Blog Highlights:

• There is some evidence, although somewhat controversial, that acupuncture can be effective in reducing frequency of hot flashes
• A small, 12-week study concluded “Acupuncture appears to be equivalent to drug therapy…”
• A large, 4-week study did not demonstrate a statistically significant reduction of hot flashes
• However, the 4-week study concluded: “We cannot exclude the possibility that a longer and more intense acupuncture intervention could produce a larger reduction of these symptoms.”

Hot flashes can be a debilitating condition for cancer patients who are being treated with chemotherapy or hormone therapy. This includes women with breast cancer and men with prostate cancer. I have written about this condition previously, including a listing of various medications that can be taken to reduce the frequency and intensity of hot flashes. (for more information, read Study May Help Cool Hot Flashes for Cancer Patients).

There is some evidence, although somewhat controversial, that acupuncture can be effective in women…and in men…who suffer from hot flashes. In a scientific study conducted at Henry Ford Hospital and published in the Journal of Clinical Oncology (February 1, 2010; vol. 28:pages 634-40; abstract listed below), 50 breast cancer patients volunteered for a  randomized controlled trial that tested whether acupuncture reduces vasomotor symptoms and produces fewer adverse effects than venlafaxine (Effexor), a commonly used drug for hot flashes. The investigators concluded that: “Acupuncture appears to be equivalent to drug therapy in these patients. It is a safe, effective and durable treatment for vasomotor symptoms secondary to long-term antiestrogen hormone use in patients with breast cancer.”

However, the evidence for acupuncture is not compelling. For example a slightly larger study from Memorial Sloan Kettering Cancer Center in 2007 did not convincingly demonstrate that acupuncture worked (J Clin Oncol. 2007 Dec 10; volume25:page 5584). They concluded: “Hot flash frequency in breast cancer patients was reduced following acupuncture. However, when compared with sham acupuncture, the reduction by the acupuncture regimen as provided in the current study did not reach statistical significance. We cannot exclude the possibility that a longer and more intense acupuncture intervention could produce a larger reduction of these symptoms.” This is an important point, since the positive Detroit trial administered acupuncture for 12 weeks while the New York trial was only 4 weeks in duration. FYI, sham acupuncture is a commonly used control group using techniques that are not intended to stimulate known acupuncture points.

While the evidence about the value of acupuncture treatments for refractory hot flashes are still preliminary, there seems to be enough potential value for this to be considered as an adjunct to conventional treatments for hot flashes, as described in previous blogs (for more information, read Study May Help Cool Hot Flashes for Cancer Patients). More research on this subject is needed.

Please read the abstracts below for more information. An interesting small study about acupuncture for hot flashes was recently reported in men with prostate cancer who were receiving hormone therapy (abstract listed below).

Acupuncture for Hot Flashes in Patients With Prostate Cancer.

Beer TM, Benavides M, Emmons SL, Hayes M, Liu G, Garzotto M, Donovan D, Katovic N, Reeder C, Eilers K.

Division of Hematology and Medical Oncology, Oregon Health and Science University, Portland, Oregon.

Urology. 2010 May 20. [Epub ahead of print]

Abstract

OBJECTIVES: To determine the effect of acupuncture on hot flash frequency and intensity, quality of life, and sleep quality in patients undergoing hormonal therapy for prostate cancer. Hot flashes are a common adverse effect of hormonal therapy for prostate cancer. METHODS: Men who had a hot flash score >4 who were receiving androgen deprivation therapy for prostate cancer underwent acupuncture with electrostimulation biweekly for 4 weeks, then weekly for 6 weeks, using a predefined treatment plan. The primary endpoint was a 50% reduction in the hot flash score after 4 weeks of therapy, calculated from the patients’ daily hot flash diaries. The hot flash-related quality of life and sleep quality and biomarkers potentially related to hot flashes, including serotonin, calcitonin gene-related peptide, and urinary 5-hydroxyindoleacetic acid, were examined. RESULTS: A total of 25 men were enrolled from September 2003 to April 2007. Of these, 22 were eligible and evaluable. After 4 weeks, 9 (41%, 95% confidence interval 21%-64%) of 22 patients had had a >50% reduction in the hot flash score. Of the 22 patients, 12 (55%, 95% confidence interval 32%-76%) met this response definition at any point during the therapy course. No patient had a significant increase in hot flash score during therapy. A reduced hot flash score was associated with improvement in the hot flash-related quality of life and sleep quality. CONCLUSIONS: Multiple placebo-controlled trials have demonstrated a 25% response rate to placebo treatment for hot flashes. Of the 22 patients, 41% had responded by week 4 and 55% overall in the present pilot study, providing evidence of a potentially meaningful benefit. Additional studies of acupuncture for hot flashes in this population are warranted. Copyright © 2010 Elsevier Inc. All rights reserved.

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Acupuncture versus venlafaxine for the management of vasomotor symptoms in patients with hormone receptor-positive breast cancer: a randomized controlled trial.

Walker EM, Rodriguez AI, Kohn B, Ball RM, Pegg J, Pocock JR, Nunez R, Peterson E, Jakary S, Levine RA.

Department of Radiation Oncology, Henry Ford Hospital, Detroit, MI 48202, USA. ewalker1@hfhs.org

J Clin Oncol. 2010 Feb 1;28(4):634-40. Epub 2009 Dec 28.

Abstract

PURPOSE: Vasomotor symptoms are common adverse effects of antiestrogen hormone treatment in conventional breast cancer care. Hormone replacement therapy is contraindicated in patients with breast cancer. Venlafaxine (Effexor), the therapy of choice for these symptoms, has numerous adverse effects. Recent studies suggest acupuncture may be effective in reducing vasomotor symptoms in menopausal women. This randomized controlled trial tested whether acupuncture reduces vasomotor symptoms and produces fewer adverse effects than venlafaxine (Effexor). PATIENTS AND METHODS: Fifty patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment. Health outcomes were measured for up to 1 year post-treatment. RESULTS: Both groups exhibited significant decreases in hot flashes, depressive symptoms, and other quality-of-life symptoms, including significant improvements in mental health from pre- to post-treatment. These changes were similar in both groups, indicating that acupuncture was as effective as venlafaxine. By 2 weeks post-treatment, the venlafaxine group experienced significant increases in hot flashes, whereas hot flashes in the acupuncture group remained at low levels. The venlafaxine group experienced 18 incidences of adverse effects (eg, nausea, dry mouth, dizziness, anxiety), whereas the acupuncture group experienced no negative adverse effects. Acupuncture had the additional benefit of increased sex drive in some women, and most reported an improvement in their energy, clarity of thought, and sense of well-being. CONCLUSION: Acupuncture appears to be equivalent to drug therapy in these patients. It is a safe, effective and durable treatment for vasomotor symptoms secondary to long-term antiestrogen hormone use in patients with breast cancer.

PMID: 20038728 [PubMed - indexed for MEDLINE]

Blog Highlights:

• Avaston has been approved by the FDA as a single agent for patients with progressive glioblastoma (GBM) following prior therapy
• Avastin is a  angiogenesis inhibitor that can block the formation of blood vessels around these brain tumors
• Without these blood vessels, a tumor is starved of the nutrients and oxygen it needs to survive and grow
• For more information, including potential side effects, go to their website:http://www.avastin.com

Avaston (Bevacizumab, from Genentech Oncology) has been approved by the FDA as a single agent for patients with progressive glioblastoma (GBM) following prior therapy. This is an important advance for treating GBM’s, a common form of brain cancer also called grade IV astrocytoma. All GBM tumors have abnormal and numerous blood vessels, a common feature of a fast-growing tumor. These blood vessels deliver necessary oxygen and nutrients to GBM tumors, helping them grow and spread. In order to grow and spread, these tumors need the nutrients and oxygen that are carried in the blood. To get blood, nearby blood vessels begin to grow toward the tumor. This new growth of vessels is called angiogenesis. Avastin is a  angiogenesis inhibitor that can block the formation of blood vessels around these brain tumors. Without these blood vessels, a tumor is starved of the nutrients and oxygen it needs to survive and grow.

The effectiveness of Avastin on GBM is based on tumor response. Currently, no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM.

Read about other advances in GBM treatment in my blog, “Advances in the Treatment of Glioblastoma of the Brain.”

For more information, including potential side effects, go to their website: http://www.avastin.com

This is an Oncology Podcast that covers three news highlights in breast cancer. The first one, and the most significant, concerns a report from Europe in women with inflammatory breast cancer (expressing the HER2 receptor) that is associated with a very high risk of dying. In a randomized study, researchers found that the complete response rate (that’s right: COMPLETE RESPONSE) in patients who received Herceptin (trastuzumab, Genentech Oncology) plus chemotherapy had a 55% complete response in these HER2+ breast cancers compared to only 19% for those women who had chemotherapy alone. Similar impressive results with Herceptin plus chemotherapy have been reported from UT MD Anderson cancer center in Houston.

The second report here describes FDA approval for a new drug Ixabepilone (Ixempra, Bristol Meyers Squibb) for advanced breast cancer refractory to other forms of chemotherapy.

The third news highlight describes a large study in Germany of 7000 women undergoing breast screening with mammography and breast MRI. The MRI scans were more accurate in detecting breast cancer, but it is a more expensive study and requires skill in interpretation. Breast MRI is used selectively in the United States, especially for women who have an inheritable form of breast cancer (BRAC! and BRAC2)

Bone marrow stimulating drugs are beneficial in some cancer treatment circumstances, but dangerous in others. A group of drugs, Aranesp, Epogen, and Procrit, have been a vital component of cancer chemotherapy management for many years. Clearly, this class of drugs (called erythropoiesis-stimulating agents) are a critical component of symptom management that allows cancer drugs to be given at higher, more therapeutic doses. Indeed, they have enabled oncologists to give a greater therapeutic dose of chemotherapy than was previously possible because the bone marrow cells (which produce white blood cells, red blood cells and platelets) could be wiped out without these drugs resulting in serious anemia, infections, and other side effects.

In 2007 and again in 2008, the FDA issued a “Black Box” warning on these drugs because of specific circumstances of serious adverse events identified from clinical trials. These are very potent drugs, and if not administered according to the FDA-approved labeling information, could themselves cause serious and life-threatening side effects and/or death (quotes from the FDA reports). They are the proverbial “two-edged sword that have benefit on the one hand and dangers on the other.

As new information has emerged from clinical trials, the FDA has made modifications in the indications for using the drugs and monitoring their effects. They recommend that doctors use the lowest possible dose to slowly raise the hemoglobin level (as a measure of anemia) to the lowest level that would avoid the need for blood transfusions. On the other hand, they are powerful drugs themselves and recent evidence from clinical trials have shown that they can have an adverse effect in some patient settings, including an actual reductions of survival rates in certain types of cancer patients if given too long or in too high a dose. They should not be used more aggressively to raise hemoglobin levels to a normal level. Moreover, they are not beneficial for cancer patients who are not getting chemotherapy.

Readers of this blog who want more extended and specific information can go to several websites. The most recent information from the FDA was posted May, 2009 (see their website:http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109375.htm). Also, the Centocor Ortho Biotech website has a lot of educational information, in language approved by the FDA, for these three drugs at http://www.procrit.com.

There is yet another drug called Neulasta (pegfilgrastim) that is prescribed to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infection-fighting white blood cells. While it also has some potentially dangerous side effects, it does not have the “black box” warnings of the three drugs listed above. For more information, see their website at http://www.neulasta.com.

If you have questions about these drugs, be sure to ask your doctor!

Tarceva, also known as Erlotinib, is an oral form of cancer therapy taken once a day that is approved by the FDA as a “second line” (i.e. backup) for patients with non-small cell lung cancer where standard chemotherapy has failed. It is an important drug as part of an initial therapy, along with gemcitabine, in patients with metastatic pancreas cancer.

This is a seven minute product description, produced by the manufacturers Genentech and OSI pharmaceutical companies, that is informative for those patients who want more details about how the drug works and some of its side effects. For more details on the web, you can go to http://www.tarceva.com.

For treatment of advanced non-small cell lung cancer, Dr. Vincent A. Miller (MSKCC) describes study results that suggest the addition of erlotinib (Tarceva, OSI pharmaceuticals) to bevacizumab extends progression-free survival compared with bevacizumab alone. Damian McNamara of the Global Medical News Network (GMNN) reports from the annual meeting of the American Society of Clinical Oncology in Orlando.

Zoledronic acid (Zometa, Novartis) is an intravenous drug that can reduce or delay bone complications from bone metastases in patients with breast, prostate, and lung cancer as well as multiple myeloma. In this important study, it was tested as an adjuvant therapy (i.e. drugs that modify the effect of other drugs) after surgery in combination with several hormone therapies used for breast cancer. Dr. Michael Gnant from the Medical University of Vienna is interviewed about an Austrian clinical trial assessing the use of zoledronic acid (Zolmeta, Novartis) to reduce breast cancer recurrence rates in premenopausal women when combined with anastrozole (Arimidex, AstraZeneca).

In this major study involving over 1800 women with breast cancer, the addition of zoledronic acid (Zometa ) to adjuvant endocrine therapy anastrozole (Arimidex) improved disease-free survival in premenopausal patients with estrogen-responsive early breast cancer. Details of the study, with Dr Gnant as the lead author, are published in the February 12, 2009 issue of the New England Journal of Medicine (vol 360; pages 679-91).

Here’s more information from patientresource.net about predicting recurrence of breast cancer:

Two new tests take advantage of a technology known as gene expression profiling, which allows for several genes in a tumor specimen to be studied at the same time. This type of analysis provides information on the expression (activity) of genes that activate and suppress the development of cancer cells. Researchers have found that the genetic profile of a tumor is related to its behavior; that is, the activity of specific genes can indicate whether the tumor will recur or metastasize. The test is currently valid only for early-stage, ER-positive breast cancers.

One test, Oncotype DX®, evaluates the activity of 21 genes (16 cancer genes and 5 control genes) in a tissue specimen and the activity is calculated as a Recurrence Score® of 0 to 100 points. ER, PR, and HER2 are included in these 21 genes. A low score indicates low risk and a high score indicates high risk of recurrence within 10 years after diagnosis. The Oncotype DX assay has been recommended by both ASCO and the NCCN to predict the risk of recurrence for women with newly diagnosed ER-positive breast cancer that had not spread to the lymph nodes (node-negative). It is performed in paraffin blocks of the tumor, readily available in all hospitals.

The other test, MammaPrint®, is an assay of 70 genes that research has found to be related to distant recurrence of breast cancer. With this test, a tissue specimen from the breast cancer is analyzed for the activity of these 70 genes, and the results indicate either a high or low risk of the cancer recurring within 10 years after diagnosis. Several studies have demonstrated that MammaPrint is a reliable predictor of disease-free survival, and in 2007, the US Food and Drug Administration cleared the test for use in the United States (not a requirement for use). This assay requires fresh tumor tissue or tissue that is frozen shortly after it has been removed from the body.

Oncotype DX® assay had been recommended by both ASCO and NCCN (which publishes treatment guidelines for all types of cancer) as a way to predict the risk of recurrence for women with newly diagnosed ER-positive, node-negative breast cancer. The ASCO statement also notes that the test can be used to identify patients who may be successfully treated with hormone therapy and therefore may safely avoid adjuvant chemotherapy.

The benefit of both MammaPrint and Oncotype DX is that treatment can be tailored—or customized —to the specific risk and needs of each individual woman. In determining the optimum treatment plan, the oncologist will consider the likelihood of recurrence (as identified by either test) as well as traditional factors, such as the size or grade of the tumor. In general, women with a low risk of recurrence can avoid the side effects of chemotherapy and be treated safely with hormone therapy alone. Women with a high risk of recurrence can be treated with adjuvant chemotherapy to help reduce that risk and can be monitored closely to help ensure early intervention if cancer does recur.

Medicare and private health insurance policies generally cover such testing for ER-positive, node-negative breast cancer, but you may want to check with your individual provider.