Kumar Shaleen, Dimri Kislay, Khurana Rohini, Rastogi Neeraj, Das Koilpillai Joseph Maria, Lal Punita
Department of Radiotherapy, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Radiother Oncol. 2007 May;83(2):139-47. doi: 10.1016/j.radonc.2007.03.013. Epub 2007 Apr 18.
Following our phase II experience, a randomised trial was undertaken to evaluate the efficacy of adding chemotherapy to radiotherapy in patients with unresectable squamous cell cancer of the esophagus.
Patients randomised to the RT group received 50 Gy/25 fx/5 weeks of teletherapy followed 1-2 weeks later with 12 Gy/2 fx of high-dose-rate intra-lumenal brachytherapy spaced a week apart. Following the first 3 years of recruitment, due to unexpected late morbidity, brachytherapy was excluded and the protocol modified to 66 Gy/33 fx/6.5 weeks. The CRT group received identical radiotherapy with concurrent weekly cisplatin at 35 mg/m(2) for 6-7 cycles.
Between April 1999 and December 2005, 125 patients were randomised to a RT (n=60) or CRT group (n=65). Radiotherapy treatment was completed in 78% (47/60) of the RT group and 89% (58/65) of the CRT group (P=0.10). Six or more cycles of cisplatin could be delivered in 63% (41/65), which resulted in RTOG grade 3 neutropenia of 3%. Late morbidity in the form of ulcers (5% vs. 15% odds ratio 0.29, 95% CI 0.08-1.11, P=0.08) and strictures (13% vs. 28%, odds ratio 0.40, 95% CI 0.16-1.01, P=0.05) was observed in the RT and CRT groups, respectively. At a median follow up of 23 months of all patients alive (range 6-82 months) and with 95/125 events, the median, 1, 2 and 5 year projected survival was 7.1 months, 32.3%, 22.8% and 13.7% vs. 13.4 months, 57.6%, 38.9% and 24.8% for the RT and CRT groups, respectively (hazard ratio 0.65, 95% CI 0.44-0.98, P=0.038).
The addition of concurrent cisplatin to radiotherapy resulted in a modest improvement in survival and was associated with manageable additional acute and late morbidity.
基于我们的II期试验经验，开展了一项随机试验，以评估在无法切除的食管鳞状细胞癌患者中，放疗联合化疗的疗效。
随机分配至放疗组的患者接受50 Gy/25次分割/5周的远距离治疗，1 - 2周后接受12 Gy/2次分割的高剂量率腔内近距离放疗，间隔1周。在招募的前3年，由于意外的晚期并发症，排除了近距离放疗，并将方案修改为66 Gy/33次分割/6.5周。同步放化疗组接受相同的放疗，同时每周给予顺铂35 mg/m²，共6 - 7个周期。
1999年4月至2005年12月期间，125例患者被随机分配至放疗组（n = 60）或同步放化疗组（n = 65）。放疗组78%（47/60）、同步放化疗组89%（58/65）完成了放疗（P = 0.10）。63%（41/65）的患者能够接受6个或更多周期的顺铂治疗，导致3%的患者出现美国放射肿瘤学会（RTOG）3级中性粒细胞减少。放疗组和同步放化疗组分别观察到以溃疡形式出现的晚期并发症（5% vs. 15%，优势比0.29，95%可信区间0.08 - 1.
