Detalhes bibliográficos
| Resumo: | BACKGROUND: Systemic chemotherapy typically converts previously unresectable liver metastases (LM) from colorectal cancer to curative intent resection in ∼15% of patients. This European multicenter phase II trial tested whether hepatic artery infusion (HAI) with triplet chemotherapy and systemic cetuximab could increase this rate to 30% in previously treated patients. PATIENTS AND METHODS: Participants had unresectable LM from wt KRAS colorectal cancer. Main non-inclusion criteria were advanced extra hepatic disease, prior HAI and grade 3 neuropathy. Irinotecan (180 mg/m(2)), oxaliplatin (85 mg/m(2)) and 5-fluorouracil (2800 mg/m(2)) were delivered via an implanted HAI access port and combined with i.v. cetuximab (500 mg/m(2)) every 14 days. Multidisciplinary decisions to resect LM were taken after every three courses. The rate of macroscopic complete resections (R0 + R1) of LM, progression-free survival (PFS) and overall survival (OS) were computed according to intent to treat. RESULTS: The patient population consisted of 42 men and 22 women, aged 33-76 years, with a median of 10 LM involving a median of six segments. Up to 3 extrahepatic lesions of <1 cm were found in 41% of the patients. A median of six courses was delivered. The primary end point was met, with R0-R1 hepatectomy for 19 of the 64 previously treated patients, 29.7% (95% confidence interval 18.5-40.9). Grade 3-4 neutropenia (42.6%), abdominal pain (26.2%), fatigue (18%) and diarrhea (16.4%) were frequent. Objective response rate was 40.6% (28.6-52.3). Median PFS and OS reached 9.3 (7.8-10.9) and 25.5 months (18.8-32.1) respectively. Those with R0-R1 hepatectomy had a median OS of 35.2 months (32.6-37.8), with 37.4% (23.6-51.2) alive at 4 years. CONCLUSION: The coordination of liver-specific intensive chemotherapy and surgery had a high curative intent potential that deserves upfront randomized testing. |
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| Autores principais: | Lévi, FA |
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| Outros Autores: | Boige, V; Hebbar, M; Smith, D; Lepère, C; Focan, C; Karaboué, A; Guimbaud, R; Carvalho, C; Tumolo, S; Innominato, P; Ajavon, Y; Truant, S; Castaing, D; De Baere, T; Kunstlinger, F; Bouchahda, M; Afshar, M; Rougier, P; Adam, R; Ducreux, M; Association Internationale pour Recherche sur Temps Biologique et Chronothérapie (ARTBC International) |
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| Assunto: | Cetuximab Clinical trials Colorectal neoplasms Antineoplastic combined chemotherapy protocols Liver neoplasms |
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| Ano: | 2016 |
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| País: | Portugal |
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| Tipo de documento: | artigo |
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| Tipo de acesso: | acesso restrito |
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| Instituição associada: | Hospital Prof. Dr. Fernando Fonseca E.P.E. |
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| Idioma: | inglês |
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| Origem: | Repositório do Hospital Prof. Doutor Fernando Fonseca |
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