title: 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.
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 < 0.0001) and gender (male vs. female-IRR 1.38, P = 0.0008). Compliance at first postbaseline evaluation was 97.75%. Median overall survival was 23.6 months, median progression-free survival 8.3 months. Cetuximab plus chemotherapy did not compromise QoL in the routine clinical setting when patients receive close monitoring plus prophylactic or reactive management of skin reactions. We observed the same correlation between overall survival (OS) and skin reactions reported in controlled clinical trials, also in this setting.
authors.affiliation: Medical Oncology, Santa Maria Nuova IRCCS Hospital, Reggio Emilia, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: Pinto
authors.affiliation: Medical Oncology, S. Orsola-Malpighi Policlinic Hospital, Bologna, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Fabio
authors.affiliation: Medical Oncology, San Carlo Hospital, Potenza, Italy.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Rosati
authors.affiliation: Medical Oncology, Saverio de Bellis IRCCS Hospital, Castellana Grotte, Italy.
authors.forename: Ivan R
authors.initials: IR
authors.lastname: Lolli
authors.affiliation: Medical Oncology, Belcolle AUSL Hospital Viterbo, Viterbo, Italy.
authors.forename: Enzo M
authors.initials: EM
authors.lastname: Ruggeri
authors.affiliation: Medical Oncology, Città della Salute e della Scienza, and San Giovanni Battista - Molinette Hospitals, Turin, Italy.
authors.forename: Libero
authors.initials: L
authors.lastname: Ciuffreda
authors.affiliation: Medical Oncology, San Paolo Hospital, Milan, Italy.
authors.forename: Daris
authors.initials: D
authors.lastname: Ferrari
authors.affiliation: Medical Oncology, Pordenone AAS5 Hospital, Pordenone, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.affiliation: Medical Oncology, Treviso Regional Hospital, Treviso, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rosti
authors.affiliation: Medical Oncology, Umberto I RAO Hospital, Siracusa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Tralongo
authors.affiliation: Medical Oncology, Mons. R. Dimiccoli Hospital, Barletta, Italy.
authors.forename: Raimondo
authors.initials: R
authors.lastname: Ferrara
authors.affiliation: Medical Oncology, Carità Hospital, Novara, Italy.
authors.forename: Oscar
authors.initials: O
authors.lastname: Alabiso
authors.affiliation: Medical Oncology, San Martino IRCCS University Hospital - National Cancer Institute, Genoa, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Chiara
authors.affiliation: Medical Oncology, Sant'Anna e San Sebastiano Hospital, Caserta, Italy.
authors.forename: Giovanni P
authors.initials: GP
authors.lastname: Ianniello
authors.affiliation: Clinical Oncology, Arcispedale Sant'Anna University Hospital, Ferrara, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Frassoldati
authors.affiliation: Medical Oncology, San Carlo Hospital, Potenza, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Bilancia
authors.affiliation: Medical Oncology, Saverio de Bellis IRCCS Hospital, Castellana Grotte, Italy.
authors.forename: Giovanna A
authors.initials: GA
authors.lastname: Campanella
authors.affiliation: Medical Oncology, Belcolle AUSL Hospital Viterbo, Viterbo, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Signorelli
authors.affiliation: Medical Oncology, Città della Salute e della Scienza, and San Giovanni Battista - Molinette Hospitals, Turin, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Racca
authors.affiliation: Merck Serono S.p.A., Rome, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Benincasa
authors.affiliation: Merck Serono S.p.A., Rome, Italy.
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Stroppolo
authors.affiliation: Careggi University Hospital, Florence, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D018631:ras Proteins / Q000235:genetics*
chemical_list: D018631:ras Proteins; D000068818:Cetuximab
keywords: Cetuximab; metastatic colorectal cancer; quality of life; skin reactions