贝伐珠单抗、卡铂和紫杉醇一线治疗晚期卵巢癌患者：IV 期 MITO-16A/MaNGO-OV2A 研究。
Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study.
机构信息
Unità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Direzione Scientifica, Policlinico Universitario Agostino Gemelli, Roma, Italy.
出版信息
Int J Gynecol Cancer. 2021 Jun;31(6):875-882. doi: 10.1136/ijgc-2021-002434. Epub 2021 Apr 30.
OBJECTIVE
To explore the clinical and biological prognostic factors for advanced ovarian cancer patients receiving first-line treatment with carboplatin, paclitaxel, and bevacizumab.
METHODS
A multicenter, phase IV, single arm trial was performed. Patients with advanced (FIGO (International Federation of Gynecology and Obstetrics) stage IIIB-IV) or recurrent, previously untreated, ovarian cancer received carboplatin (AUC (area under the curve) 5), paclitaxel (175 mg/m) plus bevacizumab (15 mg/kg) on day 1 for six 3-weekly cycles followed by bevacizumab single agent (15 mg/kg) until progression or unacceptable toxicity up to a maximum of 22 total cycles. Here we report the final analysis on the role of clinical prognostic factors. The study had 80% power with a two-tailed 0.01 α error to detect a 0.60 hazard ratio with a factor expressed in at least 20% of the population. Both progression-free and overall survival were used as endpoints.
RESULTS
From October 2012 to November 2014, 398 eligible patients were treated. After a median follow-up of 32.3 months (IQR 24.1-40.4), median progression-free survival was 20.8 months (95% CI 19.1 to 22.0) and median overall survival was 41.1 months (95% CI 39.1 to 43.5). Clinical factors significantly predicting progression-free and overall survival were performance status, stage, and residual disease after primary surgery. Neither baseline blood pressure/antihypertensive treatment nor the development of hypertension during bevacizumab were prognostic. There were two deaths possibly related to treatment, but no unexpected safety signal was reported.
CONCLUSIONS
Efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel and as maintenance were comparable to previous data. Hypertension, either at baseline or developed during treatment, was not prognostic. Performance status, stage, and residual disease after primary surgery remain the most important clinical prognostic factors.
TRIAL REGISTRATION NUMBER
EudraCT 2012-003043-29; NCT01706120.
目的
探讨接受卡铂、紫杉醇和贝伐单抗一线治疗的晚期卵巢癌患者的临床和生物学预后因素。
方法
进行了一项多中心、四期、单臂试验。晚期（国际妇产科联合会[FIGO]分期 IIIB-IV 期）或复发性、未经治疗的卵巢癌患者接受卡铂（AUC 5）、紫杉醇（175 mg/m）加贝伐单抗（15 mg/kg），每 3 周 1 次，共 6 个周期，然后使用贝伐单抗单药（15 mg/kg），直至进展或不可接受的毒性，最多 22 个总周期。在这里，我们报告了临床预后因素作用的最终分析。该研究有 80%的效能，双侧 0.01α错误，以检测至少 20%人群中表达的因素的 0.60 风险比。无进展生存期和总生存期均作为终点。
结果
从 2012 年 10 月至 2014 年 11 月，398 名符合条件的患者接受了治疗。中位随访 32.3 个月（IQR 24.1-40.4）后，中位无进展生存期为 20.8 个月（95%CI 19.1-22.0），中位总生存期为 41.1 个月（95%CI 39.1-43.5）。显著预测无进展生存期和总生存期的临床因素是体能状态、分期和初始手术后的残留疾病。基线血压/降压治疗或贝伐单抗治疗期间发生的高血压均无预后意义。有 2 例死亡可能与治疗有关，但未报告意外的安全信号。
结论
贝伐单抗联合卡铂和紫杉醇以及维持治疗的疗效和安全性与既往数据相当。高血压，无论是基线还是治疗期间发生，均无预后意义。体能状态、分期和初始手术后的残留疾病仍然是最重要的临床预后因素。
试验注册号
EudraCT 2012-003043-29；NCT01706120。
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