Golf Classic to Benefit St. Jude Children's Research Hospital

San Antonio, Texas (PRWEB) July 09, 2013

Window World TX is once again hosting the 4th annual Window World Cares Charity Golf Classic in San Antonio to benefit St. Jude Children’s Research Hospital! This year’s tournament will be played at the Canyon Springs Golf Club on September 19, 2013.

Window World is a major corporate sponsor of the amazing work performed at St. Jude Children’s Research Hospital. It is the only pediatric cancer research center in the United States where families never pay for treatment that insurance doesn’t cover. To carry out that mission, St. Jude depends on the generosity of its donors and corporate sponsors. Last year’s Window World Cares Charity Golf Classic raised more than $8,500 for St. Jude. This year, Window World TX hopes to eclipse that number by a large margin.

There are several different levels of sponsorships available for the 4th annual Window World Cares Charity Golf Classic. Any donation is appreciated and tax deductible.

To secure a sponsorship for the 4th annual Window World Cares Charity Golf Classic, please contact Rebecca Rowe of Window World TX at 210-767-0995 extension 206 or rrowe(at)windowworldtx(dot)com.

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'Designer Babies:' Who Would Really Benefit?

The argument that three-person in-vitro fertilization is a step toward engineering "designer babies" doesn't make sense to Lori Martin, whose 4-year-old son Will was born with an incurable genetic disease and likely won't survive past childhood.

Three-person IVF, called mitochondrial transfer, may be on its way to fruition in the United Kingdom as a means of eliminating mitochondrial diseases like Will's by swapping out the genetic material that causes it.

"I could never imagine myself trying to engineer some insanely talented kid because my first kid that I created had this terrible disease," said Martin, who lives in Houston. "It just doesn't register in my mind that way at all…They want to give another child a chance to have a healthy and happy life."

Read about 3-person IVF and the UK's push to make it a reality.

Will has a mitochondrial disease called Leigh's disease, which renders his cells unable to turn food into fuel. Like all mitochondrial diseases, which include muscular dystrophy, it's passed down from the mother via mitochondrial DNA and has no cure.

"There's no crystal ball to tell you what's going to happen tomorrow," Martin said. "He could wake up tomorrow and have lost all function. There's no rhyme or reason."

Read more about Will.

Because Will's condition is genetic, doctors told Martin she shouldn't have any more children without using a healthy egg from a donor. Although a baby from a donor egg would be free of Martin's bad mitochondrial DNA, it would also lack the 99.8 percent of her DNA that is not responsible for Will's condition but is to blame for her brown hair, her smile and all her other physical traits.

3-Person IVF 101

The mitochondria are the energy-producing parts of every cell — think of them as little batteries. As such, cells don't function properly if someone has a mitochondrial disease because cells can't turn food into fuel. For patients with Leigh's disease, for example, the mitochondria fail over time, and children often don't live past age 7.

Mitochondrial DNA determines how the mitochondria will function, but it's only passed on from the mother. Nuclear DNA comes from both parents and determines children's characteristics, such as eye color and height.

The three-person IVF being proposed in the United Kingdom would keep the nuclear DNA from both parents while swapping out the mother's "bad" mitochondrial DNA for a donor's mitochondrial DNA. Government officials estimate that it will be able to save 10 lives per year.

Why It Won't Be Available in the US Soon

But in the United States, the Food and Drug Administration effectively banned a similar procedure called cytoplasm transfer in 2001.

Therapy that involves manipulating cells beyond traditional IVF – an egg cell being fertilized by a sperm cell – falls under the FDA's jurisdiction.

According to a 2001 letter that went to clinics practicing cytoplasm transplants, which include injecting cytoplasm from a young egg into the cytoplasm of a new egg without removing any existing material, the FDA must conduct a clinical investigation, which can't even start until an "investigational new drug" application has been filed.

But that was more than a decade ago. Since then, no clinic has been approved, and the FDA is not allowed to comment on whether any applications have been filed, according to a spokesman.

"There are, of course, people who think this is inappropriate," said Debra Mathews, a bioethicist at the Berman Institute at Johns Hopkins University Medical School. "That this is the first step on the way to designer babies."

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No Benefit Offered By Bevacizumab For Newly Diagnosed Glioblastoma

Main Category: Cancer / Oncology
Also Included In: Neurology / Neuroscience
Article Date: 04 Jun 2013 - 0:00 PDT Current ratings for:
No Benefit Offered By Bevacizumab For Newly Diagnosed Glioblastoma

The angiogenesis inhibitor bevacizumab (Avastin) failed to increase overall survival (OS) or statistically significant progression-free survival (PFS) for glioblastoma patients in the frontline setting, according to research led by researchers at The University of Texas MD Anderson Cancer Center.

The study was presented at the American Society of Clinical Oncology 2013 Annual Meeting by Mark Gilbert, M.D., professor in MD Anderson's Department of Neuro-Oncology.

Glioblastoma is both the most common and lethal form of brain cancer. More than 12,000 people will be diagnosed with the disease in 2013, with an average survival rate of less than 18 months, said Gilbert.

Bevacizumab works as a monoclonal antibody against VEGF-A, which is produced by glioblastoma to stimulate blood vessel growth. The angiogenesis inhibitor first showed promise in glioblastoma as clinicians reported positive results treating the disease under approved compassionate use. Numerous institutional studies then found similar results: a 35-40 percent objective response rate, or tumor shrinkage, of more than 50 percent, and a six-month PFS rate in the mid-30 percent, said Gilbert. With those findings, in May, 2009, the FDA granted an accelerated registration of bevacizumab in the second line setting.

However, before this trial, no randomized, double-blind studies with the drug in glioblastoma had been conducted.

"Obviously, glioblastoma is a cancer with too few effective therapies," said Gilbert, who also holds the Blanche Bender Professorship in Cancer Research. "When we launched this study, those in the field of brain cancer - both the scientific and patient communities - were excited. Bevacizumab recently received approval in the second-line (recurrent disease) setting, and we knew some physicians were already giving the drug as a frontline therapy - even with virtually no data to support that decision. It was important from a patient care and regulatory standpoint that we conduct this trial."

The Phase III, international study (RTOG 0825) was a collaboration of three cooperative groups: RTOG, NCCTG and ECOG.

The randomized, double-blind, placebo-controlled study registered 978 and enrolled 637 patients, respectively, all of whom were newly diagnosed with glioblastoma. Participants underwent surgery to resect some or most of the tumor, received the standard of care of chemoradiation with temozolomide, and were randomized to receive either bevacizumab or placebo. The study was designed with two primary endpoints: PFS and OS.

Two distinguishing factors of the study design include: crossover to bevacizumab in the placebo arm at the time of progression, and longitudinal assessment of symptom burden, neurocognitive function and quality of life.

"With the crossover, we could determine the possible overall, or progression free survival benefits that could distinguish the potential benefits of early versus later use of bevacizumab," Gilbert said. "Also, there may be some alternative advantages for delaying progression in the disease. In order to interpret that possible delay in progression, it was important to understand what the quality of the survival of that possible progression free survival interval."

A third distinction: the study was designed to look at the impact of pre-specified molecular markers -- a nine-gene signature expression and MGMT methylation -- to determine if a subgroup that specifically benefited from bevacizumab could be identified.

The researchers found no difference in OS between the bevacizumab and placebo arms, 15.7 and 16.1 months, respectively. PFS did not reach the pre-set level statistical significance -- although longer ??in those taking bevacizumab upfront (10.7 months), compared to in those receiving placebo (7.3 months).

Bevacizumab was associated with a higher rate of toxicities, including hypertension, bleeding, deep vein thrombosis and pulmonary embolism, and gastrointestinal perforation. Those on the therapy also experienced increase rates of symptom burden and neurocognitive decline, as well decreased quality of life, compared to those on placebo.

When looking at the molecular markers, no subgroup of patients that benefitted from bevacizumab could be identified, said Gilbert.

Despite the disappointing findings, Gilbert stressed that the study did not find that bevacizumab had no place in the management of glioblastoma.

"Ultimately, our study showed that bevacizumab has the same benefit whether given early or late and because of the risk of extra toxicity upfront, its used can be reserved as a later treatment for most patients," said Gilbert.

Complementary studies detailing quality of life, symptom burden and molecular findings will all be presented by MD Anderson faculty at the meeting.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject. Abstract 1

In addition to Gilbert, others on the international study include: Kenneth D. Adalpe, M.D., Paul D. Brown, M.D., Ritsuko Komaki, M.D., Eric Sulman, M.D. Ph.D., and Jeffrey Wefel, all of MD Anderson; James Dignam, Ph.D., and Minhee Won, both of RTOG; Minesh Mehta, M.D., professor, University of Maryland Medical Center; Deborah T. Blumenthal, M.D., Tel Aviv Sourasky Medical Center; Michael A. Vogelbaum, M.D., Ph.D., Cleveland Clinic Foundation; Howard Colman, M.D., Ph.D., Huntsman Cancer Institute; Arnab Chakravarti, M.D., Arthur James Cancer Center; Robert Jeraj, Ph.D., University of Wisconsin; Terri S. Armstrong, Ph.D., University of Texas Health Science Center School of Nursing; Kurt Jaeckle, M.D., Mayo Clinic Florida; David Schiff, M.D., University of Virginia Medical Center; James Atkins, M.D., National Surgical Adjuvant Breast and Bowel Project and SCCC-CCOP; David Brachman, M.D., Arizona Oncology Services Foundation; and Maria Werner-Wasik, M.D., Thomas Jefferson University Hospital.

Gilbert is on Roche's advisory board; Genentech financially supported the 0825 study; it was also supported by NCI U10CA 21661, U10 CA37422.

University of Texas M. D. Anderson Cancer Center

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5 Jun. 2013. APA

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posted by Greg P. on 4 Jun 2013 at 1:16 pm

Wow! This is blockbuster news! In one study, patients who were expected to benefit the most from Avastin based on "genetic" testing had the worst survival rates.

Bevacizumab-induced tumor calcifications can be elicited in glioblastoma microspheroid culture and represent massive calcium accumulation death (MCAD) of tumor endothelial cells

http://precedings.nature.com/documents/7069/version/1

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'No Benefit Offered By Bevacizumab For Newly Diagnosed Glioblastoma'

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Identifying Glioblastoma Patients Most Likely To Benefit From Bevacizumab

Main Category: Cancer / Oncology
Also Included In: Neurology / Neuroscience
Article Date: 04 Jun 2013 - 0:00 PDT Current ratings for:
Identifying Glioblastoma Patients Most Likely To Benefit From Bevacizumab

A new test may help identify newly diagnosed glioblastoma patients more likely to benefit from bevacizumab (AvastinR), according to new research from The University of Texas MD Anderson Cancer Center.

The results of the study were presented at the annual meeting of the American Society of Clinical Oncology.

This study is associated with RTOG 0825, a large multi-center Phase III trial that evaluated the addition of bevacizumab to standard chemoradiation and maintenance temozolomide in treating newly diagnosed glioblastoma. Half of the participants received bevacizumab while the other half received a placebo.

Glioblastoma is the most frequent and aggressive type of brain tumor. Despite slight gains, tumors pose a high risk of recurrence and are commonly fatal.

"In general, glioblastomas are heterogeneous and no drug has been found that benefits every patient," said Erik Sulman, M.D., Ph.D., assistant professor in MD Anderson's Department of Radiation Oncology and lead author of the study. "We wanted to determine which patients are most likely to benefit from bevacizumab and use that information to develop a diagnostic tool that can predict which patients may be good candidates for the drug."

Does mesenchymal gene expression predict response to bevacizumab?

Bevacizumab is a monoclonal antibody that binds to the protein vascular endothelial growth factor. It is a type of anti-angiogenesis agent and prevents the growth of new blood vessels that tumors need to develop.

Previous studies found some patients with recurring glioblastoma have longer progression-free survival and receive some lessening of symptoms with the drug.

The goal of this study was to investigate the ability of a particular type of gene expression signature to predict response to bevacizumab.

Mesenchymal expression, poor outcomes correlated

As part of RTOG 0825, 637 randomized patients submitted specimens for molecular analysis. The umbrella study data also included molecular stratification that measured the degree of gene enrichment. These genes are known to function in cancer cell invasion and in establishing new blood supply, a function which bevacizumab is designed to prevent.

Researchers observed a significant association between a lower mesenchymal signature and better survival in patients taking bevacizamab.

Based on this association and following the examination of 43 genes in total, researchers modeled a novel gene expression predictor of outcome specific to those in the bevacizumab group.

"One of the key things about this predictor is that it's designed to be used on standard, archival tumors found in most clinical pathology labs," Sulman said. "It doesn't require fresh tissue."

Next steps

The group plans ongoing studies to determine the extent to which this gene signature represents a predictive marker for bevacizumab use in newly diagnosed glioblastoma.

"We will use data from the remaining patients on the trial to validate these findings," Sulman said. "We hope the test will be validated and used as a diagnostic tool to select patients for initial treatment with bevacizumab. Then, we plan to look beyond glioblastoma to see if it could benefit other tumor types currently treated or in clinical trials with bevacizumab."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject. Support sources for the study include Radiation Therapy Oncology Group (RTOG) grants U10 CA21661, CCOP grant U10 CA37422, Brain SPORE P50 CA127001 from the National Cancer Institute and Genentech, Inc.

Disclosures: Sulman received an honorarium from Merck.

In addition to Sulman other MD Anderson authors on the study include: Mark Gilbert, M.D., Paul Brown, M.D., Ritsuko Komaki, M.D. and Kenneth Aldape, M.D. Other authors include: Minhee Won, MA and James Dignam, Ph.D., Radiation Therapy Oncology Group; Deborah Blumenthal, M.D., Tel Aviv Sourasky Medical Center; Michael Vogelbaum, M.D., Ph.D., Cleveland Clinic; Howard Colman, M.D., Ph.D., Huntsman Cancer Institute; Robert Jenkins, M.D., Ph.D. and Kurt Jaeckle, M.D., Mayo Clinic; Arnab Chakravarti M.D., Ohio State University; Robert Jeraj, Ph.D., University of Wisconsin Madison; David Schiff, M.D., University of Virginia; James Atkins, M.D., Southeast Cancer Control Consortium; David Brachman, M.D., Arizona Oncology Services; Maria Werner-Wasik, M.D, Thomas Jefferson University Hospital; and Minesh Mehta, M.D., University of Maryland Medical Center.

University of Texas M. D. Anderson Cancer Center

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'Identifying Glioblastoma Patients Most Likely To Benefit From Bevacizumab'

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Soy Foods May Benefit Breast Cancer Patients

According to a study conducted in China, breast cancer patients with the highest soy consumption had a lower risk of breast cancer recurrence and a lower risk of death than patients with the lowest soy consumption. An editorial that accompanied the study, however, offered some words of caution about these findings. The study and editorial were published in the Journal of the American Medical Association.

Estrogen is thought to play an important role in the development of many breast cancers. Treatments that block the effects of estrogen or inhibit the production of estrogen are commonly used in the treatment of breast cancers that contain estrogen receptors.

Soy foods contain phytoestrogens (plant compounds that share some similarities with estrogen). Phytoestrogens have both estrogen-like and antiestrogenic characteristics, raising questions about the effects of dietary phytoestrogens on breast cancer risk and breast cancer treatment outcomes. Some studies have suggested that soy consumption may reduce the risk of getting breast cancer, but there is relatively little information about the effects of soy after a breast cancer diagnosis.??

To explore the relationship between post-diagnosis soy consumption and breast cancer outcomes, researchers evaluated information from the Shanghai Breast Cancer Survival Study.[1] The study enrolled more than 5,000 female breast cancer survivors in China.

Four-year risk of death was 7.4% among women with the highest intake of soy and 10.3% among women with the lowest intake of soy.Four-year risk of breast cancer recurrence was 8.0% among women with the highest intake of soy and 11.2% among women with the lowest intake of soy.

Although these results suggest that dietary soy intake may improve breast cancer outcomes, an accompanying editorial offers some words of caution: “Even though the findings by Shu et al suggest that consumption of soy foods among breast cancer patients is probably safe, studies in larger cohorts are required to understand the effects of these foods among diverse clinical subgroups of breast cancer patients and survivors. In the meantime, clinicians can advise their patients with breast cancer that soy foods are safe to eat and that these foods may offer some protective benefit for long-term health.”[2]

References:

[1] Shu XO, Zheng Y, Cai H et al. Soy food intake and breast cancer survival. JAMA. 2009;302:2437-2443.

[2] Ballard-Barbash R, Neuhouser ML. Challenges in design and interpretation of observational research on health behaviors and cancer survival. JAMA. 2009;302:2483-2484.

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Phase III Trial Fails to Find Benefit of PARP Inhibitor for Triple-Negative Breast Cancer

In a Phase III clinical trial, the addition of the PARP inhibitor iniparib to chemotherapy did not improve outcomes among women with metastatic triple-negative breast cancer. These results—which differ from those of a prior Phase II clinical trial—were presented at the 2011 annual meeting of the American Society of Clinical Oncology.??

Breast cancers that are estrogen receptor-negative, progesterone receptor-negative, and HER2-negative are called triple-negative breast cancers. Triple-negative breast cancers tend to be more aggressive than other breast cancers and have fewer treatment options.??

Iniparib belongs to a class of drugs called PARP inhibitors. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy. Because many triple-negative breast cancers are thought to have defects in DNA repair, researchers have hypothesized that triple-negative breast cancers may be particularly vulnerable to PARP inhibition.???

A Phase II clinical trial provided hope that iniparib would indeed provide a valuable new treatment option for triple-negative breast cancer. Results published in the New England Journal of Medicine early in 2011 suggested that the addition of iniparib to chemotherapy with GemzarR (gemcitabine) and carboplatin delayed cancer progression and improved overall survival.?[1] Median overall survival was 7.7 months among women treated with chemotherapy alone and 12.3 months among women treated with chemotherapy plus iniparib.?

?A subsequent Phase III clinical trial, however, did not find a benefit. The study enrolled a larger group of women (519 versus 123 in the Phase II trial), and once again compared chemotherapy alone with chemotherapy plus iniparib for the treatment of metastatic triple-negative breast cancer. According to results presented at the 2011 annual meeting of the American Society of Clinical Oncology, the addition of iniparib did not significantly improve overall or progression-free survival.?[2] ?

Although the Phase III results were a great disappointment, it remains possible that iniparib could still provide a benefit to women whose cancer has progressed (worsened) on other treatments. Researchers are continuing to explore whether there are particular subsets of women who respond well to this treatment.?

References:?

[1] O’Shaughnessy J, Osborne C, Pippen JE et al. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. New England Journal of Medicine. 2011;364:205-214.?

[2] O’Shaughnessy J, Schwartzberg LS, Danso MA et al. A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC). Presented at the 2011 annual meeting of the American Society of Clinical Oncology. Chicago, IL. June 3-7, 2011. Abstract 1007.?

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Herceptin Given At Same Time As Chemotherapy May Provide Most Benefit for Breast Cancer

The results of a Phase III clinical trial suggest that starting HerceptinR (trastuzumab) during chemotherapy for early-stage, HER2-positive breast cancer may be more effective than starting Herceptin after chemotherapy has been completed. These results were published in the Journal of Clinical Oncology.????

Fifteen to 20 percent of?breast cancers overexpress (make too much of) a protein known as HER2. Overexpression of this protein leads to increased growth of cancer cells and a worse breast cancer prognosis. Fortunately, the development of drugs such as Herceptin that specifically target HER2-positive cells has improved prognosis for women with HER2-targeted breast cancer.????

The optimal timing of Herceptin was evaluated in a Phase III clinical trial known as NCCTG N9831. The study enrolled women with Stage I-III HER2-positive breast cancer.? All women received chemotherapy with doxorubicin and cylophosphamide followed by paclitaxel, and some women also received Herceptin. Herceptin was started either at the same time as paclitaxel or later (after chemotherapy had been completed), and was given for a total of 52 weeks.????

Women who received both Herceptin and chemotherapy had a lower risk of cancer recurrence than women who received chemotherapy alone.?Women who started Herceptin at the same time as paclitaxel appeared to derive the most benefit. Five-year disease-free survival was 84.4% among women who received concurrent Herceptin and paclitaxel, compared with 80.1% among women who started Herceptin after finishing treatment with paclitaxel. This result did not meet the criteria for statistical significance, however, suggesting that it could have occurred by chance alone.?Starting Herceptin at the same time as paclitaxel did not appear to substantially increase the risk of side effects compared with starting Herceptin after chemotherapy had been completed.?

For women with early-stage, HER2-positive breast cancer, these results suggest that starting Herceptin during chemotherapy may produce better results than starting Herceptin after chemotherapy has been completed.?

Reference:?Perez EA, Suman VJ, Davidson NE et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. Journal of Clinical Oncology. 2011;29:4491-4497.?

Posted December 4, 2011

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Adding Afinitor to Herceptin May Provide Breast Cancer Benefit

For women with HER2-positive breast cancer that worsens in spite of treatment with HerceptinR (trastuzumab), treatment with a combination of Herceptin and AfinitorR (everolimus) may provide a benefit. These results were published in the Journal of Clinical Oncology.????

Approximately 20-25% of breast cancers overexpress (make too much of) the HER2 protein. HER2-targeted therapies such as Herceptin have dramatically improved outcomes for women with HER2-positive breast cancer, but researchers continue to explore new approaches to treatment. One important focus of research is the treatment of cancer that has progressed after prior HER2-targeted therapy.???

Afinitor is an oral medication that works by inhibiting a protein known as mTOR. The mTOR protein plays an important role in regulating cancer cell division and blood vessel growth.?Currently, Afinitor is used for the treatment of selected patients with kidney cancer, pancreatic neuroendocrine tumors, and subependymal giant cell astrocytoma (SEGA).?

To evaluate the combination of Herceptin and Afinitor, researchers combined information from two clinical trials that were conducted concurrently. Information was available for 47 women with HER2-positive metastatic breast cancer that had progressed during treatment with Herceptin. Study participants received Herceptin every three weeks in combination with daily Afinitor.????

Seven patients (15%) had a partial response to treatment (a reduction in detectable cancer).?An additional nine patients (19%) experienced stable disease for six months or longer. ?Median duration of survival without cancer progression was 4.1 months.?Side effects included fatigue, infection, and mouth sores (mucositis).?

These results suggest that the combination of Afinitor and Herceptin may benefit women with HER2-positive, advanced breast cancer that has worsened in spite of Herceptin treatment. Afinitor has been approved by the US Food and Drug Administration for other purposes, but has not yet been approved for breast cancer. At this time, the use of Afinitor would only be appropriate for women with ?HER2-positive breast cancer in the setting of a clinical trial.? Additional, ongoing studies are evaluating the combination of Herceptin, Afinitor, and chemotherapy in the first- and second-line treatment of metastatic breast cancer. ?

Reference: Khanh Morrow P, Wulf GM, Ensor J et al. Phase I/II study of trastuzumab in combination with everolimus (RAD001) in patients with HER2-overexpressing metastatic breast cancer who progressed on trastuzumab-based therapy. Journal of Clinical Oncology. Early online publication July 5, 2011.?

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Herceptin and Chemotherapy Benefit Breast Cancer Patients with Brain Metastases

Among women with HER2-positive breast cancer that has spread to the brain, treatment with HerceptinR (trastuzumab) and/or chemotherapy can prolong survival. These results were published in Clinical Cancer Research.???

Although important advances have been made in breast cancer treatment, the treatment of metastatic breast cancer (breast cancer that has spread to other parts of the body) remains challenging. The brain is one area to which breast cancer may spread, and researchers continue to explore how best to manage patients with brain metastases.?????

To assess the frequency and outcome of brain metastases in women with metastatic HER2-positive breast cancer, researchers conducted a study among 1,023 newly diagnosed patients. HER2-positive breast cancer refers to cancer that overexpresses (makes too much of) the HER2 protein. Treatment of HER2-positive breast cancer often includes a HER2-targeted therapy such as Herceptin.???

Brain metastases were more common in younger women, those with hormone receptor-negative breast cancer, and those with a greater amount of cancer.?Among women who were free of brain metastases at the time of their initial diagnosis but later developed brain metastases, brain metastases were diagnosed a median of 13 months after initial diagnosis.?After the diagnosis of brain metastases, treatment with Herceptin and chemotherapy each significantly improved overall survival.??

These results suggest that even after HER2-positive breast cancer spreads to the brain, standard breast cancer treatments can prolong survival.?

Reference: Brufsky AM, Mayer M, Rugo HS et al. Central nervous system metastases in patients with HER2-positive metastatic breast cancer: incidence, treatment, and survival in patients from registHER. Clinical Cancer Research. 2011; 17: 4834–43.?

Posted July 20, 2011

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Combination of HER2-Targeted Therapies May Provide Breast Cancer Benefit

Among women with early, HER2-positive breast cancer, treatment with a combination of HER2-targeted therapies may produce better outcomes than treatment with only a single HER2-targeted therapy. This was the conclusion of two studies presented at the 2010 San Antonio Breast Cancer Symposium. One of the studies evaluated neoadjuvant (before surgery) HerceptinR (trastuzumab) plus TykerbR (lapatinib), and the other evaluated neoadjuvant Herceptin plus pertuzumab.

Approximately 20-25% of breast cancers overexpress (make too much of) a protein known as HER2. Fortunately, the development of drugs that specifically target HER2-positive breast cancer has improved outcomes. These drugs include Herceptin, Tykerb, and the investigational drug pertuzumab.

Combinations of HER2-targeted therapies have shown a benefit in studies of women with metastatic breast cancer (cancer that has spread to other parts of the body), and researchers are also evaluating these combinations in women with earlier-stage breast cancer.

The NeoALTTO study is a Phase III clinical trial that has enrolled 455 women with early, HER2-positive breast cancer.[i] The study was restricted to women with operable breast cancer greater than 2 cm in size; women with inflammatory breast cancer were excluded. Study participants were assigned to one of three neoadjuvant (before surgery) treatment groups:

Tykerb plus chemotherapyHerceptin plus chemotherapyHerceptin plus Tykerb plus chemotherapy

The primary outcome of the study was the pathological complete response (pCR) rate. A pCR refers to the disappearance of detectable cancer at the time of surgery. After surgery, patients received additional chemotherapy and HER2-targeted therapy.

Response rates were highest among women treated with the combination of Herceptin and Tykerb: a pCR was achieved by 51.3% of women in the combined Herceptin/Tykerb group, 29.5% of women in the Herceptin group, and 24.7% of women in the Tykerb group.

In a second study, a Phase II clinical trial known as NeoSphere, researchers enrolled 417 women with Stage II or Stage III HER2-positive breast cancer.[ii] Study participants were assigned to one of four neoadjuvant treatment groups:

Herceptin plus chemotherapyHerceptin plus pertuzumab plus chemotherapyHerceptin plus pertuzumab (without chemotherapy)Pertuzumab plus chemotherapy

After surgery, patients received additional chemotherapy and Herceptin.

Response rates were highest among women treated with the combination of Herceptin, pertuzumab, and chemotherapy. A pCR was achieved by 45.8% of women treated with all three drugs, 29% of women treated with Herceptin plus chemotherapy, 24% of women treated with pertuzumab plus chemotherapy, and 16.8% of women treated with Herceptin plus pertuzumab without chemotherapy.

Taken together, these studies suggest that a combination of HER2-targeted therapies may be most effective against HER2-positive breast cancer.? While these data are very encouraging, both studies were small and we do not know that the improvement in pCR will result in fewer recurrences or longer survival.? At this point, these studies should stimulate additional research, but they should not be used as evidence to change clinical practice standards.

[i] Baselga J, Bradbury I, Eidtmann H et al. First results of the NeoALTTO Trial (BIG 01-06/EGF 106903): A phase III, randomized, open label, neoadjuvant study of lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2-positive primary breast cancer. Presented at the 33rd annual San Antonio Breast Cancer Symposium, December 8-12, 2010. Abstract S3-3.

[ii] Gianni L, Pienkowski T, Im Y-H et al. Neoadjuvant pertuzumab (P) and trastuzumab (H): antitumor and safety analysis of a randomized phase II study (‘NeoSphere’). Presented at the 33rd annual San Antonio Breast Cancer Symposium, December 8-12, 2010. Abstract S3-2.

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