Meeting
2012 ASCO Annual Meeting
First European phase II trial of intravenous (iv) cetuximab (Cet) and hepatic artery infusion (HAI) of irinotecan, 5-fluorouracil and oxaliplatin in patients with unresectable liver metastases from wt KRAS colorectal cancer (CRC) after systemic therapy failure (OPTILIV, NCT00852228).
Authors
Francis Levi
Medical Oncology Department, INSERM U776, Paul Brousse Hospital, Villejuif, France
Francis Levi , Michel Ducreux , Mohamed Hebbar , Philippe Rougier , C. N. J. Focan , Rosine Guimbaud , Carlos Carvalho , Salvatore Tumolo V, Pasquale F. Innominato , Yves Ajavon , Denis Castaing , Thierry De Baere , Abdoulaye Karaboué , Celine Lepere , Valerie Boige , Laetitia Proux , Rene Adam , Mohamed Bouchahda
Organizations
Medical Oncology Department, INSERM U776, Paul Brousse Hospital, Villejuif, France, Institut Gustave Roussy, Villejuif, France, Medical Oncology Unit - Hôpital Huriez, Lille, France, European Hospital George Pompidou, Paris, France, CHC Clinique Saint Joseph, Liège, Belgium, University Hospital of Purpan, Toulouse, France, Medical Oncology Unit, Hospital Fernando Fonesca - Amadora, Amadora, Portugal, Santa Maria Degli Angeli General Hospital, Pordenone, Italy, Inserm U776, Sevice de Chronothérapie, Département de Cancérologie, Hôpital Paul Brouse, Villejuif, France, Service de Radiologie, Hopital Paul Brousse, Villejuif, France, Hepato-Biliary Centre, Hopital Paul Brousse, Villejuif, France, INSERM U776, Paul Brousse Hospital, Villejuif, France, Service d'Hépato-Gastro-Entérologie, Institut Gustave-Roussy, Villejuif, France, CRESGE, Lille, France, Hepatobiliary Center and INSERM U776, Paul Brousse Hospital, Villejuif, France
Research Funding
Other
Background: HAI of chronomodulated (Chrono) irinotecan (I), 5-Fluorouracil (F) and oxaliplatin (O), or flat O combined with iv F-leucovorin allowed secondary metastases resections and prolonged survival in patients (pts) with CRC liver metastases despite prior chemotherapy failure (Bouchahda, Cancer 2009; Goere, Ann Surg 2010). Purpose: To prospectively evaluate safety and efficacy of combining iv Cet with HAI of IFO in pts with CRC liver metastases. Methods: This Phase II trial involved previously treated pts with unresectable CRC liver metastases. Pts received iv Cet (500 mg/m²) and Chrono or conventional HAI of I (180 mg/m²), F (2800 mg/m²), and O (85 mg/m²) q2 weeks. Liver metastases were resected if adequately downstaged. Results: Planned accrual of 60 pts was reached on 01/24/2012. 3 pts were not treated, 9 are ongoing. 48 consecutive treated pts (18F, 30 M; aged 32-76 years) are fully assessed and monitored. They had PS 0-1 (98%), bilobar liver lesions (69%), a median of 8 metastases (1-50; largest diameter, 57 mm – 15-172). Prior chemotherapy involved one (43%), or two or three (57%) lines. A median of 5 protocol courses (1-13) was given. Main grade 3-4 toxicities per pt were neutropenia (40%), abdominal pain (15%), fatigue (15%), nausea (15%), diarrhea (13%) and sensory neuropathy (4%). Objective response rate was 44% [30-58], with 6% radiological complete responses. Disease control rate was 85%. Secondary liver surgery was performed in 15 pts (31.3%).One pt with 25 metastases (1-6 cm) in all liver segments had pathologic complete response in 24 lesions removed through three-stage hepatectomy. She currently has an off treatment disease-free survival of 17+ months.With a follow up of 4 to 47 months, median progression-free survival is 14.2 months [9.7-18.8], 1- and 2-year survival rates are 92.8% and 59.2% respectively. Conclusions: OPTILIV offers a safe and unusually effective treatment option for patients with CRC liver metastases after failure of systemic chemotherapy within a coordinated medico-surgical strategy.
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Abstract Details
Session Type
Poster Session
Session Title
Gastrointestinal (Colorectal) Cancer
Track
Gastrointestinal Cancer—Colorectal and Anal
Sub Track
Colorectal Cancer
Clinical Trial Registration Number
NCT00852228
Citation
J Clin Oncol 30, 2012 (suppl; abstr 3547)
DOI
10.1200/jco.2012.30.15_suppl.3547
Abstract #
3547
Poster Bd #
24B
Abstract Disclosures
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