Annual Meeting Proceedings Part 1 - American Society of Clinical ...

LBA5000 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Randomized phase III study of erlotinib versus observation in patients with
no evidence of disease progression after first-line platin-based chemotherapy
for ovarian carcinoma: A GCIG and EORTC-GCG study. Presenting
Author: Ignace B. Vergote, University Hospital Leuven and KU Leuven,
Leuven, Belgium
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Saturday edition of ASCO Daily News.
LBA5002^ Oral Abstract Session, Sat, 3:00 PM-6:00 PM
AURELIA: A randomized phase III trial evaluating bevacizumab (BEV) plus
chemotherapy (CT) for platinum (PT)-resistant recurrent ovarian cancer
(OC). Presenting Author: Eric Pujade-Lauraine, GINECO and Université
Paris Descartes, Paris, France
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Saturday edition of ASCO Daily News.
Gynecologic Cancer
327s
5001 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Olaparib plus paclitaxel plus carboplatin (P/C) followed by olaparib maintenance
treatment in patients (pts) with platinum-sensitive recurrent serous
ovarian cancer (PSR SOC): A randomized, open-label phase II study.
Presenting Author: Amit M. Oza, Princess Margaret Hospital, Toronto, ON,
Canada
Background: The oral PARP inhibitor olaparib has shown antitumor activity
in pts with SOC. Our multicenter study compared the efficacy of (Arm A)
olaparib capsules plus P/C for 6 cycles then maintenance olaparib
monotherapy vs (Arm B) P/C alone for 6 cycles and no further therapy in pts
with PSR SOC (NCT01081951). Methods: Pts received 6 x 21-day(d)
cycles of olaparib (200 mg bid, d1–10/21) � P (175 mg/m2 iv, d1) � C
(AUC4 iv, d1), then olaparib monotherapy as maintenance (400 mg bid,
continuous) (Arm A), or 6 x 21d cycles of P (175 mg/m2 iv, d1) � C (AUC6
iv, d1) then no further therapy (Arm B), until progression. Randomization
(1:1) was stratified by number of platinum treatments and platinum-free
interval. Primary endpoint: progression-free survival (PFS) by central review
(RECIST 1.1). Secondary endpoints: overall survival (OS), objective response
rate (ORR), safety. Archival tissue was collected where available for
analysis of biomarker correlation. Results: Of 162 pts randomized (n�81
per arm), 156 received treatment (Arm A, n�81; Arm B, n�75) and 121
began the maintenance/no further therapy phase (Arm A, n�66; Arm B,
n�55). Olaparib � P/C (AUC4) followed by maintenance olaparib showed a
significant improvement in PFS vs P/C (AUC6) alone (HR � 0.51, 95% CI
0.34, 0.77; P�0.0012; median � 12.2 vs 9.6 months). OS data are
immature (total events: 14%). ORR was similar for Arm A and Arm B (64 vs
58%). Most common AEs during the combination phase were alopecia (74
vs 59%), nausea (69 vs 57%) and fatigue (64 vs 57%) for Arm A vs Arm B,
respectively. Pts with grade �3 AEs (65 vs 57%), serious AEs (SAEs: 15 vs
21%) and AEs leading to treatment discontinuation (19 vs 16%) were
similar for Arm A vs Arm B. Most common AEs during maintenance/no
further therapy were nausea (50 vs 6%) and vomiting (29 vs 7%). 29 vs
16% of pts had grade �3 AEs, 9 vs 7% had SAEs and 8% vs N/A
discontinued due to AEs in the olaparib vs no treatment arms, respectively.
There were no fatal AEs. Conclusions: In pts with PSR SOC, olaparib plus
P/C (AUC4) followed by olaparib 400 mg bid monotherapy maintenance
treatment resulted in a significant improvement in PFS vs P/C (AUC6)
alone.
5003 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Long-term follow-up of a randomized trial comparing conventional paclitaxel
and carboplatin with dose-dense weekly paclitaxel and carboplatin in
women with advanced epithelial ovarian, fallopian tube, or primary peritoneal
cancer: JGOG 3016 trial. Presenting Author: Noriyuki Katsumata,
Nippon Medical School Musashikosugi Hospital, Kanagawa, Japan
Background: The primary analysis of the JGOG3016 trial (Lancet 2009,
374:1331) showed that dose-dense weekly administration with paclitaxel
and carboplatin (dd-TC) demonstrated statistically significant efficiency
over tri-weekly administration withTC (c-TC) as first-line chemotherapy in
patients with stage II-IV epithelial ovarian, fallopian tube or primary
peritoneal cancer. We report the long-term follow-up results on progressionfree
survival (PFS) and overall survival (OS). Methods: Patients with stage II
to IV ovarian cancer were randomly assigned to receive c-TC (carboplatin
AUC 6 and paclitaxel 180 mg/m2 on day 1) or dd-TC (carboplatin AUC 6 on
day 1 and paclitaxel 80 mg/m2 on day 1, 8, 15). The treatments were
repeated every 3 weeks for six cycles; in responding patients, additional
three cycles were administered. Results: The analysis included eligible 631
patients. At 6.4 years of median follow-up, there continues to be a highly
statistically significant improvement in median PFS in favor of the dd-TC
group compared with the c-TC group (28.1 vs. 17.5 months, hazard ratio
[HR] 0.75, 95% CI, 0.62-0.91; P�0.0037). Median survival has not yet
been reached in the dd-TC group, and OS at 5 years was higher in the dd-TC
group than the c-TC group (58.6% vs. 51.0%, HR 0.79, 95% CI,
0.63-0.99; P �0.0448). Conclusions: The dd-TC improves long-term PFS
and OS in patients with advanced epithelial ovarian cancer.
Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.