The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.
Int J Gynecol Cancer. 2011 Oct;21(7):1266-75. doi: 10.1097/IGC.0b013e31822c2769.
Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to reduce the acute toxicity of combined therapy with extended-field irradiation, brachytherapy, and cisplatin chemotherapy in patients with cervical cancer with para-aortic or high common iliac disease. This report presents the results of part 2.
Radiation Therapy Oncology Group 0116 was a 2-part trial. Part 1 delivered extended-field irradiation, brachytherapy, and cisplatin; part 2 added amifostine and required 16 evaluable patients to assess an improved toxicity profile. Eligibility included evidence for high common iliac or para-aortic metastasis. Patients were treated for a total dose of 45 Gy in 25 fractions with intracavitary irradiation. Intensity-modulated radiation therapy was not allowed. The final point A dose was 85 Gy low-dose rate equivalent. High-dose rate techniques were allowed. The positive para-aortic and iliac nodes were to be boosted to 54 to 59.4 Gy. Amifostine at 500 mg was to be delivered with every fraction of radiotherapy.
The study opened on August 1, 2001, and closed March 3, 2007, after accruing 45 patients, 18 for the second part with amifostine. This analysis reports the primary end point for the patients entered on part 2 of the study. Three patients were excluded, one was ineligible, and 2 withdrew. The median follow-up was 22.9 months (range, 6.5-45.4 months). The median dose of amifostine delivered was 5000 mg (range, 500-13,500 mg). Thirteen patients (87%) experienced an acute grade 3/4 toxicity (excluding grade 3 leukopenia). This compared to an 81% rate in part 1 of the trial. The estimated median survival was 34.8 months with a 20% late grade 3/4 toxicity rate.
Amifostine, as delivered in this study, did not reduce acute toxicity in this patient population.
放射治疗肿瘤学组（RTOG）0116 旨在测试氨磷汀（Ethyol；MedImmuneLLC，马里兰州盖瑟斯堡）的能力，氨磷汀是一种细胞保护剂，可降低宫颈癌伴腹主动脉旁或高位骼总疾病患者接受扩展野照射、近距离放射治疗和顺铂化疗联合治疗的急性毒性。本报告介绍了第 2 部分的结果。
RTOG0116 是一项 2 部分试验。第 1 部分给予扩展野照射、近距离放射治疗和顺铂；第 2 部分添加氨磷汀，需要 16 例可评估的患者来评估改善的毒性谱。纳入标准包括高位骼总或腹主动脉转移的证据。患者接受总剂量为 45Gy 的 25 次分割腔内照射。不允许使用调强放疗。最终 A 点剂量为 85Gy 低剂量率等效。允许使用高剂量率技术。阳性腹主动脉旁和骼总淋巴结应加量至 54 至 59.4Gy。氨磷汀 500mg 与每次放射治疗的分次一起给予。
该研究于 2001 年 8 月 1 日开始，2007 年 3 月 3 日结束，共入组 45 例患者，其中 18 例接受第 2 部分氨磷汀治疗。本分析报告了进入研究第 2 部分的患者的主要终点。排除 3 例患者，1 例不符合条件，2 例退出。中位随访时间为 22.9 个月（范围，6.5-45.4 个月）。氨磷汀的中位剂量为 5000mg（范围，500-13500mg）。13 例患者（87%）发生急性 3/4 级毒性（不包括 3 级白细胞减少症）。这与试验第 1 部分的 81%的发生率相比。估计中位生存期为 34.8 个月，晚期 3/4 级毒性发生率为 20%。
在本研究中给予氨磷汀并未降低该患者人群的急性毒性。
