Universität zu Köln

Ferreira, Arlindo R., Ferreira, Sofia, Lambertini, Matteo ORCID: 0000-0003-1797-5296, Maurer, Christian, Martel, Samuel, Costa, Luis, Ponde, Noam and de Azambuja, Evandro ORCID: 0000-0001-9501-4509 (2021). Association between pertuzumab-associated diarrhoea and rash and survival outcomes in patients with HER2-positive metastatic breast cancer: Exploratory analysis from the CLEOPATRA trial. Eur. J. Cancer, 144. S. 351 - 360. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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Abstract

Background: Skin rash and diarrhoea are known side-effects of pertuzumab. Studies with other anti-HER2 agents suggested that adverse events correlate with patient outcomes. In this exploratory cohort of patients with metastatic HER2-positive breast cancer included in the CLEOPATRA trial we evaluated the value of rash and diarrhoea as prognostic markers and as predictors of pertuzumab benefit. Methods: This is a retrospective analysis of the multicenter, prospective, randomised CLEOPATRA trial. We defined two analytic cohorts: cohort 1 (C1) included patients from treatment initiation, and cohort 2 (C2) included patients after discontinuation of docetaxel. A landmark analysis was introduced to deal with immortal-time bias. Study endpoints were progression-free survival (PFS) and overall survival (OS). Univariable and multivariable Cox proportional hazards models were used. Results: Of the 808 patients and after application of the landmark analysis, C1 and C2 included 777 and 518 patients, respectively. In C1, rash occurred in 271 patients (34.9%) and diarrhoea in 470 (60.5%). Rash was prognostic for PFS and OS (C1: adjusted hazard ratio [aHR] = 0.66 [95% CI = 0.48-0.91], p = 0.010]; C2: aHR 0.52 [95% CI = 0.30-0.89], p = 0.018) in both cohorts, while diarrhoea was only prognostic for PFS in cohort 2 (aHR = 0.65 [95% CI = 0.46-0.91], p = 0.011). Rash and diarrhoea were not predictive of pertuzumab benefit (in terms of PFS/OS) in the two cohorts. Conclusions: In patients treated with pertuzumab, trastuzumab, and docetaxel, rash is prognostic whenever it occurs during treatment, while diarrhoea only has prognostic value when occurring after docetaxel discontinuation. However, neither rash nor diarrhoea predict pertuzumab benefit. (C) 2020 Elsevier Ltd. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Ferreira, Arlindo R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ferreira, Sofia UNSPECIFIED UNSPECIFIED UNSPECIFIED Lambertini, Matteo UNSPECIFIED orcid.org/0000-0003-1797-5296 UNSPECIFIED Maurer, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Martel, Samuel UNSPECIFIED UNSPECIFIED UNSPECIFIED Costa, Luis UNSPECIFIED UNSPECIFIED UNSPECIFIED Ponde, Noam UNSPECIFIED UNSPECIFIED UNSPECIFIED de Azambuja, Evandro UNSPECIFIED orcid.org/0000-0001-9501-4509 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-600011
DOI:	10.1016/j.ejca.2020.11.023
Journal or Publication Title:	Eur. J. Cancer
Volume:	144
Page Range:	S. 351 - 360
Date:	2021
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1879-0852
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRASTUZUMAB; DOCETAXEL; LAPATINIB; INHIBITOR; THERAPIES; SAFETY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60001