FinXX trial Authors: Sunil Verma Date posted: December 22 nd, 2008

R Treatment A: Docetaxel (80mg/m2) x 3 cycles Followed by Cyclo(600) Epi(75) F(600) x 3 cycles Treatment B: Docetaxel (60mg/m2) and X (900mg/m2) x 3 cycles Followed by Cyclo (600) Epi (75) X (900) x 3 cycles High risk of BC Recurrence Node +ve or Node –ve with Tumor size of > 2cm and PR -ve

RESULTS Median f/up 36 months Treatment A Treatment B p-value 3-year RFS (%) HR=0.66 p= year OS (%) ,6 HR = 0.66 P = 0.089

STUDY COMMENTARY The control arm of Docetaxel to FEC used doses that are lower than our standard chemo usage for early stage breast cancer The authors hypothesized that Docetaxel at 80mg/m2 is still an effective dose with similar benefit to Docetaxel at 100mg/m2 While the study inclusion criteria allowed node negative patients, 90% of patients on the trial had node positive disease Toxicity There were more neutropenia, Febrile neutropenia (8.8% vs. 4.4%), amenorrhea, and myalgias in patients receiving D-CEF There was increased incidence of Hand Foot Syndrome (11.1 vs. 0.3%), diarrhea (6.2% vs. 3.4%), nail changes, and stomatitis in those receiving DX-CEX

BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS The addition of capecitabine to anthracyclines and taxanes leads to a statistically significant improvement in breast cancer recurrence This is an interim analysis with a limited follow up of 36months, the final analysis will be in 2010 Though the results are exciting, it is still too early to adopt this as a treatment strategy for our patients we need to better define who are the patients who will derive benefit from such a treatment strategy the move over the last few years has been towards less chemo and more personalized care and we need longer follow up and better understanding of which population of breast cancer patients derives the most benefit from such a treatment strategy