To Anonymous

[christine]

You certainly can, I lost my Mom to metastatic bc 8 months before I was diagnosed.

She was also my best friend and I know what the loss meant to you.

Hugs
Christine

[Paul]

Dear Annonymous,

I have attached a revised cross-link to the M.D. Anderson study. If you have questions regarding the composition of the M.D. Anderson study group, you may want to have your doctor contact Dr. Buzdar at M.D. Anderson. Your point is a good one (if I'm reading it correctly) in that the study involved early bc patients.

The majority of patients reported had no node involvement. Several patients had node involvement but the numbers were few with most involving 1 to 3 nodes. I have provided you with a copy of ASCO Abstract 520. If you review the abstract at the ASCO website, you'll find a nice chart that summarizes the composition of the study participants. The "buzz" associated with this small M.D. Anderson neoadjuvant herceptin+chemo study is the 67% complete response rate -- that is, no detectable prescence of a tumor in 67% of the 42 patient study population.


Significantly higher pathological complete remission (PCR) rate following neoadjuvant therapy with trastuzumab (H), paclitaxel (P), and anthracycline-containing chemotherapy (CT): Initial results of a randomized trial in operable breast cancer (BC) with HER/2 positive disease.

Abstract No: 520

Author(s): A. U. Buzdar, K. Hunt, T. Smith, D. Francis, M. Ewer, D. Booser, E. Singletary, T. Buchholz, A. Sahin, G. N. Hortobagyi; M. D. Anderson Cancer Center, Houston, TX

Abstract: Background: In patients (pts) with metastatic BC, trastuzumab [Herceptin (H)] in combination with CT results in higher response rates, longer control of disease, and superior survival. The objective of this study was to determine whether the addition of H to CT in the neoadjuvant setting could increase PCR rate in pts with HER/2 positive disease. Methods: 42 pts with HER/2-positive disease (IHC 3+ or FISH +) with operable BC were randomized to 4 cycles of P followed by 4 cycles of FEC, or the same CT with simultaneous weekly H at 2 mg/kg for 24 weeks.The primary objective was to demonstrate a 20% improvement in PCR (assumed 21% to 41%) with addition of H to CT. At the end of CT+H, pts had definitive surgery. The planned sample size was 164 pts. Results: Prognostic factors were similar in the two groups. After 34 pts had completed therapy, the trial's Data Monitoring Committee stopped the trial for superiority of CT + H. PCR rates were 25% and 67%, respectively, for CT alone (n=16) and CT + H (n=18) (P=0.02). Additional results are included in the table. Fever during neutropenia occurred in 9 and 11 pts, respectively, in CT alone and CT + H. Of those, 3 pts in each subgroup were hospitalized. Decrease in cardiac ejection fraction (>10%) was observed in 6 and 4 pts, respectively, in CT and CT + H. No pts had clinical CHF or other clinically relevant cardiac toxicity. Troponin-T levels remained normal in all pts. The trial was stopped by an independent DMC based on a Bayesian predictive probability of 0.95 that the trial would conclude a significant benefit for CT+H if completed to originally planned 164 pts. Conclusions: Despite the small sample size, these data indicate that adding H to CT as utilized in this trial significantly increased PCR without clinical CHF.

[Go to ASCO Website, Abstract 520 to see study population summary chart].

I hope this helps or provides you with further context.

Paul