Originally published as JCO Early Release 10.1200/JCO.2004.05.111 on April 26 2004

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Magnitude of Response With Myeloma Frontline Therapy Does Not Predict Outcome: Importance of Time to Progression in Southwest Oncology Group Chemotherapy Trials

From the Cedars-Sinai Medical Center, Los Angeles, CA; Southwest Oncology Group Statistical Center, Cancer Research and Biostatistics, Seattle, WA; and Myeloma Institute for Research and Therapy, University of Arkansas for Medical Studies, Little Rock, AR.

Address reprint requests to Brian G.M. Durie, MD, Cedars-Sinai, 8201 Beverly Blvd, Los Angeles, CA 90048; e-mail: bdurie{at}salick.com

PURPOSE: Four Southwest Oncology Group (SWOG) standard-dose chemotherapy protocols for multiple myeloma (MM) initiated between 1982 and 1992 were evaluated. The purpose was to clarify the predictive value of specific levels of myeloma-associated monoclonal protein reduction and time to first progression using mature data sets.

PATIENTS AND METHODS: Study data on 1,555 eligible previously untreated patients with MM enrolled onto SWOG phase III trials 8229, 8624, 9028, and 9210 were used in these analyses. Six-month and 12-month landmark analyses were performed to evaluate the outcome for patients in each response category.

RESULTS: The overall and event-free survivals for the four protocols combined were 33 months and 18 months, respectively. Using 6- and 12-month landmarks, the median survivals of 30 to 35 months were not different for responders ( 50% and 75% regression) versus nonresponders in patients without disease progression before the landmarks. Conversely, at the 6- and 12-month landmarks, the median survivals for patients who had experienced disease progression were 13 and 15 months, respectively, versus a 34-month median for patients who did not experience progression. Using the Cox survival model, with response and progression considered as time-dependent covariates, survival duration was influenced more by the occurrence of progression than by the occurrence of response.

CONCLUSION: The magnitude of response, as a single variable, does not predict survival duration. Patients with response and stable disease have equivalent outcome. Only patients with progressive disease have a poorer outcome. The best indicator of survival is time to first progression.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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