Evista and Ovarian Cancer

[hope778]

Is there any conclusive proof that Evista may aggravate ovarian cancer? I am taking Calcium supplement and Fosamax in addition to Evista.

[Annekathryn Goodman, M.D.]

   Hi There,

I did a search on this topic. In the scientific literature, there seems to be little data to support the claim that evista induces ovarian cancer. In the non-scientific literature there seems to be some bashing of the drug company that produces Evista. this seems to be coming from just one source. I have pasted below the latest study of Evista and long term consequences with the link so you can look up the full report.

My conclusion is that evista is one of several options for the treatment of osteoporosis. The major risk is an increase in blood clots
best wishes



http://lillytrials.com/results_files/evista/evista_summary_3996.pdf

CT Registry ID#3996 Page 1
Raloxifene Copyright © 2006 Eli Lilly and Company. All rights reserved.
Summary ID# 3996
Clinical Study Summary: Study H3S-MC-GGJY
Continuing Outcomes Relevant to Evista® (CORE):
A Study of Raloxifene HCl and Placebo
in the Prevention of Invasive Breast Cancer
in Postmenopausal Women with Osteoporosis
Date summary approved by Lilly: 20 September 2006

Brief Summary of Results
Study H3S-MC-GGJY (Study GGJY) is a multicenter, double-blind, parallel, placebocontrolled study. The primary objective of the study was to test the hypothesis that a statistically significant reduction in the incidence of invasive breast cancer would occur in postmenopausal women with osteoporosis treated with raloxifene hydrochloride (HCl)
60 mg/day compared with placebo over a long-term period of observation. This study enrolled a subset of Study H3S-MC-GGGK (GGGK [CT Registry # 1363a and 1363b


The 2 secondary objectives of Study GGJY were 1) to test the hypothesis that a statistically significant reduction in the incidence of invasive, estrogen receptor–positive (ER[+]) breast cancer would occur in postmenopausal women with osteoporosis when
treated with raloxifene HCl 60 mg/day compared with placebo over a long-term period of observation; and 2) to test the hypothesis that raloxifene HCl 60 mg/day would have the effect of reducing the incidence of nonvertebral fractures in postmenopausal women with
osteoporosis, when compared with placebo, over a long-term period of observation.

The results were as follows:
• Raloxifene HCl treatment resulted in a statistically significant reduction in the incidence of adjudicated invasive breast cancer and invasive estrogen receptor–positive (ER+) breast cancer for the primary analysis dataset (PAD).
• RaloxifeneHCl treatment resulted in a statistically significant reduction in the incidence of all adjudicated breast cancers, regardless of invasiveness, for the PAD

There were statistically significant reductions in the incidence of adjudicated invasive breast cancer and invasive ER(+) breast cancer in every subpopulation at all treatment durations studied.
• There was no difference between the treatment groups in the risk of ER-) breast cancer.
• Raloxifene HCl treatment did not have a statistically significant effect on the incidence of nonvertebral fractures and on nonvertebral-six fractures. There was an imbalance between raloxifene- and placebo-treated arms of the Study GGJY population in the severity of osteoporosis by prevalent vertebral fracture and
semiquantitative visual (SQ) score assessment by a radiologist for presence of fractures in the T4-L4 vertebral bodies; scoring includes 0 (no fracture), 1 (mild),
2 (moderate), and 3 (severe) at baseline for Study GGGK.
• Post hoc analyses demonstrated proportionally fewer raloxifene-treated participants sustained ≥2 nonvertebral fractures and multiple nonvertebral-six fractures than placebo-treated women from baseline through study termination.
In participants with more severe osteoporosis, proportionally fewer raloxifene treated participants sustained ≥2 nonvertebral or nonvertebral-six fractures than placebo participants.
• There were 76 deaths (1.9%)[2 reported by the investigator to be possibly related to study drug]. There were 29 deaths [2.3%] in the placebo group, and 47 [1.7%] in the raloxifene HCl 60-mg/day treatment group. There was no statistically significant difference between the 2 treatment groups in the number of women
who died overall, nor in the number of women who died of any individual event
(using MedDRA® Preferred Terms).

• There was an increased risk of venous thromboembolism with raloxifene treatment. There was no increased risk of ovarian cancer, endometrial cancer, or cardiovascular-related events with raloxifene treatment when compared with placebo.
• Raloxifene was associated with an increased incidence of 1 serious adverse event (SAE), venous thromboembolism. Nonserious adverse events (AEs) associated with raloxifene treatment were muscle cramps, flushing (hot flashes), and peripheral edema.

[LIBBY8]

A related discussion, EVISTA and Ovarian Cancer was started.

[hope778]

Thanks doctor for clearing the doubt. I will continue with Evista. Regards