Srivastava Kirti, Paul Sayan, Chufal Kundan Singh, Shamsundar Sunkappa Dayashankara, Lal Punita, Pant Mohan C, Bhatt Madanlal, Singh Sudhir, Gupta Rajeev
Department of Radiotherapy, Chhatrapati Shahuji Maharaj Medical University, Lucknow, India.
Asia Pac J Clin Oncol. 2013 Dec;9(4):349-56. doi: 10.1111/ajco.12078. Epub 2013 May 27.
Chemo-radiotherapy (CRT) is the standard of care for treating almost all cervical carcinoma patients on the basis of the National Cancer Institute (NCI) alert. The disease burden in developing countries is more advanced with poor general condition than in patients in the trials prompting the NCI alert. Therefore, practicing CRT as standard of care should be tested in these patients.
A randomized controlled trial was conducted comparing radiotherapy (RT) alone with CRT (cisplatin 40 mg/m(2) weekly × 5) in patients with localized stage Ib to IVa cervical carcinoma between September 2006 and December 2008. External beam RT was delivered using a telecobalt unit. This was followed by 12-18 Gy of brachytherapy.
In total, 305 patients were recruited: RT alone (150) and CRT (155). The median follow up was 34 months. Locoregional relapse-free survival (LRFS) at 2 years was 55 and 54% for the RT and CRT group, respectively, with a median LRFS time of 27 and 30 months for the RT and CRT group, respectively, (P = 0.624). Overall survival (OS) at 2 years was 58 and 60%, with a median OS of 31 and 34 months for the RT and CRT group, respectively; (P = 0.9). The toxicity profile, both acute and late, were comparable in both groups;
No improvement in outcome was seen with addition of cisplatin. In the Indian subcontinent where patients present at late stages with poor general condition and limited access to good supportive care, RT alone still remains a valid option.
根据美国国立癌症研究所（NCI）的警示，化疗放疗（CRT）是几乎所有宫颈癌患者的标准治疗方法。与促使NCI发出警示的试验中的患者相比，发展中国家的疾病负担更重，患者的一般状况较差。因此，应在这些患者中对将CRT作为标准治疗方法的做法进行检验。
2006年9月至2008年12月期间，对局部晚期Ib至IVa期宫颈癌患者进行了一项随机对照试验，比较单纯放疗（RT）与CRT（顺铂40mg/m²，每周1次，共5次）的疗效。外照射放疗使用远距离钴治疗机进行。随后进行12 - 18Gy的近距离放疗。
共招募了305例患者：单纯放疗组（150例）和CRT组（155例）。中位随访时间为34个月。RT组和CRT组2年时的局部区域无复发生存率（LRFS）分别为55%和54%，RT组和CRT组的中位LRFS时间分别为27个月和30个月（P = 0.624）。2年时的总生存率（OS）分别为58%和60%，RT组和CRT组的中位OS分别为31个月和34个月；（P = 0.9）。两组的急性和晚期毒性反应情况相当；
添加顺铂未观察到疗效改善。在印度次大陆，患者就诊时病情较晚，一般状况较差，获得良好支持治疗的机会有限，单纯放疗仍然是一种有效的选择。
