Universität zu Köln

Westphalen, C. Benedikt, Kukiolka, Tobias, Garlipp, Benjamin, Hahn, Lars, Fuchs, Martin, Malfertheiner, Peter, Reiser, Marcel, Kuetting, Fabian, Heinemann, Volker, Beringer, Andreas and Waldschmidt, Dirk T. (2020). Correlation of skin rash and overall survival in patients with pancreatic cancer treated with gemcitabine and erlotinib - results from a non-interventional multi-center study. BMC Cancer, 20 (1). LONDON: BMC. ISSN 1471-2407

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Abstract

BackgroundGemcitabine/erlotinib treatment offers limited benefit in unselected patients with pancreatic ductal adenocarcinoma (PDAC). Development of skin rash has been associated with favorable outcomes in patients treated with gemcitabine/erlotinib. This study aimed to extend knowledge on the effectiveness of gemcitabine/erlotinib in metastatic PDAC in the context of clinical practice and with focus on skin rash.MethodsThis multicenter, non-interventional study enrolled 376 patients with metastatic PDAC receiving gemcitabine/erlotinib. The primary endpoint was overall survival (OS) in patients with skin rash versus no skin rash. Secondary endpoints included progression-free survival (PFS), treatment satisfaction and safety. All data were analyzed using descriptive statistics. Survival time and time to disease progression were estimated using the Kaplan-Meier method. Effectiveness endpoints were analyzed for subgroups by skin rash grade (no rash, rash grade 1, rash grade >= 2), duration of erlotinib treatment (<= 8weeks, >8weeks), Eastern Cooperative Oncology Group (ECOG) performance status at baseline (0-1, 2) and age (<= 65years, >65years).ResultsWithin the full analysis set (FAS; N=270), 48 patients (17.8%) developed grade 1 rash, 51 patients (18.9%) grade >= 2 rash, while 171 patients (63.3%) did not develop a rash. Median OS of all patients was 9.11months with an OS of 9.93months in rash-positive and 8.68months in rash-negative patients. Median PFS was 5.06months for rash-positive and 4.11months for rash-negative patients. PFS was longer in patients with rash grade >= 2 and in older patients (>65years). Examination using a multivariate Cox proportional model revealed that an age>65years was associated with longer OS (hazard ratio 0.640; p=0.0327) and PFS (hazard ratio 0.642; p=0.0026). Out of the 338 patients in the SAF, 310 patients (91.7%) experienced at least one AE, and 176 patients (52.1%) experienced skin-related side effects, all of which were CTC grade 1 to 3.ConclusionsComparing rash-positive with rash-negative patients showed no significant difference in survival. While patients with rash grade >= 2 and older patients (independent of skin reactions) showed longer PFS, this did not translate into prolonged OS. The study did not reveal new safety signals.Trial registrationClinicalTrials.gov Identifier: NCT01782690, retrospectively registered on 4 February 2013.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Westphalen, C. Benedikt UNSPECIFIED UNSPECIFIED UNSPECIFIED Kukiolka, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Garlipp, Benjamin UNSPECIFIED UNSPECIFIED UNSPECIFIED Hahn, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuchs, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Malfertheiner, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Reiser, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuetting, Fabian UNSPECIFIED UNSPECIFIED UNSPECIFIED Heinemann, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Beringer, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Waldschmidt, Dirk T. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-344114
DOI:	10.1186/s12885-020-6636-7
Journal or Publication Title:	BMC Cancer
Volume:	20
Number:	1
Date:	2020
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-2407
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PHASE-III TRIAL; FOLFIRINOX; EFFICACY; OUTCOMES; DEATHS; SAFETY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34411