Overall Survival With Maintenance

original reports
Olaparib at a 7-Year Follow-Up in Patients With
Newly Diagnosed Advanced Ovarian Cancer and
a BRCA Mutation: The SOLO1/GOG 3004 Trial
Paul DiSilvestro, MD1; Susana Banerjee, MD, PhD2; Nicoletta Colombo, MD, PhD3; Giovanni Scambia, MD4; Byoung-Gie Kim, MD, PhD5;
Ana Oaknin, MD, PhD6; Michael Friedlander, MD7; Alla Lisyanskaya, MD8; Anne Floquet, MD9,10; Alexandra Leary, MD10,11;
Gabe S. Sonke, MD, PhD12; Charlie Gourley, MD, PhD13; Amit Oza, MD14; Antonio González-Martı́n, MD, PhD15,16;
Carol Aghajanian, MD17; William Bradley, MD18; Cara Mathews, MD1; Joyce Liu, MD19; John McNamara, MSc20; Elizabeth S. Lowe, MD21;
Mei-Lin Ah-See, MB BChir, MD22; and Kathleen N. Moore, MD23; on behalf of the SOLO1 Investigators
abstract

PURPOSE In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the
poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in
patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We
report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for
any poly(ADP-ribose) polymerase inhibitor in the first-line setting.
METHODS This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian
cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib
(n 5 260) or placebo (n 5 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end
point, was conducted after a 7-year follow-up.
RESULTS The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and
the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to
0.76; P 5 .0004 [P , .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients
versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not
received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome
and acute myeloid leukemia remained low, and new primary malignancies remained balanced between
treatment groups.
CONCLUSION Results indicate a clinically meaningful, albeit not statistically significant according to prespecified
criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian
cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this
setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term
ASSOCIATED follow-up.
CONTENT J Clin Oncol 41:609-617. © 2022 by American Society of Clinical Oncology
Appendix Creative Commons Attribution Non-Commercial No Derivatives 4.0 License
Data Supplement
Protocol INTRODUCTION The poly(ADP-ribose) polymerase (PARP) inhibitor ola-
Author affiliations parib represents the new standard of care in the man-
and support The ultimate goal of treatment in women newly diag-
nosed with ovarian cancer is cure. However, disease is agement of patients with newly diagnosed advanced
information (if
applicable) appear often advanced at the time of diagnosis and approxi- ovarian cancer and a BRCA1 and/or BRCA2 (BRCA)
at the end of this
mately 70% of patients who receive cytoreductive mutation. In the pivotal SOLO1/GOG 3004 trial, main-
article. tenance olaparib provided a sustained progression-free
surgery followed by first-line platinum-based chemo-
Accepted on
therapy will relapse within 3 years,1 with a 10-year survival (PFS) benefit beyond the end of treatment,
September 9, 2022
and published at survival of 17% in patients with advanced epithelial which was capped at 2 years, in patients with newly
ascopubs.org/journal/ ovarian cancer.2 Relapsed advanced ovarian cancer is diagnosed advanced ovarian cancer and a BRCA
jco on September 9, mutation.3,4 In the primary analysis (data cutoff [DCO]:
typically incurable, highlighting the need for effective
2022: DOI https://doi.
org/10.1200/JCO.22. first-line treatments that delay relapse, prolong survival, May 17, 2018), maintenance olaparib provided a sig-
01549 and enhance the potential for cure. nificant PFS benefit compared with placebo (hazard ratio

Volume 41, Issue 3 609

 DiSilvestro et al

CONTEXT
Key Objective
No overall survival (OS) benefit has yet been reported for poly(ADP-ribose) polymerase inhibitor maintenance therapy in
women with newly diagnosed advanced ovarian cancer. The authors here report OS with maintenance olaparib in SOLO1
patients with newly diagnosed advanced BRCA-mutated ovarian cancer after a 7-year follow-up.
Knowledge Generated
Results indicate a clinically meaningful, albeit not statistically significant, improvement in OS with maintenance olaparib
versus placebo, with two thirds of olaparib patients, versus fewer than half of placebo patients, alive at 7 years. No new
safety signals were observed.
Relevance (G. Fleming)
The SOLO1 data support the use of maintenance olaparib therapy in patients with newly diagnosed advanced ovarian
cancer and a BRCA mutation.*

*Relevance section written by JCO Associate Editor Gini Fleming, MD.

[HR], 0.30; 95% CI, 0.23 to 0.41; P , .001).3 In an updated partial response after first-line platinum-based chemo-
PFS analysis conducted after a 5-year follow-up (DCO: therapy (without bevacizumab). Patients who had re-
March 5, 2020), the median PFS was 56.0 months in the ceived prior PARP inhibitor therapy or who had a history
olaparib group compared with 13.8 months in the placebo or myelodysplastic syndrome (MDS) or acute myeloid
group (HR, 0.33; 95% CI, 0.25 to 0.43).4 On the basis of leukemia (AML) were ineligible. Full eligibility criteria are
Kaplan-Meier estimates, 48.3% versus 20.5% of patients, given in the Data Supplement (online only).
respectively, were progression-free at 5 years; overall survival The study Protocol (online only) was approved by the ethics
(OS) data were immature.4 committees at each participating site and performed in
We report a descriptive analysis of OS after a 7-year follow-up accordance with the Declaration of Helsinki, Good Clinical
in SOLO1. To our knowledge, this is the longest follow-up for Practice guidelines, and the AstraZeneca policy on bio-
any PARP inhibitor in newly diagnosed advanced ovarian ethics.6 All patients provided written informed consent.
cancer and the first report of long-term OS data for any PARP Treatment
inhibitor in this setting. Seven years is considered a clinically
relevant time point for survivorship, as modeling indicates Patients were randomly assigned (2:1) to receive olaparib
that most ovarian cancer–related deaths occur within 7 years tablets (300 mg twice daily) or placebo within 8 weeks of
of diagnosis, with mortality approaching that of women in the receiving their last dose of chemotherapy. Random as-
general population after a 9-year follow-up.5 signment was stratified according to clinical response
(complete or partial) after platinum-based chemotherapy.
Patients received treatment for up to 2 years or until
METHODS investigator-assessed objective radiologic disease pro-
Study Design and Patients gression (according to modified RECIST, version 1.1),
The design of the randomized, double-blind, placebo- whichever occurred first, or treatment was stopped if other
controlled, international, phase III SOLO1/GOG 3004 discontinuation criteria were met (Data Supplement). Pa-
study has been reported previously.3 In brief, eligible patients tients with no evidence of disease at 2 years stopped re-
had newly diagnosed, histologically confirmed advanced ceiving study treatment, but patients with evidence of
(International Federation of Gynaecology and Obstetrics disease at 2 years could continue to receive study treatment
[FIGO] stage III or IV) high-grade serous or endometrioid in a blinded manner if, in the opinion of the investigator, this
ovarian, primary peritoneal, and/or fallopian tube cancer. was in the patient’s best interest. Within the study, cross-
over between the treatment groups was not permitted. After
Patients were eligible for SOLO1 regardless of the timing of study treatment discontinuation, patients could receive
cytoreductive surgery or surgical outcome. Patients with subsequent therapies at the investigators’ discretion.
FIGO stage III disease had undergone an attempt at optimal
upfront or interval cytoreductive surgery, and those with Outcomes
FIGO stage IV disease had undergone a biopsy and/or Secondary end points reported in this analysis are OS
upfront or interval cytoreductive surgery. Patients had a (defined as the time from random assignment to death
germline or somatic BRCA1 and/or BRCA2 mutation on because of any cause), time from random assignment to
local or central testing and were in clinical complete or first subsequent therapy or death (TFST), time from random

610 © 2022 by American Society of Clinical Oncology Volume 41, Issue 3

 Overall Survival With Maintenance Olaparib at 7 Years in SOLO1

assignment to second subsequent therapy or death (TSST), patients (42.7%) and 92 patients (70.8%), respectively,
time from random assignment to discontinuation of study discontinued study treatment before 2 years, and 26 patients
treatment or death (TDT), and safety and tolerability. Adverse (10.0%) and three patients (2.3%), respectively, continued
events (AEs) were monitored using the National Cancer study treatment beyond 2 years. Seven of the 13 patients
Institute’s Common Terminology Criteria for Adverse Events who were receiving olaparib at the primary DCO (May 17,
(version 4.0) throughout the treatment period and for 2018)3 were still receiving olaparib at the current DCO.
30 days after discontinuation of study treatment. In addition,
At DCO (March 7, 2022), 149 of 391 patients had died
patients were proactively followed for MDS/AML and new
(data maturity 38.1%). The median OS was not reached
primary malignancies beyond the 30-day post-treatment
(95% CI, not reached to not reached) in the olaparib group
safety follow-up period.
compared with 75.2 months (95% CI, 65.4 to not reached)
Investigator-assessed PFS, the primary end point,3,4 and in the placebo group, with an HR of 0.55 (95% CI, 0.40 to
additional end points3,4,7,8 have been reported previously. 0.76; P 5 .0004 [P , .0001 required to declare statistical
Statistical Analysis significance]; Fig 2). This analysis was unadjusted for
subsequent therapy, and the OS benefit was achieved
Efficacy was analyzed in all randomly assigned patients (full despite 44.3% of patients in the placebo group having
analysis set), and safety was analyzed in all patients who received a PARP inhibitor in a subsequent line of therapy
received at least one dose of randomized treatment. (Table 1). Of the 122 olaparib patients and 97 placebo
This prespecified descriptive OS analysis was conducted patients who received any subsequent therapy (Data
7 years after the last patient was randomly assigned (DCO: Supplement), 31.1% and 59.8%, respectively, received a
March 7, 2022). A final OS analysis is currently planned to PARP inhibitor. On the basis of Kaplan-Meier estimates,
be conducted at approximately 60% data maturity as 67.0% of olaparib patients versus 46.5% of placebo pa-
prespecified in the study Protocol.3 OS was analyzed using tients were alive 7 years after random assignment.
a log-rank test stratified by response to first-line platinum- The median TFST (data maturity 59.6%) was 64.0 months
based chemotherapy, with HRs and 95% Cls estimated (95% CI, 47.7 to 93.2) with olaparib compared with
using a Cox proportional hazards model, including the 15.1 months (95% CI, 12.7 to 20.5) with placebo, with an
stratification variable as a covariate. OS was not adjusted for HR of 0.37 (95% CI, 0.28 to 0.48; Fig 3A). On the basis of
subsequent PARP inhibitor therapy. A two-sided P value Kaplan-Meier estimates, 45.3% of olaparib patients versus
of , .0001 was required to declare statistical significance 20.6% of placebo patients were alive and had not received
(Haybittle-Peto a 5 .0001). Kaplan-Meier methods were a first subsequent treatment after a 7-year follow-up. At the
used to generate time-to-event curves, from which medians time of DCO, 122 (46.9%) patients in the olaparib group
and survival proportions were calculated. and 95 (72.5%) in the placebo group had received a first
Analyses of TFST, TSST, and TDT were performed using a subsequent therapy (Data Supplement).
method similar to that used for the analysis of OS. The median TSST (data maturity 48.6%) was 93.2 months
All statistical analyses were performed using SAS software (95% CI, 84.2 to not reached) with olaparib compared with
version 9.4 (SAS Institute Inc, Cary, NC). 40.7 months (95% CI, 32.9 to 54.4) with placebo, with an
HR of 0.50 (95% CI, 0.37 to 0.67; Fig 3B). On the basis of
RESULTS Kaplan-Meier estimates, 56.9% of olaparib patients versus
32.5% of placebo patients were alive and had not received
All 260 patients randomly assigned to olaparib and 130 of
a second subsequent treatment after a 7-year follow-up. At
the 131 patients randomly assigned to placebo received
the time of DCO, 68 (26.2%) patients in the olaparib group
study treatment (one patient assigned to placebo withdrew
and 59 (45.0%) in the placebo group had received a
before receiving the intervention; Fig 1). Baseline char-
second subsequent therapy (Data Supplement).
acteristics were well balanced between the treatment
groups (Data Supplement). Consistent with the results reported previously,4 the median
TDT (data maturity 98.2%) was 24.6 months (95% CI, 24.0
For this descriptive OS analysis, DCO (March 7, 2022) took
to 24.8) in the olaparib group compared with 13.8 months
place 7 years after the last patient was randomly assigned,
(95% CI, 11.2 to 16.4) in the placebo group, with an HR of
with a median (interquartile range) duration of follow-up for
0.63 (95% CI, 0.51 to 0.78; Data Supplement).
OS of 88.9 (85.7-93.6) months in the olaparib group and
87.4 (84.3-91.7) months in the placebo group. The median After a 7-year follow-up, the safety profile of maintenance
(range) duration of treatment in the safety analysis set was olaparib was consistent with that reported at previous DCOs.3,4
24.6 (0.0-97.5) months in the olaparib group, consistent The most common AEs of any grade reported in olaparib
with the 2-year treatment cap, and 13.9 (0.2-60.9) months patients were nausea, fatigue/asthenia, vomiting, and anemia,
in the placebo group. Study treatment was completed at and the most common grade $ 3 AE was anemia (Table 2).
2 years, per the study Protocol, in 123 olaparib patients Serious AEs occurred in 21.2% of olaparib patients and
(47.3%) and 35 placebo patients (26.9%; Fig 1); 111 13.8% of placebo patients. The most commonly reported

Journal of Clinical Oncology 611

 DiSilvestro et al

Patients enrolled (N = 1,084)

Excluded (n = 693)
Did not meet eligibility criteria (n = 674)
Declined to participate (n = 14)
Lost to follow-up (n = 3)
Died (n = 2)

Patients randomly assigned and included

in efficacy analyses (n = 391)

Allocated to receive placebo (n = 131)

Allocated to receive olaparib (n = 260) Did not receive placebo owing (n = 1)
Received olaparib and included in (n = 260) to early withdrawal
safety analyses Received placebo and included in (n = 130)
safety analyses

Discontinued olaparib (n = 130) Discontinued placebo (n = 95)

Disease progression (n = 53) Disease progression (n = 78)
AEs (n = 31) AEs (n = 3)
Patient decision (n = 23) Patient decision (n = 2)
Study-specific discontinuation criteria (n = 6) Study-specific discontinuation criteria (n = 1)
Discontinued because of other reasons (n = 13) Discontinued because of other reasons (n = 10)
Severe noncompliance to protocol (n = 3) Lost to follow-up (n = 1)
Unknown reason (n = 1)
Completed treatment at 2 years, per protocol (n = 35)
Completed treatment at 2 years, per protocol (n = 123)

Received olaparib at DCO (n = 7) Received placebo at DCO (n = 0)

FIG 1. CONSORT diagram of patients. AE, adverse event; DCO, data cutoff.

serious AEs were anemia (7.3% of olaparib patients v 0.0% of tongue [n 5 1], and chronic myeloid leukemia [n 5 1]).
placebo patients) and neutropenia (1.5% v 0.0%). Six (2.3%) new primary malignancies occurred in olaparib
patients, and three (2.3%) occurred in placebo patients
Data on MDS/AML and new primary malignancies were
since the March 5, 2020, DCO.
collected both during study treatment and after discon-
tinuation of study treatment up to the time of DCO (March AEs were usually managed by dose interruption or re-
7, 2022). Since the primary DCO (May 17, 2018), one duction, with few patients (11.9% of olaparib patients and
(0.4%) new case of MDS has been reported in the olaparib 3.1% of placebo patients) requiring treatment discontin-
group and one (0.8%) new case of acute myelomonocytic uation because of AEs (Table 2).
leukemia has been reported in the placebo group. In total,
after a 7-year follow-up, four (1.5%) cases of MDS/AML DISCUSSION
were reported in the olaparib group and one (0.8%) case The median duration of follow-up of approximately
of MDS/AML was reported in the placebo group. In total, 88 months reported in this descriptive SOLO1 analysis
after a 7-year follow-up, new primary malignancies were represents the longest follow-up for any PARP inhibitor in
reported in 14 (5.4%) olaparib patients (breast cancer newly diagnosed advanced ovarian cancer. With an HR for
[n 5 10], lip and/or oral cavity cancer [n 5 1], thyroid OS of 0.55 (95% CI, 0.40 to 0.76) observed with main-
cancer [n 5 1], pancreatic adenocarcinoma [n 5 1], and tenance olaparib (administered for # 2 years in most
gall bladder adenocarcinoma [n 5 1]) and eight (6.2%) patients) versus placebo and 67.0% of olaparib patients
placebo patients (breast cancer [n 5 5], lung adeno- (v 46.5% of placebo patients) alive at 7 years, SOLO1 is
carcinoma [n 5 1], squamous cell carcinoma of the the first study to indicate a clinically meaningful

612 © 2022 by American Society of Clinical Oncology Volume 41, Issue 3

 Overall Survival With Maintenance Olaparib at 7 Years in SOLO1

TABLE 1. Subsequent PARP Inhibitor Therapy previously reported in patients with newly diagnosed ad-
Olaparib (n 5 260), Placebo (n 5 131), vanced ovarian cancer and a BRCA mutation,9 the 5-year
Patients Receiving PARP Inhibitor No. (%) No. (%) and 7-year OS rates of 73.1% and 67.0%, respectively, seen
Subsequent PARP inhibitor (any line) 38 (14.6) 58 (44.3) in SOLO1 patients receiving maintenance olaparib represent
First subsequent therapy 15 (5.8) 32 (24.4) an important advance; it should be noted that OS rates in
SOLO1 were calculated from the time of random assignment
Second subsequent therapy 14 (5.4) 17 (13.0)
rather than from the time of diagnosis.
Third subsequent therapy 7 (2.7) 5 (3.8)
It is difficult to demonstrate improvements in OS in ovarian
Fourth subsequent therapy 0 3 (2.3)
cancer trials because of the number and variety of uncon-
Fifth subsequent therapy 2 (0.8) 1 (0.8)
trolled postprogression treatment options including experi-
Abbreviation: PARP, poly(ADP-ribose) polymerase. mental agents.10,11 In this descriptive OS analysis, more than
40% of placebo patients (v 14.6% of olaparib patients) re-
ceived subsequent therapy with a PARP inhibitor (and 59.8%
improvement in OS with PARP inhibitor maintenance of placebo patients v 31.1% of olaparib patients who received
therapy in the first-line setting. any subsequent therapy received a PARP inhibitor); this is
Data maturity for OS was 38.1% in the current analysis, and likely to have affected the OS results, which were unadjusted
the SOLO1 final OS analysis is currently planned to be for subsequent PARP inhibitor therapy. Subsequent treatment
conducted once data maturity reaches approximately with a PARP inhibitor may also partly explain the relatively long
60%.3 Given that the event rate for OS is slower than that median OS of 75.2 months observed in the placebo arm. This
anticipated at the onset of the study and it may be many compares with a median OS of 58.3 months in patients,
years before the threshold to conduct the final OS analysis irrespective of biomarker status, who were in clinical complete
is met, performing a descriptive OS analysis at 7 years, a response after first-line platinum-based chemotherapy and
clinically relevant time point, was important to help inform enrolled in the surveillance arm of the phase III GOG 0212
treatment decisions. The Haybittle-Peto a spending trial; , 20% of patients were alive and progression-free after a
function required a P , .0001 to show statistical signifi- median follow-up in the overall patient population of 8.1
cance in the current descriptive analysis (administrative a years.12 BRCA-mutated patients in the placebo arm of the
spending), allowing the statistical power of the final OS phase III GOG 0218 trial had a median OS of 61.2 months13; it
analysis to be preserved. Although not reaching the should be noted that compared with SOLO1, patients in GOG
threshold for statistical significance, we consider the OS 0218 had a worse prognosis (patients with FIGO stage III
benefit shown in this 7-year descriptive analysis to be disease and complete resection after cytoreductive surgery
clinically meaningful. Given the 5-year survival rate of 38.1% were excluded), and random assignment in GOG 0218

Olaparib Placebo
(n = 260) (n = 131)
Events, No. (%) 84 (32.3) 65 (49.6)
100 Median OS, months NR 75.2

90 HR 0.55 (95% CI, 0.40 to 0.76); P = .0004

80
73.1
70 67.0
63.4
60
OS (%)

Olaparib
50 46.5

40

30 Placebo

20

10

0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102

Time Since Random Assignment (months)

No. at risk:
Olaparib 260 252 246 236 227 214 203 194 185 177 170 165 159 157 153 79 21 0
Placebo 131 128 125 114 108 100 97 92 87 80 73 67 60 54 52 21 6 0

FIG 2. Kaplan-Meier estimates of OS. HR, hazard ratio; NR, not reached; OS, overall survival.

Journal of Clinical Oncology 613

 DiSilvestro et al

A B
Olaparib Placebo Olaparib Placebo

Subsequent Therapy or Death (%)

(n = 260) (n = 131) (n = 260) (n = 131)
Subsequent Therapy or Death (%)
Events, No. (%) 135 (51.9) 98 (74.8) Events, No. (%) 110 (42.3) 80 (61.1)
100 100

Patients Free From Second

Median TFST, months 64.0 15.1 Median TSST, months 93.2 40.7
Patients Free From First

90 HR 0.37 (95% CI, 0.28 to 0.48) 90 HR 0.50 (95% CI, 0.37 to 0.67)

80 80
70 70
61.9
60 60 56.9
51.2
50 45.3 50
Olaparib
40 40 35.3 32.5
30 Olaparib 30
22.5 Placebo
20.6
20 20
Placebo
10 10

0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102

Time Since Random Assignment (months) Time Since Random Assignment (months)
No. at risk: No. at risk:
Olaparib 260 240 223 203 190 160 147 141 132 125 119 115 111 102 75 31 5 0 Olaparib 260 248 240 227 206 188 175 162 153 148 142 140 132 125 95 41 8 0
Placebo 131 114 79 55 45 39 32 28 26 25 25 24 24 23 18 4 1 0 Placebo 131 126 118 102 85 74 65 56 50 46 39 38 38 36 30 9 1 0

FIG 3. Kaplan-Meier estimates of (A) TFST and (B) TSST. HR, hazard ratio; TFST, time to first subsequent therapy or death; TSST, time to second
subsequent therapy or death.

occurred before the start of chemotherapy. Advances in the versus placebo in the time between random assignment
management of relapsed ovarian cancer, including im- and the first subsequent treatment, with 45.3% of olaparib
provements in the sequencing of therapies and supportive patients (v 20.6% of placebo patients) alive and still to
care, might have also contributed to the median OS seen in receive a first subsequent therapy after a 7-year follow-up.
placebo patients in SOLO1. OS results from other ongoing These data suggest that maintenance olaparib might en-
trials evaluating PARP inhibitor maintenance therapy in the hance the potential for cure although longer follow-up is
newly diagnosed setting (eg, combination maintenance needed for a more definitive evaluation of cure. Modeling
therapy with olaparib plus bevacizumab in PAOLA-1,14 data suggest that 10-year survival appears to be an ap-
maintenance niraparib in PRIMA,15 and maintenance ruca- propriate surrogate of cure in this setting.5
parib in ATHENA-MONO16) are awaited with interest.
TSST data are also consistent with the previously reported
The results of SOLO1 emphasize the importance of both PFS benefit3,4 and indicate that the benefit of maintenance
testing for both germline and somatic BRCA mutations and
olaparib persists beyond the first subsequent therapy.19
providing PARP inhibitor maintenance therapy to all BRCA-
mutated patients with advanced disease in the first-line After a 7-year follow-up, the safety profile of maintenance
setting, rather than delaying the introduction of PARP in- olaparib was consistent with that reported at earlier DCOs
hibitors until patients have experienced relapse. On the (May 17, 2018,3 and March 5, 20204), with no new safety
basis of the results of SOLO1, maintenance therapy with signals detected. It is reassuring that the incidence of MDS/
olaparib is capped at 2 years in the first-line setting al- AML remained low and the incidence of new primary ma-
though patients with evidence of disease at this time point lignancies remained balanced between the treatment arms
can be treated beyond 2 years.17,18 This descriptive OS after 7 years of active follow-up for these events in SOLO1.
analysis (DCO March 7, 2022) confirms findings from Only one new case of MDS/AML has been reported in the
earlier PFS analyses in SOLO1 (DCO May 17, 2018,3 and olaparib arm since the primary DCO on May 17, 2018. The
March 5, 20204) that the benefit of maintenance olaparib low risk of MDS/AML observed in SOLO1 is consistent with
extends well beyond its 2-year treatment cap in patients that reported in other PARP inhibitor maintenance therapy
with newly diagnosed advanced ovarian cancer and a trials in the newly diagnosed setting.14-16 A higher incidence of
BRCA mutation. Indeed, the SOLO1 OS data support the MDS/AML has been observed in PARP inhibitor maintenance
use of maintenance olaparib to achieve long-term remis- therapy trials in patients with relapsed ovarian cancer.20,21 The
sion in BRCA-mutated patients with newly diagnosed ad- incidence of MDS/AML in the relapsed disease setting should
vanced ovarian cancer. be considered in the context of potential baseline risk factors
It is noteworthy that for a considerable proportion of ola- for MDS/AML (eg, prior chemotherapy with DNA-damaging
parib patients, the SOLO1 OS data reflect disease-free agents) and the long latency of these events. A contributing
survival. Although updated PFS data are not available, role for PARP inhibitors cannot be excluded, and long-term
TFST was evaluated as a proxy for PFS.19 TFST data active surveillance for MDS/AML events after discontinuation
showed a substantial delay with maintenance olaparib of PARP inhibitor maintenance therapy is prudent.

614 © 2022 by American Society of Clinical Oncology Volume 41, Issue 3

 Overall Survival With Maintenance Olaparib at 7 Years in SOLO1

TABLE 2. Summary of AEsa

Olaparib (n 5 260), No. (%) Placebo (n 5 130), No. (%)

Patient With AE Any Grade Grade ‡ 3 Any Grade Grade ‡ 3

Any 256 (98.5) 103 (39.6) 120 (92.3) 26 (20.0)
Nausea 202 (77.7) 2 (0.8) 49 (37.7) 0.0
Fatigue or asthenia 167 (64.2) 10 (3.8) 54 (41.5) 2 (1.5)
Vomiting 104 (40.0) 1 (0.4) 19 (14.6) 1 (0.8)
b
Anemia 104 (40.0) 57 (21.9) 13 (10.0) 2 (1.5)
Diarrhea 90 (34.6) 8 (3.1) 32 (24.6) 0.0
Arthralgia 75 (28.8) 0.0 39 (30.0) 0.0
Constipation 72 (27.7) 0.0 25 (19.2) 0.0
Abdominal pain 67 (25.8) 4 (1.5) 25 (19.2) 1 (0.8)
Headache 60 (23.1) 1 (0.4) 31 (23.8) 3 (2.3)
Neutropeniac 60 (23.1) 22 (8.5) 15 (11.5) 6 (4.6)
Dysgeusia 56 (21.5) 0.0 5 (3.8) 0.0
Dizziness 53 (20.4) 0.0 20 (15.4) 1 (0.8)
Decreased appetite 53 (20.4) 0.0 13 (10.0) 0.0
Upper abdominal pain 45 (17.3) 0.0 17 (13.1) 0.0
Cough 44 (16.9) 0.0 28 (21.5) 0.0
Dyspepsia 43 (16.5) 0.0 16 (12.3) 0.0
Back pain 42 (16.2) 0.0 16 (12.3) 0.0
Dyspnea 41 (15.8) 0.0 7 (5.4) 0.0
Pyrexia 32 (12.3) 0.0 12 (9.2) 0.0
Urinary tract infection 31 (11.9) 2 (0.8) 8 (6.2) 0.0
Upper respiratory tract infection 30 (11.5) 0.0 12 (9.2) 0.0
Pain in extremity 30 (11.5) 0.0 11 (8.5) 0.0
d
Thrombocytopenia 29 (11.2) 2 (0.8) 5 (3.8) 2 (1.5)
Nasopharyngitis 28 (10.8) 0.0 17 (13.1) 0.0
Insomnia 27 (10.4) 0.0 16 (12.3) 0.0
Myalgia 26 (10.0) 0.0 13 (10.0) 0.0
Depression 14 (5.4) 1 (0.4) 13 (10.0) 1 (0.8)
Leading to dose interruption 137 (52.7) — 22 (16.9) —
Leading to dose reduction 75 (28.8) — 4 (3.1) —
Leading to treatment discontinuation 31 (11.9) — 4 (3.1) —

Abbreviation: AE, adverse event.

a
Data are shown for treatment-emergent AEs that occurred in at least 10.0% of patients in either treatment group during study treatment or up to 30 days
after discontinuation of study treatment.
b
Includes patients with anemia or decreased hemoglobin.
c
Includes patients with neutropenia, febrile neutropenia, or decreased neutrophil count.
d
Includes patients with thrombocytopenia or decreased platelet count.

In conclusion, after a 7-year follow-up, results indicate a diagnosed advanced ovarian cancer and a BRCA mutation.
clinically meaningful, albeit not statistically significant These data support the use of maintenance olaparib to
according to prespecified criteria, improvement in OS with achieve long-term remission in this setting; the potential for
maintenance olaparib versus placebo in patients with newly cure may also be enhanced.

Journal of Clinical Oncology 615

 DiSilvestro et al

AFFILIATIONS CLINICAL TRIAL INFORMATION

1
Program in Women’s Oncology, Women & Infants Hospital, Providence, RI NCT01844986
2
The Royal Marsden NHS Foundation Trust and Institute of Cancer
Research, London, United Kingdom
3
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF
University of Milan-Bicocca and Istituto Europeo di Oncologia IRCCS,
Milan, Italy
INTEREST
4
Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy Disclosures provided by the authors are available with this article at DOI
5
Samsung Medical Center, Sungkyunkwan University School of https://doi.org/10.1200/JCO.22.01549.
Medicine, Seoul, South Korea
6
Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology DATA SHARING STATEMENT
(VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Data underlying the findings described in this manuscript may be
Hospital Campus, Barcelona, Spain obtained in accordance with AstraZeneca’s data sharing policy described
7
University of New South Wales Clinical School, Prince of Wales Hospital, at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/
Randwick, New South Wales, Australia Disclosure.
8
St Petersburg City Oncology Dispensary, St Petersburg, Russia
9
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, France
10
Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Paris,
AUTHOR CONTRIBUTIONS
France Conception and design: Paul DiSilvestro, Giovanni Scambia, Gabe S.
11
Institut Gustave-Roussy, Villejuif, France Sonke, Amit Oza, Elizabeth S. Lowe, Kathleen N. Moore
12
The Netherlands Cancer Institute, Amsterdam, the Netherlands Administrative support: John McNamara
13
Cancer Research UK Scotland Center, University of Edinburgh, Provision of study materials or patients: Susana Banerjee, Nicoletta
Edinburgh, United Kingdom Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael
14
Princess Margaret Cancer Center, Toronto, ON, Canada Friedlander, Alla Lisyanskaya, Anne Floquet, Alexandra Leary, Gabe S.
15
Clı́nica Universidad de Navarra, Madrid, Spain Sonke, Charlie Gourley, Amit Oza, Antonio González-Martı́n, Carol
16
Program In Solid Tumours, CIMA, Pamplona, Spain Aghajanian, William Bradley, Cara Mathews, Joyce Liu, Kathleen N.
17
Memorial Sloan Kettering Cancer Center, New York, NY Moore
18
Froedtert and the Medical College of Wisconsin, Milwaukee, WI Collection and assembly of data: Susana Banerjee, Nicoletta Colombo,
19
Dana-Farber Cancer Institute, Boston, MA Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander,
20
Biostatistics, Oncology Biometrics, Oncology R&D, AstraZeneca, Alla Lisyanskaya, Anne Floquet, Alexandra Leary, Gabe S. Sonke, Charlie
Cambridge, United Kingdom Gourley, Amit Oza, Antonio González-Martı́n, Carol Aghajanian, William
21
Global Medicines Development, Oncology, AstraZeneca, Gaithersburg, MD Bradley, Cara Mathews, Joyce Liu, John McNamara, Elizabeth S. Lowe,
22
Oncology R&D, Late-stage Development, AstraZeneca, Cambridge, Mei-Lin Ah-See, Kathleen N. Moore
United Kingdom Data analysis and interpretation: All authors
23
Stephenson Oklahoma Cancer Center, Oklahoma City, OK Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
CORRESPONDING AUTHOR
Paul DiSilvestro, MD, Women & Infants Hospital, 101 Dudley St,
Providence, RI 02905; e-mail: pdisilvestro@wihri.org.
ACKNOWLEDGMENT
We thank all the women who participated in this study, their families, and
the investigators. We thank Steve Keefe (Merck & Co Inc) for his
SUPPORT contributions to this study. A complete list of collaborators from the
Supported by AstraZeneca and this work is part of an alliance between SOLO1 investigators is provided in Appendix Table A1 (online only).
AstraZeneca and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co
Inc, Rahway, NJ. Medical writing assistance was provided by Gillian
Keating MBChB of Cence.

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14. Ray-Coquard I, Pautier P, Pignata S, et al: Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med 381:2416-2428, 2019
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n n n

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 DiSilvestro et al

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

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
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted.
Relationships are self-held unless noted. I 5 Immediate Family Member, Inst 5 My Institution. Relationships may not relate to the subject matter of this manuscript.
For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Paul DiSilvestro Gabe S. Sonke

Consulting or Advisory Role: AstraZeneca, GlaxoSmithKline/Tesaro Consulting or Advisory Role: Novartis (Inst), Seattle Genetics (Inst), Biovica
Research Funding: Janssen Oncology (Inst), Tesaro (Inst), AstraZeneca (Inst), (Inst)
Genentech (Inst), AbbVie (Inst) Research Funding: Merck Sharp & Dohme (Inst), Agendia (Inst), AstraZeneca/
Merck (Inst), Roche (Inst), Novartis (Inst)
Susana Banerjee
Honoraria: AstraZeneca, GlaxoSmithKline, Clovis Oncology, Pfizer, Immunogen, Charlie Gourley
MSD Oncology, Mersana, Roche, Takeda, Amgen Honoraria: AstraZeneca, GlaxoSmithKline, MSD Oncology, Clovis Oncology,
Consulting or Advisory Role: Amgen, GlaxoSmithKline, MSD Oncology, Takeda
Mersana, AstraZeneca, Seattle Genetics, OncXerna Therapeutics, Shattuck Consulting or Advisory Role: AstraZeneca, Cor2Ed, GlaxoSmithKline, MSD
Labs, Merck Serono, Immunogen Oncology, Clovis Oncology
Research Funding: GlaxoSmithKline (Inst), AstraZeneca (Inst) Research Funding: AstraZeneca (Inst), GlaxoSmithKline (Inst), MSD Oncology
(Inst), Novartis (Inst), BerGenBio (Inst), MedAnnex (Inst)
Nicoletta Colombo
Patents, Royalties, Other Intellectual Property: One patent issued and four
Employment: Sarepta Therapeutics (I)
pending for a gene expression signature to predict cancer sensitivity to
Honoraria: Roche/Genentech, AstraZeneca, Tesaro, GlaxoSmithKline, MSD
antiangiogenic therapy (Inst)
Oncology, Clovis Oncology, Pfizer, Amgen, Immunogen, Novartis, Pfizer,
Expert Testimony: Amgen
Mersana, Eisai, Advaxis, Nuvation Bio
Consulting or Advisory Role: Roche/Genentech, AstraZeneca, Clovis Oncology, Amit Oza
Pfizer, MSD Oncology, Tesaro, GlaxoSmithKline, Immunogen, Pfizer, Mersana, Uncompensated Relationships: Ozmosis Research
Eisai, Advaxis, Nuvation Bio
Antonio González-Martı́n
Giovanni Scambia Consulting or Advisory Role: Roche, Tesaro/GSK, Clovis Oncology, AstraZeneca,
Consulting or Advisory Role: Clovis Oncology, AstraZeneca, PharmaMar, Roche, MSD, Genmab, Immunogen, Oncoinvent, Pfizer/EMD Serono, Amgen, Mersana,
Tesaro SOTIO, Sutro Biopharma, MacroGenics, Novartis, Alkermes, Hedera Dx,
Speakers’ Bureau: Clovis Oncology, MSD Novocure, Seattle Genetics, Takeda
Speakers’ Bureau: Roche, AstraZeneca, Tesaro/GSK, PharmaMar, Clovis
Ana Oaknin
Oncology, MSD Oncology
Consulting or Advisory Role: Roche, AstraZeneca, PharmaMar, Clovis Oncology,
Research Funding: Roche (Inst), Tesaro/GSK (Inst)
Tesaro, Immunogen, Genmab, Mersana, GSK, Deciphera, AGENUS, Corcept
Travel, Accommodations, Expenses: Roche, AstraZeneca, PharmaMar,
Therapeutics, Eisai, EMD Serono, F. Hoffmann-La Roche, Medison, Merck
Tesaro/GSK, MSD Oncology
Sharp & Dohme, Novocure, prIME Oncology, Shattuck Labs, Sutro Biopharma,
ITeos Therapeutics, Amgen Carol Aghajanian
Research Funding: AbbVie (Inst), Ability Pharmaceuticals (Inst), Advaxis (Inst), Consulting or Advisory Role: Eisai, AstraZeneca/Merck, Roche/Genentech,
Aeterna Zentaris (Inst), Aprea Therapeutics (Inst), Clovis Oncology Inc (Inst), Repare Therapeutics
Eisai (Inst), Roche (Inst), Regeneron (Inst), Agenus (Inst), AstraZeneca (Inst), Research Funding: Genentech/Roche (Inst), AbbVie (Inst), Clovis Oncology
BeiGene (Inst), Belgian Gynaecological Oncology Group (BGOG) (Inst), Bristol (Inst), AstraZeneca (Inst)
Myers Squibb International Corporation (BMS) (Inst), Corcept Therapeutics
William Bradley
(Inst), Immunogen (Inst), Iovance Biotherapeutics (Inst), Lilly (Inst),
Consulting or Advisory Role: Celsion, Inovio Pharmaceuticals
Medimmune (Inst), Merck (Inst), Merck Sharp & Dohme (Inst), Mundipharma
Travel, Accommodations, Expenses: Inovio Pharmaceuticals, Clovis Oncology
Research (Inst), /Inst), Seagen (Inst), Seattle Genetics (Inst), Sutro Biopharma
(Inst), Tesaro (Inst), Verastem (Inst) Cara Mathews
Travel, Accommodations, Expenses: AstraZeneca, Clovis Oncology, Research Funding: AstraZeneca (Inst), Tesaro/GSK (Inst), Syros
PharmaMar, Roche Pharmaceuticals (Inst), Astellas Pharma (Inst), Seattle Genetics (Inst),
Deciphera (Inst), Moderna Therapeutics (Inst), Regeneron (Inst), Roche/
Michael Friedlander
Genentech (Inst), Pfizer (Inst), Laekna Therapeutics (Inst), EMD Serono (Inst),
Honoraria: AstraZeneca, MSD, Lilly, Takeda, Novartis, GlaxoSmithKline
Merck (Inst)
Consulting or Advisory Role: AstraZeneca, MSD, AbbVie, Lilly, Takeda, Novartis,
GlaxoSmithKline, Eisai, Incyclix Joyce Liu
Speakers’ Bureau: AstraZeneca, ACT Genomics, GlaxoSmithKline Consulting or Advisory Role: Clovis Oncology, Genentech/Roche,
Research Funding: BeiGene (Inst), AstraZeneca (Inst), Novartis (Inst) GlaxoSmithKline, Regeneron, AstraZeneca, Eisai
Travel, Accommodations, Expenses: AstraZeneca Research Funding: Genentech/Roche (Inst), AstraZeneca (Inst), Boston
Biomedical (Inst), Acetylon Pharmaceuticals (Inst), Bristol Myers Squibb (Inst),
Alla Lisyanskaya
Agenus (Inst), CytomX Therapeutics (Inst), Regeneron (Inst), Tesaro (Inst),
Honoraria: Incuron (Inst), MSD (Inst), AstraZeneca (Inst), Regeneron (Inst),
Clovis Oncology (Inst), Surface Oncology (Inst), 23 Oncology (Inst), Vigeo
Roche (Inst)
Therapeutics (Inst), Aravive (Inst), Arch Oncology (Inst), Zentalis (Inst)
Research Funding: Incuron, Roche, AstraZeneca, Regeneron, MSD
Uncompensated Relationships: Merck
Anne Floquet
John McNamara
Honoraria: GlaxoSmithKline
Employment: AstraZeneca
Travel, Accommodations, Expenses: GlaxoSmithKline, PharmaMar,
Stock and Other Ownership Interests: AstraZeneca
AstraZeneca
Consulting or Advisory Role: AstraZeneca
Alexandra Leary Travel, Accommodations, Expenses: AstraZeneca
Honoraria: Medscape
Elizabeth S. Lowe
Consulting or Advisory Role: Clovis Oncology (Inst), AstraZeneca (Inst), Tesaro
Employment: AstraZeneca
(Inst), MSD (Inst), GlaxoSmithKline (Inst), Merck Serono (Inst), Zentalis,
Stock and Other Ownership Interests: AstraZeneca
PEGASCY, Blueprint Medicines (Inst)
Research Funding: Inivata (Inst), Sanofi (Inst)
Travel, Accommodations, Expenses: AstraZeneca, Tesaro

© 2022 by American Society of Clinical Oncology Volume 41, Issue 3

 Overall Survival With Maintenance Olaparib at 7 Years in SOLO1

Mei-Lin Ah-See (Inst), InxMed (Inst), Mereo BioPharma (Inst), OncXerna Therapeutics,
Employment: AstraZeneca Onconova Therapeutics, Mereo BioPharma, Novartis
Stock and Other Ownership Interests: AstraZeneca Research Funding: PTC Therapeutics (Inst), Lilly (Inst), Merck (Inst), Tesaro
Consulting or Advisory Role: AstraZeneca (I), Bard1 Bioscience (I) (Inst), Genentech (Inst), Clovis Oncology (Inst), Lilly Foundation (Inst),
Research Funding: GRAIL (I), Johnson and Johnson (I) Regeneron (Inst), Advaxis (Inst), Bristol Myers Squibb (Inst), Verastem (Inst),
Patents, Royalties, Other Intellectual Property: Progression of precancerous Novartis Pharmaceuticals UK Ltd (Inst), AstraZeneca (Inst), Agenus (Inst),
lesion predictor (I) Takeda (Inst), Forty Seven (Inst), Stem CentRx (Inst), Immunogen (Inst), Bayer
(Inst), Novogen (Inst), AbbVie/Stemcentrx (Inst), Artios (Inst), Bolt
Kathleen N. Moore
Biotherapeutics (Inst), Amgen (Inst), Daiichi Sankyo/Lilly (Inst), Cyteir (Inst),
Leadership: GOG Partners, NRG Oncology (Inst)
Immunocore (Inst)
Honoraria: Research To Practice, Prime Oncology, Physicians’ Education
Patents, Royalties, Other Intellectual Property: UpToDate
Resource, Great Debates and Updates
Other Relationship: GOG Partners (Inst)
Consulting or Advisory Role: Genentech/Roche, Immunogen, AstraZeneca, VBL
Therapeutics, Merck, Aravive, Eisai, Mersana (Inst), Myriad Genetics, Alkermes No other potential conflicts of interest were reported.
(Inst), Blueprint Pharmaceuticals (Inst), GlaxoSmithKline/Tesaro (Inst), I-Mab

Journal of Clinical Oncology

 DiSilvestro et al

APPENDIX

TABLE A1. List of SOLO1 Principal Investigators for Each Site That Randomly Assigned Patients in the Study
Site No. Principal Investigator No. of Patients Randomly Assigned Country
4102 Nicoletta Colombo 20 Italy
4106 Giovanni Scambia 18 Italy
6003 Byoung-Gie Kim 11 South Korea
7001 Ana Oaknin 11 Spain
0305 Michael Friedlander 10 Australia
6203 Alla Lisyanskaya 10 Russia
2804/2805 Susana Banerjee 9 United Kingdom
2302 Anne Floquet 9 France
2307 Catherine Lhommea/Alexandra 9 France
Leary
5001 Gabe Sonke 9 the Netherlands
2801 Charlie Gourley 9 United Kingdom
1001 Amit Oza 8 Canada
7002 Antonio González-Martı́n 8 Spain
7907 Carol Aghajanian 7 United States
4107 Francesco Raspagliesi 6 Italy
6002 Jae-Weon Kim 6 South Korea
7849 William Bradley 6 United States
7803/7804/7805 Joyce Liu 5 United States
1005 Lucy Gilbert 5 Canada
1004 Diane Provencher 5 Canada
4105 Francesco Cognetti 5 Italy
6001 Joo-Hyun Nam 5 South Korea
5706 Magdalena Sikorska 5 Poland
6205 Sergey Tjulandin 5 Russia
7861 Daniel Anderson 5 United States
7801 Cara Mathews 5 United States
0304 Clare Scott 4 Australia
1007 Allan Covens 4 Canada
1002 Hal Hirte 4 Canada
a
2309 Frédéric Selle /Jean-Pierre Lotz 4 France
4003 Amnon Amit 4 Israel
4001 Roni Shapira Frommer 4 Israel
6006 Sang-Yoon Park 4 South Korea
7004 Andrés Poveda 4 Spain
7873 Robert Burger 4 United States
7855 Guilherme Cantuaria 4 United States
1003 Stephen Welch 3 Canada
2306 Alain Lortholary 3 France
4005 Ram Eitan 3 Israel
4309 Koji Matsumoto 3 Japan
4312 Kazuhiro Takehara 3 Japan
(continued on following page)

© 2022 by American Society of Clinical Oncology Volume 41, Issue 3

 Overall Survival With Maintenance Olaparib at 7 Years in SOLO1

TABLE A1. List of SOLO1 Principal Investigators for Each Site That Randomly Assigned Patients in the Study (continued)
Site No. Principal Investigator No. of Patients Randomly Assigned Country
5705 Mariusz Bidzinski 3 Poland
5702 Tomasz Byrski 3 Poland
6204 Olga Mikheeva 3 Russia
7007 Beatriz Pardo Búrdalo 3 Spain
7829 Michael Callahan 3 United States
7927 Michael Carney 3 United States
7816 Robin Farias-Eisner 3 United States
7850 Joanie Hope 3 United States
7826 Daniel Kredentser 3 United States
7846 David O’Malley 3 United States
7823 Jeanne Schilder 3 United States
0306 Linda Mileshkin 2 Australia
1306 Rutie Yin 2 China
1307 Jianqing Zhu 2 China
4108 PierFranco Conte 2 Italy
4101 Sandro Pignata 2 Italy
4301 Keiichi Fujiwara 2 Japan
4313 Yasuyuki Hirashima 2 Japan
4305 Toshiaki Saito 2 Japan
6005 Sang-Young Ryu 2 South Korea
6210 Galina Statsenko 2 Russia
7006 Andrés Redondo 2 Spain
7005 Marı́a Jesús Rubio Pérez 2 Spain
2808 James Brenton 2 United Kingdom
7890 Sarah Adams 2 United States
7872 Deborah Armstrong 2 United States
7879 Michael Carney 2 United States
7802 Oliver Dorigo 2 United States
7892 John Farley 2 United States
7864 James Kendrick 2 United States
7895 Joseph Lucci 2 United States
7888 Donna McNamara 2 United States
7807 Kathleen Moore 2 United States
7874 Heather Pulaski 2 United States
7840 Luis Rojas-Espaillat 2 United States
7825 Peter Rose 2 United States
7865 Mark Shahin 2 United States
7830 Nicholas Taylor 2 United States
7819 Timothy Vanderkwaak 2 United States
7847 Robert Wenham 2 United States
0701 Roberto Hegg 1 Brazil
1006 Marie Plante 1 Canada
1317 Qi Zhou 1 China
(continued on following page)

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 DiSilvestro et al

TABLE A1. List of SOLO1 Principal Investigators for Each Site That Randomly Assigned Patients in the Study (continued)
Site No. Principal Investigator No. of Patients Randomly Assigned Country
2305 Florence Joly 1 France
2310 Béatrice Webera/Marie-Christine 1 France
Kaminsky
4002 Yfat Kadan 1 Israel
4304 Kenji Tamura 1 Japan
4310 Hidemichi Watari 1 Japan
6004 Jae Hoon Kim 1 South Korea
5704 Pawel Rózanowski 1 Poland
7003 Andrés Cervantes Ruipérez 1 Spain
2802 Jonathan Ledermann 1 United Kingdom
2806 Christopher Poole 1 United Kingdom
7914 Jamie Bakkum-Gamez 1 United States
7815 Kian Behbakht 1 United States
7843 Christopher Darus 1 United States
7841 Babak Edraki 1 United States
7901 David Engle 1 United States
7919/7926 Lou Fehrenbacher 2 United States
7878 Charles Harrison 1 United States
7917 Monica Hayes 1 United States
7860 Robert Higgins 1 United States
7903 Timothy Lestingi 1 United States
7806 Nathalie McKenzie 1 United States
7867 Peter Morris 1 United States
7828 David Mutch 1 United States
7883 Janet Osborne 1 United States
7876 Elena Ratner 1 United States
7899 Bobbie Jo Rimel 1 United States
7814 Shohreh Shahabi 1 United States
7886 Gamini Soori 1 United States
7851 Nicola Spirtos 1 United States
7908 Diane Yamada 1 United States
a
Former principal investigator.

© 2022 by American Society of Clinical Oncology Volume 41, Issue 3