Abstract 230P
Background
SOLO1 (NCT01844986) is a randomized, double-blind, phase III trial evaluating the efficacy and safety of the PARP inhibitor, olaparib, as maintenance monotherapy in newly diagnosed advanced OC pts with a BRCAm. A separate pt cohort evaluated the efficacy and safety of olaparib in Chinese pts in this setting.
Methods
The China cohort of SOLO1 planned to enrol ∼53 newly diagnosed OC pts who had completed first-line platinum-based chemotherapy and were in clinical complete or partial response. This sample size provided around a 90% chance to observe a hazard ratio (HR) of < 1, assuming a true HR of 0.62. Pts were randomized 2:1 to olaparib (300 mg bid; tablet) vs placebo. The primary endpoint was investigator-assessed progression-free survival (PFS; modified RECIST v1.1). Sensitivity analysis of PFS was performed by blinded independent central review (BICR).
Results
All 64 randomized pts received study treatment (olaparib, n = 44; placebo n = 20). Median follow-up was ∼30 months in both arms. Median PFS was not reached in the olaparib arm and was 9.3 months in the placebo arm (Table).
Table: 230P
PFS events, n | Median PFS, months | HR (95% CI; P value) | |||
---|---|---|---|---|---|
Olaparib (n = 44) | Placebo (n = 20) | Olaparib (n = 44) | Placebo (n = 20) | Full analysis set (n = 64) | |
PFS, investigator assessed (48.4% maturity) | 18 | 13 | NR | 9.3 | 0.46 (0.23, 0.97; 0.0320) |
PFS, BICR (39.1% maturity) | 13 | 12 | NR | 9.3 | 0.39 (0.17, 0.86; 0.0168) |
CI, confidence interval; NR, not reached.
The most common AEs in the olaparib group were nausea (n = 28, 63.6%), anaemia (n = 25, 56.8%) and vomiting (n = 18, 40.9%). Grade ≥3 AEs occurred in 56.8% of olaparib pts vs 30.0% of placebo pts; the most common grade ≥3 AE was anaemia (n = 16, 36.4%). Olaparib dose interruptions, reductions and discontinuations occurred in 56.8%, 27.3% and 6.8% of pts, respectively (vs 30.0%, 10% and 0% of pts in the placebo arm).
Conclusions
In the China cohort of SOLO1, a clinically relevant improvement in investigator-assessed PFS was observed in newly diagnosed OC pts receiving olaparib maintenance therapy. Olaparib treatment led to a 54% reduction in risk of progression or death vs placebo. The safety results were consistent with the known profile of olaparib in Chinese pts.
Clinical trial identification
NCT01844986, release date 19 February 2016.
Editorial acknowledgement
Medical writing assistance was provided by Laura Smart, MChem, from Mudskipper Business Ltd, funded by AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD).
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
J. Liu: Research grant / Funding (institution): AstraZeneca. X. Ma: Full / Part-time employment: AstraZeneca. J. Zhang: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
133P - Prognostic and predictive factors from the phase III CELESTIAL trial of cabozantinib (C) versus placebo (P) in previously treated advanced hepatocellular carcinoma (aHCC)
Presenter: Thomas Yau
Session: Poster display session
Resources:
Abstract
134P - Identification, development and validation of a circulating miRNA-based diagnostic signature for early detection of gastric cancer
Presenter: Daisuke Izumi
Session: Poster display session
Resources:
Abstract
135P - The promising key genes associated with tumour microenvironment and prognosis of hepatocellular carcinoma
Presenter: Jing Fang
Session: Poster display session
Resources:
Abstract
136P - Helicobacter pylori-positive gastric diffuse large B-cell lymphoma: A subset with distinct prognostic features
Presenter: Yuan Cheng
Session: Poster display session
Resources:
Abstract
137P - Significant benefit of pyrotinib combined with SHR6390 in patients with multiline-resistant HER2-positive advanced gastric cancer
Presenter: Zuhua Chen
Session: Poster display session
Resources:
Abstract
138P - Incidence of supracarinal lymph node positivity in operated cases of total esophagectomy: Short term results from a tertiary cancer centre
Presenter: Akhil Palod
Session: Poster display session
Resources:
Abstract
139P - Prognostic usefulness of advanced lung cancer inflammation index in locally-advanced pancreatic carcinoma patients treated with radical chemoradiotherapy
Presenter: Ayberk Besen
Session: Poster display session
Resources:
Abstract
140P - Pancreaticoduodenectomy versus combined neoadjuvant chemotherapy and pancreaticoduodenectomy: Survival patterns among patients with stage II & III periampullary carcinoma
Presenter: Mai Abdelkader
Session: Poster display session
Resources:
Abstract
141P - A 13-gene signature of DNA repair predicts prognosis in gastric cancer patients
Presenter: Jinjia Chang
Session: Poster display session
Resources:
Abstract
142P - Relation between Interleukin -4 (590C/T) gene polymorphism and hepatocellular carcinoma risk in HBV and HCV patients
Presenter: Suzy Gohar
Session: Poster display session
Resources:
Abstract