Presurgical Progesterone in Early Breast Cancer

Anonymous · June 2011

From the Journal of Clinical Oncology June 2011

Single-Injection Depot Progesterone Before Surgery and Survival in Women With Operable Breast Cancer: A Randomized Controlled Trial.

Badwe R, Hawaldar R, Parmar V, Nadkarni M, Shet T, Desai S, Gupta S, Jalali R, Vanmali V, Dikshit R, Mittra I.

PURPOSE Many nonrandomized studies have suggested better outcome for patients with breast cancer who undergo surgery during the luteal (progestogenic) phase of their menstrual cycle, but this is controversial. We investigated the effect of a single preoperative injection of hydroxyprogesterone in women with operable breast cancer (OBC) in a randomized controlled trial (ClinicalTrials.gov identifier, NCT00123669).

PATIENTS AND METHODS One thousand patients with OBC were randomly assigned to receive surgery or an intramuscular injection of depot hydroxyprogesterone 500 mg 5 to 14 days before surgery. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), respectively. An analysis by axillary lymph node status was preplanned. Results At a median follow-up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In the progesterone group versus control group, 5-year DFS and OS rates were 73.9% v 70.2% (hazard ratio [HR], 0.87; 95% CI, 0.68 to 1.09; P = .23) and 80.2% v 78.4% (HR, 0.92; 95% CI, 0.69 to 1.21; P = .53), respectively. In 471 node-positive patients, the 5-year DFS and OS rates in the progesterone group versus control group were 65.3% v 54.7% (HR, 0.72; 95% CI, 0.54 to 0.97; P = .02) and 75.7% v 66.8% (HR, 0.70; 95% CI, 0.49 to 0.99; P = .04), respectively. In multivariate analysis, DFS was significantly improved with progesterone in node-positive patients (adjusted HR, 0.71; 95% CI, 0.53 to 0.95; P = .02),

whereas there was no significant effect in node-negative patients (P for interaction = .04). CONCLUSION A single injection of hydroxyprogesterone before surgery did not improve outcomes in all women with OBC.

*****This intervention showed significant improvement in node-positive women that may be considered hypothesis generating. If replicated in other studies, this could be a simple and inexpensive intervention, especially in developing countries where the incidence of lymph node metastasis is high.

elimar86861 · June 2011

When was this study done?

kira1234 · June 2011

elimar, The date shows June 11 2011.

Husband11 · June 2011

What's the significance of the presurgical timing?

elimar86861 · June 2011

I had heard of timing your surgery to a specific time in your menstrual cycle once before. It may have been in Susan Love's book, but I'm not sure because at the time i was reading books, I had borrowed a half dozen from my Breast Center's resource library.

Anyway, I read about it after my surgery, so my thought was, "Dang, too late for me to try this out." However, I turned out to be node negative and this study reports no significant difference, so I don't have to feel like I missed the boat anymore.

When I had read that first article, I thought, "What about menopausal women, not having cycles?" but this study actually supports getting a progesterone shot. I guess they could give that to menopausal and premenopausal alike. I guess they would have to give the shot to all women, because most of us do not find out whether we are node pos. or node neg. until the surgical path. report. That certainly would be nothing new, as we currently take the adjuvant hormonals not really knowing if we fall into the group of womenheaded for recurrence or not. We take those "just in case" so this shot soulds like another "just in case" scenario for some.

Just having thoughts and rambling.

Presurgical Progesterone in Early Breast Cancer

Comments

Categories