. 2020 Oct 20;26(1):e164–e172. doi: 10.1002/onco.13551

Table 2.

Key features of the SOLO‐1 and PAOLA‐1 trial designs

Trial name	Patient population studied	Key demographics	Biomarker subgroups	Key clinical characteristics	Randomization	Stratification factors	Treatment duration	Endpoints
SOLO‐1 (n = 391)	Serous or endometrioid carcinomas with BRCA mutation	ECOG 0: 78% ECOG 1: 22% Stage III: 83% Stage IV: 17%	gBRCA: 388/391 sBRCA: 2/391 BRCA1: 72% BRCA2: 27% Both BRCA1/2: 1.2%	PSC: 63% IDS: 35% CR: 82% PR: 18%	2:1 olaparib 300 mg BID maintenance vs. placebo	Response to first‐line platinum‐based chemotherapy	Until disease progression or up to 2 years	Primary: PFS Secondary: OS
PAOLA‐1 (n = 806)	Serous or endometrioid carcinomas	ECOG 0: 70% ECOG 1: 28% Stage III: 70% Stage IV: 30%	HRD positive: 48% tBRCAm: 29% HRD negative: 34% HRD unknown: 18%	NED at PSC: 32% NED/CR at IDS: 31% NED/CR with incomplete resection/no debulking surgery: 15% PR: 22%	2:1 olaparib 300 mg BID + bevacizumab maintenance vs. placebo + bevacizumab maintenance	tBRCAm status determined by prospective local testing and first‐line treatment outcome (timing and outcome of cytoreductive surgery and response to platinum‐based chemotherapy)	Until disease progression or up to 2 years	Primary: PFS Secondary: OS

Trial name

Patient population studied

Key demographics

Biomarker subgroups

Key clinical characteristics

Randomization

Stratification factors

Treatment duration

Endpoints

SOLO‐1 (n = 391)

Serous or endometrioid carcinomas with BRCA mutation

ECOG 0: 78%

ECOG 1: 22%

Stage III: 83%

Stage IV: 17%

gBRCA: 388/391

sBRCA: 2/391

BRCA1: 72%

BRCA2: 27%

Both BRCA1/2: 1.2%

PSC: 63%

IDS: 35%

CR: 82%

PR: 18%

2:1 olaparib 300 mg BID maintenance vs. placebo

Response to first‐line platinum‐based chemotherapy

Until disease progression or up to 2 years

Primary: PFS

Secondary: OS

PAOLA‐1 (n = 806)

Serous or endometrioid carcinomas

ECOG 0: 70%

ECOG 1: 28%

Stage III: 70%

Stage IV: 30%

HRD positive: 48%

tBRCAm: 29%

HRD negative: 34%

HRD unknown: 18%

NED at PSC: 32%

NED/CR at IDS: 31%

NED/CR with incomplete resection/no debulking surgery: 15%

PR: 22%

2:1 olaparib 300 mg BID + bevacizumab maintenance vs. placebo + bevacizumab maintenance

tBRCAm status determined by prospective local testing and first‐line treatment outcome (timing and outcome of cytoreductive surgery and response to platinum‐based chemotherapy)

Until disease progression or up to 2 years

Primary: PFS

Secondary: OS

Abbreviations: BID, twice daily; CR, complete response; ECOG, Eastern Cooperative Oncology Group; gBRCA, germline BRCA; HRD, homologous recombination deficient; IDS, interval debulking surgery; NED, no evidence of disease; OS, overall survival; PFS, progression‐free survival; PR, partial response; PSC, primary surgical cytoreduction; sBRCA, somatic BRCA; tBRCAm, BRCA mutation detected in the tumor.