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In Reply:

Division of Hematology/Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA

In this report of a large phase II trial of single-agent temozolomide (28-day cycles) for the treatment of brain metastases, we reported an objective response rate of 7% among 117 previously untreated patients and a single partial response among 34 patients who had been previously treated with chemotherapy.¹ In addition, 29% of previously untreated patients and 18% of previously treated patients had stable disease. We reported that the duration of stable disease was 2 cycles (range, one to eight cycles) for previously untreated patients and 1 cycle (range, one to three cycles) for previously treated patients. Not reported in the manuscript was the median duration of objective response (one complete and eight partial), which was 2 cycles (range, one to three cycles).

With respect to how we characterized the antitumor activity of temozolomide in the treatment of melanoma brain metastases, we stated that the activity of temozolomide was modest in this study, but suggested that temozolomide may have potential applications in this setting in combination with either radiotherapy or other chemotherapy agents. On the basis of these results, further study is warranted. We did not say that temozolomide has more promising activity than other chemotherapy agents in the treatment of melanoma brain metastases. With regard to fotemustine, we agree that this agent has activity in the treatment of melanoma brain metastases, although it is not available for use in the United States. It is difficult to compare results between the fotemustine studies and our trial because of differences in the extent of cranial disease and other important prognostic factors. Similar to temozolomide, the majority of responses to fotemustine have been observed in previously untreated patients and patients presenting with a single brain metastasis.^2,3 In our study, the majority of patients had two or more brain lesions (median, three lesions). It is also important to keep in mind that the clinical experience with fotemustine in patients with melanoma brain metastases (approximately 140 patients across many small studies) is limited, and one cannot rule out the potential contribution of selection bias to the reported median response rate of 24%.⁴ In comparison, our study represents the largest clinical experience with any chemotherapy agent in patients with melanoma brain metastases using standardized gadolinium-enhanced magnetic resonance imaging in all patients with central, blinded, radiologic assessment of response.

Author's Disclosures of Potential Conflicts of Interest

The following author or their immediate family members have 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. Honoraria: Sanjiv S, Agarwala, Schering Plough, Chiron. For a detailed description of these 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 of Information for Contributors found in the front of every issue.

REFERENCES

1. Agarwala SS, Kirkwood JM, Gore M, et al: Temozolomide for the treatment of brain metastases associated with metastatic melanoma: A phase II study. J Clin Oncol 22:2101-2107, 2004[Abstract/Free Full Text]

2. Jacquillat C, Khayat D, Banzet P, et al: Final report of the French multicenter phase II study of the nitrosourea fotemustine in 153 evaluable patients with disseminated malignant melanoma including patients with cerebral metastases. Cancer 66:1873-1878, 1990[CrossRef][Medline]

3. Jacquillat C, Khayat D, Banzet P, et al: Chemotherapy by fotemustine in cerebral metastases of disseminated malignant melanoma. Cancer Chemother Pharmacol 25:263-266, 1990[CrossRef][Medline]

4. Khayat D, Giroux B, Berille J, et al: Fotemustine in the treatment of brain primary tumors and metastases. Cancer Invest 12:414-420, 1994[Medline]

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