Dermatology-related quality-of-life outcomes in patients with RAS wild-type metastatic colorectal cancer treated with fluorouracil and folinic acid with or without panitumumab (Pmab) maintenance after FOLFOX + Pmab induction: a prespecified secondary analysis of the phase II randomized PanaMa (AIO KRK 0212) trial.

Autor:	Ballhausen A; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin. Electronic address: alexej.ballhausen@charite.de., Karthaus M; Klinikum Neuperlach/Klinikum Harlaching, Department of Hematology, Oncology, and Palliative Care, Munich., Fruehauf S; Klinik Dr. Hancken GmbH, Department of Hematology, Oncology, and Palliative Care, Stade., Graeven U; Kliniken Maria Hilf GmbH, Department of Hematology, Oncology, and Gastroenterology, Mönchengladbach., Müller L; Oncological Practice UnterEms, Leer., König AO; Department of Gastroenterology and Gastrointestinal Oncology Göttingen, Göttingen., von Weikersthal LF; Gesundheitszentrum St. Marien, Amberg., Sommerhäuser G; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin., Jelas I; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin., Alig AHS; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin., Kurreck A; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin., Stahler A; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin., Goekkurt E; Practice of Hematology and Oncology (HOPE), Hamburg., Held S; ClinAssess GmbH, Leverkusen., Kasper S; West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen., Heinrich K; University Hospital, LMU Munich, Department of Medicine III, Munich; Comprehensive Cancer Center Munich, Munich., Heinemann V; University Hospital, LMU Munich, Department of Medicine III, Munich; Comprehensive Cancer Center Munich, Munich; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg., Stintzing S; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg., Trarbach T; West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen; Reha-Zentrum am Meer, Bad Zwischenahn, Germany., Modest DP; Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin; German Cancer Consortium (DKTK), German Cancer Research Centre (DKFZ), Heidelberg.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2024 Jul; Vol. 9 (7), pp. 103628. Date of Electronic Publication: 2024 Jul 13.
DOI:	10.1016/j.esmoop.2024.103628
Abstrakt:	Background: The key endpoints for the assessment of the effect of maintenance therapy for metastatic colorectal cancer (mCRC) are survival and quality-of-life outcomes. We aimed to compare dermatology-related quality of life (DRQOL) in patients with RAS wild-type (wt) mCRC treated with fluorouracil and folinic acid (FU/FA) + panitumumab (Pmab) versus FU/FA alone as maintenance therapy after folinic acid, fluorouracil and oxaliplatin + Pmab induction. Patients and Methods: The phase II randomized PanaMa (AIO KRK 0212; NCT01991873) trial included 387 patients at 70 community/academic sites in Germany. For this prespecified secondary analysis, DRQOL outcomes were assessed using the Functional Assessment of Cancer Therapy-epidermal growth factor receptor inhibitor (FACT-EGFRI), Dermatology Life Quality Index (DLQI), and Skindex-16 questionnaires at every second cycle of therapy until disease progression/death. Results: At least one DRQOL questionnaire was completed by a total of 310/377 (82%) patients who received induction therapy, and by 216/248 (87%) patients who were randomized and received maintenance therapy. Patients who experienced skin toxicity according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) during induction therapy had significantly worse DRQOL according to all three measures, compared to those who did not [i.e. Skindex-16, mean difference at cycle 2 -12.87; 95% confidence interval (CI) -20.01 to -5.73; P < 0.001]. During maintenance therapy, significantly improved recovery was observed in all DRQOL measures for patients receiving FU/FA, compared to those receiving additional Pmab (i.e. Skindex-16, mean difference at cycle 6 -16.53; 95% CI -22.68 to -10.38; P < 0.001). Conclusions: In this secondary analysis of a phase II randomized clinical trial, patient-reported DRQOL outcomes correlated with skin toxicity according to NCI-CTCAE during induction therapy. Maintenance therapy with FU/FA + Pmab was associated with deteriorated DRQOL versus FU/FA alone in patients with RAS wt mCRC. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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