Westermann Anneke M, Jones Ellen L, Schem Baard-Christian, van der Steen-Banasik Elzbieta M, Koper Peter, Mella Olav, Uitterhoeve Apollonia L J, de Wit Ronald, van der Velden Jacobus, Burger Curt, van der Wilt Clasina L, Dahl Olav, Prosnitz Leonard R, van der Zee Jacoba
Department of Medical Oncology, Academic Medical Center, Amsterdam, The Netherlands.
Cancer. 2005 Aug 15;104(4):763-70. doi: 10.1002/cncr.21128.
Patients with advanced cervical carcinoma are treated routinely with radiotherapy and cisplatin-containing chemotherapy. It has been shown that hyperthermia can improve the results of both radiotherapy and cisplatin. In the current study, the feasibility and efficacy of the combination of all three modalities was studied in previously untreated patients with cervical carcinoma.
Patients with advanced cervical carcinoma were registered prospectively in the U.S., Norway, and the Netherlands. External-beam radiotherapy and brachytherapy were administered for a biologically effective dose > or = 86.7 gray. At least 4 courses of weekly cisplatin (40 mg/m(2)) and 4 sessions of weekly locoregional hyperthermia were added to radiotherapy.
Sixty-eight patients with a median age of 45 years were enrolled. Full-dose radiotherapy was delivered to all patients according to plan. At least 4 courses of chemotherapy were received by 97% of patients, and at least 4 courses of hyperthermia treatment were received by 93% of patients. Toxicity was fully comparable to that described for chemoradiotherapy alone, and the median total treatment time was 45 days. Complete remission was achieved by 61 patients (90%). After a median follow-up of 538 days, 74% of patients remained alive without signs of recurrence, and the overall survival rate was 84%.
The combination of full-dose radiotherapy, chemotherapy, and hyperthermia was feasible and effective in a multicenter international setting among patients with advanced cervical carcinoma. A Phase III study comparing this novel triplet with standard chemoradiation, designed to show at least a 15% improvement in overall survival, has been launched.
晚期宫颈癌患者通常接受放疗和顺铂化疗。已有研究表明，热疗可提高放疗和顺铂治疗的效果。在本研究中，我们对先前未接受过治疗的宫颈癌患者采用这三种治疗方式联合应用的可行性和疗效进行了研究。
美国、挪威和荷兰前瞻性登记了晚期宫颈癌患者。给予外照射放疗和近距离放疗，生物等效剂量≥86.7 格雷。放疗过程中至少每周给予 4 个疗程顺铂（40mg/m²）及 4 次局部热疗。
共纳入 68 例患者，中位年龄 45 岁。所有患者均按计划接受了全量放疗。97%的患者接受了至少 4 个疗程的化疗，93%的患者接受了至少 4 个疗程的热疗。毒性反应与单纯放化疗相当，中位总治疗时间为 45 天。61 例患者（90%）达到完全缓解。中位随访 538 天后，74%的患者存活且无复发迹象，总生存率为 84%。
在多中心国际研究中，全量放疗、化疗和热疗联合应用于晚期宫颈癌患者是可行且有效的。一项旨在显示总生存率至少提高 15%的 III 期研究已启动，该研究将这种新型三联疗法与标准放化疗进行比较。
