Complete remission sustained 3 years from treatment initiation is a powerful surrogate for extended survival in multiple myeloma

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Abstract
BACKGROUND.: Complete response (CR) has been considered a necessary although not sufficient early clinical endpoint for extended survival in multiple myeloma.METHODS.: By using Total Therapy 2 (TT2) clinical outcome data in 668 patients, whether sustained CR (SUS‐CR) was potentially a superior surrogate for survival than attaining CR status per se was evaluated.RESULTS.: Compared with not achieving CR (NON‐CR) and especially achieving and subsequently losing CR status (LOS‐CR) within a 3‐year landmark from treatment initiation, SUS‐CR was associated with highly superior postlandmark survival (P< .0001). These results were validated in 231 untreated patients enrolled in the predecessor trial, TT1 (hazard ratio [HR] = 0.54,P= .013) and in 1103 previously treated patients on other transplant protocols (HR = 0.49;P< .001).CONCLUSIONS.: In all 3 trial settings the survival benefit of SUS‐CR was independent of metaphase abnormalities as a dominant adverse parameter. Given its bleak prognosis despite high CR rates, SUS‐CR should be evaluated as a primary trial endpoint in high‐risk myeloma. Cancer 2008. © 2008 American Cancer Society.

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