Hi NatureGirl,

I took Megace for hormone-positive advanced breast cancer back in 1995 - not currently!

At that time there were no AIs (aromatase inhibitors) and my cancer had continued to progress while on tamoxifen.

I think I took the M. for about 4 months and the cancer progressed, so I went on to radiation.

It's now used mainly as an appetite stimulant for people with advanced cancer and with AIDS wasting. Back then it had a reputation for causing much weight gain - I didn't have that. Just an icky feeling that I was willing to accept for stability or disease response. Since I got neither, I got off of it.

There aren't many recent reports of Megace ( megestrol acetate) in MBC, but I found this one small, 2-year-old study from Brazil that might interest you. Note NSAI is femara/letrazole or arimidex/anastrozole.

Activity of megestrol acetate in postmenopausal women with advanced breast cancer after nonsteroidal aromatase inhibitor failure: a phase II trial.

This is an abstract. The article's free full text is at http://annonc.oxfordjournals.org/content/25/4/831....

Bines J(1), Dienstmann R, Obadia RM, Branco LG, Quintella DC, Castro TM, Camacho

PG, Soares FA, Costa ME.

Author information: (1)Department of Medical Oncology, Instituto Nacional de Câncer, Rio de Janeiro, Brazil.

Ann Oncol. 2014 Apr;25(4):831-6. doi: 10.1093/annonc/mdu015. Epub 2014 Mar 10.

BACKGROUND: As novel treatments carry substantial price tags and are mostly cost-prohibitive in low- and middle-income countries, there is an urgent need to develop alternatives, such as off-patent drugs. Megestrol acetate (MA) has a longstanding history in the treatment of breast cancer, but recently it is being used less often due to the advent of newer agents.

PATIENTS AND METHODS: This two-stage phase II trial evaluated the antitumor activity and toxicity of MA in postmenopausal women with hormone-sensitive advanced breast cancer who had experienced disease progression on a third-generation nonsteroidal aromatase inhibitor (NSAI). Eligible patients had

metastatic breast cancer treated with a NSAI with at least 6-month progression-free survival (PFS), or relapse after ≥1 year on adjuvant NSAI.

Patients received MA at a single daily oral dose of 160 mg. Primary end point was clinical benefit rate (CBR).

RESULTS: Forty-eight patients were enrolled. The CBR was 40% [95% confidence interval (CI) 25% to 55%], and the median duration of clinical benefit was 10.0 (95% CI 8.0-14.2) months. The median PFS was 3.9 (95% CI 3.0-4.8) months. The most common grade 3 adverse events were anemia (2%), dyspnea (2%), fatigue (2%), musculoskeletal pain (4%), deep vein thrombosis (10%), and weight gain (2%).

CONCLUSIONS: This is the first study to prospectively evaluate the efficacy and safety of MA in postmenopausal women with hormone-sensitive disease progressing on a NSAI. MA has demonstrated activity and acceptable tolerability in this setting, and therefore remains a reasonable treatment option in a cost-sensitive environment. These results also provide the background for further evaluation of progestins in the treatment of breast cancer.

CLINICAL TRIALS: local trial number, related to the approval by the IRB: CEP 108/06.

PMID: 24615412 [PubMed - indexed for MEDLINE]

Excerpt from the article:

efficacy

There was no complete or partial response. Nineteen patients had SD for >24 weeks, for a CBR of 39.6% (95% CI 25.2–54.9%), and the median duration of clinical benefit was 10.0 (95% CI 8.0–14.2) months (Table 2). Median PFS for the overall patient population was 3.9 (95% CI 3.0–4.8) months (Figure 1). At a median follow-up of 51 months, all patients had disease progression. Immediate subsequent treatment consisted of chemotherapy, hormonal treatment, and no further systemic therapy for 54%, 31%, and 15% of patients, respectively. The most common endocrine agents in sequence were exemestane (36%) and fulvestrant (36%). At the time of this analysis, 36 patients had died, and the median OS was 19.4 (95% CI 15.1–23.6) months (Figure 2).

This may not be relevant to your decision, because my short, sad story is over 20 years old and most postmenopausal hormone-positive MBC folks now have more treatment options - the AIs, faslodex/fulvestrant, Ibrance/palbociclib and Afinitor/everolimus. Megace isn't used often any more - http://www.breastcancer.org/treatment/druglist/meg...

Naturegirl, good wishes and good luck with your new treatment with this old drug.

sending warm healing light, Stephanie

Hi Nature Girl,

Thanks for receiving my submission...I realize it's totally out-of-date and likely irrelevant.

If I were in your shoes and wanted to stay the hormonal route to the end-of-the-line, I'd probably press for Tamoxifen, since you've never had it and many women have had good and long term responses to it. If you still have your uterus, be aware of risk of endometrial cancer. And if you've a tendency to blood clots, it might not be the drug for you.

I'd also look at estradiol 6 mg daily, not 30 mg daily DES which used to be a standard of breast cancer care before Megace and Tamoxifen.

Lower-Dose vs High-Dose Oral Estradiol Therapy of Hormone Receptor–Positive, Aromatase Inhibitor–Resistant Advanced Breast Cancer

A Phase 2 Randomized Study

FREE Full Text!

Matthew J. Ellis, MB, BChir, PhD; Feng Gao, PhD; Farrokh Dehdashti, MD; Donna B. Jeffe, PhD; P. Kelly Marcom, MD; Lisa A. Carey, MD; Maura N. Dickler, MD; Paula Silverman, MD; Gini F. Fleming, MD; Aruna Kommareddy, MB BS; S. Jamalabadi-Majidi, DMD, MPH; Robert Crowder, PhD; Barry A. Siegel, MD

August 19, 2009

http://jama.jamanetwork.com/article.aspx?articleid...

I had a very good time with 2 mg daily estradiol after Femara, Aromasin and Faslodex (have never done Afinitor or Ibrance). The estradiol resensitized the cancer to anti-hormonal treatment and my third time with Femara seems to be good for my body and bad for the cancer in and around my lung.

I also have been taking testosterone (topical androgel) for a while. At first for its possible anti-cancer, hormone scrambling effects. But now for cachexia - muscle wasting - and strength.

Therapeutic Activity of Testoterone in Metastatic Breast Cancer

March 2014

http://ar.iiarjournals.org/content/34/3/1287.abstr...

I'm sure there's more out there on testosterone, just can't find the needle in the haystack now.

Naturegirl, if you decide to move on to chemotherapy starting with Xeloda, I was assured that it can be taken in very small doses, important for us sensitive types!

Hope this is somewhat helpful for plotting your own course!

warmest healing regards, Stephanie

PS, be sure to search the bco archives for Megace. I noticed that GatorGal was taking it. Maybe worth PMing her?

Hi NatureGirl,

Happy anniversary!

Next month, I'll have been with my oncologist for 24 years and I'm so very, very grateful for him and our relationship. I've questioned him the whole time and brought up many possible treatments along with documentation. What we've done as a team is unbelievable.

Makes sense to ask about the baby aspirin to reduce stroke risk, though I doubt there are many large studies to assess it. It seems from my reading that Megace is used for appetite stimulation more than MBC these days.

Keep up your good healing and collaborative work, dear NatureGirl.

warmest healing wishes, Stephanie

I had a brief brush with Megace a few months back. In Jan 2015 I was diagnosed with ER/PR +, HER- IDC, with mastectomy and removal of 22/24 nodes. Post surgical scans showed Stage 4, all in bones. I was put on Tamoxifen, which did not stop progression, so was switched to Arimidex in November. Arimidex was stopped in February due to side effects (chronic joint pain and unrelenting hot flashes), along with more progression. These symptoms subsided when I stopped Arimidex, and I was then put on Megace.

I only took it for 3 days. I spent those 3 days in bed with severe pain in all my joints and hot flashes which lasted hours. I could not function, and slept when I took enough pain relief. I can't vouch for appetite or weight gain, as I was too ill to eat.

6 weeks after this disaster, I had a post-menopausal bleed, which has been put down to a combination of Tamoxifen causing a build up of the endometrial lining, and a trigger from the progesterone Megace. It has not happened again, and hopefully has done no permanent damage.

I still don't understand why a PR+ person was given artificial progesterone, and have now been told that hormone treatments don't seem to work with me. (Duh, ya think?) My ER/PR status has never been re-checked since surgery, and my MO says there is no point in bothering.

My cancer continues to progress, and is now in my liver. I am now on Chemo, which will hopefully slow things down at last.

Hopefully my experience is not typical (whose is?), but I decided to add my experience to this thread as a possibility to be aware of.

All the best,

Sue.