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Journal of Clinical Oncology, Vol 22, No 3 (February 1), 2004: pp. 572-573 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.273
In Reply:Fox Chase Cancer Center, Philadelphia, PA; Duke University, Durham, NC Dr Nitschke discusses several interesting questions regarding our study [1]. He highlights the heterogeneity in our sample with regard to the types of phase I studies offered to patients, suggesting that there might be systematic differences in outcome expectations based on the type of study being considered by the patients. Indeed, our study was not designed to examine outcomes by subtype of phase I trial; however, several methodologic features ensured a homogeneous patient population with regard to relevant characteristics. All 54 of the studies offered to our study participants were in fact phase I dose escalation trials, including 20 single-agent trials (not 20 patients, as indicated in Dr Nitschke’s letter). Our eligibility criteria required that all patients had metastatic disease and had either experienced treatment failure from standard approaches or had cancers for which an effective standard approach did not exist. Thus, although we included several types of phase I trials (ie, experimental agent monotherapy, combinations of investigational and standard agents, combinations of standard agents), we believe that our patient population was relatively homogeneous with regard to important clinical characteristics, and largely representative of the universe of patients considering phase I trial participation. Dr. Nitschke raises the possibility that incomplete discussion of a no therapy option may have contributed to the high expectations of benefit from therapy in our patients. We did not directly ask patients whether a supportive care option was discussed. However, 31% of the patients reported that a standard treatment option was not offered. It is likely that a supportive care approach was discussed in these cases. Table 1 compares the treatment outcome expectations of those patients offered a standard therapy option with those of patients who reported not having been offered this option. These data support the hypothesis that patients offered phase I trial participation do discriminate potential benefit of treatments based on what they perceive as the options presented to them. It is also notable that even among the patients who reported not being offered a standard treatment option, the median expectation of benefit from standard therapy was still 20%, underscoring the high level of confidence and hope that characterizes this population.
We agree with Dr Nitschke that open discussion of a supportive care approach is appropriate for adult patients with advanced cancers for whom standard therapies have failed or do not exist. We asked the physicians in our sample to estimate the potential benefit (0% to 100%) from supportive care for each of the patients in the study. The median response was 10% (minimum, 0; maximum, 100; interquartile range, 5 to 20). One tenth of physician responses estimated at least a 50% chance of benefit from supportive care. Thus, although the physician sample in our study comprised phase I investigators, they did recognize the potential benefits of supportive care. Conversely, our finding of significant discordance between reports of patients and physicians regarding topics addressed in consultations raises a concern regarding the content and effectiveness of physician-patient communication. This study did not assess directly what transpired during these interactions. An ongoing follow-up study will include audiotaping of consultations to address this issue. We are pleased that our report has raised more questions than it has answered. Additional research is clearly needed to help us better understand and optimize patient-physician communication about treatment options. Authors’ Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.
REFERENCE
1. Meropol NJ, Weinfurt KP, Burnett CB, et al: Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physician-patient communication. J Clin Oncol 21: 2589-2596, 2003
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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