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Deprecated: Implicit conversion from float 334.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Cancer 2014 ; 120 (19): 2980-5 Nephropedia Template TP
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Dual blockade of epidermal growth factor receptor (EGFR) and insulin-like growth factor receptor-1 (IGF-1R) signaling in metastatic pancreatic cancer: phase Ib and randomized phase II trial of gemcitabine, erlotinib, and cixutumumab versus gemcitabine plus erlotinib (SWOG S0727) #MMPMID25041791
Philip PA; Goldman B; Ramanathan RK; Lenz HJ; Lowy AM; Whitehead RP; Wakatsuki T; Iqbal S; Gaur R; Benedetti JK; Blanke CD
Cancer 2014[Oct]; 120 (19): 2980-5 PMID25041791show ga
Purpose: Targeting a single pathway in pancreatic adenocarcinoma (PC) is unlikely to impact its natural history. We tested the hypothesis that simulataneous targeting of the EGFR and IGF-1R pathways would significantly improve progression free survival (PFS) by abrogating reciprocal signaling that promote drug resistance. Methods: This was a phase Ib/II study testing cixutumumab, combined with erlotinib and gemcitabine (G) in patients with untreated metastatic PC. The control arm was erlotinib plus G. The primary endpoint was PFS. Eligibility included performance status 0/1 and normal fasting blood glucose. Polymorphisms in genes involved in G metabolism and in EGFR pathway were also studied. Results: The Phase I results (n=10) established the safety of cixutumumab 6 mg/kg IV/week, erlotinib 100 mg/day orally and G 1000 mg/m2 IV D 1, 8, and 15 of a 28-day cycle. In the RP2 portion (116 eligible patients, median age 63) the median PFS and overall survival (OS) were 3.6 and 6.7 months on the cixutumumab arm, and 3.6 and 7.0 on the control arm. Major grade 3 and 4 toxicities were (cixutumumab/control) elevation of transaminases (12%/6%), fatigue (16%/12%), gastrointestinal (35%/28%), neutropenia (21%/10%), and thrombocytopenia (16%/7%). Grade 3/4 hyperglycemia was seen in 16% of patients on cixutumumab. Grade 3 or 4 skin toxicity was similar in both arms of the study (< 5%). No significant differences in PFS by genotype were seen for any of the polymorphisms. Conclusion: Adding the IGF-1R inhibitor, cixutumumab to erlotinib and G did not lead to longer PFS or OS in metastatic PC.