( hree weeks or weekly for 12 weekscomp...)Updated Overall Survival Data From Pivotal Herceptin Adjuvant,Studies in HER2-Positive Breast Cancer,Health

These results showed that the addition of Herceptin to standard adjuvant therapy continued to significantly reduce the risk of breast cancer recurrence, the primary endpoint of the studies, by 52 percent (based on a hazard ratio of 0.48) in women with HER2-positive, node-positive breast cancer, compared to patients who received standard adjuvant therapy alone. At four years of follow-up, 85.9 percent of women treated with Herceptin plus chemotherapy were disease free, compared to 73.1 percent of women treated with chemotherapy alone. The demonstrated treatment benefit of Herceptin plus chemotherapy was consistent across many important patient subgroups.

Notably, despite some patients crossing over to the Herceptin-containing arm, the additional follow-up data presented today showed an improvement in overall survival; 92.6 percent of women treated with Herceptin plus chemotherapy were still alive at four years of follow-up, compared with 89.4 percent of women treated with chemotherapy alone. This updated survival analysis showed a statistically significant 35 percent reduction in the risk of death (based on a hazard ratio of 0.65, p-value = 0.0007), which is equivalent to a 54 percent improvement in overall survival.

Each study had an independent external Data Monitoring Committee (DMC) that reviewed data from the studies, including cardiac safety data, on a regular basis. According to the investigators, serious or life-threatening (and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the heart muscle), occurred approximately 3 to 4 percent more often in the Herceptin plus chemotherapy arms than in the chemotherapy alone arms. Other adverse events reported in both studies included dyspnea and interstitial pneu
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