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卡铂-紫杉醇-贝伐珠单抗(CPB)后间隔减瘤手术(IDS)的可行性和结果:MITO-16A-MaNGO OV2A 四期试验的亚组分析。

Feasibility and outcome of interval debulking surgery (IDS) after carboplatin-paclitaxel-bevacizumab (CPB): A subgroup analysis of the MITO-16A-MaNGO OV2A phase 4 trial.

机构信息

Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy.

Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.

出版信息

Gynecol Oncol. 2017 Feb;144(2):256-259. doi: 10.1016/j.ygyno.2016.12.011. Epub 2016 Dec 16.

Abstract

BACKGROUND

Few data are available on the outcome of surgery after a bevacizumab-containing regimen. The MITO 16A- MaNGO OV2A phase 4 trial evaluates the outcomes of first-line CPB in a clinical-practice-like setting. Here we present the results of the subgroup of patients undergoing IDS after neoadjuvant treatment or suboptimal primary surgery.

METHODS

400 chemonaïve epithelial ovarian cancer patients, age≥18, ECOG PS 0-2 were eligible to receive C (AUC 5 d1, q21) plus P (175mg/m d1, q21) and B (15mg/kg d1 q21) for 6cycles followed by B maintenance until cycle 22nd.

RESULTS

79 patients (20%) underwent IDS. Overall, 74 patients received at least one administration of B before IDS. Median age was 61.2, 70% of the patients had FIGO IIIC disease. The median number of cycles before IDS was 3 both for chemotherapy and bevacizumab respectively. A residual disease ≤1cm was achieved in 64 patients (86.5%). Four percent of the patients experienced fever and 4% required blood transfusion after surgery. Surgical wound infection and/or dehiscence, pelvic abscess, intestinal sub-occlusion and fistula were experienced by one patient each.

CONCLUSIONS

In the MITO16A-MaNGO OV2A phase 4 trial, combined chemotherapy and bevacizumab did not hamper IDS and the rate of perioperative complications was similar to what expected without bevacizumab. These data support the hypothesis that adding bevacizumab to first line chemotherapy for ovarian cancer might not be denied to patients for whom IDS is planned.

摘要

背景

贝伐珠单抗方案治疗后的手术结局数据有限。MITO16A-MaNGO OV2A 期 4 试验评估了临床实践样环境下一线 CPB 的结果。这里我们报告了新辅助治疗或初次手术不理想后接受IDS 的患者亚组的结果。

方法

400 名年龄≥18 岁、ECOG PS 0-2 的初治上皮性卵巢癌患者符合接受 C(AUC 5 d1,q21)+ P(175mg/m d1,q21)和 B(15mg/kg d1 q21)6 个周期治疗的条件,随后接受 B 维持治疗直至第 22 个周期。

结果

79 例患者(20%)接受了 IDS。总体而言,74 例患者在接受 IDS 前至少接受过一次 B 治疗。中位年龄为 61.2 岁,70%的患者有FIGO III C 期疾病。IDS 前化疗和贝伐珠单抗的中位周期数分别为 3 个。64 例患者(86.5%)获得了≤1cm 的残留疾病。4%的患者术后出现发热,4%的患者需要输血。1 例患者分别出现手术部位感染和/或裂开、骨盆脓肿、肠部分阻塞和瘘。

结论

在 MITO16A-MaNGO OV2A 期 4 试验中,联合化疗和贝伐珠单抗并不妨碍 IDS,且围手术期并发症的发生率与无贝伐珠单抗时相似。这些数据支持这样一种假设,即对于计划进行 IDS 的患者,将贝伐珠单抗添加到一线化疗中可能不会被拒绝。

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