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Annals of Oncology
(Siemens Syngo Via Oncology) and manual measurement of the LD (RECIST 1.1)
and the LOD. Agreement between the tumor volume algorithm and volumetry for
each rater and the corresponding inter rater agreement (IA) were investigated using
Bland-Altman (BA) plots. Agreement between the RECIST-based and
volumetry-based relative changes was quantified by intraclass correlation (ICC)
where 1.0 would indicate perfect agreement.
Results: 222 target lesions from 25 pts were measured at 99 TAs. BA plots indicated
that the volume algorithm showed negligible constant bias for both raters (rater 1,
0.09 with p = 0.25, and rater 2 -0.05 with p = 0.41). IA with regard to the volumetry
showed a smaller constant bias (-0.16 with p = 0.17) compared with the volume
algorithm (-0.31 with p = 0.04). The relative change in tumor size between baseline
and first TA was investigated. The ICCs for RECIST-based versus volumetry-based
relative changes for the 2 raters were 0.79 and 0.62. Application to mCRC patients
from the CRYSTAL (n = 1198) and OPUS (n = 337) studies showed the ICCs for
RECIST-based versus volume algorithm-based relative changes to be 0.60 and 0.77.
Conclusions: The algorithm for estimating the tumor volume was validated as
demonstrated by the negligible bias and the BA plots. The moderate ICCs for early
changes in tumor size in the 25 Munich pts and those from the CRYSTAL and
OPUS studies indicate clear differences between RECIST- and volume-based TAs and
suggest that RECIST underestimates both tumor shrinkage and tumor growth.
Disclosure: R. Laubender: RPL receives travel support and research funding by Merck
KGaA. U. Sartorius: The author is an employee of Merck KGaA. M. Schlichting: The
author is an employee of Merck KGaA. S. Stintzing: The author receives: Honoraria
and travel support from Merck Serono and Roche AG Honoraria from Amgen GmbH.
A. Graser: The author declares that he is a member of the Siemens speakers’ bureau
and that he receives grant money from Bayer Pharma. V. Heinemann: The author
declares: Honoraria (lectures) from Merck, Roche, Sanofi Honoraria (Ad Boards) from
Merck, Roche, Sanofi Research support from Merck, Roche, Sanofi.
555P EFFICACY AND SAFETY OF BEVACIZUMAB IN METASTATIC
COLORECTAL CANCER (MCRC): FIRST-LINE ANALYSIS OF
POOLED DATA FROM RANDOMIZED CONTROLLED TRIALS
(RCTS)
F.F. Kabbinavar 1 , H.I. Hurwitz 2 , N.C. Tebbutt 3 , B.J. Giantonio 4 , Z. Guan 5 ,
L. Mitchell 6 , D. Waterkamp 7 , J. Tabernero 8
1 Thoracic Oncology and Kidney Cancer Programs, David Geffen School of
Medicine at UCLA, Los Angeles, CA, UNITED STATES OF AMERICA, 2 Division
of Hematology and Oncology, Duke University Medical Center, Durham, NC,
UNITED STATES OF AMERICA, 3 Austin Health, University of Melbourne,
Melbourne, VIC, AUSTRALIA, 4 The Abramson Cancer Center, University of
Pennsylvania, Philadelphia, PA, UNITED STATES OF AMERICA, 5 Cancer Center,
Sun Yatsen University, Guangzhou, CHINA, 6 Global Medical Affairs Biometrics,
F. Hoffmann-La Roche Ltd, Basel, SWITZERLAND, 7 Global Medical Affairs,
F. Hoffmann-La Roche Ltd, Basel, SWITZERLAND, 8 Medical Oncology /
Gastrointestinal Tumors Group, Vall d’Hebron University Hospital / VHIO,
Barcelona, SPAIN
Background: Bevacizumab (BV) with chemotherapy (CT) is a standard treatment for
mCRC. This analysis pooled individual patient data from the clinical databases of six
RCTs (phase 2 or 3) of BV to further define clinical outcomes with first-line
treatment, including within subgroups.
Methods: Patient data were pooled from first-line (AVF2107, NO16966, ARTIST,
AVF2192, AVF0780, AGITG MAX) mCRC trials of BV. All analyses were based on
the intent-to-treat population. Overall and progression-free survival estimates (OS,
PFS) were calculated by Kaplan-Meier methods. To assess differences in time to
response variables by treatment arm (CT vs BV + CT), stratified random (overall)
and fixed (subgroup comparisons) models were used to estimate pooled hazard ratios
(HRs) and 95% confidence intervals (CIs), with each study included as a stratum.
Overall: BV + CT vs CT
HR (95% CI) P value
OS 0.81 (0.70 − 0.93) .0034
PFS
Subgroup comparisons: BV + CT vs
CT
0.58 (0.46 − 0.73)