학술논문
Observational study on quality of life, safety, and effectiveness of first‐line cetuximab plus chemotherapy in KRAS wild‐type metastatic colorectal cancer patients: the ObservEr Study
Document Type
article
Author
Carmine Pinto; Francesca Di Fabio; Gerardo Rosati; Ivan R. Lolli; Enzo M. Ruggeri; Libero Ciuffreda; Daris Ferrari; Giovanni Lo Re; Giovanni Rosti; Paolo Tralongo; Raimondo Ferrara; Oscar Alabiso; Silvana Chiara; Giovanni P. Ianniello; Antonio Frassoldati; Domenico Bilancia; Giovanna A. Campanella; Carlo Signorelli; Patrizia Racca; Elena Benincasa; Maria Elena Stroppolo; Francesco Di Costanzo
Source
Cancer Medicine, Vol 5, Iss 11, Pp 3272-3281 (2016)
Subject
Language
English
ISSN
2045-7634
Abstract
Abstract Cetuximab improves efficacy when added to chemotherapy for metastatic colorectal cancer (mCRC). Effective management of skin reactions from cetuximab improves quality of life (QoL), and treatment compliance in clinical trials. No data are available from real‐world settings. The ObservEr observational, multicenter, prospective study evaluated QoL, the incidence of skin reactions, and management of chemotherapy plus cetuximab in first‐line for mCRC. The primary endpoint was QoL measured with the Dermatology Life Quality Index (DLQI) and EORTC QLQ‐C30. Secondary endpoints were the incidence of skin and serious adverse events, median overall and progression‐free survival, tumor response, and resection rates. Between May 2011 and November 2012, 228 patients with KRASwt mCRC were enrolled at 28 Italian centers, 225 evaluable, median age 65 years. QoL did not change during treatment and was not affected by the choice of prophylactic or reactive skin management. The incidence of cetuximab‐specific grade ≥3 skin reactions was 14%, with no grade 4/5 events. Skin reactions correlated with survival (P = 0.016), and their incidence was influenced by chemotherapy regimen (oxaliplatin vs. irinotecan—Incidence rate ratio [IRR] 1.72, P