Bevacizumab plus chemotherapy continued beyond first disease progression in patients with metastatic colorectal cancer previously treated with bevacizumab-based therapy: Patterns of disease progression and outcomes based on extent of disease in the ML18147 study.

Authors

null

Richard Greil

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

Organizations

Universitätsklinikum der PMU, Salzburg, Austria, Kantonal Hospital Graubünden, Chur, Switzerland, Institut de Cancerologie de l’Ouest, Nantes, France, Helsinki University Central Hospital, Helsinki, Finland, Hôpital Saint Antoine, Paris, France, University Hospital Gasthuisberg, Leuven, Belgium, District Clinic Reutlingen, Reutlingen, Germany, Hubertus Wald Tumor Center, University Cancer Center Hamburg (UCCH), Hamburg, Germany, Central University Hospital of Asturias (HUCA), Oviedo, Spain, Centre Hospitalier Universitaire Robert Debré, Reims, France, Hospital Universitario Miguel Servet, Zaragoza, Spain, University Hospital Besançon, Besançon, France, Diakoniekrankenhaus Rotenburg GmbH, Rotenburg, Germany, MVZ Haematologie/Onkologie Klinik Dr. Hancken, Stade, Germany, F. Hoffmann-La Roche Ltd, Basel, Switzerland, Hospital Clínico San Carlos, Madrid, Spain

Research Funding

Pharmaceutical/Biotech Company

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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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Clinical Trial Registration Number

NCT00700102

Citation

J Clin Oncol 31, 2013 (suppl; abstr 3604)

DOI

10.1200/jco.2013.31.15_suppl.3604

Abstract #

3604

Poster Bd #

9F

Abstract Disclosures