局部晚期宫颈癌新辅助放化疗的临床结局：德国东北部妇科肿瘤学会一项开放前瞻性多中心2期研究的结果

Clinical Outcome of Neoadjuvant Radiochemotherapy in Locally Advanced Cervical Cancer: Results of an Open Prospective, Multicenter Phase 2 Study of the North-Eastern German Society of Gynecological Oncology.

作者信息

Koensgen Dominique, Sehouli Jalid, Belau Antje, Weiss Martin, Stope Matthias B, Grokopf Vivien, Eichbaum Michael, Ledwon Peter, Lichtenegger Werner, Zygmunt Marek, Köhler Günter, Mustea Alexander

机构信息

*Department of Gynecology and Obstetrics, University Medicine Greifswald, Greifswald; †Department of Gynecology and Gynecological Oncology, Charité Berlin, Berlin; ‡Department of Urology, University Medicine Greifswald, Greifswald; §Department of Obstetrics and Gynecology, University Hospital Heidelberg; and ∥Department of Obstetrics and Gynecology, Städtisches Klinikum Brandenburg, Germany.

出版信息

Int J Gynecol Cancer. 2017 Mar;27(3):500-506. doi: 10.1097/IGC.0000000000000894.

DOI:10.1097/IGC.0000000000000894

PMID:28187089

Abstract

OBJECTIVE

The aim of this study was to determine the response rate, toxicity, operability, and surgical complication rate of neoadjuvant concomitant radiochemotherapy (cRCH) (ifosfamide + carboplatin) followed by radical hysterectomy plus external-beam radiotherapy with curative intention in locally advanced primary inoperable stages IIB and IIIB squamous cell cervical cancer.

METHODS

Patients with cervical cancer from 8 departments were enrolled. Patients received 3 cycles of ifosfamide 1.2 mg/m (+mesna 20%) plus carboplatin (area under the curve = 4), every 21 days, and concomitant external-beam radiotherapy (50.4 Gy [1.8 Gy/d]). Operability and remission were evaluated by clinical gynecological examination in general anesthesia (magnetic resonance imaging was optional), 4 weeks after the third cycle of cRCH. In case of achieved operability, a radical hysterectomy with pelvic lymphadenectomy was performed within 6 weeks after cRCH. If surgery was not performed because of incomplete remission or patient preferences, vaginal brachytherapy (15 Gy [5 Gy/d]) was given additionally.

RESULTS

Forty-four patients were enrolled. Distribution of FIGO (International Federation of Gynecology and Obstetrics) tumor stage was as follows: IIB (19 patients) and IIIB (25 patients). All patients completed cRCH. Grade 3/4 hematologic toxicities (% of all cycles) were moderate: leukopenia, 7.3; thrombocytopenia, 2.4; and anemia, 3.2. In 13.8%, treatment cycles were delayed because of hematologic toxicity. Blood transfusions were given in 17.7% and granulocyte colony-stimulating factor in 39.5%. Overall, grade 3/4 nonhematologic toxicities were seldom (6.5%). Clinical overall response rate was 95.2%. Operability was achieved in 85.7%. Surgery was performed in 83.3%. Pathological response rates were as follows: pathological complete remission, 33.3%; partial remission, 63.3%; stable disease, 3.3%.

CONCLUSIONS

Our study demonstrates that cRCH is an effective and tolerable regimen in locally advanced cervical cancer treatment.

摘要

目的

本研究旨在确定新辅助同步放化疗（cRCH）（异环磷酰胺+卡铂）联合根治性子宫切除术及体外照射放疗，对局部晚期、初始无法手术的IIB期和IIIB期宫颈鳞状细胞癌进行根治性治疗的缓解率、毒性、可手术性及手术并发症发生率。

方法

纳入来自8个科室的宫颈癌患者。患者每21天接受3个周期的异环磷酰胺1.2mg/m²（+美司钠20%）加卡铂（曲线下面积=4），并同步进行体外照射放疗（50.4Gy[1.8Gy/天]）。在cRCH的第三个周期后4周，通过全身麻醉下的临床妇科检查（磁共振成像为可选检查）评估可手术性和缓解情况。若达到可手术性，则在cRCH后6周内进行根治性子宫切除术及盆腔淋巴结清扫术。若因缓解不完全或患者意愿未进行手术，则额外给予阴道近距离放疗（15Gy[5Gy/天]）。

结果

共纳入44例患者。国际妇产科联盟（FIGO）肿瘤分期分布如下：IIB期（19例）和IIIB期（25例）。所有患者均完成cRCH。3/4级血液学毒性（占所有周期的百分比）为中度：白细胞减少，7.3%；血小板减少，2.4%；贫血，3.2%。13.8%的治疗周期因血液学毒性而延迟。17.7%的患者接受了输血，39.5%的患者接受了粒细胞集落刺激因子治疗。总体而言，3/4级非血液学毒性很少见（6.5%）。临床总缓解率为95.2%。可手术性达到85.7%。83.3%的患者进行了手术。病理缓解率如下：病理完全缓解，33.3%；部分缓解，63.3%；疾病稳定，3.3%。