Biological agents, including monoclonal antibodies, improve outcomes for a number of cancers; however, access to these treatments is limited in many countries. Development of biosimilars—products highly similar to but not structurally duplicative of a reference product—could improve global availability of these drugs. In a randomized clinical trial involving 458 patients with ERBB2-positive metastatic breast cancer, Rugo and colleagues found that compared with trastuzumab—an anti-ERBB2 monoclonal antibody—treatment with a proposed trastuzumab biosimilar resulted in an equivalent overall response rate at 24 weeks. Two Editorials discuss biosimilars in cancer treatment and financial obligations to ensure patient access to these therapies.
Editorials 1 and 2
The optimal dosing interval for zoledronic acid, a bisphosphonate drug that reduces the incidence of skeletal-related events in patients with bone metastases, is uncertain. In a randomized, open-label clinical trial involving 1822 patients with bone metastases due to breast cancer, prostate cancer, or multiple myeloma, Himelstein and colleagues found that use of zoledronic acid every 12 weeks, compared with the standard dosing interval of every 4 weeks, did not result in an increased risk of skeletal events over 2 years.
The US Zika Pregnancy Registry collects data on Zika virus infection during pregnancy and fetal and infant outcomes. In an analysis of registry data from 442 pregnancies completed in the continental United States or Hawaii from December 2015 through September 22, 2016, Honein and colleagues found that 26 fetuses or infants (6%) had evidence of Zika-associated birth defects, primarily brain abnormalities and microcephaly. Among women with first-trimester Zika infection, 11% had a fetus or infant with a birth defect. In an Editorial, Muller and Miller discuss implications of the study findings for patient care and public health.
In an analysis of national county-level (n = 2865) data from mainland China’s 31 provinces, Li and colleagues assessed temporal and geographic trends in cesarean delivery rates from 2008 through 2014. The authors report that China’s annual rate of cesarean deliveries increased from 28.8% in 2008 to 34.9% in 2014. Major geographic variation in cesarean delivery rates and trends over time were documented, including declining cesarean rates in some large urban areas.
An article in JAMA Surgery reported that among patients aged 70 years or older who underwent major elective surgical procedures, major postoperative complications and delirium were separately associated with adverse events and demonstrated a combined effect. In this From The JAMA Network article, Zenilman discusses the importance of recognizing and aggressively treating delirium in the postoperative period.
This JAMA Clinical Guidelines Synopsis article by Culbertson and Davis summarizes a clinical practice guideline from the American College of Physicians: Nonsurgical Management of Urinary Incontinence in Women. Guideline recommendations endorse pelvic floor muscle training as first-line therapy for stress urinary incontinence, pelvic floor muscle training and bladder training for mixed urinary incontinence, and use of pharmacologic therapy when bladder training is unsuccessful in treating urgency urinary incontinence.
A 41-year-old man who had immigrated to the United States from Costa Rica a decade ago presented with a 2-year history of tingling and pain in his hands and feet. Findings on skin examination included near-complete loss of eyebrows and eyelashes, a scaly plaque on the shin, and erythema of the earlobes, distal fingers, and toes. What would you do next?
Highlights. JAMA. 2017;317(1):3-5. doi:10.1001/jama.2016.12932