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Clinical Trial
. 2024 Apr;130(6):941-950.
doi: 10.1038/s41416-023-02567-6. Epub 2024 Jan 20.

Results of a randomised Phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer

Shibani Nicum  1 , Naomi McGregor  2 , Rachel Austin  3 , Linda Collins  3 , Susan Dutton  4 , Iain McNeish  5 , Rosalind Glasspool  6 , Marcia Hall  7 , Rene Roux  8 , Agnieszka Michael  9 , Andrew Clamp  10 , Gordon Jayson  10 , Rebecca Kristeleit  11 , Susana Banerjee  12 , Anita Mansouri  4
Affiliations
Clinical Trial

Results of a randomised Phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer

Shibani Nicum et al. Br J Cancer. 2024 Apr.

Abstract

Background: OCTOVA compared the efficacy of olaparib (O) versus weekly paclitaxel (wP) or olaparib + cediranib (O + C) in recurrent ovarian cancer (OC).

Aims: The main aim of the OCTOVA trial was to determine the progression-free survival (PFS) of olaparib (O) versus the oral combination of olaparib plus cediranib (O + C) and weekly paclitaxel (wP) in recurrent ovarian cancer (OC).

Methods: In total, 139 participants who had relapsed within 12 months of platinum therapy were randomised to O (300 mg twice daily), wP (80 mg/m2 d1,8,15, q28) or O + C (300 mg twice daily/20 mg daily, respectively). The primary endpoint was progression-free survival (PFS) of olaparib (O) versus olaparib plus cediranib (O + C) or weekly paclitaxel (wP). The sample size was calculated to observe a PFS hazard ratio (HR) 0.64 in favour of O + C compared to O (20% one-sided type I error, 80% power).

Results: The majority had platinum-resistant disease (90%), 22% prior PARPi, 34% prior anti-angiogenic therapy, 30% germline BRCA1/2 mutations. The PFS was increased for O + C vs O (O + C 5.4 mo (2.3, 9.6): O 3.7 mo (1.8, 7.6) HR = 0.73; 60% CI: 0.59, 0.89; P = 0.1) and no different between wP and O (wP 3.9 m (1.9, 9.1); O 3.7 mo (1.8, 7.6) HR = 0.89, 60% CI: 0.72, 1.09; P = 0.69). The main treatment-related adverse events included manageable diarrhoea (4% Grade 3) and hypertension (4% Grade 3) in the O + C arm.

Discussion: OCTOVA demonstrated the activity of O + C in women with recurrent disease, offering a potential non-chemotherapy option.

Trial registration: ISRCTN14784018, registered on 19th January 2018 http://www.isrctn.com/ISRCTN14784018 .

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Conflict of interest statement

Competing interests for each author have been declared.

Figures

Fig. 1
Fig. 1. Consort diagram.
AE adverse events, SAE serious adverse events.
Fig. 2
Fig. 2. Kaplan-Meier graphs of progression free survival (a) and overall survival (b) for the intention to treat population.
a Kaplan–Meier display of progression-free survival for the ITT analysis. b Kaplan–Meier display of overall survival for the ITT analysis.
Fig. 3
Fig. 3. Drug related adverse events.
Adverse reactions that occurred in at least 10% of patients (maximal grade).
Fig. 4
Fig. 4
Forest plot demonstrating PFS in subgroup analysis of stratification factors.
See this image and copyright information in PMC

References

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