Originally published as JCO Early Release 10.1200/JCO.2008.20.5237 on January 12 2009

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Other Problems With Phase III Best Supportive Care Studies

University of Colorado Comprehensive Cancer Center, Aurora, CO

To the Editor:

In addition to the problems with such studies as discussed by Zafar et al,¹ another surprisingly unaddressed issue is the frequency of patient visits by health care professionals. In the panitumumab versus best supportive care (BSC) studies,^2,3 patients who received the drug were presumably seen by health care professionals every 2 weeks at the time of drug delivery, whereas those receiving only BSC were assessed, perhaps only, radiographically every 4 or even 8 weeks. In the cetuximab study,⁴ the differences in frequency of visits were even greater, with the treated group seen weekly and the BSC group seen every 4 weeks.

This may result in the treated group having a shorter progression-free survival because of earlier recognition of disease progression. On the other hand, complications and problems can be noted and addressed earlier in the treated group, possibly prolonging time on treatment, progression-free survival, and altering overall survival. In the future, such studies should consider having patients seen with the same frequency in both the treatment and BSC arms.

Given that the overall survival differences were either not significant³ or perhaps not clinically meaningful,⁴ especially given the cost of the treatment, collecting the data in such a manner may have led to results different from those obtained.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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

REFERENCES

1. Zafar SY, Currow D, Abernathy AP: Defining best supportive care. J Clin Oncol 26:5139–5140, 2008.[Free Full Text]

2. Amado RG, Wolf M, Peeters M, et al: Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 26:1626–1634, 2008.[Abstract/Free Full Text]

3. Van Cutsem E, Peeters M, Siena S, et al: Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 25:1658–1664, 2007.[Abstract/Free Full Text]

4. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al: Cetuximab for the treatment of colorectal cancer. N Engl J Med 357:2040–2048, 2007.[Abstract/Free Full Text]

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