Medical Oncology Department, INSERM U935, Paul Brousse Hospital, Villejuif, France
Mohamed Bouchahda , Valerie Boige , Denis Michel Smith , Abdoulaye Karaboué , Mohamed Hebbar , Céline Lepère , C. N. J. Focan , Rosine Guimbaud , Pasquale F. Innominato , Sameh Awad , Carlos Carvalho , Salvatore Tumolo , Stephanie Truant , Thierry De Baere , Denis Castaing , Philippe Rougier , Julien Taïeb , Jean F. Morere , Michel Ducreux , Francis Levi
Background: Early tumor shrinkage has been associated with improved long-term outcome in patients (pts) with chemotherapy (chemo)-refractory LM-CRC. We examined the prognostic relevance of early tumor response after hepatic artery infusion of triplet chemotherapy combined with intravenous (IV) Cetuximab (Cet) in pts with unresectable LM-CRC. Methods: Pts received IV-Cet (500 mg/m2) and HAI of Irinotecan (180mg/m2), 5–Fluorouracil (2800 mg/m2), and Oxaliplatin (85mg/m2) every two weeks. Tumor response (RECIST) was based on CT scans ± MRI q3 courses. Pts were categorized as early-responders (CR or PR after 3 courses – at » 6 weeks), late responders (CR or PR > 3 courses) and non-responders (SD or PD). The rate of conversion to liver surgery (R0-R1), progression free survival (PFS) and overall survival (OS) were compared. Results: 57/64 registered pts (89%) received ³ 3 courses. They were assessed for response, which occurred early for 16/57 pts (28%), late for 10 pts (17.5%) or not at all for 31 pts (54.4%). The early-responders had similarly extensive disease as the other pts (median of 12 LM, median largest diameter = 37 mm, bilateral LM for 81% pts). Grade 3-4 diarrhea and asthenia were least in the early responders (6.3% vs 22.0%, and 0% vs 26.8%, p = 0.024, respectively).R0-R1 resection rate was twice as high in the early response group as compared to the other group (7/16; 48,8% vs 10/41; 24,4%, p = 0.10). PFS curves did not differ. In contrast. median OS was significantly longer in the 16 early-responders - 34.5 months [32.1 -36.9] - as compared to both the 41 non-early responders - 20.2 [13.6 – 26.8]; p = 0.010); and the 10 late responders - 12.0 [6.9 -17.2]; p = 0.001. Conclusions: Best clinical tolerability, LM conversion-to-resection, and survival outcomes were obtained in pts achieving an early tumor response on combined triplet hepatic artery infusion and IV Cet. The rapid disease-modifying effect of HAI is an important asset for curative intent medico-surgical strategies, and awaits prospective confirmation. Clinical trial information: NCT00852228
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Abstract Disclosures
2012 ASCO Annual Meeting
First Author: Francis Levi
2013 Gastrointestinal Cancers Symposium
First Author: Francis Levi
2016 ASCO Annual Meeting
First Author: Francis Levi
2017 ASCO Annual Meeting
First Author: Abdoulaye Karaboue