Universitätsklinikum der PMU, Salzburg, Austria
Richard Greil , Roger Von Moos , Jaafar Bennouna , Pia J. Osterlund , Thierry André , Eric Van Cutsem , Stefan Kubicka , Dirk Arnold , Jose Maria Vieitez de Prado , Olivier Bouche , Vicente Alonso , Christophe Borg , Christoph Schlichting , Claus-Christoph Steffens , Stuart Osborne , Daniel Waterkamp , Martina Makrutzki , Javier Sastre
Background: ML18147 demonstrated that bevacizumab (BEV) + chemotherapy (CT) continued beyond first disease progression (PD) significantly prolongs overall survival (OS) and progression-free survival (PFS) as second-line treatment for metastatic colorectal cancer (mCRC) [Bennouna et al. Lancet Oncol 2012]. Here we report exploratory analyses of patterns of PD and outcomes based on extent of disease. Methods: In ML18147, patients (pts) with unresectable, histologically confirmed mCRC who progressed ≤3 months after discontinuation of first-line BEV were randomised to second-line CT±BEV. This exploratory analysis evaluated PD patterns, time from discontinuation of study medications to PD, and survival outcome (OS, PFS) based on liver-limited vs extensive disease. Results: Details on patterns of PD and outcome by extent of disease are shown in the table. Conclusions: These exploratory analyses suggest that pts with liver-limited or extensive disease seem to benefit equally from BEV+CT continued beyond PD. Our findings indicate that the pattern of PD does not appear to differ between the two treatment arms following cessation of BEV treatment in this setting. Clinical trial information: NCT00700102.
Patterns of PD, n (%) | CT alone (n=410) | BEV+CT (n=409) |
---|---|---|
No. of pts with PD | 321 (78.3%) | 302 (73.8%) |
No. of pts with PD due to new lesion | 163 (50.8%) | 132 (43.7%) |
Site of baseline lesion (in pts with PD due to new lesion) | ||
Lung Liver | 87 (53.4%) 132 (81.0%) | 59 (44.7%) 118 (89.4%) |
Site of new lesion | ||
Lung Liver Peritoneum Local lymph nodes Other | 74 (45.4%) 53 (32.5%) 10 (6.1%) 7 (4.3%) 48 (29.4%) |
51 (38.6%) 55 (41.7%) 13 (9.8%) 8 (6.1%) 26 (19.7%) |
n=345 (84.1%) | n=329 (80.4%) | |
Time from discontinuation of study medication to PD | HR=0.82 (95% CI 0.69–0.98; p=0.02) | |
Median | 0.4 months | 0.5 months |
Liver-limited disease | n=117 (28.5%) | n=109 (26.7%) |
OS | HR=0.79 (95% CI 0.59–1.06) | |
Median | 9.3 months | 11.6 months |
PFS | HR=0.68 (95% CI 0.52–0.89) | |
Median | 4.1 months | 5.7 months |
Extensive disease | n=292 (71.2%) | n=300 (73.3%) |
OS | HR=0.81 (95% CI 0.67–0.97) | |
Median | 10.0 months | 11.0 months |
PFS | HR=0.68 (95% CI 0.57–0.80) | |
Median | 4.1 months | 5.6 months |
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