Prospective feasibility study of neoadjuvant dose-dense paclitaxel plus carboplatin with bevacizumab therapy followed by interval debulking surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer patients
Prospective feasibility study of neoadjuvant dose-dense paclitaxel plus carboplatin with bevacizumab therapy followed by interval debulking surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer patients
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新辅助剂量密集紫杉醇加卡铂联合贝伐单抗治疗随后间隔减瘤手术治疗晚期卵巢癌、输卵管癌和原发性腹膜癌患者的前瞻性可行性研究
DOI：
10.1007/s10147-021-02050-3
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发表时间：
2022
期刊：
影响因子：
3.3
通讯作者：
Aoki D
中科院分区：
文献类型：
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作者：
Iwasa-Inoue N;Nomura H;Kataoka F;Chiyoda T;Yoshihama T;Nanki Y;Sakai K;Kobayashi Y;Yamagami W;Morisada T;Hirasawa A;Aoki D
本研究旨在探讨大剂量紫杉醇联合卡铂(TC)联合贝伐单抗治疗晚期卵巢癌、输卵管癌和腹膜癌的临床疗效。方法卵巢、输卵管或腹膜癌III-IV期患者每3周接受一次新辅助化疗(NAC)，包括紫杉醇(80 mg/m2)第1、8、15天；卡铂(AUC 6.0 mg/×m L)；第1天给予贝伐单抗(15 mg/kg)，第1天给予贝伐单抗(15 mg/kg)。连续3个周期的高剂量TC-贝伐单抗治疗后进行间歇性去髓核手术(IDS)。主要终点是入侵检测系统的完全切除率。次要终点是治疗完成率、治疗暴露、对NAC的应答率、不良事件和围手术期并发症。中位年龄55.5岁(37~80岁)，以高级别浆液性癌为主(n= ，18例)。所有患者均接受了IDS，完全切除率为75%(95%可信区间：57.7-92.3%)。下限超过了预设的55%的门槛。NAC的有效率为79%，57%的患者在NAC治疗后血清CA125水平在正常范围。NAC期间发生4级血液毒性和3/4级非血液毒性的患者分别为29%和17%。29%的患者出现3/4级围手术期并发症，无胃肠道穿孔和治疗相关死亡。结论新辅助剂量密集的TC-贝伐单抗治疗耐受性好，经入侵检测获得满意的完全切除率。
BackgroundThis study aimed to investigate the clinical benefit of dose-dense paclitaxel plus carboplatin (TC) with bevacizumab therapy for advanced ovarian, fallopian tube, and primary peritoneal cancer patients in the neoadjuvant setting.MethodsOvarian, fallopian tube or primary peritoneal cancer patients with stage III–IV disease received neoadjuvant chemotherapy (NAC) every 3 weeks consisting of paclitaxel (80 mg/m2) on days 1, 8, and 15; carboplatin (AUC 6.0 mg/mL × min.) on day 1; and bevacizumab (15 mg/kg) on day 1. Interval debulking surgery (IDS) was performed after 3 cycles of dose-dense TC-bevacizumab therapy. The primary endpoint was the rate of complete resection by IDS. Secondary endpoints were treatment completion rate, treatment exposure, response rate to NAC, adverse events, and perioperative complications.ResultsTwenty-four patients were included in this study. The median age was 55.5 years (37–80 years), and most patients had high-grade serous carcinoma accounted (n= 18). IDS was performed in all patients with complete resection achieved in 75% (95% confidence interval: 57.7–92.3%). The lower limit exceeded the preset threshold rate of 55%. The response rate to NAC was 79%, and serum CA125 levels were in the normal range after NAC in 57% of patients. Grade 4 hematological toxicities and grade 3/4 non-hematological toxicities occurred in 29% and 17% of patients during NAC, respectively. Grade 3/4 perioperative complications were seen in 29% of patients, but no gastrointestinal perforations or treatment-related deaths occurred.ConclusionsNeoadjuvant dose-dense TC-bevacizumab therapy was well tolerated, and a satisfactory rate of complete resection by IDS was achieved.