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Debate 27A - Is progression-free survival a rational surrogate endpoint in front-line ovarian cancer clinical trials?

Yes

from Section III - Ovarian Cancer

Published online by Cambridge University Press:  20 July 2023

Dennis S. Chi
Affiliation:
Memorial Sloan-Kettering Cancer Center, New York
Nisha Lakhi
Affiliation:
Richmond University Medical Center, Staten Island
Nicoletta Colombo
Affiliation:
University of Milan-Bicocca
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Summary

When considering the best overall management strategy of recurrent granulosa cell tumors (GCT), given the long survivals and multiple recurrences many patients will experience, chemotherapy is an important component of overall treatment. The recommended first-line chemotherapy regimen includes BEP (bleomycin, etoposide, and cisplatin) and more recently carboplatin and paclitaxel. While chemotherapy has not shown strong OS benefit, the extension of PFS is meaningful and can lead to longer intervals between surgery and perhaps an overall decrease in the total number of surgeries a patient has in their lifetime. There is ongoing research to better understand the various systemic treatment approaches for GCT, bevacizumab, hormonal therapies, and immunotherapy. Overall, a multimodal approach is essential for the effective treatment of recurrent GCT with systemic chemotherapy being an important part of the treatment paradigm for this tumor.

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Publisher: Cambridge University Press
Print publication year: 2023

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References

Herzog, TJ, et al. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology White Paper. Gynecol Oncol 2014;132(1):817.CrossRefGoogle ScholarPubMed
Broglio, KR, et al. Detecting an overall survival benefit that is derived from progression-free survival. JNCI J Natl Cancer Inst 2009;101(23):16421649.CrossRefGoogle ScholarPubMed
Herzog, TJ, et al. SGO guidance document for clinical trial designs in ovarian cancer: a changing paradigm. Gynecol Oncol 2014;135:37.Google Scholar
Herzog, TJ, et al. FDA ovarian cancer clinical trial endpoints workshop: Society of Gynecologic Oncology White Paper. Gynecol Oncol. 2017;147(1):310.Google Scholar

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