Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Combo therapy after disease progression no advantage in chemotherapy-naïve metastatic castration-resistant prostate cancer

Attard G et al. Journal of Clinical Oncology; published online 20 July 2018. http://ascopubs.org/doi/abs/10.1200/JCO.2018.77.9827

Key clinical point: When prostate-specific antigen levels rise in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer, combining enzalutamide with abiraterone acetate and prednisone in not indicated as it results in more adverse events without therapeutic advantage.

Major finding: Of 509 patients enrolled in period one, 251 were randomly assigned in period two. Median progression-free survival was 5.7 months in the combination group and 5.6 months in the control group (hazard ratio, 0.83; 95% CI, 0.61 to 1.12; P = .22). There was no difference in the secondary end points. Adverse events were more prevalent in the combination group than the control group: Grade 3 hypertension (10% vs. 2%) and increased ALT (6% vs. 2%) or AST (2% v 0%), respectively.

Study details: PLATO (NCT01995513) used a randomized, double-blind, placebo-controlled design. In period one, men with chemotherapy-naïve metastatic castration-resistant prostate cancer received open-label enzalutamide 160 mg daily. Men with no prostate-specific antigen (PSA) increase at weeks 13 and 21 were treated until PSA progression (≥ 25% increase and ≥ 2 ng/mL above nadir), then randomly assigned at a one-to-one ratio in period two to abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily with either enzalutamide or placebo (combination or control group, respectively) until disease progression as defined by the primary end point: progression-free survival (radiographic or unequivocal clinical progression or death during study). Secondary end points included time to PSA progression and PSA response in period two.

Disclosures: The study was supported by Medivation, a Pfizer company, and Astellas Pharma, which also funded medical writing and editorial support. Dr. Attard is a consultant to Astellas and Medivation, as well as various other drug companies.

Source: Attard G et al. Journal of Clinical Oncology; published online 20 July 2018. http://ascopubs.org/doi/abs/10.1200/JCO.2018.77.9827

Citation:

Attard G et al. Journal of Clinical Oncology; published online 20 July 2018. http://ascopubs.org/doi/abs/10.1200/JCO.2018.77.9827

This Week's Must Reads

Inadequate emergency care a challenge for rural pediatric patients, Walling EB et al. J Oncol Pract. 2019 Jan 31. doi: 10.1200/JOP.18.00115.

QC measures improve with CMS Oncology Care Model, Rocque G et al. J Oncol Pract. 2019. doi: 10. 1200/JOP.18.00390.

Women less likely to receive industry funds, Weng JK et al. JAMA Netw Open. 2019 Jan. 25. doi: 10.1001/jamanetworkopen.2018.7377.

A shift in Medicare drug coverage may boost costs for patients, Hwang TJ et al. JAMA Int Med. 2019. doi: 10.1001/jamainternmed.2018.6417.

President Trump requests $500 million for pediatric cancer, Trump D. State of the Union Address, Feb. 5, 2019.

Must Reads in Genitourinary Cancer

Obesity-related cancers such as kidney cancer rising among young adults, Sung H et al. Lancet Public Health. 2019 Feb 4.

Leptin expression may aid in differentiation of renal lesions, Gobe G et al. Pathology. 2018 Aug;50(5):504-10

Hypofractionated radiation offers 'tailored treatment' approach to RCC mets, Felice F et al. Crit Rev Oncol Hematol. 2018 Aug 1. doi: 10.1016/j.critrevonc.2018.06.002.

Concern over SREs rises with increasing incidence of metastatic RCC, Umer M et al. Ann Med Surg. 2018 Jan 21. doi: 10.1016/j.amsu.2018.01.002