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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

Westphalen CB, Kukiolka T, Garlipp B, Hahn L, Fuchs M, Malfertheiner P, Reiser M, Kütting F, Heinemann V, Beringer A, Waldschmidt DT (2020)

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Publication Type: Journal article

Publication year: 2020

Journal

Book Volume: 20

Article Number: 155

Journal Issue: 1

DOI: 10.1186/s12885-020-6636-7

Abstract

Background: Gemcitabine/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. Methods: This 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 (≤8 weeks, > 8 weeks), Eastern Cooperative Oncology Group (ECOG) performance status at baseline (0-1, 2) and age (≤65 years, > 65 years). Results: Within 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 9.11 months with an OS of 9.93 months in rash-positive and 8.68 months in rash-negative patients. Median PFS was 5.06 months for rash-positive and 4.11 months for rash-negative patients. PFS was longer in patients with rash grade ≥ 2 and in older patients (> 65 years). Examination using a multivariate Cox proportional model revealed that an age > 65 years 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. Conclusions: Comparing 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 registration: ClinicalTrials.gov Identifier: NCT01782690, retrospectively registered on 4 February 2013.

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How to cite

APA:

Westphalen, C.B., Kukiolka, T., Garlipp, B., Hahn, L., Fuchs, M., Malfertheiner, P.,... Waldschmidt, D.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). https://dx.doi.org/10.1186/s12885-020-6636-7

MLA:

Westphalen, C. Benedikt, et al. "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 (2020).

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