A phase 2 study of panitumumab with irinotecan as salvage therapy in chemorefractory KRAS exon 2 wild-type metastatic colorectal cancer patients
Elez, Elena; Pericay, Carles; Valladares Ayerbes, Manuel; Bando, Inmaculada; Safont, Maria Jose; Gallego, Javier; Gravalos, Cristina; Arrivi, Antonio; Carrato, Alfredo; Conde, Veronica; Ortiz, Maria Jose; Lopez, Carlos; Alonso, Beatriz; Ruiz de Mena, Inmaculada; Diaz-Rubio, Eduardo; Tabernero, Josep; Aranda, Enrique
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Identificadores
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Fecha de publicación
2019Título de revista
BRITISH JOURNAL OF CANCER
Tipo de contenido
Artigo
DeCS
resultado del tratamiento | diarrea | GTP fosfohidrolasas | tasa de supervivencia | ganglios linfáticos | mediana edad | tratamiento de última línea | adulto | desequilibrio hidroelectrolítico | magnesio | erupciones por medicamentos | proteínas protooncogénicas p21(ras) | protocolos de quimioterapia antineoplásica combinada | anciano | proteínas de membranas | neoplasias peritoneales | humanos | PTEN fosfohidrolasa | neoplasias hepáticas | neoplasias pulmonares | astenia | proteínas protooncogénicas B-raf | adenocarcinoma | neoplasias colorrectalesMeSH
Membrane Proteins | Adult | Peritoneal Neoplasms | Proto-Oncogene Proteins B-raf | Middle Aged | GTP Phosphohydrolases | Adenocarcinoma | Lymph Nodes | Proto-Oncogene Proteins p21(ras) | Survival Rate | Drug Eruptions | Magnesium | Antineoplastic Combined Chemotherapy Protocols | Diarrhea | Lung Neoplasms | Humans | Treatment Outcome | Asthenia | Water-Electrolyte Imbalance | Liver Neoplasms | Salvage Therapy | Aged | Colorectal Neoplasms | PTEN PhosphohydrolaseResumen
BACKGROUND: Targeted agents are standard treatment for RAS wild-type metastatic colorectal cancer in the first- and second-line settings. This phase 2 study determined the benefit of targeting the epidermal growth factor receptor (EGFR) with panitumumab plus irinotecan in irinotecan-refractory patients. METHODS: KRAS exon-2 wild-type patients failing prior irinotecan received panitumumab (6 mg/kg) and irinotecan (180 mg/m(2)) every 2 weeks. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). KRAS exon-2 status was evaluated centrally, along with NRAS, BRAF mutations, epiregulin, amphiregulin, PTEN and EGFR copy number status, and correlated with efficacy. RESULTS: Sixty-one patients were treated. Among the 46 wild-type RAS patients, the ORR was 15.2% (seven partial responses), with median PFS of 3.8 months (95% CI 2.7-4.3) and median OS of 12.5 months (95% CI 6.7-15.9). Wild-type BRAF patients showed a 13.0% response rate. No significant correlations between response and baseline biomarker expression were identified. Common grade 3-4 adverse events were diarrhoea and rash (18.0% each), hypomagnesaemia and asthenia (8.2% each). CONCLUSIONS: The addition of panitumumab to irinotecan as salvage therapy is feasible but has limited activity in irinotecan-refractory metastatic colorectal cancer. No biomarkers predictive of response were identified.
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