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

Carmine Pinto, Francesca Di Fabio, G. Rosati, Ivan Lolli, Enzo Maria Ruggeri, Libero Ciuffreda, Daris Ferrari, Giovanni Lo Re, G. Rosti, Paolo Tralongo, Raimondo Ferrara, Oscar Alabiso, Silvana Chiara, G. Ianniello, A. Frassoldati, D. Bilancia, Giovanna Campanella, Carlo Signorelli, Patrizia Racca, Elena BenincasaMaria Elena Stroppolo, Francesco Di Costanzo

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalCancer Medicine
DOIs
Publication statusAccepted/In press - 2016

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Observational Studies
Colorectal Neoplasms
Quality of Life
Safety
Drug Therapy
Skin
Incidence
oxaliplatin
irinotecan
Disease-Free Survival
Survival
Cetuximab
Controlled Clinical Trials
Dermatology
Compliance
Multicenter Studies
Clinical Trials
Prospective Studies
Therapeutics
Neoplasms

Keywords

  • Cetuximab
  • Metastatic colorectal cancer
  • Quality of life
  • Skin reactions

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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. / Pinto, Carmine; Di Fabio, Francesca; Rosati, G.; Lolli, Ivan; Ruggeri, Enzo Maria; Ciuffreda, Libero; Ferrari, Daris; Lo Re, Giovanni; Rosti, G.; Tralongo, Paolo; Ferrara, Raimondo; Alabiso, Oscar; Chiara, Silvana; Ianniello, G.; Frassoldati, A.; Bilancia, D.; Campanella, Giovanna; Signorelli, Carlo; Racca, Patrizia; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco.

In: Cancer Medicine, 2016.

Research output: Contribution to journalArticle

Pinto, C, Di Fabio, F, Rosati, G, Lolli, I, Ruggeri, EM, Ciuffreda, L, Ferrari, D, Lo Re, G, Rosti, G, Tralongo, P, Ferrara, R, Alabiso, O, Chiara, S, Ianniello, G, Frassoldati, A, Bilancia, D, Campanella, G, Signorelli, C, Racca, P, Benincasa, E, Stroppolo, ME & Di Costanzo, F 2016, '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', Cancer Medicine. https://doi.org/10.1002/cam4.888
Pinto, Carmine ; Di Fabio, Francesca ; Rosati, G. ; Lolli, Ivan ; Ruggeri, Enzo Maria ; Ciuffreda, Libero ; Ferrari, Daris ; Lo Re, Giovanni ; Rosti, G. ; Tralongo, Paolo ; Ferrara, Raimondo ; Alabiso, Oscar ; Chiara, Silvana ; Ianniello, G. ; Frassoldati, A. ; Bilancia, D. ; Campanella, Giovanna ; Signorelli, Carlo ; Racca, Patrizia ; Benincasa, Elena ; Stroppolo, Maria Elena ; Di Costanzo, Francesco. / 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. In: Cancer Medicine. 2016.
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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.",
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T1 - Observational study on quality of life, safety, and effectiveness of first-line cetuximab plus chemotherapy in KRAS wild-type metastatic colorectal cancer patients

T2 - The ObservEr Study

AU - Pinto, Carmine

AU - Di Fabio, Francesca

AU - Rosati, G.

AU - Lolli, Ivan

AU - Ruggeri, Enzo Maria

AU - Ciuffreda, Libero

AU - Ferrari, Daris

AU - Lo Re, Giovanni

AU - Rosti, G.

AU - Tralongo, Paolo

AU - Ferrara, Raimondo

AU - Alabiso, Oscar

AU - Chiara, Silvana

AU - Ianniello, G.

AU - Frassoldati, A.

AU - Bilancia, D.

AU - Campanella, Giovanna

AU - Signorelli, Carlo

AU - Racca, Patrizia

AU - Benincasa, Elena

AU - Stroppolo, Maria Elena

AU - Di Costanzo, Francesco

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

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