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[子宫颈IIb期或III期癌症的新辅助化疗。151例患者多中心随机试验的长期结果]

[Neoadjuvant chemotherapy of stage IIb or III cancers of the uterine cervix. Long-term results of a multicenter randomized trial of 151 patients].

作者信息

Chauvergne J, Lhommé C, Rohart J, Héron J F, Ayme Y, Goupil A, Fargeot P, David M

机构信息

Fondation Bergonié, Bordeaux, France.

出版信息

Bull Cancer. 1993 Dec;80(12):1069-79.

PMID:8081045
Abstract

Present chemotherapy, with cisplatin combinations, currently offers the possibility of seeking adjuvant therapy in locally advanced and bulky carcinomas of the cervix, which have an unfavorable prognosis (nodal involvement). This initial adjuvant chemotherapy may improve the results of classical pelvic irradiation. From 1982 to 1987, a randomized phase III trial was performed in order to determine the long term effect of induction chemotherapy before irradiation in stage IIb-N1, III, M0 squamous cell carcinomas of the cervix. Radiotherapy (R) for all patients consisted in 50 Gy in the pelvis with a boost by external irradiation of the brachytherapy (cumulative dose of 68 Gy). The chemotherapy regimen (C + R group) was an association of methotrexate, chlorambucil, vincristine and cisplatin, given every 3 weeks, at least two courses were to be given before assessing efficacy and two more courses were given to patients who responded. After a follow up of 5-10 years, 76 patients were fully evaluable in the R arm and 75 in the C + R arm. The response rate (> 50%) to chemotherapy was 42.5% and after completion of treatment, remission rate was 93% in the R arm and 96% in the C + R arm. The disease-free survival was 40% in the C + R group and 35% in the R group, and the median survival was 42 and 45 months respectively (NS). The survival of patients with a complete response at the end of radiotherapy was significantly better in the C + R group when they are responding to chemotherapy, than in R group (P < 0.05). Radiotherapy was not modified whether patients had an initial chemotherapy or not; tolerance was not significantly different between the two groups. Efficacy of induction chemotherapy is an available test for long term results. This approach has the potential for improving the outlook in patients with high-risk primary cancer: earlier use and higher dose intensity of chemotherapy may be associated with a better cytoreduction, and probably a better survival. Further controlled investigations are warranted to confirm the value of adjuvant chemotherapy in cervical cancer.

摘要

目前,顺铂联合化疗为局部晚期和体积较大的宫颈癌(预后不良,有淋巴结转移)提供了进行辅助治疗的可能性。这种初始辅助化疗可能会改善传统盆腔放疗的效果。1982年至1987年,进行了一项随机III期试验,以确定IIb-N1、III、M0期宫颈鳞状细胞癌放疗前诱导化疗的长期效果。所有患者的放疗方案为盆腔50 Gy,通过近距离放疗进行外照射增敏(累积剂量68 Gy)。化疗方案(C + R组)为甲氨蝶呤、苯丁酸氮芥、长春新碱和顺铂联合使用,每3周给药一次,在评估疗效前至少给予两个疗程,对有反应的患者再给予两个疗程。经过5至10年的随访,放疗组有76例患者可进行全面评估,C + R组有75例。化疗的缓解率(> 50%)为42.5%,治疗结束后,放疗组的缓解率为93%,C + R组为96%。C + R组的无病生存率为40%,放疗组为35%,中位生存期分别为42个月和45个月(无显著性差异)。放疗结束时完全缓解的患者中,C + R组对化疗有反应者的生存率显著高于放疗组(P < 0.05)。无论患者是否接受初始化疗,放疗方案均未改变;两组的耐受性无显著差异。诱导化疗的疗效是评估长期结果的一项可用指标。这种方法有可能改善高危原发性癌症患者的预后:更早使用和更高剂量强度的化疗可能与更好的细胞减灭效果相关,可能生存率也更高。需要进一步的对照研究来证实辅助化疗在宫颈癌中的价值。

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Neoadjuvant chemotherapy in woman with early or locally advanced cervical cancer.早期或局部晚期宫颈癌女性患者的新辅助化疗
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Neoadjuvant chemotherapy for locally advanced cervix cancer.
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Management of gynaecological cancers.妇科癌症的管理
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