Letrozole for hormone receptor-positive low-grade ovarian cancer: Preliminary toxicity results of a phase III trial.

IF 2 4区医学 Q3 ONCOLOGY

Tumori Pub Date : 2026-02-01 Epub Date: 2025-12-14 DOI:10.1177/03008916251395596

Alessio Carbone, Elena Biagioli, Vanda Salutari, Domenica Lorusso, Nicoletta Provinciali, Luca Bocciolone, Grazia Artioli, Chiara Abeni, Nicoletta Colombo, Ugo De Giorgi, Valentina Guarneri, Chiara Cassani, Giovanna Scarfone, Laura Zavallone, Nicoletta Donadello, Violante Di Donato, Monica Giordano, Elvira Scelzi, Germana Tognon, Maria Cristina Petrella, Maurizio D'Incalci, Sergio Marchini, Hoai Thu Dang, Maria Francesca Alvisi, Davide Corradengo, Tania Buttiron Webber, Laura Paleari, Irene Maria Briata, Mariangela Rutigliani, Martino Oliva, Eliana Rulli, Andrea DeCensi

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引用次数: 0

Abstract

Background: Epidemiological and retrospective studies suggest that letrozole may improve outcomes in low-grade serous carcinoma of the ovary (LGSCO) by targeting estrogen-driven tumor progression.

Methods: We designed a multicenter, randomized, open-label, phase III trial to compare letrozole versus standard chemotherapy (carboplatin plus paclitaxel) in prolonging progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), quality of life (MENQoL), and musculoskeletal pain (BPI-SF). Translational objectives explore mutational and expression profiles (NGS, RAD51/BRCA1 foci) and circulating tumor DNA (ctDNA) as markers of treatment response. Eligible patients are postmenopausal women with stage III-IV ER/PgR-positive LGSCO after primary cytoreductive surgery. Patients are randomized 1:1 to letrozole 2.5 mg daily until progression or unacceptable toxicity, or to carboplatin-paclitaxel for 6-8 cycles. Disease progression is assessed by RECIST, CA-125, and imaging every 3-6 months.

Results: As of March 2025, 46 patients have been randomized (23 per arm). Preliminary analysis shows a favorable safety profile for letrozole compared with chemotherapy.

Conclusions: Early findings suggest letrozole is well tolerated and may represent a viable therapeutic option for hormone receptor-positive LGSCO. Ongoing molecular and clinical analyses will clarify its role in this rare subtype.

Trial registration: ClinicalTrials.gov Identifier: NCT05601700; https://clinicaltrials.gov/study/NCT05601700.

查看原文本刊更多论文

来曲唑治疗激素受体阳性的低级别卵巢癌：III期试验的初步毒性结果。

背景：流行病学和回顾性研究表明，来曲唑可以通过靶向雌激素驱动的肿瘤进展来改善低级别卵巢浆液性癌（LGSCO）的预后。方法：我们设计了一项多中心、随机、开放标签的III期试验，比较来曲唑与标准化疗（卡铂+紫杉醇）在延长无进展生存期（PFS）方面的效果。次要终点包括总生存期（OS）、客观缓解率（ORR）、生活质量（MENQoL）和肌肉骨骼疼痛（BPI-SF）。翻译目的探讨突变和表达谱（NGS， RAD51/BRCA1病灶）和循环肿瘤DNA （ctDNA）作为治疗反应的标志物。符合条件的患者是经原发性细胞减少手术后患有III-IV期ER/ pgr阳性LGSCO的绝经后妇女。患者以1:1的比例随机分配给来曲唑2.5 mg /天，直到病情进展或出现不可接受的毒性，或卡铂-紫杉醇治疗6-8个周期。通过RECIST、CA-125评估疾病进展，每3-6个月进行一次影像学检查。结果：截至2025年3月，46例患者被随机分配（每组23例）。初步分析表明，与化疗相比，来曲唑具有良好的安全性。结论：早期研究结果表明来曲唑耐受性良好，可能是激素受体阳性LGSCO的可行治疗选择。正在进行的分子和临床分析将阐明其在这种罕见亚型中的作用。试验注册：ClinicalTrials.gov标识符：NCT05601700；https://clinicaltrials.gov/study/NCT05601700。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Tumori 医学-肿瘤学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

6 months

期刊介绍： Tumori Journal covers all aspects of cancer science and clinical practice with a strong focus on prevention, translational medicine and clinically relevant reports. We invite the publication of randomized trials and reports on large, consecutive patient series that investigate the real impact of new techniques, drugs and devices inday-to-day clinical practice.