Real-world evidence of poly ADP-ribose polymerase inhibitors in the treatment of ovarian cancer: A systematic literature review

Abstract

Objective The treatment landscape for ovarian cancer has shifted in recent years with the approval of poly ADP-ribose polymerase inhibitors in 2014. Most patients with ovarian cancer have advanced disease at diagnosis. Understanding how treatments for advanced disease work in real-world settings must be assessed to provide care for these patients. Therefore, the objective of this study was to locate and assess real-world studies measuring the safety and effectiveness of poly ADP-ribose polymerase inhibitors and analyze the results. Data sources: A targeted systematic literature review was conducted in April 2020 of PubMed/Medline. Inclusion criteria consisted of observational studies using real-world data of olaparib, rucaparib, or niraparib as an intervention in the treatment of ovarian cancer. In addition, studies needed to assess either clinical effectiveness or safety. Once studies were identified, we aimed to narratively describe the studies’ patient population, intervention effectiveness, and/or safety. Data summary: Our systematic review identified six studies assessing the real-world effectiveness and/or safety of poly ADP-ribose polymerase inhibitors, with five assessing olaparib, one assessing poly ADP-ribose polymerase inhibitors as a composite, and none assessing either niraparib or rucaparib. The median progression free survival in the real-world trials for olaparib ranged from 12.7 to 15.6 months. The median overall survival in the real-world trials for olaparib ranged from 30.9 to 35.4 months. Rates of treatment discontinuation due to adverse events for olaparib ranged from 4.4% to 12.5%. Conclusions The identified studies showed slightly higher, but comparable results for median progression free survival, median overall survival, and discontinuation due to adverse events compared to the respective randomized controlled trials.

Utilization of Poly(ADP-Ribose) Polymerase Inhibitors in Ovarian Cancer: A Retrospective Cohort Study of US Healthcare Claims Data

“…RCT data suggest differences between PARPi in terms of tolerability and dose modifications [15][16][17][18]. Real-world evidence of PARPi use in clinical practice reported a safety profile largely consistent with RCT data [19][20][21][22][23][24], with emerging data supporting distinct tolerability profiles for each PARPi [25]. Tolerability is likely to be an important factor for long-term PARPi maintenance therapy.…”

A Real World Perspective of PARP Inhibitor Use in Gynecological Cancer Patients

“…29 Other real world studies with olaparib have reported a median PFS ranging from 12.7 to 15.6 months and a median OS ranging from 30.9 to 35.4 months. 22-28 Although our study was not able to determine OS, these survival data should be interpreted with caution taking into account the line of therapy and other factors such as HRD status.…”

“…Other real word evidence studies have looked at PARPi, mostly olaparib. 22-28 A retrospective review in Italy investigated the use of olaparib as maintenance therapy in patients with BRCA 1/2 mutated recurrent platinum sensitive ovarian cancer in 234 patients. They found the most frequently reported toxicities were nausea (35.7%), anemia (35.7%), and fatigue (35.1%), with anemia (5.6%) being the most common grade ≥3 toxicity.…”