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Alternate efficacy measure better predictor of survival for advanced NSCLC
‘Disease control rate’ had a much stronger association with survival than the standard measure of tumor response or shrinkage.
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Disease control rate is an alternative method of measuring treatment effectiveness for patients with advanced non-small-cell lung cancer and may be a more powerful predictor of survival than measuring tumor response and shrinkage, according to researchers at University of California Davis Cancer Center.
Typical efficacy measures for new treatments in advanced NSCLC, including objective response and overall survival, have their limitations, according to the Southwest Oncology Group (SWOG) study presented at the 2006 ASCO Annual Meeting in Atlanta.
“Some patients have no measurable disease or achieve only disease stabilization, while overall survival is influenced by effective salvage therapies,” said lead researcher Primo N. Lara Jr., MD, associate professor of hematology and oncology at UC Davis Cancer Center, in a prepared statement. “If validated, this ‘early look’ statistical measure could enhance efficacy assessment, with broad implications for the design of future cancer clinical trials for advanced non–small-cell lung cancer.”
Calculating disease control rates
Lara and colleagues defined the disease control rate as the percentage of patients who have a partial or complete response to an investigational treatment plus those whose disease stabilizes.
“In the past, we have used the complete response rate plus the partial response rate, or CR + PR, as our sole efficacy measure,” Lara said. “The disease control rate (DCR) is the complete response rate plus the partial response rate plus the rate of patients with stabilized disease, or DCR = CR + PR + SD. This measure may better predict how a new drug will affect survival.”
Applying DCR in trials
Researchers pooled data from 984 patients with advanced NSCLC who participated in three randomized SWOG trials of platinum-based chemotherapy regimens.
Of the 886 patients who were alive two months after beginning treatment, 62% had stable disease. Another 19% had a complete or partial response. Adding the two measures together yielded a disease control rate of 81%.
When Lara and colleagues compared the disease control rate to the standard measure (CR+PR), they found that the disease control rate had a much stronger association with survival.
“The cancer community is actively looking for ways to improve clinical trials, so that we can get better answers more efficiently and bring advances to our patients more rapidly. Nowhere is this more important than in lung cancer,” Lara said. “These findings will be prospectively tested in SWOG, but if they bear out, they may help us to design smarter clinical trials for lung and perhaps other cancers.”
For more information:
- Lara PN, Redman MW, Kelly K, et al. Alternative measures predicting clinical benefit in advanced non–small-cell lung cancer from Southwest Oncology Group randomized trials: Implications for clinical trial design. Abstract 7006. Presented at: 2006 ASCO Annual Meeting; June 2-6; Atlanta.