دورية أكاديمية
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PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer.

التفاصيل البيبلوغرافية
العنوان: PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer.
المؤلفون: Mineur L; Institut Sainte-Catherine, Avignon, France., François E; Lacassagne Anticancer Center, Nice, France., Plassot C; Institut Universitaire de Recherche Clinique, Montpellier, France., Phelip JM; Hopital universitaire CHU Nord Saint Etienne, Saint Etienne, France., Miglianico L; Saint Gregoire Hospital, Saint Gregoire, France., Dourthe LM; Strasbourg Oncologie Libérale, Strasbourg, France., Bonichon N; Clinique TIVOLI, Bordeaux, France., Moreau L; Clinique les Domes, Clermont-Ferrand, France., Guimbaud R; CHU Rangueil, Toulouse, France., Smith D; Hopital Saint-André, Bordeaux, France., Achille E; Clinique de l'Orangerie, Strasbourg, France., Hervé R; CH Privé Clairval, Marseille, France., Bons JM; Polyclinique Saint-Francois, Desertine, France., Remy S; Centre d'Oncologie de la côte Basque, Bayonne, France., Faroux R; CHD, La Roche-sur-Yon, France., Villing AL; CH Auxerre, Auxerre, France., Mahamat A; CHU Archet II, Nice, France., Rabbia I; Cabinet médical, Orange, Paris, France., Soulié P; CLCC Paul Papin, Angers, France., Baumgaertner I; CH Henri Mondor, Créteil, France., Mathé N; Centre Clinique de Soyaux, Soyaux, France., Vazquez L; Institut Sainte-Catherine, Avignon, France., Boustany R; Institut Sainte-Catherine, Avignon, France.
المصدر: PloS one [PLoS One] 2020 Dec 21; Vol. 15 (12), pp. e0243997. Date of Electronic Publication: 2020 Dec 21 (Print Publication: 2020).
نوع المنشور: Clinical Trial; Journal Article; Multicenter Study; Observational Study; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Antineoplastic Agents, Immunological/*therapeutic use , Cetuximab/*therapeutic use , Colorectal Neoplasms/*drug therapy , Folliculitis/*epidemiology , Paronychia/*epidemiology , Smoking/*epidemiology, Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Cetuximab/administration & dosage ; Cetuximab/adverse effects ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; Compliance ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Proto-Oncogene Proteins p21(ras)/genetics ; Treatment Outcome
مستخلص: Background: Cetuximab improves progression-free survival (PFS) and overall survival (OS) in patients with KRAS wild type (wt) metastatic colorectal cancer (mCRC). Few data are available on factors impacting both efficacy and compliance to cetuximab treatment, which is, in combination with chemotherapy, a standard-of-care first-line treatment regimen for patients with KRAS wt mCRC.
Patients and Methods: PREMIUM is a prospective, French multicenter, observational study that recruited patients with KRAS wt mCRC scheduled to receive cetuximab, with or without first-line chemotherapy, as part of routine clinical practice, between October 28, 2009 and April 5, 2012 (ClinicalTrials.gov Identifier: NCT01756625). The main endpoints were the factors impacting on efficacy and compliance to cetuximab treatment. Predefined efficacy endpoints were PFS and safety.
Results: A total of 493 patients were recruited by 94 physicians. Median follow-up was 12.9 months. Median progression-free survival was 11 months [9.6-12]. In univariate analyses, ECOG performance status (PS), smoking status, primary tumor location, number of metastatic organs, metastasis resectability, surgery, folliculitis, xerosis and paronychia maximum grade, and acne preventive treatment were statistically significant. In multivariate analysis (Hazard Ratios of multivariate stepwise Cox models), ECOG PS, surgery, xerosis and folliculitis were positive prognostics factors for longer PFS. Among all patients, 69 (14%) were non-compliant. In multivariate analysis, no variables were statistically significant. The safety profile of cetuximab was consistent with previous studies.
Conclusions: ECOG PS <2, surgical treatment performed, and maximum grade xerosis or folliculitis developed were predictive factors of cetuximab efficacy on KRAS wt mCRC patients. Unfortunately, we failed in identifying predictive factors for compliance in these patients.
Competing Interests: The PREMIUM study was funded by Merck Serono, France., an affiliate of Merck KGaA Darmstadt, Germany. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The authors declare no financial, non-financial, professional or personal conflict of interest other than the funding of the study.
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سلسلة جزيئية: ClinicalTrials.gov NCT01756625
المشرفين على المادة: 0 (Antineoplastic Agents, Immunological)
0 (KRAS protein, human)
EC 3.6.5.2 (Proto-Oncogene Proteins p21(ras))
PQX0D8J21J (Cetuximab)
تواريخ الأحداث: Date Created: 20201221 Date Completed: 20210217 Latest Revision: 20210217
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC7752147
DOI: 10.1371/journal.pone.0243997
PMID: 33347495
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0243997