Cancer Treatment Today » Hormonal Treatment

Faslodex for breast cancer

M Levin, MD — Sun, 03 Feb 2013 17:59:16 +0000

Fulvestrant is FDA indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy. (Faslodex)Fulvestrant is a hormonal treatment that works differently than other hormonal treatments. It acts not by competing with estrogen but by selectively down modulating it and causing it to be degraded and disappear. It used to be thought that this unique mechanism of action gives fulvestrant greater efficacy than other hormonal treatments but that does not appear to be the case. Four comparative clinical trials showed similar efficacy to the other hormonal agents (aromatase inhibitors and tamoxifen) with good tolerability profile. Nevertheless, Fulvestrant provided effective second-line therapy in this setting for postmenopausal women who had relapsed or progressed after previous endocrine therapy.

One might wonder then if fulvestrant has anything to recommend it in first line, especially since it is very often used in that line. For this reason,creating quite a stir, the U.K. National Institute for Health and Clinical Excellence (NICE) said in 2011 that it found no evidence Faslodex was significantly better than existing treatments, and it did not recommend its routine use in the country’s National Health Service. It is a more convenient drug in some situations, since it is an injectable drug that is administered once monthly. There are patients, especially in institutional setting, such as nursing homes, for whom once monthly fulvestrant is more realistic than either IV or daily oral drugs.

Fulvestrant In combinations is discussed in the Professional version.

For Professional version see here

Generic Versus Brand Name Aromasin

M Levin, MD — Sun, 05 Aug 2012 14:58:56 +0000

Brand-name Aromasin is manufactured by Pfizer, Inc. However, the patent for this medicine has expired in early 2012, and it is now available in generic form. Aromasin is available in generic form in one strength: exemestane 25 mg tablets.

Generic Aromasin is made by Roxane Laboratories, Inc., and Greenstone LLC. The version made by Greenstone is an “authorized generic,” which means that it is actually made by Pfizer and is actually the real, brand-name tablet but is packaged and sold as a generic.

There is no literature to support that brand is better then generic. All generic medications must undergo testing for bio-equivalence before the U.S. Food and Drug Administration (FDA) decides if the generics are equivalent to the brand-name medications and assigns a rating to each one.

An “AB” rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. The generic exemestane currently available has an “AB” rating, meaning it has been determined to be equivalent to Aromasin.

Read the Professional version here.

Herceptin and Arimidex for HER+, ER/PR+ Metastatic Breast Cancer

M Levin, MD — Thu, 19 Jul 2012 02:29:08 +0000

Is there a way to make cancers that stop responding to hormones increase their sensitivity to these drugs? Preclinical evidence suggests Herceptin (trustusumab) can restore and amplify responsiveness to hormonal therapy. The combination of Tykerb, which like Herceptin works on the HER receptor, and Femara is FDA approved and is thought to work through this mechanism. A randomized phase III TAnDEM study investigated Trastuzumab plus Arimidex(anastrozole) versus anastrozole alone for the treatment of postmenopausal women with receptors was for epidermal growth factor (EGFR), that suggests responsiveness to Herceptin, and hormones in metastatic breast cancer. Patients who received trastuzumab and anastrozole had longer period to progression (PFS, progression free survival) than patients who received anastrozole only. There was, however, no difference in overall survival between the two treatments. The numbers of adverse events and severe adverse events from treatment were higher with the to drug arm of the study compared to anastrozole only arm. This was a crossover design, in which patients who failed on anastrozole arm could crossover to the combination arm, which may have interfered with finding a difference in survival between the two arms.

Much more research needs to be done and guidelines have not yet incorporated Herceptin and Arimidex as standard recommendation. The editorial that accompanied the publication of the study suggested that such evidence, “should be viewed as pioneering and hypothesis driven; they are likely to become obligatory references in the field of HER2 breast cancer.”

Read the Professional version here.

Tamoxifen, Endometrium and Hysterectomy

M Levin, MD — Tue, 19 Jun 2012 14:12:27 +0000

Tamoxifen has different effects on different tissues. Whereas it blocks estrogen in the breast, it has pro- estrogenic effects on bone and in the uterus. Working as an estrogen-like substance, it can cause dysfunctional uterine bleeding and endometrial thickening and very rarely, superficial, easily treatable, endometrial cancer and sarcoma. In a review of all NSABP breast cancer treatment trials, the rate of sarcoma in women treated with tamoxifen was 17 per 100,000 patient years versus none in the placebo group. Similarly, in a separate trial of high-risk women without breast cancer taking tamoxifen as part of a breast cancer prevention trial with a median follow-up of 6.9 years, there were four in the tamoxifen group versus none in the placebo group, translating into a very low risk. This is compared with the incidence of one to two per 100,000 patient years in the general population.

Some women develop endometrial thickening when taking tamoxifen. The significance of endometrial thickening is not clear. At one time, women were regularly subjected to regular screening, ultrasound and even intra-uterine biopsies. Experience had not borne out such an approach. Beyond a routine gynecologic examination eliciting any history of abnormal bleeding, it has been recommended that screening studies and procedures for detecting endometrial pathology in women taking tamoxifen should be left to the discretion of the individual gynecologist. Routine ultrasound screening is not recommended because of significant incidents of false-positive endovaginal ultrasound screening tests. Of course, any abnormal uterine bleeding should be completely evaluated.

There are no guidelines to recommend hysterectomy routinely for patients of tamoxifen. One guideline that has taken up this issue is this Society of Gynecologic Oncology pf Canada and it recommends: “In asymptomatic women on tamoxifen, a routine ultrasound for endometrial thickening should not be performed.” It does not recommend routine hysterectomy.

Read the Professional version here.