To the Editor:

Agrawal et al¹ recently reviewed the patient decision-making process for participation in phase I oncology trials. Their study showed that cancer patients enroll onto these trials even if there may be serious adverse effects, “including a 10% chance of dying.” The courage of patients with cancer was illustrated by this report. Another important issue, seen in their demographic data, was not adequately addressed in the article: health care disparity in cancer clinical trials.

The study by Agrawal et al reviewed 163 phase I participants from five major cancer centers in the United States. The vast majority of the participants were white (88%), had health insurance (96%), and many were financially secure (40% had household incomes > $75,000; 26% > $100,000). Only 3% were African American and 4% were uninsured. These numbers do not reflect the population at large, and are in stark contrast with what is seen in urban areas (the five cancer centers from the study were located in Philadelphia, PA, Chicago, IL, Houston, TX, San Antonio, TX, and Bethesda, MD). According to the 2000 US Census, 12.3% of the US population is African American (higher in urban areas). At our cancer center in Cleveland, OH, 35% of our patients are African American and 17% are uninsured. Of the US population younger than 65 years (which is a similar group to that studied by Agrawal, as the mean age in their study was 57.7, with an interquartile of range 48 to 68), recent data shows that 18% are uninsured.²

The economic status of the patients in the article by Agrawal et al is also at odds with the poverty levels seen in urban areas. The authors noted that only 11% of patients had a household income lower than $25,000 (with presumably even fewer who were below the poverty level, defined by the US Census Bureau as an income of < $18,660/year for a family of four). Based on 2005 data³ in the city of Cleveland, 32.4% of residents were living below the poverty level.

The level of education for the patients in the study by Agrawal et al is also not commensurate with what is seen in many urban areas. In their study, 51% of patients had a college degree or higher. This contrasts with only 14.3% of all persons older than 25 years in the Cleveland area having a college degree,³ with similar numbers from other urban areas, such as Miami, FL, and Detroit, MI.

Although the overabundance of affluent, well-educated patients is noted by Agrawal et al (“consistent with prior studies of patients enrolled in phase I oncology trials, the patients had moderate to high socioeconomic status” and “…the vast majority of these individuals are white, well educated, with higher incomes, and have the flexibility associated with having health insurance”), the under-representation of less educated, indigent minorities is not. There is also no comment made about this as a problem or any potential solutions.

The sociodemographic characteristics of the patients in the authors' study are, as is stated in the article, similar to the characteristics of participants from other phase I trials, but they clearly do not reflect those of the community, certainly not in urban areas. This raises the question of the validity of conclusions drawn from phase I trials to be used for the population at large. It is particularly unfortunate that more African Americans are not entered onto phase I trials because it has recently been noted that “African American males develop cancer 25% more frequently than whites and have a 43% higher mortality rate compared with white men for all cancers combined.”⁴ It is hoped that cutting-edge, state-of-the-art phase I trials could be available to all patients with cancer, regardless of their insurance status, ethnicity, education level, or socioeconomic status. Indigent minorities should be able to enroll onto the same trials as wealthy, insured white patients. Unfortunately, as the data by Agrawal et al illustrate, this is not the case. There are likely many factors which have led to this inequity, including access problems, cultural barriers, educational needs, and social injustice. One proposed solution for this under-representation has been the use of a patient navigator⁵ but clearly more efforts to solve this problem are needed.

The findings made by Agrawal et al are important but the striking sociodemographic findings should have led to a discussion of health care disparity in phase I oncology trials.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author(s) indicated no potential conflicts of interest.