Metastatic Breast Cancer News from the 2011 San Antonio Breast Cancer Symposium

Today we'll continue to cover headlines from the 2011 San Antonio Breast Cancer Symposium, with a focus on six studies relevant to women with metastatic breast cancer.

Links may be found on the treatment pages of our LATESTBreastCancer.com website.

Omnitarg for HER2 positive metastatic breast cancer

The phase III Omnitarg (pertuzumab) study, known as CLEOPATRA (CLinical Evaluation Of Pertuzumab and TRAstuzumab), was big news. Reuters, Medical News Today, The New York Times and Los Angeles Times all ran stories. The study was published in the New England Journal of Medicine on December 7. (Link to full text.)

In the study, 808 women with HER2 positive metastatic breast cancer were randomly assigned to receive Herceptin (trastuzumab) and Taxotere (docetaxel) either with or without Omnitarg.

For the Omnitarg group, median progression-free survival, meaning the amount of time the cancer remains stable, was 18.5 months compared to 12.4 months for the Herceptin/Taxotere only group.

Although it's too early to confirm overall survival data, preliminary results show 69 deaths among the 402 women treated with Omnitarg compared to 96 deaths among the 406 women who did not receive Omnitarg.

Genentech and its parent company, Roche, have applied for permission to market Omnitarg in the US and Europe as first-line treatment for HER2 positive metastatic breast cancer.

Avastin for HER2 positive metastatic breast cancer

After the recent FDA decision to pull approval of Avastin for metastatic patients, there has been interest in identifying subsets of patients who may benefit from Avastin.

The phase III study (AVEREL) of Avastin (bevacizumab) in HER2 positive metastatic patients was similar in design to the Omnitarg study. 208 women were treated with Herceptin and Taxotere alone. 216 also received Avastin. The New York Times, Los Angeles Times and US News and World Report/HealthDay covered the study.

For the Avastin group, progression-free survival was 16.5 months, compared to 13.7 months for the 208 in the Herceptin/Taxotere only group.

But some question whether small benefits in progression-free survival are important.

According to the New York Times, "there was absolutely no difference in how long the women lived." Genentech has decided not to apply for FDA approval for HER2 positive breast cancer. A company representative noted, "Our bottom line is we do not believe that the difference in P.F.S. is of a sufficient magnitude that it is likely to gain regulatory approval."

Future research will attempt to identify the subset of patients who benefit from Avastin. As Dr. Gabriel Hortobagyi from MD Anderson noted in Los Angeles Times,

"I have no doubt that Avastin is a very powerful drug for some patients. . . The problem with Avastin is we don’t have a biomarker to help us identify the sub-group."

Afinitor for hormone-receptor positive metastatic breast cancer

A study (BOLERO-2) of Afinitor (everolimus) involving 704 women with hormone-receptor positive breast cancer which progressed on prior hormone therapy was covered by The New York Times, Los Angeles Times and Medical News Today. The study was published in The New England Journal of Medicine on December 7. (Link to full text.)

For women who took Afinitor plus the aromatase inhibitor Aromasin (exemestane), median progression-free survival was 7.4 months, compared to 3.2 months for women who took Aromasin alone.

However, the New York Times (Dec. 7) noted that because all women had already failed to benefit from hormone therapy, "perhaps it is not surprising that the control arm did not do that well on exemestane alone."

But, the trial researchers said that doctors often prescribe Aromasin in practice when other hormone therapies fail.

Medical News Today quoted Dr. Hortobagyi, a study coauthor, to say, "These findings may establish a new standard of care for advanced breast cancer."

Faslodex for hormone-receptor positive metastatic breast cancer

A phase III trial (SWOG S0226) of Faslodex (fulvestrant) plus Arimidex (anastrozole) for women with hormone-receptor positive metastatic breast cancer was covered by the Medical News Today on December 9.

In the study, 707 postmenopausal women were assigned to receive Arimidex plus Faslodex or Arimidex alone. Compared to the Arimidex alone arm, the Faslodex arm experienced longer median overall survival (47.7 months vs. 41.3 months) and longer progression-free survival (15 months vs. 13.5 months).

Both Arimidex and Faslodex are already used to treat breast cancer, though not in comination. The lead study coordinator noted that "these patients have not had a new treatment that gave them an overall survival benefit in more than a decade."

Entinostat for hormone-receptor positive metastatic breast cancer

A small phase II study (ENCORE 301) of entinostat for locally recurrent or metatstatic breast cancer was covered in a PR Newswire press release and the New York Times (Dec. 7)

In the study, 130 patients were treated with Aromasin (exemestane) alone or Aromasin plus entinostat. The median overall survival for the entinostat group was 26.9 months, compared to 19.8 months in the Aromasin alone group. Progression-free survival was also better with entinostat (4.3 months vs. 2.3 months.)

A randomized phase III study is anticipated to begin enrollment in the first half of 2012.

Abraxane as first-line treatment for metastatic breast cancer

A phase II study comparing Abraxane (nab-paclitaxel) to Taxotere (docetaxel) as first-line therapy for metastatic breast cancer was covered by Medical News Today on December 12.

In the study, 300 women who received no prior chemotherapy for metastatic disease were divided into four groups. Three groups received different doses of Abraxane. The fourth group received Taxotere.

The best median overall survival was achieved by the group that received 150 mg of Abraxane twice weekly (33.8 months.) The other two Abraxane dose schedules achieved median overall survival of 22.2 months and 27.7 months. For the Taxotere group, median overall survival was 26.6 months.

Progression-free survival was also better for the Abraxane 150mg/twice weekly group at 14.6 months, compared to 7.5 months and 10.9 months for the other Abraxane doses and 7.8 months for the Taxotere group.


We'll continue to follow research developments for women with metastatic breast cancer. We add links to media stories and journal abstracts to our website, LATESTBreastCancer.com everyday. The latest news and research may be explored anytime by clicking the Treatments tab.

Breast Cancer News (8/10): Exercise, Avastin and Soy

In today's breast cancer news update, we'll share the latest media headlines on exercise, Avastin and soy. As always, links to the news stories discussed below may be found on the treatment pages of the LATESTBreastCancer.com website.

The New York Times: "The Benefits of Exercise After Cancer"

Yesterday, The New York Times shared a recent report on the benefits of exercise during and after cancer treatment. In the report, "The importance of physical activity for people living with and beyond cancer:
A concise evidence review," Macmillan Cancer Support (UK) reviewed 60 studies on exercise during and after cancer treatment. Exercise was found to reduce the risk of breast-cancer mortality and recurrence. It also improved physical function, fatigue, well-being, body composition and bone health. For women with advanced breast cancer receiving chemotherapy, exercise affected quality of life and fatigue. The Macmillan Cancer Support webpage is full of additional information on physical activity for cancer patients and healthcare providers.

Bloomberg: "Roche Seeks ‘Middle Ground’ in U.S. Appeal of Avastin Breast Cancer Ruling"

The Avastin (bevacizumab) regulatory saga continues. According to a story in Bloomberg, Roche has appealed the recent FDA withdrawal of approval of Avastin for metastatic breast cancer with a "middle ground proposal." Roche asked the FDA to allow patients with advanced, aggressive cancer with few treatment options to use Avastin with Taxol (paclitaxel). The proposal includes an offer to provide doctors with a "risk-evaluation strategy" and additional information on Avastin effectiveness and risks. Roche also plans a 480 patient follow-up trial. Trial failure would trigger an "immediate voluntary withdrawal of Avastin for breast cancer." The trial is to include a test of a protein biomarker (VEGF-A) to identify patients who may benefit from Avastin.

The Los Angeles Times: "Study indicates soy won't fight bone loss after menopause"

After breast cancer treatment, some women turn to natural remedies, such as soy, for menopausal symptoms such as hot flashes and bone loss. According to a story in yesterday's Los Angeles Times, a recent study in the Archives of Internal Medicine has found that soy tablets do not reduce bone loss in post-menopausal women. Further, the women who took soy experienced more hot flashes and constipation. The women in the study were not breast cancer survivors, but the effects of soy on menopausal symptoms should still apply.

Please check back tomorrow for more breast cancer news and research updates from LATESTBreastCancer.com.

The Breast Cancer Update: July 1

Today in breast cancer news, we'll wrap up the week's big story by looking at what's next for Avastin. We'll also look at a UK decision to deny cost coverage for Tykerb or Herceptin plus hormone therapy for some metastatic patients and surgical scar treatment and prevention advice.

What's next for Avastin?

There's been a great deal of activity on the LATESTBreastCancer.com Avastin (bevacizumab) news page this week. Earlier this week, an FDA advisory panel held hearings on the risks and benefits of Avastin for metastatic breast cancer. In the end, the panel voted 6-0 against the use of Avastin for breast cancer. The FDA Commissioner will make the final decision, which will likely follow the panel's recommendation.

So, what's next for Avastin?

First, because Avastin will still be available for other cancers, doctors may continue to prescribe it off-label for metastatic breast cancer. At a cost of about $8,000 a month, the real question is if insurance will continue to pay.

According to the New York Times, Medicare will continue to cover Avastin for metastatic breast cancer even if the FDA revokes approval. This may eventually change, but such a change in policy "would take at least a year and involve public input." Representatives from several private insurance companies indicated that they would review coverage after the FDA final decision. A UnitedHealthcare representative told the New York Times that it would continue to base chemotherapy coverage on National Comprehensive Cancer Network (NCCN) guidelines.

A Reuters story noted that Roche is "undeterred" and is planning another breast cancer trial for early 2012. The new trial will include a biomarker to try to identify which patients may benefit from Avastin.

Both the New York Times and Reuters mentioned that Europe expanded its approval for Avastin for breast cancer to allow it to be combined with a second type of chemotherapy, Xeloda (capecitabine). Avastin "can be used for breast cancer in more than 80 countries."

UK won't pay for Tykerb or Herceptin plus hormone therapy for some patients

In foreign regulatory news, Bloomberg reports that the UK National Institute for Health and Clinical Excellence has denied cost coverage for Tykerb (lapatinib) or Herceptin (trastuzumab) in combination with aromatase inhibitor therapy for older, HER2 positive, metastatic patients. Unlike the recent Avastin hearing, the UK decision was based on a cost/benefit analysis. Both Tykerb and Herceptin have previously been approved in the UK for use in "certain other patients."

Breast cancer surgical scar prevention and treatment

According to a recent Cure Today article, surgical scars "can be managed and minimized." Breast surgeries, such as breast conserving surgery (lumpectomy) and mastectomy, are "associated with a high incidence of scarring." The International Advisory Panel on Scar Management recommends silicone gel sheeting be used as the "first-line preventative measure" for the first month after surgery. For more severe cases, intralesional corticosteroid injections are recommended as second-line treatment. Pressure wrapping may also be an option. In some cases, surgical excision may be necessary.

Please check back on Monday for more breast cancer news updates from LATESTBreastCancer.com. You may find all the news and research on any breast cancer test or treatment option, including complementary therapies on our website anytime.

The Breast Cancer News Update: June 30

With all the coverage of the Avastin hearing, yesterday was the most one-sided breast cancer news day we can remember.

But if you're following this story you might find it worthwhile to quickly see how different respected news organizations like The New York Times, Washington Post, LA Times, US News and World Report and others all covered it by accessing all their links from our single Avastin news page.

I should mention one interesting take on the Avastin: a blog entry by Dr. Debu Tripathy on the CureToday site (link). Dr. Tripathy calls the Avastin hearings "the end of an era in drug discovery." He does a nice job summarizing the situation and then links it to drug companies' need to do more research to identify predictive tests for new drugs.

If such a test existed for Avastin (in the same way that HER2 testing identifies patients who should receive Herceptin) then those Avastin patients who testified at the hearing wouldn't have to pit their own personal clinical benefit against the large number of patients who get no benefit, only side effects.

As Dr. Tripathy stated: "It is now necessary to define predictive factors at the same time a drug is initially being developed. Not only is FDA approval in jeopardy, but drug companies can no longer afford the cost of huge trials to show a tiny difference in outcomes. The FDA hearings mark a milestone in this turn - the end the old era of cancer drug development."

...and another step toward the inevitable: truly personalized medicine.

Anyway, regarding other stories yesterday, we won't waste your time. All were either repeats of stories we've already mentioned or weren't of broad relevance.

More tomorrow.