.56-1.12）。仅接受放疗组的估计3年生存率为40%（95%CI 30-50%），联合治疗组为47%（95%CI 37-57%）。化疗的加入并未增加放疗的急性和晚期毒性。
