Two manuscripts highlight topics focused on breast cancer in The American Journal of Hematology/Oncology® this month. In the Nixon and Verma manuscript, “The Window Is Wide Open: Evaluating the Rationale for Window of Opportunity Studies in Breast Cancer With a Focus on Immune Therapies,” the researchers propose greater use of window of opportunity (WOO) studies. These particular studies present an exciting opportunity to learn about mechanisms of action of novel therapies, molecular activity, and efficacy. They also provide an opportunity for biomarker evaluation to appropriately enrich the study population for later-stage clinical trials.

WOO study designs focus on treatment-naïve patients who are exposed to 1 or more doses of a new therapy in order to observe changes in tumor biology. It is distinct from a neoadjuvant treatment trial in which the primary aim is to improve disease outcomes and evaluate surrogate endpoints such as pathologic response. In a WOO trial, the investigational agent or intervention is given prior to the definitive treatment strategy, whether it be local or systemic. The authors caution, however, that careful multidisciplinary considerations must be made in designing these studies.

In “Constructing a Clinicopathologic Prognostic Model for Triple-Negative Breast Cancer (TNBC),” Thomas et al performed a retrospective analysis using patients in the University of Texas Southwest TNBC registry. The authors note that clinicopathologic variables deserve more investigation specifically within the triple-negative histology—lymphovascular invasion and the use of preoperative magnetic resonance imaging (MRI).

Their findings suggest that lymphovascular invasion significantly predicted for overall survival (OS), disease-free survival (DFS), and locoregional control. Preoperative MRI predicted for improved DFS among all groups. They note that African American women had a significantly longer time delay from diagnosis to treatment and a significantly lower OS compared with Caucasian women.

In “The Biology and Therapeutic Approach to BRAF-Mutant Cutaneous Melanoma,” Wood and Luke discuss the molecular biology of BRAF-mutant melanoma and summarize key clinical trials involving combined BRAF/MEK inhibition, which have demonstrated improved OS compared with standard chemotherapy.

The case report submitted by Wang et al focuses on a case of synchronous renal cell carcinoma and penile squamous cell carcinoma with metastasis to the inguinal region. Such synchronous malignancies should be considered on an individual case basis and therapy should be directed more toward malignancy that has more prognostic significance, they write. An integrated multidisciplinary management should be employed to determine the best source of treatment for patients.

In the CME article, “CDK4/6 Inhibitors in Breast Cancer,” Richard Finn, MD, associate professor of medicine at the Geffen School of Medicine at UCLA offers his insights on the mechanistic rationale that supports these agents’ use in breast cancer and their efficacy and safety from some of the landmark clinical trials.

Michael J. Hennessy, Sr
Chairman and Chief Executive Officer