Oncology Vol 29 No 11

This commentary addresses our perspectives from a regulatory standpoint, as well as some controversies related to the use of neoadjuvant therapy as a platform for drug development.

We acknowledge that the “more is better” approach may not always hold true. For example, preclinical data provided a rationale for combining pertuzumab with T-DM1, but recent reports suggest that this strategy may not prove more effective than single-agent T-DM1 therapy in the clinic.

The preferred status of CLEOPATRA-like regimens in the first-line HER2-positive metastatic breast cancer setting has recently been challenged by antibody-drug conjugate regimens based on ado-trastuzumab emtansine (T-DM1).

This evolving issue is increasingly concerning, as studies regarding the causes of non-relapse late mortality in childhood cancer survivors consistently include cardiovascular disease as one of the major contributors to this mortality risk.

The ultimate benefit to patients will come from a demonstration of clinically worthwhile benefits of new drugs that have been tested in well-designed and adequately powered clinical trials performed in an expedited fashion.

The biologic rationale for the initial evaluation of preoperative chemotherapy or neoadjuvant chemotherapy in patients with early-stage breast cancer was based on experimental and clinical observations regarding primary tumor cell growth and dissemination.

In this interview we discuss sexual health during cancer treatment and some of the disappointments of precision medicine.