A new breast cancer treatment uses an unusual method of administering chemotherapy— patients soak their breasts in hot water, which forces the chemotherapy drugs that are encapsulated in liposomes to release most of their contents into the breast tissue. The liposomal packaging melts above the usual body temperature (in this study, 104° F).

The encapsulation allows delivery of 30 times more of the drug to the breast tissue, without poisoning the rest of the body, according to researchers who reported on their study at the annual meeting of the American Society of Clinical Oncology. The 12-week, phase I trial of doxorubicin encased in liposomes (Myocet, The Liposome Company Inc.) and paclitaxel (Taxol, Bristol-Myers Squibb Company) is the only clinical trial of its kind in the U.S.

Of the 21 patients with newly diagnosed, large invasive breast tumors, 33% had complete remission; 17% were able to have lumpec-tomy instead of mastectomy, and 11% had complete pathologic responses. Tumor growth was arrested in all women in the study and half of the women had at least partial tumor shrinkage, even though many of the tumors were initially inoperable. Moreover, the researchers observed that nausea, fatigue, and cardiac tox-icity were lower than with traditional chemotherapy.

The study reversed the usual order of surgery, followed by chemotherapy and radiation. After a traditional infusion of chemotherapy, patients underwent hyperthermia drug treatments every three weeks for four cycles, followed by the least invasive surgery needed to remove the tumor. Additional chemotherapy and radiation might be needed postoperatively, the researchers say.

Data from a new study point to an alarming pattern in breast cancer treatment: more than 50% of women with early-stage breast cancer have not received their full, recommended dose of potentially life-saving chemotherapy.

A comprehensive retrospective analysis showed that 56% of the almost 20,800 women who were being treated for cancer in 1,243 community-based oncology practices in the U.S. received less than 85% of their recommended dose intensity, as prescribed in the optimal treatment plan, because of delays of at least one week (in 25% of patients) or dose reductions (in 37%). Earlier studies have indicated that receiving less than 85% of the recommended dose intensity can result in lower survival rates for patients.

The primary reason for the chemo­therapy delays is the presence of neutro-penia, a deficiency of white blood cells, which fight infection and which are destroyed by the effects of the chemotherapy. If the white blood cell count falls too low, patients are at increased risk for infection and, consequently, chemotherapy must be delayed until the cells are replenished.

Although white blood cell “boosters,” known as colony-stimulating factors, are available for the treatment of neutro-penia, only 25% of patients received them during chemotherapy.

The researchers noted that these results are particularly disturbing because earlier studies have underscored the importance of maintaining full chemotherapy dose intensity, especially in responsive and potentially curable malignancies, such as early-stage breast cancer. The study also disclosed a tendency of oncologists to lower dose intensity in order to reduce side effects.

Almost two-thirds of patients older than age 65 were less likely to receive the recommended doses, even though studies have shown that elderly patients can benefit from chemotherapy as much as younger patients. African-American women were also more likely to experience delays in treatment because of lower white blood cell counts.

The women in the study ranged in age from 11 to 90, with a mean age of 52.

Aspirin, often used to help prevent heart attacks and strokes, also appears to reduce the risk of the most common type of breast cancer— that is, tumors whose growth was fueled by estrogen or progesterone. Approximately 70% of women with breast cancer have the hormone receptor-positive type.

The women who used aspirin at least four times a week for at least three months were almost 30% less likely to develop hormone-related breast cancer than women who used no aspirin. Aspirin had no effect on the risk for hormone receptor-negative tumors.

Researchers believe that aspirin works by interfering with the body’s production of estrogen.

Many studies have relied on subjects’ recollections of how often they took aspirin. A more rigorous study has linked the use of low-dose aspirin and a reduced risk of growths that can eventually turn into colon cancer. That study involved randomly assigning patients to take aspirin or placebos, the gold-standard method.

For now, it is not recommended that all women take aspirin, because it can cause side effects such as stomach bleeding. Although the findings are exciting, more research is needed before doctors recommend aspirin to prevent breast cancer.

A new study from the University of Southern California in Los Angeles indicates that women using the NSAID ibuprofen every day for five years or longer are 50% more likely than non-users to develop breast cancer, whereas women using aspirin every day for five years or longer are 81 percent more likely than non-users to develop the estrogen-receptor, or progesterone receptor-negative, subtype of cancer.

The researchers had expected NSAIDs to reduce the risk of cancer.

No link was observed between acetaminophen use and breast cancer risk.

Further study is needed, in view of the well-known benefits of low-dose aspirin for preventing cardiovascular disease.

Letrozole (Femara generic, Novartis), an aro-matase inhibitor, has been granted FDA approval as adjuvant therapy for patients with early hormone receptor-positive breast cancer.

With the added indication, letrozole becomes the second agent in its class to gain an equal footing with tamoxifen (Medication Nolvadex, AstraZeneca) for immediate use after surgery in postmenopausal women with early breast cancer. It joined generic anastrozole (Canadian Arimidex, AstraZeneca), which earned a similar green light from the FDA in September 2005. A year ago, once-daily oral drug letrozole was approved for the extended adjuvant treatment of early breast cancer in postmenopausal women who had received five years of adjuvant tamoxifen canadian therapy.

The FDA has expanded the approved use of trastuzumab (Herceptin, Genen-tech), a biological cancer drug. In combination with other cancer drugs, tras-tuzumab is indicated for patients with HER2-positive breast cancer after surgery.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. An excessive amount of HER2 protein causes cancer cells to grow more rapidly, and standard chemotherapy may be less effective. Approximately 25% of women with breast cancer have tumors that produce excessive HER2 protein.

In 1998, the drug was approved for the treatment of metastatic breast cancer. The new approval expands its use to women with cancer only in the breast or lymph nodes that has been surgically removed.

Studies conducted by the National Cancer Institute were ended early because of the positive results. Women who received trastuzumab combined with chemotherapy had fewer relapses for up to three years after surgery. The estimated three-year disease-free rates were 87% in patients receiving tras-tuzumab and chemotherapy and 75% in those patients receiving chemotherapy alone.

The most serious side effect was heart failure. Patients must be screened for heart function before and during therapy.

Patients with advanced breast cancer drug that has not responded to other anti-cancer drugs may soon have a new treatment option. Ixabepilone (Ixempra, Bristol-Myers Squibb) has been approved for use in combination with another cancer agent, capecitabine (generic Xeloda, Roche), in patients who no longer benefit from treatment with an anthracycline (such as doxorubicin [Adriamycin, Bedford]) and a taxane (such as paclitaxel [Taxol, Bristol-Myers Squibb] or docetaxel [Taxotere, Sanofi-Aventis]). Ixabepilone is also approved for use alone in patients who no longer benefit from an anthracycline, a taxane, and capecitabine.

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