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.

anti-EGFR colorectal cancer maintenance therapy patient-reported outcomes quality of life

Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
11 Jul 2024
Historique:
received: 04 04 2024
revised: 05 06 2024
accepted: 07 06 2024
medline: 13 7 2024
pubmed: 13 7 2024
entrez: 12 7 2024
Statut: aheadofprint

Résumé

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. 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. 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). 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.

Sections du résumé

BACKGROUND 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 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 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 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.

Identifiants

DOI: 10.1016/j.esmoop.2024.103628 PMID: 38996519
pubmed: 38996519
pii: S2059-7029(24)01397-8
doi: 10.1016/j.esmoop.2024.103628
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103628

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Auteurs

A 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.

M Karthaus (M)

Klinikum Neuperlach/Klinikum Harlaching, Department of Hematology, Oncology, and Palliative Care, Munich.

S Fruehauf (S)

Klinik Dr. Hancken GmbH, Department of Hematology, Oncology, and Palliative Care, Stade.

U Graeven (U)

Kliniken Maria Hilf GmbH, Department of Hematology, Oncology, and Gastroenterology, Mönchengladbach.

L Müller (L)

Oncological Practice UnterEms, Leer.

A O König (AO)

Department of Gastroenterology and Gastrointestinal Oncology Göttingen, Göttingen.

L F von Weikersthal (LF)

Gesundheitszentrum St. Marien, Amberg.

G Sommerhäuser (G)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin.

I Jelas (I)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin.

A H S Alig (AHS)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin.

A Kurreck (A)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin.

A Stahler (A)

Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hematology, Oncology, and Cancer Immunology (CVK/CCM), Berlin.

E Goekkurt (E)

Practice of Hematology and Oncology (HOPE), Hamburg.

S Held (S)

ClinAssess GmbH, Leverkusen.

S Kasper (S)

West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen.

K Heinrich (K)

University Hospital, LMU Munich, Department of Medicine III, Munich; Comprehensive Cancer Center Munich, Munich.

V 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.

S 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.

T Trarbach (T)

West German Cancer Center, Department of Medical Oncology, University Hospital Essen, Essen; Reha-Zentrum am Meer, Bad Zwischenahn, Germany.

D P 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.

Classifications MeSH