Prostate Cancer

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for patients receiving moderately emetogenic chemotherapy. Additionally, the FDA granted breakthrough therapy designations to 2 therapies, as well as an orphan drug designation, a priority review, and 2 fast track designations.

In an interview with Targeted Oncology, Raoul S. Concepcion, MD, discussed the existing challenges with implementing genetic testing and genetic counseling in community practices and how they can potentially be addressed.

The FDA has approved a supplemental New Drug Application for a single dose of aprepitant injectable emulsion for intravenous use in patients receiving moderately emetogenic chemotherapy. The approval expands the dose for aprepitant to include a 130 mg single-dose regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.<br /> &nbsp;

James Mohler, MD, discusses the rationale for the latest updates to the National Comprehensive Cancer Network guidelines for genetic testing in prostate cancer.

In an interview with Targeted Oncology, Maha Hussain, MD, discussed targeting DNA repair defects in metastatic castration-resistant prostate cancer with the PARP inhibitor olaparib in the phase III PROfound trial.

The introduction of<strong> </strong>CDK4/6 inhibitors for the treatment of hormone receptor&ndash;positive, HER2-negative breast cancer has transformed therapy management and extended survival for this patient population. The next step in the process of tailoring therapy towards individual patients is the introduction of targeted therapies for patient subsets with driver aberrations.

The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

The FDA has granted a breakthrough therapy designation to niraparib for the treatment of patients with <em>BRCA1/2</em>-mutated metastatic castration-resistant prostate cancer who have previously received taxane chemotherapy and androgen receptor&ndash;targeted therapy.

Using a measure known as the growth modulation index, patients with TRK fusion&ndash;positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

In September 2019, the FDA approved new treatment options for patients with endometrial carcinoma, prostate cancer, and multiple myeloma. The FDA also expanded the indication for the Cologuard noninvasive screening test for colorectal cancer. During the month there were 2 breakthrough therapy designations, 2 fast track designations, 1 orphan drug designation, and 1 priority review granted.

In the phase III PROfound trial, olaparib improved radiographic progression-free survival compared to either abiraterone acetate or enzalutamide in men with heavily pretreated metastatic castration-resistant prostate cancer, who had homologous recombination repair gene alterations, according to findings presented at the 2019 ESMO Congress.&nbsp;

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase&nbsp;inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

In the phase III SPARTAN trial, the combination of androgen receptor apalutamide and androgen deprivation therapy led to an overall survival OS benefit&nbsp;compared with placebo/androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer, based on the updated findings presented at the 2019 ESMO Congress.

Christopher Sweeney, MBBS, professor of medicine, Harvard Medical School, and physician, Dana-Farber Cancer Institute, discusses the treatment-related adverse events associated with adding enzalutamide or non-steroidal anti-androgens to testosterone suppression treatment and docetaxel in patients with metastatic hormone-sensitive prostate cancer, as seen in the ENZAMET trial.<br /> &nbsp;

Prostate Cancer

Advances in molecular profiling have driven development and use of personalized medicine approaches in oncology, enabling detection of biomarkers for predicting prognosis and treatment response and determining inheritable cancer risk.

The FDA has approved a supplemental New Drug Application for apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

Cabazitaxel in combination with carboplatin demonstrated an improvement in progression-free survival in comparison with cabazitaxel alone in men with metastatic castration-resistant prostate cancer. Adverse events were more common with the combination regimen, but the doublet was generally well tolerated.

Kim N. Chi, MD, discusses the safety findings for the next-generation androgen receptor inhibitor apalutamide in combination with androgen deprivation therapy in patients with metastatic castration-sensitive prostate cancer, according to findings from the phase III TITAN study. This combination was compared with placebo and ADT and presented at the 2019 ASCO Annual Meeting.

Cristina Magi-Galluzzi, MD, PhD, discussed the role of pathologists in the diagnosis and treatment decision for patients with prostate, bladder, and renal cancers.&nbsp;

In an interview with&nbsp;Targeted Oncology, John Bartlett, MD, explained the standardized cancer testing project, its relevance, and how it could be used to improve the treatment of patients with pancreatic, prostate, breast cancer.&nbsp;

Men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer who had baseline prostate-specific antigen levels &le;5.27 ng/mL demonstrated a median overall survival approaching 4 years with sipuleucel-T treatment, according to findings from the large real-world PROCEED trial.

The FDA has granted a priority review to a supplemental New Drug Application for a new indication for enzalutamide as a treatment for men with metastatic hormone-sensitive prostate cancer.

In an interview with <em>Targeted Oncology</em>, Agarwal, professor of medicine at the Huntsman Cancer Institute, University of Utah, gave an overview of the TALAPRO-2 trial and discussed its potential for changing the standard of care for patients with mCRPC.