Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer.
BACKGROUND
Maintenance monotherapy with the poly(ADP-ribose) polymerase inhibitor olaparib significantly prolongs progression-free survival over placebo in patients with platinum-sensitive relapsed serous ovarian cancer, with greatest benefit seen in patients with a BRCA1/2 mutation (BRCAm). Preservation of health-related quality of life (HRQoL) is important during maintenance therapy; we evaluated the effect of olaparib on HRQoL in this Phase II trial (NCT00753545, Study 19).


METHODS
Patients received olaparib 400 mg b.i.d. (capsules) or placebo until progression. Patient-reported HRQoL and disease-related symptoms were evaluated using the FACT-Ovarian (FACT-O) questionnaire (completed at baseline and every 28 days until progression), the FACT/NCCN Ovarian Symptom Index (FOSI) and the Trial Outcome Index (TOI). TOI of the FACT-O was the primary measure.


RESULTS
Overall, 265 women were randomised to maintenance olaparib (n=136) or placebo (n=129). Compliance for HRQoL assessment was high (∼80% over time). Most patients in both arms reported a best response of 'no change' on TOI (81%) and other HRQoL measures. There were no statistically significant differences in time to worsening or improvement rates of TOI, FOSI and FACT-O scores in the overall, BRCAm and germline BRCAm populations.


CONCLUSIONS
Maintenance treatment with olaparib was well tolerated and had no adverse impact on HRQoL in this study of patients with platinum-sensitive relapsed serous ovarian cancer who had responded to their most recent platinum-based therapy (partial or complete response). Interpretation of the HRQoL results in this population may differ from patients who have not responded to their most recent platinum-based therapy.
University College London, Cancer Research UK and UCL Cancer Trials Centre, 90 Tottenham Court Road, London W1T 4TJ, UK.
Jonathan A
JA
Ledermann
Kliniken Essen Mitte, Henricistraße 95, D-45136 Essen, Germany.
Philipp
P
Harter
University of Edinburgh Cancer Research UK Centre, MRC IGMM, Western General Hospital, Crewe Road South, Edinburgh EH4 2XR, UK.
Charlie
C
Gourley
UNSW Clinical School, Prince of Wales Hospital, High Street, Randwick, NSW 2031, Australia.
Michael
M
Friedlander
University of Leuven, Herestraat 49, 3000 Leuven, Belgium.
Ignace
I
Vergote
Mount Vernon Hospital, Rickmansworth Road, Northwood HA6 2RN, UK.
Gordon
G
Rustin
Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia.
Clare
C
Scott
Evangelisches Krankenhaus, Kirchfeldstraße 40, 40217 Düsseldorf, Germany.
Werner
W
Meier
Chaim Sheba Medical Center, Derech Sheba 2, Tel Hashomer 52621, Israel.
Ronnie
R
Shapira-Frommer
Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv 64239, Israel.
Tamar
T
Safra
Indiana University School of Medicine, 980 West Walnut Street, Indianapolis, IN 46202, USA.
Daniela
D
Matei
AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Anitra
A
Fielding
AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Bryan
B
Bennett
AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
David
D
Parry
AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Stuart
S
Spencer
AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TG, UK.
Helen
H
Mann
Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.
Ursula
U
Matulonis
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010793:Phthalazines / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011788:Quality of Life; D055815:Young Adult
D000970:Antineoplastic Agents; D010793:Phthalazines; D010879:Piperazines; D010919:Placebos; C531550:olaparib