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SOLO-1

Two years of an olaparib pill after chemotherapy made a large share of women with BRCA-mutated ovarian cancer long-term survivors.

PFS HR 0.30 at the primary analysis (NEJM 2018). At 7 years, 67.0% of olaparib patients were alive versus 46.5% on placebo (HR 0.55; JCO 2023), the first PARP inhibitor trial with a clinically meaningful overall survival gain in the first-line setting and the basis for the 2018 maintenance approval. Roughly half of olaparib patients remained progression-free at 5 years.

Setting
Newly diagnosed advanced BRCA-mutated ovarian cancer in response to platinum chemotherapy: olaparib maintenance for 2 years vs placebo
Phase
Phase 3
Sponsor
AstraZeneca / Merck
Registry
Headline result
PFS HR 0.30; 7-year OS 67.0% vs 46.5% (HR 0.55).
Reported
2018
Enrolled
391
Replication
PRIMA (niraparib) and PAOLA-1 (olaparib + bevacizumab) reproduced the PFS effect in HRD-positive disease; only SOLO-1 has shown a clear OS gain.

Outcomes

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In plain words
What these results mean for people, not percentages
391 people took part
Progression-free survivalprimarysurrogate endpoint
  • The treated group had about 70 percent lower chance of the event at any given time (hazard ratio 0.3).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survival at 7 yearssurvival endpoint
  • 67 vs 46.5 out of 100 alive at 7 years with Olaparib compared with Placebo; 20.5 more per 100.
  • Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 45 percent lower chance of the event at any given time (hazard ratio 0.55, likely range 0.4 to 0.76).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Newly diagnosed advanced BRCA-mutated ovarian cancer in response to platinum chemotherapy: olaparib maintenance for 2 years vs placebo. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (BRCA); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

391 participants enrolled.

Progression-free survivalprimary
HR 0.3 (0.23–0.41)

Numbers not yet public.

Source
Overall survival at 7 years
HR 0.55 (0.4–0.76)
Olaparib67 of 100
Placebo46.5 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryOlaparib2600.3 (0.23–0.41)link
Placebo131
Overall survival at 7 yearsOlaparib67%0.55 (0.4–0.76)link
Placebo46.5%
Replication
PRIMA (niraparib) and PAOLA-1 (olaparib + bevacizumab) reproduced the PFS effect in HRD-positive disease; only SOLO-1 has shown a clear OS gain.

Connected

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