Cancer Network spoke with Debu Tripathy, MD, Chair of Breast Medical Oncology at MD Anderson Cancer Center, on how ribociclib plus hormone therapy extends survival for patients with premenopausal advanced HR-positive breast cancer.
Debu Tripathy, MD
The opening chapters in the investigation of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitors as cancer therapeutics have been interpreted by some as a quantum leap forward in targeted and personalized medicine and by others as another example of disappointment following a flurry of promising preclinical and early clinical trials based on elegant biology.
In early 2008, based on the results of its E2100 trial, which showed significant improvements in progression-free survival when combined with paclitaxel, Avastin (bevacizumab) gained an FDA accelerated approval. Median progression-free survival in the Avastin arm was 11.3 months compared with 5.8 months for paclitaxel alone (although overall survival in the two arms was similar). However, final approval would be dependent on subsequent trials showing similar degrees of benefit. When two additional trials were submitted for review, both showed significant improvements in progression-free survival, but again with no difference in overall survival. Subsequently, on July 20th of this year, the Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 not to recommend permanent approval of Avastin as first-line therapy in advanced breast cancer.
Ron Piana, Executive Editor for Special Projects with the journal ONCOLOGY, spoke with nationally regarded breast cancer specialist, Dr. Debu Tripathy, co-course director for the 27th Annual Miami Breast Cancer Conference.