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
3082 - Prognostic and predictive role of body mass index (BMI) in metastatic colorectal cancer (mCRC): a pooled analisys of TRIBE and TRIBE-2 studies by GONO
Presenter: Emanuela Dell'Aquila
Session: Poster Display session 2
Resources:
Abstract
3618 - Drug holidays and overall survival in patients treated for metastatic colorectal cancer
Presenter: Silvio Ken Garattini
Session: Poster Display session 2
Resources:
Abstract
6111 - Quality of life during 1st-line FOLFOXIRI+/- panitumumab in RAS wild-type metastatic colorectal cancer: Results from the randomized VOLFI trial (AIO KRK-0109)
Presenter: Michael Geissler
Session: Poster Display session 2
Resources:
Abstract
1042 - A biomarker combination indicating resistance to FOLFOX plus bevacizumab in metastastic colorectal cancer : results of phase I of the PERMAD trial
Presenter: Thomas Seufferlein
Session: Poster Display session 2
Resources:
Abstract
3291 - Microsatellite Instability (MSI) status and prognosis in colorectal cancer: meta-analysis
Presenter: James Toh
Session: Poster Display session 2
Resources:
Abstract
2046 - Choosing the right strategy based on individualized treatment effect predictions: Combination versus sequential chemotherapy in patients with metastatic colorectal cancer.
Presenter: Miriam Koopman
Session: Poster Display session 2
Resources:
Abstract
2589 - Noninferiority on overall survival of every-2-weeks vs weekly schedule of cetuximab for first-line treatment of RAS wild-type metastatic colorectal cancer
Presenter: Stefan Kasper
Session: Poster Display session 2
Resources:
Abstract
4944 - POLAF study: Efficacy and safety of FOLFIRI/aflibercept in a phase II trial in patients with metastatic colorectal cancer: Results of plasmatic prognostic and predictive markers
Presenter: Maria Elena Elez Fernandez
Session: Poster Display session 2
Resources:
Abstract
2042 - The accuracy of the clinical PCI score in patients with peritoneal carcinomatosis of colorectal cancer
Presenter: Nadine De Boer
Session: Poster Display session 2
Resources:
Abstract
2667 - The impact of late-line treatment on overall survival (OS) from the initiation of first-line chemotherapy (CT) for patients (pts) with metastatic colorectal cancer (mCRC).
Presenter: Takeshi Kawakami
Session: Poster Display session 2
Resources:
Abstract