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J. Symanowski
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P2.09 - Mesothelioma (ID 710)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Mesothelioma
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.09-001 - Effects of Tumor Burden Reduction on Survival in Epithelioid Pleural Mesothelioma (ID 7518)
09:30 - 09:30 | Author(s): J. Symanowski
- Abstract
Background:
Surrogate endpoints are commonly utilized in oncology clinical trials and have been adopted by regulatory agencies for the approval of many agents. To date, the effects of tumor size reduction on survival have not been determined for the only Food and Drug Administration (FDA)-approved regimen fo malignant pleural mesothelioma (MPM), but its widespread use mandates its validation. MPM is a challenging disease to assess and standard Response Evaluation Criteria for Solid Tumors (RECIST) were not optimized to measure pleural disease. Modified pleural RECIST (mRECIST) have been adopted by mesothelioma experts for the measurement of responses in MPM and mRECIST are the most commonly used response criteria in clinical trials for MPM. Although the gold standards for oncology outcomes are overall survival and quality of life, cross-over to subsequent therapies and competing risks influence survival outcomes. We sought to evaluate the relationship of response with survival in the clinical trial of the only FDA approved regimen for MPM.
Method:
We reviewed the clinical trial that randomized patients with MPM to receive cisplatin or cisplatin and pemetrexed. Patients with epithelioid MPM were categorized by whether or not they responded to cisplatin or the combination of cisplatin and pemetrexed accoring to the original study determination. Responders had >30% reduction in the thickness of the pleural rind measured at up to 3 points on 3 separate slices of the CT scan. Median progression-free (PFS) and overall survivals (OS) were determined and the hazard ratios for responders and non-responders were determined and compared by the logrank test.
Result:
We identified that patients with epithelioid MPM who responded to front-line therapy had a significantly longer overall survival (HR 0.341, 95% CI 0.239-0.486; median 20.6 months, 95% CI: 15.3-not reached) than those who did not respond (median 9.4 months, 95% CI: 8.1-11.0; p<0.001). Similarly patients who responded to front-line therapy had a significantly longer progression-free survival (HR 0.496, 95% CI: 0.385-0.639; median 7.8 months, 95% CI: 6.5-8.5) than those who did not respond (median 3.7 months, 95% CI: 2.9-4.3; p<0.001).
Conclusion:
Our findings demonstrate that a reduction in tumor burden was strongly associated with OS and PFS in epithelioid MPM treated with cisplatin or cisplatin and pemetrexed.
