Dr Fader on Letrozole With or Without Paclitaxel and Carboplatin in Ovarian Serous Carcinoma

Amanda Nickles Fader, MD, vice chair, Gynecologic Surgical Operations, Johns Hopkins Health System, professor of gynecology and obstetrics, Johns Hopkins Medicine, discusses the randomized, phase 3 NRG-GY019 trial (NCT04095364) evaluating letrozole (Femara) with or without paclitaxel and carboplatin in patients with stage II to IV primary low-grade serous carcinoma of the ovary or peritoneum.

A previous joint retrospective study with the Cleveland Clinic and Johns Hopkins Medicine evaluated the omission of chemotherapy in 27 patients with advanced low-grade serous ovarian carcinoma, who received adjuvant hormonal therapy alone following primary cytoreductive surgery. At a median follow-up of 41 months, only 22.2% of patients developed tumor recurrence, and 2 patients died of disease. The median progression-free survival (PFS) and overall survival (OS) was not yet reached, and the 3-year PFS and OS rates were 79.0% and 92.6%, respectively. Among the 27 patients, letrozole was given to 55.5%.

These findings helped lead to the inception of the randomized, two-arm NRG-GY019 trial that will evaluate patients with stage II to IV low-grade serous ovarian carcinoma. Patients will be randomly assigned to receive carboplatin and paclitaxel, followed by letrozole maintenance therapy in the absence of progressive disease or unacceptable toxicity, or letrozole alone.

Fader notes that this may be the first ovarian cancer trial in the advanced stage setting that does not include chemotherapy in one of the treatment arms. This study could help understand whether giving letrozole alone could produce efficacy benefits compared with its use in combination with paclitaxel/carboplatin for patients with low-grade serous ovarian carcinoma, Fader concludes.