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

LBA3500^ Oral Abstract Session, Sun, 9:45 AM-12:45 PM
Bevacizumab (Bev) with or without erlotinib as maintenance therapy,
following induction first-line chemotherapy plus Bev, in patients with
metastatic colorectal cancer (mCRC): Efficacy and safety results of the
international GERCOR DREAM phase III trial. Presenting Author: Christophe
Tournigand, Hôpital Saint-Antoine, Paris, France
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3,
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 Sunday edition of ASCO Daily News.
3502 Oral Abstract Session, Sun, 9:45 AM-12:45 PM
Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC).
Presenting Author: Eric Van Cutsem, Digestive Oncology Unit, Leuven Cancer
Institute, University Hospital Gasthuisberg, Leuven, Belgium
Background: Regorafenib (REG) is an oral multi-kinase inhibitor. The CORRECT
trial was conducted to evaluate REG in patients (pts) with mCRC who had
progressed after all approved standard therapies. Methods: Enrollment criteria
included documented mCRC and progression during or �3 months after last
standard therapy. Pts were randomized 2:1 to receive best supportive care plus
either REG (160 mg od po, 3 wks on/1 wk off) or placebo (PL). The primary
endpoint was overall survival (OS). Secondary endpoints included progressionfree
survival (PFS), overall response rate, disease control rate, safety and quality
of life (QoL). Efficacy analyses across prespecified subgroups were evaluated
using univariate Cox regression. Results: 760 pts were randomized (REG: 505;
PL: 255). The OS primary endpoint was met at a preplanned interim analysis. OS
and PFS were significantly improved in REG arm compared to PL arm: hazard
ratio (HR) for OS 0.77 (95% CI 0.64-0.94, 1-sided p�0.0052), median OS 6.4
vs 5.0 mos; HR for PFS 0.49 (95% CI 0.42-0.58, 1-sided p�0.000001),
median PFS 1.9 vs 1.7 mos. Comparable OS and PFS benefits were observed in
exploratory subgroup analyses by region, age, time from diagnosis of mCRC to
randomization, prior lines of treatment, and KRAS status (shown in table). The
most common grade 3� AEs related to REG were hand-foot skin reaction
(16.6%), fatigue (9.6%), hypertension (7.2%), diarrhea (7.2%) and rash/
desquamation (5.8%). QoL data will be presented. Conclusions: REG demonstrated
statistically significant improvement in OS and PFS over PL, as well as
comparable efficacy benefits across pt subgroups analyzed.
OS PFS
Subgroups N HR 95% CI HR 95% CI
Region*
North America, Western EU, 632 0.77 0.62-0.95 0.50 0.42-0.60
Israel and Australia
Asia 104 0.79 0.43-1.46 0.43 0.28-0.68
Age
< 65 yrs 475 0.72 0.56-0.91 0.42 0.34-0.51
> 65 yrs 285 0.86 0.61-1.19 0.65 0.50-0.86
Time from Dx of mCRC to randomization
< 18 mo 140 0.82 0.53-1.25 0.58 0.41-0.84
> 18 mo 620 0.76 0.61-0.95 0.48 0.40-0.58
No. of prior treatment lines on or after metastatic disease
< 3 395 0.79 0.60-1.04 0.53 0.43-0.67
> 3 365 0.75 0.56-0.99 0.47 0.37-0.59
KRAS ^
WT 299 0.65 0.48-0.90 0.48 0.36-0.62
MUT 430 0.87 0.67-1.12 0.53 0.43-0.65
* 24 pts from other regions not shown. ^ Historical record.
Gastrointestinal (Colorectal) Cancer
203s
LBA3501 Oral Abstract Session, Sun, 9:45 AM-12:45 PM
Results of the X-PECT study: A phase III randomized double-blind
placebo-controlled study of perifosine plus capecitabine (P-CAP) versus
placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic
colorectal cancer (mCRC). Presenting Author: Johanna C. Bendell, SCRI/
Tennessee Oncology, Nashville, TN
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3,
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 Sunday edition of ASCO Daily News.
CRA3503 Oral Abstract Session, Sun, 9:45 AM-12:45 PM
Bevacizumab (BEV) plus chemotherapy (CT) continued beyond first progression
in patients with metastatic colorectal cancer (mCRC) previously
treated with BEV plus CT: Results of a randomized phase III intergroup
study (TML study). Presenting Author: Dirk Arnold, Hubertus Wald Tumor
Center, University Cancer Center Hamburg (UCCH), Hamburg, Germany
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3,
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 Sunday edition of ASCO Daily News.
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