Who really benefits from intraperitoneal chemotherapy in advanced
ovarian cancer? A treatment-free survival analysis
Abstract
Objective: To investigate whether the extent of peritoneal disease may
predict the survival benefit from IP/IV therapy. Design: A TFS analysis.
Setting: Censored on August 27, 2020, the extended follow-up of AICE
(Additional Intraperitoneal Cisplatin and Etoposide in ovarian cancer)
trial. Population: Patients were categorized into the high tumor burden
(HTB) and low tumor burden (LTB) subgroups. Methods: Overall survival
(OS) was partitioned into time on protocol treatment exposure (T), time
to subsequent treatment initiation or death (TFS), and time after first
subsequent therapy or death (REL). TFS analyses and quality-adjusted OS
were calculated by multiplying mean time in each health state by its
assigned utility (Quality-adjusted OS =ut *T+TFS+urel *REL). Main
Outcome Measures: The area under each Kaplan-Meier curve was estimated
by the 96-month restricted mean time, with the threshold utility
analyses illustrating the quality-adjusted OS comparisons. Results: In
the HTB subgroup, restricted mean TFS was 33.9 months and 18.7 months in
the IP/IV and IV groups, respectively (difference, 15.2 months; 95%CI,
4.6 to 25.7; P = .005), with a significant quality-adjusted OS gain
(ranging from 13.2 to 16.0 months). In the LTB subgroup, there was no
survival benefit from IP/IV therapy in either TFS (difference, 7.1
months; 95%CI, -5.5 to 19.8; P = .268) or quality-adjusted OS (ranging
from 1.4 to 6.3 months). Conclusions: IP/IV therapy provided
significantly longer TFS and quality-adjusted OS across all values of
utility weights than standard IV therapy in the HTB subgroup, while
patients did not benefit from it in the LTB subgroup.