Abstract 1790
Background
SA are widely used and recommended to ameliorate skin reactions induced by EGFR inhibition. Randomised studies have shown a positive impact of SA on severity of skin reactions, but the influence on outcome are widely unknown. Recent data suggests that antibiotics negatively influence the efficacy of checkpoint-inhibitor therapies. Therefore, an evaluation of the impact of SA on the outcome of RAS-wt mCRC pts treated with cetuximab-based therapy is highly needed.
Methods
Pts with RAS-wt mCRC treated with a cetuximab-based first-line combination and written informed consent were eligible for this prospective, non-interventional study. According to a thorough questionnaire about prophylactic treatments for skin management, pts were categorized in 2 groups: SA and no SA. Outcome endpoints like objective remission rate (ORR), progression free survival (PFS), overall survival (OS), and time to treatment failure (TTF) were compared between the two subgroups.
Results
Data from 583 of 875 enrolled pts were evaluable at the data cut-off (SA: n = 183; no SA: n = 400). Pts were not included for the following reasons: no cetuximab therapy (34), not fully documented (131), no first-line therapy (95), no RAS-wt (2), and no skin questionnaire (30). Pts in the SA group showed compared to the no SA group a significantly increased median PFS with 12.30 vs 9.51 months (p = 0.033) and OS with 28.22 vs. 20.79 months (p = 0.0063). Number of cetuximab infusions were numerically higher in the SA group (mean: 30.6 vs 27.4, p = 0.0581), as well as ORR with 63.9% and 56.5% (p = 0.09) and TTF with 5.46 vs 4.61 months (p = 0.0746), but all three endpoints did not reach significance. In a multivariate analysis the impact of SA was an independent significant factor on OS (p < 0.05), but not on PFS (p = 0.09).
Conclusions
Data of this large non-interventional trial suggests that SA have a positive impact on the OS outcome of RAS-wt mCRC pts treated with a cetuximab-based first-line therapy. Hence, the data supports the recommendations for SA in the treatment management of EGFR inhibitors in mCRC.
Clinical trial identification
Editorial acknowledgement
Felix Eilenberger, Alcedis GmbH, Gießen, Germany.
Legal entity responsible for the study
Merck Serono GmbH, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
Funding
Merck Serono GmbH, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
Disclosure
S.W. Sahm: Shareholder / Stockholder / Stock options: Merck KGaA; Honoraria (self): Fresenius Kabi; Research grant / Funding (institution): Merck Serono GmbH. M. Zahn: Honoraria (self): Merck Serono GmbH. J. Janssen: Advisory / Consultancy, Research grant / Funding (self): Bayer; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Sanofi; Advisory / Consultancy, Research grant / Funding (institution): PharmaMar; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Onyx; Research grant / Funding (institution): Baxter; Research grant / Funding (institution): Biotest; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Janssen Cilag Ltd; Research grant / Funding (institution): Kedrion Biopharma; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Merck Serono GmbH; Research grant / Funding (institution): Octapharma; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Puma Biotechnology; Research grant / Funding (institution): Teva Pharmaceutical; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): Servier. C. Hering-Schubert: Honoraria (self): Novartis; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self): Sanofi. I. Zander: Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self): Pfizer; Honoraria (self): Mundipharma; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Ribosepharm; Travel / Accommodation / Expenses: Merck Serono GmbH. K.G. Stenzel: Full / Part-time employment: Merck Serono GmbH; Shareholder / Stockholder / Stock options: Merck KGaA. F. Overkamp: Leadership role, Full / Part-time employment: OncoConsult. Hamburg GmbH; Leadership role, Full / Part-time employment: onkowissen.de GmbH; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self): AstraZeneca; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Cellex; Advisory / Consultancy: ClinSol; Honoraria (self), Advisory / Consultancy: Gilead; Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Iomedico; Honoraria (self), Advisory / Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Riemser; Advisory / Consultancy: Roche; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Teva; Honoraria (self): Chugai; Honoraria (self): Celgene; Honoraria (self): Eisai; Honoraria (self): Ipsen; Honoraria (self): Janssen-Cilag; Honoraria (self): Merck Serono GmbH; Honoraria (self): Novo Nordisc; Honoraria (self): Servier; Honoraria (self): Shire. All other authors have declared no conflicts of interest.
Resources from the same session
5203 - Novel fusion genes identified from matched primary and recurred breast cancers by RNA-sequencing
Presenter: Soojeong Choi
Session: Poster Display session 2
Resources:
Abstract
5873 - Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer
Presenter: Donna Fitzgerald
Session: Poster Display session 2
Resources:
Abstract
3588 - The role of AXL as mechanism of resistance to trastuzumab and a prognostic factor in breast cancer HER2 positive: a translational approach.
Presenter: Anna Adam-Artigues
Session: Poster Display session 2
Resources:
Abstract
5640 - Untargeted assessment of tumor fractions in plasma for monitoring and prognostication from metastatic breast cancer patients undergoing systemic treatment
Presenter: Marija Balic
Session: Poster Display session 2
Resources:
Abstract
2616 - Clinical application of mutational analysis in breast cancer patients: the relevance of PIK3CA analysis for precision medicine.
Presenter: Juan Miguel Cejalvo
Session: Poster Display session 2
Resources:
Abstract
3870 - A retrospective gene expression analysis of surgically-removed Breast Cancer Brain Metastasis (BCBM)
Presenter: Meritxell Mallafré-Larrosa
Session: Poster Display session 2
Resources:
Abstract
1240 - Endocrine therapy alone versus targeted combination strategy as first line treatment in elderly patients with hormone receptor-positive advanced breast cancer: meta-analysis of Phase II and III randomized clinical trials
Presenter: Claudia Omarini
Session: Poster Display session 2
Resources:
Abstract
5535 - Alpelisib (ALP) + fulvestrant (FUL) for patients with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC): management and time course of key adverse events of special interest (AESIs) in SOLAR-1
Presenter: Hope Rugo
Session: Poster Display session 2
Resources:
Abstract
3093 - Changes in Hormone-Receptor status in Luminal breast cancers between primary tumor and metastases: results of the observational cohort GIM-13 AMBRA Study
Presenter: Marina Cazzaniga
Session: Poster Display session 2
Resources:
Abstract
1378 - MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Presenter: Miguel Martín
Session: Poster Display session 2
Resources:
Abstract