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局部晚期宫颈癌采用伊立替康和顺铂联合盆腔放疗的 I 期研究:GINECO 试验。

Phase I study of irinotecan and cisplatin in combination with pelvic radiotherapy in the treatment of locally advanced cervical cancer: A GINECO trial.

机构信息

Centre de Lutte contre le Cancer Val d'Aurelle, Montpellier, France.

出版信息

Gynecol Oncol. 2010 May;117(2):276-80. doi: 10.1016/j.ygyno.2009.12.027. Epub 2010 Mar 11.

DOI:10.1016/j.ygyno.2009.12.027
PMID:20226502
Abstract

PURPOSE

To define the recommended dose of the association of weekly irinotecan (Iri) and cisplatin (CP) with pelvic radiotherapy in Locally Advanced Cervical Cancer.

PATIENTS AND METHODS

Stage IB2-IV cervix cancer patients were treated with escalating doses of Iri starting from 30 mg/m(2) and a fixed dose of CP at 20 mg/m(2), both weekly concomitantly with a 45-Gy pelvic irradiation.

RESULTS

Fifteen patients entered the study, 6 at level 1 (Iri 30 mg/m(2)), 3 at level 2 (Iri 40 mg/m(2)) and 6 at intermediate dose (Iri 35 mg/m(2)). Median age was 47 years (34-72), FIGO stage IB (n=1), IIB (n=7), III (n=6), IVA (n=1). The recommended dose was weekly Iri 35 mg/m(2) and CP 20 mg/m(2). Dose limiting toxicities (grades 3-4) were diarrhea, abdominal pain, febrile neutropenia and fatigue.

CONCLUSION

In cervix cancer patients, radiosensitization with weekly cisplatin and irinotecan is feasible, and the recommended doses are cisplatin 20 mg/m(2)/week and irinotecan 35 mg/m(2)/week for future phase II studies.

摘要

目的

确定每周伊立替康(Iri)联合顺铂(CP)与盆腔放疗联合用于局部晚期宫颈癌的推荐剂量。

患者和方法

对 IB2-IV 期宫颈癌患者进行递增剂量的 Iri 治疗,起始剂量为 30mg/m²,同时每周给予固定剂量的 CP 20mg/m²,并与 45Gy 的盆腔照射同时进行。

结果

15 名患者入组本研究,1 名患者处于 1 级(Iri 30mg/m²),3 名患者处于 2 级(Iri 40mg/m²),6 名患者处于中间剂量(Iri 35mg/m²)。中位年龄为 47 岁(34-72 岁),FIGO 分期 IB(n=1),IIB(n=7),III(n=6),IVA(n=1)。推荐剂量为每周 Iri 35mg/m²和 CP 20mg/m²。剂量限制毒性(3-4 级)为腹泻、腹痛、发热性中性粒细胞减少和疲劳。

结论

在宫颈癌患者中,每周顺铂和伊立替康联合放疗是可行的,未来的 II 期研究推荐剂量为每周顺铂 20mg/m²和伊立替康 35mg/m²。

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