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Title: First-line panitumumab plus FOLFOX4 or FOLFIRI in colorectal cancer with multiple or unresectable liver metastases: A randomised, phase II trial (PLANET-TTD).
Authors: Carrato, Alfredo
Abad, Albert
Massuti, Bartomeu
Grávalos, Cristina
Escudero, Pilar
Longo-Muñoz, Federico
Manzano, José-Luis
Gómez, Auxiliadora
Safont, María José
Gallego, Javier
García-Paredes, Beatriz
Pericay, Carles
Dueñas, Rosario
Rivera, Fernando
Losa, Ferrán
Valladares-Ayerbes, Manuel
González, Encarnación
Aranda, Enrique
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Keywords: FOLFIRI;FOLFOX;First-line;Liver-limited disease;Metastatic colorectal cancer;Panitumumab;Resection
metadata.dc.subject.mesh: Adult
Aged, 80 and over
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Colorectal Neoplasms
Liver Neoplasms
Middle Aged
Organoplatinum Compounds
Survival Analysis
Issue Date: 19-Jun-2017
Abstract: In first-line wild-type (WT)-Kirsten rat sarcoma viral oncogene homologue (KRAS) metastatic colorectal cancer (mCRC), panitumumab (Pmab) improves outcomes when added to FOLFOX [folinic acid, 5-fluorouracil, and oxaliplatin] or FOLFIRI [folinic acid, 5-fluorouracil, and irinotecan]. However no trial has directly compared these combinations. Multicentre, open-label study in untreated patients ≥ 18 years with (WT)-KRAS mCRC and multiple or unresectable liver-limited disease (LLD) randomised to either Pmab-FOLFOX4 or Pmab-FOLFIRI. The primary end-point was objective response rate (ORR). Secondary end-points included liver metastases resection rate (R0 + R1), progression-free survival (PFS), overall survival (OS), adverse events and perioperative safety. Exploratory end-points were: response by RAS status, early tumour shrinkage (ETS) and depth of response (DpR) in WT-RAS patients. Data on 77 patients were analysed (38 Pmab-FOLFOX4; 39 Pmab-FOLFIRI; WT-RAS: 27/26, respectively). ORR was 74% with Pmab-FOLFOX4 and 67% with Pmab-FOLFIRI (WT-RAS: 78%/73%). Out of the above, 45% and 59% underwent surgical resection, respectively (WT-RAS: 37%/69%). The R0-R1 resection rate was 34%/46% (WT-RAS:26%/54%). Median PFS was 13/14 months (hazard ratio [HR] Pmab-FOLFIRI versus Pmab-FOLFOX4: 0.9; 95% confidence interval: [0.6-1.5]; WT-RAS:13/15; HR: 0.7 [0.4-1.3]). Median OS was 37/41 months (HR:1.0 [0.6-1.8]; WT-RAS: 39/49; HR:0.9 [0.4-1.9]). In WT-RAS patients with confirmed response, median DpR was 71%/66%, and 65%/77% of patients showed ETS ≥ 30%/ ≥ 20% at week 8, without significant differences between arms; these patients had longer median PFS and OS and higher resectability rates. Surgery was associated with longer survival. Perioperative and overall safety were similar, except for higher grade 3/4 neutropenia (40%/10%; p = 0.003) and neuropathy (13%/0%; p = 0.025) in the Pmab-FOLFOX4 arm. In patients with WT-KRAS mCRC and LLD, both first-line Pmab-FOLFOX4 and Pmab-FOLFIRI resulted in high ORR and ETS, allowing potentially curative resection. No significant differences in efficacy were observed between the two regimens. (
metadata.dc.identifier.doi: 10.1016/j.ejca.2017.04.024
Appears in Collections:Producción 2020

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