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Anastrozole Effective for Advanced Ovarian, Peritoneal and Fallopian Tube Carcinomas: Presented at SGO

By Charlene Laino
Special to DG News

NEW ORLEANS -- February 4, 2003 -- The selective aromatase inhibitor anastrozole (Arimidex®, AstraZeneca) may extend disease-free survival in patients with recurrent ovarian, peritoneal or fallopian tube carcinomas without significant toxicity, a new study suggests.

Marcela G. Del Carmen, MD, an assistant professor at the Kelly Gynecological Oncology Service of Johns Hopkins Medical Institutions, in Baltimore, Maryland, United States, presented the findings here February 1^st during a poster session at the 34^th Annual Meeting of the Society of Gynecologic Surgeons.

Dr. Del Carmen performed the study while she was fellow-in-training at Massachusetts General Hospital in Boston, United States.

The Phase II trial enrolled 53 women with asymptomatic recurrent and/or persistent cancers of the ovary, peritoneum or fallopian tube. All patients had an Eastern Cooperative Oncology Group (ECOG) performance status of less than 1, and none needed immediate systemic chemotherapy.

"These patients are not really salvageable," Dr. Del Carmen told Doctor's Guide. "So the aim is to keep them comfortable, to see how long we can keep them off systemic chemotherapy and on something with a pretty acceptable toxicity profile."

Based on previous results in patients with breast cancer, her team thought that anastrozole might fit the bill, she said. Anastrozole is an orally active, nonsteroidal agent that inhibits the aromatase enzyme, thereby suppressing oestrogen levels.

Patients were divided into 2 cohorts, depending on whether they had measurable disease on computed tomography (CT) scan. Twenty-eight women were enrolled in Cohort 1 (measurable disease on CT scan), and 25 women in Cohort 2. Forty-three women had ovarian, 7 had primary peritoneal, and 3 had fallopian tube carcinomas.

They all received 1 mg of anastrozole orally daily. Follow-up comprised physical exam with interim history every month, and CA-125 testing with radiologic evaluation every 3 months. Oestrogen, progesterone and HER-2/neu receptor status were evaluated in archived tumour samples.

Of the 52 women evaluable for treatment toxicity and response, the median time to disease progression was 85 days, Dr. Del Carmen said. "While this might not seem like a long time, it is 3 months [that] they are on the relatively mild anastrozole and not getting a toxic chemotherapy drug," she said.

Response rates were similar in both cohorts. Even better, she said, 23% of patients had stable disease for more than 3 months, with 13% and 8% of patients stable for over 6 months and over 9 months, respectively. And, 1 patient is still taking anastrozole at 15 months without signs of relapse or toxicity, she said.

The most common toxicities were fatigue and hot flashes, both of which the women found acceptable. There were no thrombotic events.

The median time to progression for patients with oestrogen receptor-positive tumours was 61 days, compared with 82 days for those with oestrogen receptor-negative tumors. The median time to progression in patients with progesterone receptor-positive tumours was 63 days, compared with 69 days for those with progesterone receptor-negative tumours.

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