Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

Herceptin is basically a cure so after it was approved it’s not possible to get a greater statistically significant result vs cure.

This is not a proper way of thinking of herceptin or future AE37 results. The statement is basically saying it would be impossible to have better results than the "cure" herceptin. I think women who have received herceptin after major surgery and with multiple cycles of adjuvant chemotherapy would be surprised to hear that herceptin is a cure. Why did I cut my breast off and vomit through 52 weeks of paclitaxel if herceptin was the cure?


Far from it. From UpToDate (behind paywall):

Improvement in overall survival (OS; HR for mortality 0.66, 95% CI 0.57-0.77).

•Trastuzumab administered for 12 months in the adjuvant setting was associated with an improvement in OS (HR 0.67, 95% CI 0.57-0.80). While trastuzumab treatment for ≤6 months also showed a trend towards an improvement in OS, it did not reach statistical significance (HR 0.55, 95% CI 0.27-1.11).

•The benefit in OS was associated with concurrent administration of trastuzumab with chemotherapy (HR 0.64, 95% CI 0.53-0.76), but not with sequential treatment of chemotherapy followed by single-agent trastuzumab (HR 0.85, 95% CI 0.43-1.67).

Subsequent data show that the addition of trastuzumab to adjuvant chemotherapy results in durable survival benefits for patients with HER2-positive breast cancer. This was shown in the combined analysis of the North Central Cancer Treatment Group N9831 trial and the National Adjuvant Breast and Bowel Project B-31 clinical trials [12,13]. With a median on-study time of 8.4 years, the addition of trastuzumab resulted in a 37 percent improvement in OS (HR 0.63, 95% CI 0.54-0.73) and a 40 percent improvement in DFS (HR 0.60, 95% CI 0.53-0.68).