Activity of dalotuzumab, a selective anti-IGF1R antibody, in combination with erlotinib in unselected patients with Non-small-cell lung cancer : a phase I/II randomized trial
Morán, Teresa (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Felip, Enriqueta (Hospital Universitari Vall d'Hebron)
Keedy, Vicki (Vanderbilt University Medical Center)
Borghaei, Hossein (Fox Chase Cancer Center, Philadelphia)
Shepherd, Frances A. (University of Toronto)
Insa, Amelia (Hospital Clínic Universitari (València))
Brown, Holly (Merck & Co., Inc., Whitehouse Station)
Fitzgerald, Timothy (Merck & Co., Inc., Whitehouse Station)
Sathyanarayanan, Sriram (Whitehouse Station, NJ USA)
Reilly, John F.. (Merck & Co., Inc., Whitehouse Station)
Mauro, David (Merck & Co., Inc., Whitehouse Station)
Hsu, Karl (Sanofi Aventis)
Yan, Li (Merck & Co., Inc., Whitehouse Station)
Universitat Autònoma de Barcelona

Date:	2014
Abstract:	We investigated the safety and antitumor activity of dalotuzumab, a selective anti-insulin growth factor 1 receptor monoclonal antibody (IGF1R MoAb), plus erlotinib in a sequential phase I/II trial in unselected patients with refractory advanced non-small-cell lung cancer (NSCLC). The phase I trial determined the recommended dose and safety of erlotinib plus dalotuzumab at 5 mg/kg or 10 mg/kg weekly in 20 patients. The phase II trial compared outcomes to erlotinib alone and erlotinib plus dalotuzumab at the mg/kg established in the phase I trial. Erlotinib at 150 mg plus dalotuzumab at 10 mg/kg was safe. The phase II trial included 37 patients in the erlotinib arm and 38 patients in the erlotinib plus dalotuzumab arm. Progression-free survival was 1. 6 versus 2. 5 months, overall survival was 10. 2 and 6. 6 months, and the objective response rate was 7. 9% and 2. 7%, respectively, with no significant differences between the two arms. Grade 3-5 adverse events occurred in 11 (28. 9%) versus 13 (35. 1%) patients, respectively. The most frequent adverse events were asthenia (36. 8% vs. 37. 8%), dehydration (5. 3% vs. 2. 7%), diarrhea (71% vs. 81. 1%), hyperglycemia (13. 1% vs. 18. 9%), and skin-related toxicities (92. 1% vs. 86. 4%). The addition of dalotuzumab to erlotinib did not improve efficacy outcome in patients with refractory advanced NSCLC.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Non-small-cell lung cancer ; Epidermal growth factor receptor ; Insulin growth factor receptor ; Dalotuzumab ; Phase I/II trial
Published in:	Experimental Hematology & Oncology, Vol. 3 (november 2014) , ISSN 2162-3619

DOI: 10.1186/2162-3619-3-26
PMID: 25414803
PMID: 24387242

8 p, 455.0 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles