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Journal of Clinical Oncology, Vol 22, No 3 (February 1), 2004: pp. 571-572
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.99.229

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CORRESPONDENCE

Physician-Patient Communication in Phase I Cancer Trials

Ruprecht Nitschke

Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK

To the Editor:

The authors evaluated patients’ and physicians’ perceptions about the effect of phase I drugs [1]. Both patients who participated in the experimental therapy and those who did not participate were included in the study. As stated by the authors, the results were similar to those in their pilot study and to those reported in other publications [1,2]: a high percentage of the patients with a poor prognosis expect therapeutic benefits. The authors give several possible explanations for this interesting finding. Some of them need further elaboration and one reason can be added: not all trials onto which patients were entered fit the criteria of a phase I drug study. Only 20 patients in this study were participating solely in trials to determine toxicities and maximum-tolerated dose [1]. Most of the others, if not all of them, received some kind of standard therapy plus an anticancer agent, the tolerated dose of which was still to be determined. These patients expected a therapeutic effect as a result of the standard therapy, whereas the former patients had no reassurance of any therapeutic benefit. It would be advisable to evaluate the phase I patients separately and to compare them with the other cohort of patients.

One possible reason for the patients’ relatively high expectancy of a therapeutic effect was mentioned by Daugherty in 1995 [3]; namely, the lack of or incomplete discussion of the no therapy option. It is surprising that the authors did not pursue the question posed in that publication and continue to explore in more depth the mind set of patients and physicians. The term no therapy, with its possibly negative implications, should be replaced by the term supportive or palliative care without anticancer therapy [3]. After having been informed about this option in detail, patients might become more aware of their guarded prognosis with or without experimental therapy. I agree with the authors that the factors that were used to describe quality of life were not well outlined in their study, which makes it difficult to interpret their findings.

In response to the needs of our families, the hematology/oncology section of The Children’s Hospital of Oklahoma has developed a program for all parents and the majority of children older than 5 years who do not respond to standard therapy [4,5]. We have tabulated not only the facts of the experimental treatment group but also those of the supportive treatment group. In the data we cover the disease, therapy, progression, possibility of cure, remission and life expectancy, and quality-of-life issues such as hospitalization, laboratory tests, unexpected serious side effects, follow-up examinations by physicians, and the value of time at home with families and friends. Many of these considerations are applicable to adult patients—others may need to be added such as career, relationship, and life-story closure activities. This open, informative approach seems to address more precisely the concerns of patients with a serious prognosis. It also guarantees that the information necessary for a full consent is given to the family. There exists a concern that some of the physicians participating in the study failed to explain fully the experimental therapy and the other option. Only 90% of the physicians presented side effects, benefits, and possible risks of the treatment to the patients, and between 27% to 47% of the physicians failed to mention changes in quality of life and life expectancy with and without experimental therapy [1].

Author’s Disclosures of Potential Conflicts of Interest

The author indicated no potential conflicts of interest.

REFERENCES

1. Meropol NJ, Weinfurt KP, 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[Abstract/Free Full Text]

2. Cheng JD, Hitt J, Koczwara B, et al: Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol 18: 421-428, 2000[Abstract/Free Full Text]

3. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trails. J Clin Oncol 13: 1062-1072, 1995[Abstract]

4. Nitschke R, Humphrey GB, Sexauer CL, et al: Therapeutic choices made by patients with end-stage cancer. J Pediatr 101: 471-476, 1982[CrossRef][Medline]

5. Nitschke R, Meyer WH, Sexauer CL, et al: Care of terminally ill children with cancer. Med Pediatr Oncol 34: 268-270, 2000[CrossRef][Medline]


Related Article

  • Perceptions of Patients and Physicians Regarding Phase I Cancer Clinical Trials: Implications for Physician-Patient Communication
    Neal J. Meropol, Kevin P. Weinfurt, Caroline B. Burnett, Andrew Balshem, Al B. Benson, III, Liana Castel, Sandra Corbett, Michael Diefenbach, Darrell Gaskin, Yun Li, Sharon Manne, John Marshall, Julia H. Rowland, Elyse Slater, Daniel P. Sulmasy, David Van Echo, Shakira Washington, and Kevin A. Schulman
    JCO 2003 21: 2589-2596 [Abstract] [Full Text]

Related Reply

  • In Reply:
    Neal J. Meropol, Liana D. Castel, Kevin A. Schulman, and Kevin P. Weinfurt
    JCO 2004 22: 572-573 [Full Text]



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