A few highlights out of ASCO, the big cancer conference on in Orlando this weekend:

Roche’s breast-cancer drug Herceptin extended the lives of some patients with stomach cancer. The drug is used in people whose tumors produce excessive amounts of a protein called her-2. That occurs in about 20%-25% of breast cancer and stomach cancer cases. Patients with advanced stomach cancer that overexpressed her-2 survived a median of 13.8 months when they received Herceptin and chemotherapy, compared with 11.1 months for patients who received chemotherapy and a placebo, Dow Jones Newswires reports.

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A new class of experimental drugs may help women with types of breast cancer that are difficult to treat with existing therapies. The drugs, known as PARP inhibitors, prevent damaged tumor cells from repairing themselves. While the drugs are still in early stages of development, some have shown promise in human trials. Merck, Abbott, AstraZeneca and Sanofi-Aventis are all working on compounds in this class. Here’s a story on the drugs from this morning’s WSJ.

Hormone drugs and antidepressants may affect cancer patients, studies suggested. In one very large study of giving hormone pills to women to receive the symptoms of menopause, women who took a certain hormone combination and went on to develop lung cancer were more likely to die of the disease than women who took a placebo and went on to get lung cancer, the AP reports. Researchers urged caution in interpreting the finding, because there have only been 106 lung cancer deaths in the study so far, too few to make broad conclusions about risk.

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In a separate study, researchers found that women taking certain antidepressants along with the breast-cancer drug tamoxifen were more likely to see their tumors return than women who were taking tamoxifen alone. The drugs, which inhibit an enzyme called CYP2D6, include Paxil, Prozac and Zoloft. Laboratory studies have suggested the drugs might interfere with Tamoxifen, Dow Jones Newswires notes.

Source: The Wall Street Journal

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Roche reported that Herceptin (trastuzumab) decreased the risk of death in patients with HER2-positive advanced stomach cancer by 26 percent, compared to chemotherapy alone, according to findings from a Phase III study. The additional details, presented at ASCO, follow the company’s announcement earlier this year that the trial had met its primary endpoint of improving overall survival. ASCO’s president, Richard Schilsky, remarked that the data will change medical practice and “will force us to test patients for HER2, treat patients who are HER2-positive, and conduct research on gastric cancer that is HER2-positive.”

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The randomised ToGA study enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer, who received first-line treatment with either Herceptin plus chemotherapy, or chemotherapy alone. Data showed that patients in the Herceptin arm had a median overall survival time of 13.8 months, compared to 11.1 months for those in the chemotherapy-only group. Furthermore, Roche stated that patients with tumours exhibiting high levels of HER2 lived 16 months on average when Herceptin was added to treatment with chemotherapy.

Principal investigator Eric Van Cutsem commented that “this is the first Phase III study to report improved overall survival with a personalised, targeted treatment for gastric cancer” and “the first time a biological [drug] has improved survival in gastrointestinal cancer.” He also noted that Herceptin reduced the size of tumours and increased survival significantly beyond the one-year mark that has been a hurdle for patients with advanced gastrointestinal tumours.

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Corinne Wolter remarked that the drugmaker will file Herceptin, which is currently approved for the treatment of breast cancer, for regulatory approval in the stomach cancer indication in countries outside the US. Spokesperson Kristina Becker of Genentech said a decision to file for expanded approval with the FDA is under review. Nomura analyst Amit Roy estimated that approval of Herceptin in patients with HER2-positive stomach cancer could add $450 million to the product’s annual worldwide sales, which exceeded $4.7 billion last year.

Source: FirstWord

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Roche released full details from a Phase III study of Avastin (bevacizumab) showing that the drug failed to improve disease-free survival (DFS), compared with chemotherapy, in patients with early-stage colon cancer. The presentation of the data at ASCO follows Roche’s announcement in April that the trial did not meet its primary endpoint.

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The C-08 study involved 2710 patients with surgically-resected stage II or III adenocarcinoma of the colon who received either six months of treatment with chemotherapy alone, or six months of treatment with chemotherapy plus Avastin followed by six months of Avastin monotherapy. After a follow up of three years, findings demonstrated that 77.4 percent of patients in the Avastin arm were free of disease, compared with 75.5 percent of those in the control group. The result was not statistically significant, but lead investigator Norman Wolmark noted that Avastin reduced the risk of cancer recurrence or death by about 40 percent at the one-year mark.

Philippe Bishop, head of clinical development at Roche’s Genentech unit, explained that “as patients come off treatment, the events come back…The one-year duration of treatment was insufficient to derive clinical benefit.” Wolmark stated that “these results suggest longer durations of Avastin treatment should be considered for future studies in early-stage colon cancer to further reduce the risk of the cancer coming back,” and he added that researchers hope to begin a trial in the near future using Avastin for a two-year treatment period.

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A separate late-stage study of Avastin in the adjuvant setting in early-stage colon cancer is in progress, with results expected next year. Bishop indicated that the results from the C-08 study are influencing Roche’s and Genentech’s ongoing clinical trial programme for the drug, which includes use in early-stage breast cancer and non-small-cell lung cancer.

Source: FirstWord

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Results from a study presented at ASCO demonstrated that women who took certain antidepressant drugs while taking tamoxifen to treat their breast cancer had more than double the risk of cancer recurrence, compared with those who took tamoxifen alone. Researchers stated that this is “the first time that a comparative analysis has been done looking at various selective serotonin reuptake inhibitors [SSRIs] and what’s clear is that several of these drugs are extremely risky for women to take with tamoxifen, while others don’t present a problem.”

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The retrospective analysis examined the pharmacy and medical records for nearly 1300 women with breast cancer who were newly prescribed tamoxifen between 2003 and 2005 and who were followed up for an average of 2.7 years. The initial analysis involved one group of 353 women who were taking tamoxifen plus a moderate-to-potent CYP2D6 inhibitor, which included several types of SSRIs but was not limited to antidepressants, and a second group of 945 women who were taking tamoxifen and no CYP2D6 inhibitor.

Overall, results showed that the breast cancer recurrence rate for women using a CYP2D6 inhibitor plus tamoxifen was 13.9 percent, compared with a rate of 7.5 percent for those using only tamoxifen. Further analyses showed that the rate of recurrence for women whose treatment included use of moderate-to-potent CYP2D6 inhibitor SSRIs, such as Eli Lilly’s Prozac (fluoxetine), GlaxoSmithKline’s Paxil (paroxetine) and Pfizer’s Zoloft (sertraline), was 16 percent. In addition, data showed that those whose treatment included “weak” CYP2D6 inhibitor SSRIs, such as Forest’s Celexa (citalopram) and Lexapro (escitalopram) and Solvay’s Luvox (fluvoxamine), had a recurrence rate of 8.8 percent, which was considered to demonstrate no increase in risk for the disease.

Robert Epstein, one of the study’s authors, remarked that scientists were aware that CYP2D6 inhibitor drugs blocked the activation of tamoxifen chemically “but this is the first time there’s evidence that these drugs are putting women at a much higher risk for recurrent breast cancer.”

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A retrospective analysis of data from the Women’s Health Initiative study, which was presented at ASCO, showed that women with non-small-cell lung cancer who used hormone replacement therapy were more than twice as likely to die from their cancer as those who did not take HRT. Richard Schilsky, president of ASCO, stated that the findings are “another piece of evidence to suggest that hormone replacement therapy should be used with great caution.”

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Researchers examined data from more than 16 600 women who were divided approximately equally into groups who took HRT or placebo. After more than five years taking HRT, data showed 96 cases of NSCLC and 67 deaths from the disease. In comparison, there were 72 cases of NSCLC and 39 related deaths among women in the study who took placebo. Researchers noted that the difference in the number of cases was not significant, but that the difference in the number of deaths was.

Further analysis indicated that among smokers in the study, 3.4 percent of women treated with HRT died of lung cancer, compared with 2.3 percent of those who received placebo. For non-smokers, 0.2 percent of women in the HRT group died from the disease, compared with 0.1 percent of those in the placebo arm. In response to the data, lead author Rowan Chlebowski warned that “women almost certainly shouldn’t be using combined hormone therapy and tobacco at the same time.”

Commenting on the findings, Wyeth, which markets Prempro (oestrogen and progestin), stated that the same risks observed in the analysis might no longer apply, given the current manner in which the drug is prescribed. The company’s head of medical affairs Joseph Camardo remarked that women in the WHI trial used high doses of HRT over a long period of time and started treatment at an average age of 63 years. “Practice has already changed significantly. Guidance and the label have changed…use has shifted toward much shorter duration and lower doses,” he explained.

In addition, Len Lichtenfeld of the American Cancer Society noted that the number of deaths so far in the study is too small for researchers to be able to make broad conclusions about risk in the general population.

Source: FirstWord

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