TAILORx
New data released from the Trial Assigning Individualised Options for Treatment (TAILORx) study at the American Society of Clinical Oncology (ASCO) has found that 70% of women with early ER- positive, HER2-negative, node-negative Breast Cancer derive no additional benefit from chemotherapy (CT) over endocrine treatment (ET).
This multicentre study assessed the expression of 21 genes used to predict breast cancer recurrence (Oncotype DX) and placed patients (n=10,273) into low-risk (score 0-10), intermediate risk (score 11-25) and high risk (score 25-100) groups. Those patients in the intermediate group were randomised to CT +HT or HT alone.
At 5 and 9 years the disease free survival (DFS) for the intermediate group was 93.1% vs 92.8% and 84.3% vs 83.3% for CT+HT vs HT alone and overall survival rates were 98.1% vs 98.0% and 93.9% vs 93.8% respectively. None of these differences were statistically significantly different.
According to the authors these findings suggest that CT can be avoided in approximately 70% of women with 'all ER positive breast cancers' , HER2-negative, node-negative breast cancers:
- Those older than 50 with a recurrence scores of 11-25 (45%)
- Those of any age with a recurrence score of 0-10 (16%)
- Those 50 years or younger with a recurrence score 11-15 (8%)
And may be considered for:
- Those at any age with a recurrence score of 26-100 (17%)
- Those 50 years or younger with a recurrence score of 16-25 (14%)
The authors states that “Any woman with breast cancer <75 should have the 21- gene expression test and discuss the results with her doctor to guide the decision to the right therapy”.
PERSEPHONE
New data released from the PERSEPHONE study at the American Society of Clinical Oncology (ASCO) has shown that shortening adjuvant Herceptin (Trastuzsumab) treatment from 12 months to 6 months is effective whilst reducing cardiac toxicity.
This large multicentre UK study stratified patients (n=4,088) according to ER- status, chemotherapy (CT) type and chemotherapy and Herceptin timing and randomised them into having Herceptin for 6 vs 12 months. All patients also received CT (either anthracycline, taxane or a combination).
The primary end point was disease free survival (DFS) defining non-inferiority of the 6 month arm as ”no worse than 3% below the 12 month arm’s assumed 80% 4 year DFS”
At 4.9 years there were 319 deaths (8%) and 500 DFS events (12%). The 4 year DFS was 89% in both arms with a hazard ratio of 1.05 demonstrating non-inferiority of 6 months treatment over 12 months. Importantly, cardiac events were reduced in patients on the 6-month arm (4% vs 8% patients stopping treatment due to cardiotoxicity which was highly significant (p<0.0001).
Although the authors concluded that their results would support a reduction of standard Herceptin treatment from 12 months to 6 months, they noted that further analysis is warranted before oncologists change practice.