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

Alessio Carbone1, Elena Biagioli2, Vanda Salutari3

  • 1Oncology Department, E.O. Ospedali Galliera, Genoa, Italy.

Tumori
|December 15, 2025
PubMed
Summary
This summary is machine-generated.

Letrozole shows a favorable safety profile compared to chemotherapy in a phase III trial for low-grade serous ovarian cancer (LGSCO). Early findings suggest letrozole is well-tolerated and a potential treatment for hormone receptor-positive LGSCO.

Keywords:
endocrine therapyhormone receptorletrozolelow-grade serous carcinomaovarian cancerphase III trial

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Area of Science:

  • Gynecologic Oncology
  • Medical Oncology
  • Clinical Trials

Background:

  • Retrospective studies suggest letrozole may improve outcomes in low-grade serous carcinoma of the ovary (LGSCO) by targeting estrogen-driven tumor progression.
  • Hormone receptor-positive status is a key characteristic of LGSCO, indicating potential for endocrine therapy.

Purpose of the Study:

  • To compare the efficacy and safety of letrozole versus standard chemotherapy (carboplatin plus paclitaxel) in prolonging progression-free survival (PFS) for patients with LGSCO.
  • To evaluate secondary endpoints including overall survival (OS), objective response rate (ORR), quality of life, and pain.
  • To explore molecular markers (NGS, ctDNA) for treatment response.

Main Methods:

  • A multicenter, randomized, open-label, phase III trial comparing letrozole to carboplatin-paclitaxel in postmenopausal women with stage III-IV ER/PgR-positive LGSCO.
  • Patients were randomized 1:1 to receive either letrozole or chemotherapy for 6-8 cycles.
  • Disease progression assessed by RECIST, CA-125, and imaging; translational objectives include mutational and expression profiling.

Main Results:

  • As of March 2025, 46 patients were randomized (23 per arm).
  • Preliminary analysis indicates a favorable safety profile for letrozole when compared to standard chemotherapy.
  • The trial is ongoing, with further analyses planned.

Conclusions:

  • Early findings suggest letrozole is well-tolerated and may be a viable therapeutic option for hormone receptor-positive LGSCO.
  • Ongoing molecular and clinical analyses are expected to further clarify the role of letrozole in this rare subtype of ovarian cancer.