PRODIGE 20: Bevacizumab + chemotherapy (BEV-CT) versus chemotherapy alone (CT) in elderly patients (pts) with untreated metastatic colorectal cancer (mCRC)—A randomized phase II trial.

Authors

null

Thomas Aparicio

Hôpital Avicenne, Assistance Publique Hôpitaux de Paris, Bobigny, France

Thomas Aparicio , Olivier Bouche Sr., Eric Francois , Emilie Maillard , Sylvie Kirscher , Julien Taïeb , Pierre-Luc Etienne , Roger Faroux , Faiza Khemissa , Farid El Hajbi , Christophe Locher , Yves Rinaldi , Thierry Lecomte , Sandrine Lavau-Denes , Mathieu Baconnier , Alice Oden-Gangloff , Dominique Genet , Elena Paillaud , Frederic Retornaz , Laurent Bedenne

Organizations

Hôpital Avicenne, Assistance Publique Hôpitaux de Paris, Bobigny, France, Centre Hospitalier Universitaire Robert Debré, Reims, France, Department of Medical Oncology, Centre Antoine-Lacassagne, Nice, France, Biostatistic Unit, Fédération Francophone de Cancérologie Digestive, Dijon, France, Institut Sainte Catherine, Avignon, France, APHP and Paris Descartes University, Paris, France, Clinique de l'Armoricaine, Saint-Brieuc, France, Centre Hospitalier Départemental Les Oudairies, La Roche sur Yon, France, CH Saint Jean, Perpignan, France, Centre Oscar Lambret, Lille, France, Department of Hepato-Gastroenterology, Meaux Hospital, Meaux, France, Hôpital Ambroise Paré, Marseille, France, Hôpital Trousseau, Tours, France, Unité de Recherche Clinique, Hôpital Dupuytren, Limoges, France, Department of Gastroenterology, General Hospital, Annecy, France, Digestive Oncology Unit, Department of Hepato-Gastroenterology, Rouen University, Rouen, France, ARCH/Polyclinique de Limoges, Limoges, France, Henri Mondor's Hospital, Creteil, France, Hopital européen, Marseille, France, HGE CHU Le Bocage, Dijon, France

Research Funding

Pharmaceutical/Biotech Company

Background: AVEX study has demonstrated increased progression-free survival (PFS) with capecitabine + bevacizumab compared to capecitabine alone in pts aged over 70 with mCRC. The treatment with bevacizumab has so far not been evaluated in combination with other standard chemotherapy regimens for elderly pts. Methods: Pts aged 75 and over were randomly assigned in a 1:1 ratio to BEV-CT versus CT. Following regimens were authorized: LV5FU2, FOLFOX and FOLFIRI, chosen by the investigators. The primary endpoint, assessed 4 months after randomization was composite, based on efficacy: tumor control (stable disease or objective tumor response) and absence of decrease of the Spitzer QoL index and safety: absence of severe cardiovascular toxicities and unexpected hospitalization. The decision rules for the experimental arm were: if >15 pts met the efficacy criterion and if >25 pts met the safety criterion, the BEV-CT treatment is considered efficient and well tolerated. Results: 102 pts were randomized (51 BEV-CT and 51 CT arm), median age was 80 (range 75-91), men (55%), ECOG 0: 27%, 1: 53% and 2: 20%. CT was LV5FU2 in 53 pts (27 BEV-CT and 26 CT) and a doublet regimen in 49 pts (24 BEV-CT and 25 CT) including 23 FOLFOX and 26 FOLFIRI. Primary tumor was resected in 31 pts in BEV-CT and 30 pts in CT. Of the 46 pts evaluable in the BEV-CT arm, 23 pts (50% [90% CI: 37.1-62.9]) responded to the efficacy criterion and 28 pts (61% [90% CI: 47.7-73.0]) to the safety criterion. Multivariate analysis show that primary tumor resected and normal independent activity of daily living are predictive for the composite criterion. Conclusions: BEV-CT arm responded to the efficacy and safety criterion. Addition of bevacizumab to 1st line chemotherapy in pts aged over 75 years with a mCRC is efficient and well tolerated. Clinical trial information: NCT01417494

Preliminary follow-up results.

CTBEV + CT
Grade 3-5 toxicities65%80%
Median time to autonomy
failure in months (m)
5.5 [95% CI: 3.8-NA]5.9 [95% CI: 3.8-14.8]
Median time to QoL
deterioration (m)
13.6 [95% CI: 11.6-NA]Not achieved
Median PFS (m)7.8 [95% CI: 6.6-10.6]10.7 [95% CI: 8.2-13.8]
Median overall
survival (m)
19.7 [95% CI: 13.4-21.9]21.7 [95% CI: 14.6-NA]

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Abstract Details

Meeting

2015 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

NCT01417494

Citation

J Clin Oncol 33, 2015 (suppl; abstr 3541)

DOI

10.1200/jco.2015.33.15_suppl.3541

Abstract #

3541

Poster Bd #

33

Abstract Disclosures