Who Says Vitamin B6 May Protect Against Breast Cancer? Kasperzyk et al. Am J Clin Nutr, 90, pp. 561-9, 2009 and Key et al. Cancer Epidemiol Biomarkers Prev, 18, pp. 1538-43 1997. In our own laboratory and clinical practice we confirmed that several patients with various cancers had low levels of vitamin B6. This is not an uncommon issue. Too much B6 may be toxic however "Just Enough and Not Too Much" as delivered by BD Maintenance Plus++ was able to correct patients blood levels of B6. Both abnormally low and abnormally high doses of B and D vitamins adversely affect the expression of genes some of which are tumor promoting. That is why we developed BD Maintenance Plus++.

Purpose: The ABC adjuvant trials (5/2007-11/2013) were developed to determine if a regimen of TC (Taxotere (docetaxil) or Taxol (paclitaxel) plus Cytoxan (cyclophosphamide) for 6 cycles is non-inferior to combination regimens of Adriamycin = (doxorubicin, an anthracycline) plus cyclophosphamide with docetaxel or paclitaxel (TaxAC see various TaxAC regimens below)) in women with resected high-risk, HER2-negative breast cancer.

1870 patients (pts) from B-49 were combined with 1077 from the TaxAC and TC groups of B-46-I/USOR 07132, and 1295 from USOR 06-090, for a total of 4242.

The primary endpoint was invasive disease-free survival (iDFS), defined as time to local, regional or distant tumor recurrence, invasive contralateral (other breast) cancer, second primary cancer, or death. Pts were stratified for: parent trial, number of tumor-containing lymph nodes (pos nodes (0, 1-3, 4-9, 10+)), and hormonal status (neg, pos). A hazard ratio (HR) of 1.18 or more was pre-defined as inferior. HRs above 1 favor usual TaxAC protocol (see below). If HR was >1.18 then the Adriamycin (anthracycline)-containing treatment regimen was judged superior.

Summary: There were 2078 pts randomized to TC and 2052 to TaxAC (total 4130). These pts were followed for a median of 3.2 yrs. Pt and tumor characteristics were balanced by treatment: 69% hormone pos, 41% node neg, 51% with high grade tumors. With 334 iDFS (invasive Disease-free Survival) events, observed HR (hazard ratio) for TC (either Taxol or Taxotere + Cytoxan) v TaxAC (see below for various Adriamycin combinations allowed) is 1.202 (95% CI 0.97-1.49), which exceeds 1.18, thus the inferiority of the TC regimen as compared to the TaxAC regimens. With 397 iDFS (invasive disease-free survival) events, 3 yr iDFS is 91.7% for TC v 92.4% for TaxAC. Doesn't seem like much difference however note the following breakdown for effectiveness as illustrated in what is labeled the Forest Plot of IDFS By Stratification Variables and the Forest Plot of IDFS by Hormonal and Nodal Status. Note the red circle revealing that in spite of Hormone Receptor Negative Disease (which is relatively resistant to chemotherapy), the addition of Adriamycin was effective in high-risk, node positive patients containing 4 or more tumor-positive lymph nodes.

WHAT THIS MEANS: If your doctor says you have a high-risk breast cancer (high risk for recurrence) such could justify the use of an Adriamycin-containing adjuvant chemotherapy. This means you will temporarily lose your hair and your heart function may be compromised thus mandating close follow-up with either cardiac ECHO or MUGA scans at start of therapy and monthly while on therapy to monitor cardiac output (heart function).

Glenn Tisman, M.D.