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
304P - Survival outcomes and survival predictors in recurrent and metastatic head and neck squamous cell cancer (R/M-HNSCC) patients treated with chemotherapy (CT) plus cetuximab as first-line therapy in a real-world study
Presenter: Filipa Pontes
Session: Poster display session
Resources:
Abstract
305P - A retrospective study to evaluate patient characteristics for recurrent head and neck cancer after definitive treatment
Presenter: Tetsuro Wakasugi
Session: Poster display session
Resources:
Abstract
306P - Efficacy and safety of apatinib in heavily pretreated metastatic adenocarcinoma of the head and neck
Presenter: Lin Gui
Session: Poster display session
Resources:
Abstract
307P - Lacrimal gland tumours: Clinical and epidemiological patterns in the United States
Presenter: Mahmoud KhalafAllah
Session: Poster display session
Resources:
Abstract
308P - Dental prophylaxis and 5-fluorouracil related oral mucositis in head and neck cancer patients: A population-based cohort study
Presenter: Yi-Fang Huang
Session: Poster display session
Resources:
Abstract
309P - Evaluation of a pharmacist-led opioid de-escalation (PLODE) program after chemoradiotherapy completion in head and neck cancer patients
Presenter: Ai Horinouchi
Session: Poster display session
Resources:
Abstract
310P - Laser and PDT for the oral leukoplakia
Presenter: Sadykov Rasul
Session: Poster display session
Resources:
Abstract
311P - Incidence of thyroid carcinoma in the Philippines: A retrospective study from a tertiary university hospital
Presenter: Priscilla Caguioa
Session: Poster display session
Resources:
Abstract
312P - Oral health disparities among privileged and underprivileged tribes of south India - A study on precancerous oral lesions prevalence
Presenter: Shanavas Palliyal
Session: Poster display session
Resources:
Abstract
313P - Immunotherapy application for advanced cancers: One institution experiences since 2016 to 2019
Presenter: Jo Pai Chen
Session: Poster display session
Resources:
Abstract