. Author manuscript; available in PMC: 2016 Jan 4.

Published in final edited form as: Gynecol Oncol. 2014 Aug 12;135(1):3–7. doi: 10.1016/j.ygyno.2014.08.004

Table 1.

Endpoints and study settings. In addition to statistically significant difference, other means of benefit would need to be demonstrated such as significant difference in time off therapy or at least an OS trend. Opportunities to develop metrics of clinical benefit that integrate response elements with context to better define treatment effect. Modified from Herzog TJ, Armstrong DK, Brady MF, Coleman RL, Einstein MH, Monk BJ, Mannel RS, Thigpen JT, Umpierre SA, Villella JA, and Alvarez RD. Gynecol Oncol. 2014 Jan; 132 (1):8–17.doi: 10.1016/j.ygyno.2013.11.008. Reproduced with permission of Elsevier.

	Frontline	Platinum-sensitive	Platinum-resistant
OS	Approve	Approve	Approve
PFS (statistically significant) + other (QoL/PRO)	Approve	Approve	Consider
PFS (statistically significant) with clinically meaning MOE	Consider	Consider	Consider
Response Rate/CBR Overall- high grade serous	No	No	Consider
Response rate/CBR selected histologies (eg. clear cell, mucinous, and low grade serous)	Consider	Consider	Consider

MOE = magnitude of effect; QOL = quality of life; PRO = patient reported outcomes; CBR = clinical benefit rate.