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Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer

(2010) JOURNAL OF CLINICAL ONCOLOGY. 28(31). p.4706-4713
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Abstract
Purpose: Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status. Patients and Methods: Patients with mCRC, one prior chemotherapy regimen for mCRC, Eastern Cooperative Oncology Group performance status 0 to 2, and available tumor tissue for biomarker testing were randomly assigned 1:1 to panitumumab 6.0 mg/kg plus FOLFIRI versus FOLFIRI every 2 weeks. The coprimary end points of PFS and overall survival (OS) were independently tested and prospectively analyzed by KRAS status. Results: From June 2006 to March 2008, 1,186 patients were randomly assigned 1: 1 and received treatment. KRAS status was available for 91% of patients: 597 (55%) with wild-type (WT) KRAS tumors, and 486 (45%) with mutant (MT) KRAS tumors. In the WT KRAS subpopulation, when panitumumab was added to chemotherapy, a significant improvement in PFS was observed (hazard ratio [HR] = 0.73; 95% CI, 0.59 to 0.90; P = .004); median PFS was 5.9 months for panitumumab-FOLFIRI versus 3.9 months for FOLFIRI. A nonsignificant trend toward increased OS was observed; median OS was 14.5 months versus 12.5 months, respectively (HR = 0.85, 95% CI, 0.70 to 1.04; P = .12); response rate was improved to 35% versus 10% with the addition of panitumumab. In patients with MT KRAS, there was no difference in efficacy. Adverse event rates were generally comparable across arms with the exception of known toxicities associated with anti-EGFR therapy. Conclusion: Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.
Keywords
CHEMOTHERAPY, FAILURE, SUPPORTIVE CARE, CONTROLLED-TRIAL, CETUXIMAB PLUS IRINOTECAN, 1ST-LINE TREATMENT, KRAS, OXALIPLATIN, SURVIVAL

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Chicago
Peeters, Marc, Timothy Jay Price, Andrés Cervantes, Alberto F Sobrero, Michel Ducreux, Yevje Hotko, Thierry André, et al. 2010. “Randomized Phase III Study of Panitumumab with Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared with FOLFIRI Alone as Second-line Treatment in Patients with Metastatic Colorectal Cancer.” Journal of Clinical Oncology 28 (31): 4706–4713.
APA
Peeters, Marc, Price, T. J., Cervantes, A., Sobrero, A. F., Ducreux, M., Hotko, Y., André, T., et al. (2010). Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. JOURNAL OF CLINICAL ONCOLOGY, 28(31), 4706–4713.
Vancouver
1.
Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. JOURNAL OF CLINICAL ONCOLOGY. 2010;28(31):4706–13.
MLA
Peeters, Marc, Timothy Jay Price, Andrés Cervantes, et al. “Randomized Phase III Study of Panitumumab with Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared with FOLFIRI Alone as Second-line Treatment in Patients with Metastatic Colorectal Cancer.” JOURNAL OF CLINICAL ONCOLOGY 28.31 (2010): 4706–4713. Print.
@article{1193691,
  abstract     = {Purpose: Panitumumab is a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS) in chemotherapy-refractory metastatic colorectal cancer (mCRC). This trial evaluated the efficacy and safety of panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone after failure of initial treatment for mCRC by tumor KRAS status.
Patients and Methods: Patients with mCRC, one prior chemotherapy regimen for mCRC, Eastern Cooperative Oncology Group performance status 0 to 2, and available tumor tissue for biomarker testing were randomly assigned 1:1 to panitumumab 6.0 mg/kg plus FOLFIRI versus FOLFIRI every 2 weeks. The coprimary end points of PFS and overall survival (OS) were independently tested and prospectively analyzed by KRAS status.
Results: From June 2006 to March 2008, 1,186 patients were randomly assigned 1: 1 and received treatment. KRAS status was available for 91% of patients: 597 (55%) with wild-type (WT) KRAS tumors, and 486 (45%) with mutant (MT) KRAS tumors. In the WT KRAS subpopulation, when panitumumab was added to chemotherapy, a significant improvement in PFS was observed (hazard ratio [HR] = 0.73; 95% CI, 0.59 to 0.90; P = .004); median PFS was 5.9 months for panitumumab-FOLFIRI versus 3.9 months for FOLFIRI. A nonsignificant trend toward increased OS was observed; median OS was 14.5 months versus 12.5 months, respectively (HR = 0.85, 95% CI, 0.70 to 1.04; P = .12); response rate was improved to 35% versus 10% with the addition of panitumumab. In patients with MT KRAS, there was no difference in efficacy. Adverse event rates were generally comparable across arms with the exception of known toxicities associated with anti-EGFR therapy.
Conclusion: Panitumumab plus FOLFIRI significantly improved PFS and is well-tolerated as second-line treatment in patients with WT KRAS mCRC.},
  author       = {Peeters, Marc and Price, Timothy Jay and Cervantes, Andrés and Sobrero, Alberto F and Ducreux, Michel and Hotko, Yevje, and André, Thierry and Chan, Emily and Lordick, Florian and Punt, Cornelis JA and Strickland, Andrew H and Wilson, Gregory and Ciuleanu, Tudor-Eliade and Roman, Laslo and Van Cutsem, Eric and Tzekova, Valentina and Collins, Simon and Oliner, Kelly S and Rong, Alan and Gansert, Jennifer},
  issn         = {0732-183X},
  journal      = {JOURNAL OF CLINICAL ONCOLOGY},
  keywords     = {CHEMOTHERAPY,FAILURE,SUPPORTIVE CARE,CONTROLLED-TRIAL,CETUXIMAB PLUS IRINOTECAN,1ST-LINE TREATMENT,KRAS,OXALIPLATIN,SURVIVAL},
  language     = {eng},
  number       = {31},
  pages        = {4706--4713},
  title        = {Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer},
  url          = {http://dx.doi.org/10.1200/JCO.2009.27.6055},
  volume       = {28},
  year         = {2010},
}

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