gynaecological cancers

Annals of Oncology 25 (Supplement 4): iv305–iv326, 2014
doi:10.1093/annonc/mdu338.11
885PD
HEALTH-RELATED QUALITY OF LIFE (HRQOL) DURING
OLAPARIB MAINTENANCE THERAPY IN PATIENTS WITH
PLATINUM-SENSITIVE RELAPSED SEROUS OVARIAN
CANCER (PSR SOC) AND A BRCA MUTATION (BRCAM)
Aim: Maintenance monotherapy with the PARP inhibitor olaparib significantly
prolonged progression-free survival (PFS) versus placebo in patients with PSR SOC,
and subsequent analysis has shown that patients with a BRCAm receive greater
treatment benefit (Ledermann et al Lancet Oncol 2014). As preserved HRQoL may
support chronic administration in the maintenance setting, the effect of olaparib on
HRQoL was evaluated in this randomized, double-blind Phase II trial (NCT00753545).
Methods: Patient-reported HRQoL and disease-related symptoms were evaluated
using the Functional Assessment of Cancer Therapy Ovarian (FACT-O) questionnaire,
FACT/NCCN Ovarian Symptom Index (FOSI) and Trial Outcome Index (TOI).
Patients completed the FACT-O questionnaire at baseline and every 28 days until
progression. Individual symptom severity over 7 days was measured using the five-item
Likert scale; physical, social/family, emotional, functional wellbeing and specific
concerns to ovarian cancer patients were assessed. The TOI of the FACT-O was the
primary HRQoL endpoint. FOSI is the sum of a subset of eight symptom-related items.
Table: 885PD
BRCAm
Overall
BRCAwt
Olaparib
Placebo
Olaparib
Placebo
Olaparib
Placebo
TOI
N = 115
N = 111
N = 64
N = 53
N = 49
N = 54
Improved*
No change†
Worsened††
Non-evaluable
23 (20.0)
72 (62.6)
16 (13.9)
4 (3.5)
20 (18.0)
67 (60.4)
20 (18.0)
4 (3.6)
16 (25.0)
38 (59.4)
7 (10.9)
3 (4.7)
10 (18.9)
30 (56.6)
10 (18.9)
3 (5.7)
7 (14.3)
32 (65.3)
9 (18.4)
1 (2.0)
10 (18.5)
36 (66.7)
8 (14.8)
0
*Best response of improved defined as two visit responses of ’improved’ a
minimum of 21 days apart without an intervening visit response of ’worsened’.
†
Defined as two visit responses of ’no change’ or a response of ’no change’ and
a response of ’improved’ a minimum of 21 days apart without an intervening
visit response of ’worsened’. No change is defined as a change from baseline of
greater than -7 but less than +7.
††
Defined as a visit of ’worsened’ without a response of ’improved’ or ’no
change’ within 21 days. Worsened is defined as a change from baseline of less
than or equal to -7.
BRCAwt, BRCA wild type, includes patients with no known BRCAm or a
variant of unknown significance.
Conclusions: HRQoL was not negatively impacted during maintenance therapy with
olaparib. Phase III trials are enrolling.
Disclosure: J.A. Ledermann: Travel grants from AstraZeneca; P. Harter: Received a
grant from AstraZeneca; C. Gourley: Served on advisory boards for, and received travel
grants from, AstraZeneca; G.J.S. Rustin: Served on advisory boards for AstraZeneca,
Oxigene, Roche, Amgen, Boehringer Ingelheim and Clovis; C. Scott: Received travel
grants from AstraZeneca; A. Fielding, S. Spencer, B. Bennett and D. Parry: Employee of
AstraZeneca and stock ownership. All other authors have declared no conflicts of
interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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J.A. Ledermann1, P. Harter2, C. Gourley3, M. Friedlander4, I.B. Vergote5,
G.J.S. Rustin6, C. Scott7, W. Meier8, R. Shapira-Frommer9, T. Safra10,
D.E. Matei11, A. Fielding12, S. Spencer12, B. Bennett12, D. Parry12, U. Matulonis13
1
Cancer Research UK and UCL Cancer Trials Centre, University College London
Cancer Institute, London, UK
2
Dept Gynecology & Gyn. Oncology, Kliniken Essen-Mitte, Essen, GERMANY
3
MRC Institute of Genetics and Molecular Medicine, Edinburgh Cancer Research
UK Centre, Edinburgh, UK
4
University of New South Wales, Prince of Wales Clinical School, Sydney, NSW,
AUSTRALIA
5
Obstetrics & Gynaecology, University Hospitals Leuven - Campus Gasthuisberg,
Leuven, BELGIUM
6
Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK
7
Royal Melbourne Hospital, Melbourne, AUSTRALIA
8
Dept. of Gynecology, Evangelisches Krankenhaus, Dusseldorf, GERMANY
9
Chaim Sheba Medical Center, Tel Hashomer, ISRAEL
10
Tel Aviv Sourasky Medical Center, Tel Aviv, ISRAEL
11
Medicine, Indiana University, Indianapolis, IN, USA
12
Research and Development, AstraZeneca, Macclesfield, UK
13
Gynecology, Dana Farber Cancer Institute, Boston, MA, USA
Results: Of patients randomized to olaparib (n = 136) or placebo (n = 129), BRCA
mutation status data were available for 254/265 (96%), of whom 136/254 (53.5%) had a
known deleterious/suspected deleterious germline or somatic BRCA mutation. Most
patients reported a best response of ‘improved’ or ‘no change’ on TOI (Table); this
trend was also seen in other HRQoL measures. There were no statistically significant
differences in improvement rates or time to worsening of TOI, FOSI and Total
FACT-O.
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gynaecological cancers

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