Hypofractionated Radiotherapy for Locally Advanced Non–Small Cell Lung Cancer—Does Size Matter?

Abstract

In Reply We appreciate the comments from Chen et al on our Research Letter evaluating the inclusion of women in global oncology drug trials over the past 20 years. 1 Our central conclusion was that women were underrepresented in certain tumor types.Chen et al argue that we ought to have adjusted our analysis 1 for the participation to prevalence ratio. We agree that adjustment is needed for the number of people eligible to participate, but prevalence does not capture that. The incidence of a specific tumor indication (eg, second-line metastatic breast cancer or newly diagnosed multiple myeloma) is a better indicator of individuals eligible for frontline therapy and has been used in similar studies. 2,3 Accordingly, we reanalyzed our data 1 using a statistical test to evaluate the difference between female incidence and enrollment. We found that the proportion of women enrolled in colon and thyroid cancer trials were significantly underrepresented. These findings support our conclusion that female enrollment is not proportional to expected rates in colon and thyroid cancer.Finally, Chen et al cite a study that purportedly claimed that women are adequately represented across premarketing and postmarketing studies. 4 However, the study aggregated trials across multiple indications, including female-predominant cancers (breast, cervical, and ovarian). Including multiple trials of female-predominant indications will lead to an overrepresentation of women in the aggregate estimate cited by Chen et al. Looking by disease, the results support those we identified in our study, 1 including the similarity to thyroid cancer, which demonstrated one of the largest disparities in premarketing and postmarketing trials (participation to prevalence ratio, 0.64; 95% CI, 0.60-0.68; and 0.44; 95% CI, 0.72-0.77, respectively).