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- Title
A phase 2 study of panitumumab with irinotecan as salvage therapy in chemorefractory KRAS exon 2 wild-type metastatic colorectal cancer patients.
- Authors
Elez, Elena; Pericay, Carles; Valladares-Ayerbes, Manuel; Bando, Inmaculada; Safont, Maria Jose; Gallego, Javier; Grávalos, Cristina; Arrivi, Antonio; Carrato, Alfredo; Conde, Verónica; Ortiz, Maria José; López, Carlos; Alonso, Beatriz; Ruiz de Mena, Inmaculada; Díaz-Rubio, Eduardo; Tabernero, Josep; Aranda, Enrique
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>KRAS exon-2 wild-type patients failing prior irinotecan received panitumumab (6 mg/kg) and irinotecan (180 mg/m²) 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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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.
- Publication
British Journal of Cancer, 2019, Vol 121, Issue 5, p378
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-019-0537-z