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Bending the Curve Trial by Trial
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SOLO-1

Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Phase 3N = 391NCT01844986

Population
Newly diagnosed advanced (FIGO stage III-IV) high-grade serous or endometrioid ovarian, primary peritoneal or fallopian-tube cancer with a BRCA1/2 mutation, in complete or partial clinical response after platinum-based chemotherapy
Design
International, randomised, double-blind phase 3 trial. Patients with newly diagnosed advanced (FIGO stage III or IV) high-grade serous or endometrioid ovarian, primary peritoneal or fallopian-tube cancer with a BRCA1/2 mutation and a complete or partial clinical response after platinum-based chemotherapy were randomised 2:1 to olaparib tablets 300 mg twice daily or placebo, for up to 2 years. Primary end point PFS.
Primary endpoint
PFS
Arms
  • Olaparib (experimental, n = 260): Olaparib tablets 300 mg twice daily for up to 2 years
  • Placebo (control, n = 131): Placebo tablets for up to 2 years
People
Moore K
PFSHR 0.30 (95% CI 0.23–0.41)Δ 36-month PFS+33 pointsPFSHR 0.33 (95% CI 0.25–0.43)Δ median PFS+42.2 monthsOSHR 0.55 (95% CI 0.40–0.76)Δ 84-month OS+20.5 points
Show the numbers
Results reported for SOLO-1
EndpointAnalysisOlaparibPlaceboEffect
PFSRandomised patients (n=391); analysis population not stated in the abstractprimarymedian follow-up 41 monthsMoore 201860% at 3 y27% at 3 yHR 0.30 (95% CI 0.23–0.41)P<0.001Kaplan-Meier estimate of freedom from disease progression and death at 3 years; the abstract gives no median PFS values. 388 patients had a centrally confirmed germline BRCA1/2 mutation and 2 a somatic mutation.
PFSlong term-updateBanerjee 2021median 56 monthsmedian 13.8 months (11.1–18.2)HR 0.33 (95% CI 0.25–0.43)Post-hoc update, investigator-assessed. The 95% CI for the olaparib median is 41.9 to not reached. Median follow-up 4.8 years with olaparib and 5.0 years with placebo.
OSRandomised patients (olaparib n=260, placebo n=131)long term-updateDiSilvestro 202367% at 7 y46.5% at 7 yHR 0.55 (95% CI 0.40–0.76)P=0.0004Prespecified descriptive analysis of OS (secondary end point) after 7 years of follow-up; p<0.0001 was required to declare statistical significance. Median follow-up 88.9 months (olaparib) and 87.4 months (placebo). Alive and without a first subsequent treatment at 7 years: 45.3% vs 20.6%. No median OS is given in the abstract.
Results reported for SOLO-1
EndpointAnalysisOlaparibPlaceboEffect
PFSRandomised patients (n=391); analysis population not stated in the abstractprimarymedian follow-up 41 monthsMoore 201860% at 3 y27% at 3 yHR 0.30 (95% CI 0.23–0.41)P<0.001Kaplan-Meier estimate of freedom from disease progression and death at 3 years; the abstract gives no median PFS values. 388 patients had a centrally confirmed germline BRCA1/2 mutation and 2 a somatic mutation.
PFSlong term-updateBanerjee 2021median 56 monthsmedian 13.8 months (11.1–18.2)HR 0.33 (95% CI 0.25–0.43)Post-hoc update, investigator-assessed. The 95% CI for the olaparib median is 41.9 to not reached. Median follow-up 4.8 years with olaparib and 5.0 years with placebo.
OSRandomised patients (olaparib n=260, placebo n=131)long term-updateDiSilvestro 202367% at 7 y46.5% at 7 yHR 0.55 (95% CI 0.40–0.76)P=0.0004Prespecified descriptive analysis of OS (secondary end point) after 7 years of follow-up; p<0.0001 was required to declare statistical significance. Median follow-up 88.9 months (olaparib) and 87.4 months (placebo). Alive and without a first subsequent treatment at 7 years: 45.3% vs 20.6%. No median OS is given in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.30.23–0.41
PFS0.330.25–0.43
OS0.550.4–0.76
Illustrative — modelled from reported values, not trial data. PFS, long term-update.
0%25%50%75%100%020406080100120140Months (modelled)
  • Olaparib (experimental)
  • Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsOlaparibPlacebo
0100.0%100.0%
3564.8%17.2%
7042.0%3.0%
10527.3%0.5%
14017.7%0.1%
Primary publication: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018;379(26):2495-2505. PubMedDOI

Appears in

Sources

  1. Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018;379(26):2495-2505.

    PubMedDOI

  2. Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, et al. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021;22(12):1721-1731.

    PubMedDOI

  3. DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, et al. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023;41(3):609-617.

    PubMedDOI