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In Reply

University of Michigan, Department of Medicine, Ann Arbor, MI

Eva Culakova

University of Rochester, Department of Medicine, Rochester, NY

Melony E.S. Sorbero

RAND Corporation, Pittsburgh, PA

Gary H. Lyman

University of Rochester, Department of Medicine, Rochester, NY

We appreciate the letter from Dr Felman, who makes two important points. The first point is that patients who are treated outside of clinical trials have a higher likelihood of serious adverse events than the rates reported in clinical trials. The second point is that women of lower socioeconomic status (SES) are less likely to participate in clinical trials than patients of higher SES. There is strong evidence in the literature for both of these conclusions. There is not, however, evidence that the rates of adverse effects are higher among women of lower SES or that higher toxicity would even be biologically plausible. Nor is there any evidence that the absolute or relative benefits of chemotherapy are less in women of lower SES. In contrast, it is possible that patients of lower SES who encounter toxicity may have different responses to toxicity due to having fewer financial and other resources. As a result, they may receive less chemotherapy, have more delays, or even terminate chemotherapy before all courses are completed. It is also possible that supportive measures are less available to patients of lower SES, which might in turn increase the likelihood of adverse events.¹

We believe that health care providers not only anticipate an individual patient's response to adverse events but may also take patients' resources into account when making a decision—implicit or explicit—to administer lower than standard breast cancer adjuvant chemotherapy doses. The intention of such prescribing practices is based on the principle of nonmalfeasance and is not, we are convinced, ill-intentioned. However, given the importance of quality of chemotherapy in breast cancer outcomes, particularly in the adjuvant setting, intentional dose reductions are ill-advised.

Remedies for such prescribing practices extend beyond those of the individual health care provider. Health care systems, payers, and providers should strive to deliver the same quality of care to all patients.

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Melony E.S. Sorbero, Amgen, Inc. Stock Ownership: None Honoraria: Gary H. Lyman, Amgen, GlaxoSmithKlein Research Funding: Gary H. Lyman, Amgen, GlaxoSmithKlein Expert Testimony: None Other Remuneration: None

REFERENCE

1. Griggs JJ, Culakova E, Sorbero MES, et al: Effect of patient socioeconomic status and body mass index on the quality of breast cancer adjuvant chemotherapy. J Clin Oncol 25:277-284, 2007[Abstract/Free Full Text]

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Related Correspondence

• Impact of Toxicity Assumptions on Socioeconomic Analysis of Breast Cancer Chemotherapy
  Ira E. Felman
  JCO 2007 25: 2331-2332 [Full Text]

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