J Cancer 2018; 9(5):872-879. doi:10.7150/jca.17664
Overall survival and post-progression survival are potent endpoint in phase III trials of second/third-line chemotherapy for advanced or recurrent epithelial ovarian cancer
1. Cancer Biostatistics Laboratory, Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan;
2. Department of Developmental Therapeutics, National Cancer Center Hospital East, Chiba, Japan;
3. Department of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;
4. Gynecologic Service, National Kyushu Cancer Center, Fukuoka, Japan;
5. Department of Medical Oncology, National Kyushu Medical Center, Fukuoka, Japan;
6. Department of Health Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Purpose: A growing number of treatment options and active compounds in treatments have led to better outcomes for patients with advanced or recurrent epithelial ovarian cancer. We examined the association between progression-free survival (PFS), post-progression survival (PPS) and overall survival (OS) in phase III trials of second- and third-line chemotherapy for advanced or recurrent epithelial ovarian cancer. We aim to determine whether PFS or PPS is a surrogate of OS so that we can decide progress of disease is optimal endpoint for ovarian cancer.
Methods: We identified 22 trials conducted between January 1, 2000 through December 31, 2014 by literature search. We divided OS into PFS and PPS, and assessed the association between OS and PFS/PPS. We also examined whether the year of trial enrollment completion was associated with any variables.
Results: The median PPS was slightly longer in recent trials compared to older trials (10.0 vs. 8.8 months). While PPS was strongly associated with OS (r = 0.88) in all trials, PFS was moderately correlated with OS (r = 0.72). The correlation between OS and PPS in recent trials (r = 0.93) was stronger than in older trials (r = 0.84).
Conclusions: Our findings indicate that PPS is highly associated with OS in second/third-line chemotherapy for advanced or recurrent epithelial ovarian cancer, while the association between PFS and OS is moderate. We recommend using OS as primary endpoint for clinical trial of ovarian cancer, however PFS is still an optional endpoint.
Keywords: Ovarian Cancer, Chemotherapy, Overall Survival, Post-Progression Survival, Phase III trial
Shimokawa M, Kogawa T, Shimada T, Saito T, Kumagai H, Ohki M, Kaku T. Overall survival and post-progression survival are potent endpoint in phase III trials of second/third-line chemotherapy for advanced or recurrent epithelial ovarian cancer. J Cancer 2018; 9(5):872-879. doi:10.7150/jca.17664. Available from http://www.jcancer.org/v09p0872.htm