Introducing Clinical Trial Updates

Abstract

I didn't have time to write a short letter, so I wrote a long one instead.-Mark TwainInitially reported in Journal of Clinical Oncology in 2019, 1 the ARCHES trial compared the addition of enzalutamide or placebo with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Enzalutamide significantly prolonged radiographic progression-free survival and prostate-specific antigen progression; overall survival (OS) data were immature. That report immediately changed clinical practice, but key questions remained. Many worried about long-term tolerability and were reluctant to use enzalutamide earlier in the course of disease without an improvement in OS, especially in older men. Specially, they argued that OS might be maintained with enzalutamide used at the time of progression on ADT, limiting toxicity and cost during initial therapy. In the article that accompanies this editorial, Armstrong et al 2 address those questions. Now with an additional 30-month follow-up, the addition of enzalutamide reduced the risk of death by 34% compared with ADT alone (hazard ratio 5 0.66; P , .001), despite cross over in nearly one third of patients. These updated results firmly place enzalutamide plus ADT as a preferred first-line treatment approach for mHSPC. ASSOCIATED CONTENT See accompanying article doi:10.1200/ JCO.22.00193 Author affiliations and support information (if applicable) appear at the end of this article.

Timing and Reporting of Secondary Overall Survival End Points for Phase III Trials in Advanced/Metastatic Disease

“…In our review of trials in advanced/metastatic setting that reported OS as a secondary end point, we found substantial variation in methodology for OS reporting and many trials lacked or deviated from the prespecified plan for OS reporting. Although there may be some reluctance from journals to publish secondary analyses, we note the recently introduced Clinical Trial Updates section of this Journal 33 should help with this situation. Publication of mature OS results is especially important for trials that were initially reported as positive in the primary publication.…”

A New Look as JCO Looks to the Future

“…The publishing redesign joins other recent enhancements, including the introduction of the Clinical Trial Updates 1 and living guidelines 2 article types, visual abstracts, revamped podcasts, and a greater social media presence, all of which were informed by our strategic plan. 3 In keeping with the expanding breadth of research in oncology, we have highlighted our vision to expand the scope of published content to include economic analyses, 4 cutting-edge epidemiological studies, and studies using artificial intelligence techniques.…”