Abstract 1162P
Background
CRISP is a non-interventional, prospective, multi-center clinical research platform whose aim is to understand the treatment reality of patients (pts) with lung carcinoma in Germany. Here we present first data of pts diagnosed with NSCLC in stages II or III (IIIB/C if treated with curative intent).
Methods
Between August 2018 and February 2020 around 100 sites in Germany recruited more than 800 pts diagnosed with NSCLC stage II/III. Basic demographic data, details about treatment reality, outcome and PRO data are collected and analyzed. Here we present first data on 715 pts followed until 30 June 2020.
Results
25% of the pts were diagnosed with stage II (4% in stage IIA, 21% in stage IIB), and 68% with stage III disease (33% in stage IIIA, 34% in stage IIB/C). 51% of the tumors were adenocarcinomas. The median age at primary diagnosis was 65 years (38% women, 62% men), 83% of the pts had an ECOG 0/1. 80% of the pts presented with comorbidities; 47% had a Charlson comorbidity index of 0. 25% of the pts were current smokers; 43%, heavy ex-smokers, and 9% were never-smokers. Most of the pts with tumors in stage II underwent surgery (84%, n=153) followed by adjuvant chemotherapy (CTx) (currently 67%, n=123). For pts with stage IIIA tumors the most frequent sequence of treatment was also surgery (56%, n=134) followed by adjuvant CTx (currently 37%, n=89). 24% (n=57) of the pts with stage IIIA received radiochemotherapy (RTCTx). For pts with stage IIIB/C tumors the most frequent treatment was RTCTx (n=101, 41 %); 35% (n=85) started with CTx, and 20% (n=50) had surgery (followed mostly by CTx, currently n=35, 14%). 67% (n=80) of pts with an inoperable stage III tumor who received RTCTx were tested for PD-L1 expression. 48 pts had a positive PD-L1 expression, which corresponds to 40% of all pts and 60% of the tested pts. 30 pts out of 41 eligible (best response CR/PR/SD) received consolidation therapy with durvalumab.
Conclusions
CRISP presents comprehensive current real-life data of patients with NSCLC in stage II or III covering all treatment settings in Germany. With longer follow-up outcome in routine care will be analyzed.
Clinical trial identification
NCT02622581; Actual study start date: December 2015.
Editorial acknowledgement
Legal entity responsible for the study
AIO-Studien-gGmbH.
Funding
AIO-Studien-gGmbH.
Disclosure
M. Stuschke: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Sanofi-Aventis; Financial Interests, Personal, Advisory Board: Janssen-Cilag. P. Christopoulos: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheimer. M. Reck: Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Advisory Role: AbbVie; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Invited Speaker: Samsung; Financial Interests, Personal, Advisory Role: Samsung. D.C. Christoph: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Takeda. M. Reiser: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Celgene. M. Sebastian: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Invited Speaker: BioNTech; Financial Interests, Personal, Invited Speaker: CureVac; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Tesaro; Financial Interests, Personal, Advisory Board: Tesaro. F. Griesinger: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Personal, Invited Speaker: Siemens; Financial Interests, Institutional, Research Grant: Siemens; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Institutional, Research Grant: Amgen. M. Thomas: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Institutional, Research Grant: Takeda. W.E.E. Eberhardt: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Janssen-Cilag; Financial Interests, Personal, Invited Speaker: Baumgart Consult; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS. All other authors have declared no conflicts of interest.