Letrozole for hormone receptor-positive low-grade ovarian cancer: Preliminary toxicity results of a phase III trial.
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Carbone Alessio, Biagioli Elena, Salutari Vanda, Lorusso Domenica, Provinciali Nicoletta, Bocciolone Luca, Artioli Grazia, Abeni Chiara, Colombo Nicoletta, De Giorgi Ugo, Guarneri Valentina, Cassani Chiara, Scarfone Giovanna, Zavallone Laura, Donadello Nicoletta, Donato Violante Di, Giordano Monica, Scelzi Elvira, Tognon Germana, Petrella Maria Cristina, D'Incalci Maurizio, Marchini Sergio, Dang Hoai Thu, Alvisi Maria Francesca, Corradengo Davide, Buttiron Webber Tania, Paleari Laura, Briata Irene Maria, Rutigliani Mariangela, Oliva Martino, Rulli Eliana, DeCensi Andrea
Аннотация
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.