1164P - Patient-reported outcomes in patients with advanced NSCLC before and during the COVID-19 pandemic in the German prospective CRISP Registry real-world cohort (AIO-TRK-0315)

Background

Patients (pts) with lung cancer under treatment have been associated with a high risk of COVID-19 infection and potentially worse outcome, but real-world data on patient-reported outcomes (PRO) are still scarce. We show pts’ characteristics and PRO before and during the COVID-19 pandemic in a representative advanced non-small cell lung cancer (NSCLC) cohort in Germany.

Methods

Pts with locally advanced or metastatic NSCLC from the prospective, multicenter, observational registry CRISP (NCT02622581) who started 1^st-line treatment between March 1^st, 2019 and February 29^th, 2020 (pre-pandemic group) and those with 1^st-line treatment start between March 1^st, 2020 and February 28^th, 2021 (pandemic group) were included in this analysis. Quality of life was assessed by FACT-G plus lung cancer subscale, anxiety and depression by PHQ-4. Pts were asked to fill in questionnaires (QRS) at time of recruitment (baseline, T0), every 2 months (mo) until mo 12 (T1-6) and thereafter every 3 mo for up to 36 mo. Here, we evaluated QRS until T6 using descriptive statistics.

Results

Recruitment was slightly higher in the pre-pandemic (n=1616) than in the pandemic period (n=1233). PRO data were documented for 1162 pts (72%) in the pre-pandemic and for 916 (74%) in the pandemic group, with a marginally higher return rate of QRS in the pandemic group at early time points (T0-2). In both groups, almost 60% of pts were male, median age was 65-67 years. ECOG was 0 in about 30% of pts, comorbidities occurred in 85% of pts. Mean baseline total scores (for FACT-G, 70.9 for both groups; for PHQ-4, 3.6 for pre-pandemic vs. 3.5 for pandemic group) and sub scores were almost identical between samples. There were no substantial differences in the mean-change-from-baseline plots between groups. Approximately 20% of pts reported anxiety, about 25% signs of depression.

Conclusions

These prospectively collected real-world data provide insight into characteristics and PRO of pts with advanced NSCLC prior to and during the COVID-19 pandemic. For the pts, the pandemic seems to be less of a burden than the disease itself, as there is a considerable proportion of pts with high anxiety and depression scores in both groups.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

CRISP is supported by grants from Amgen GmbH, AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, Janssen-Cilag GmbH, Lilly Deutschland GmbH, MSD Sharp & Dohme GmbH, Novartis Pharma GmbH and Pfizer Pharma GmbH., Roche Pharma AG and Takeda Pharma Vertrieb GmbH & Co. KG.

Disclosure

M. Sebastian: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Takeda, BMS, MSD, Merck-Serono, Pfizer, Novartis, Lilly, Roche, Janssen-Cilag, Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Takeda, BMS, MSD, Merck-Serono, Pfizer, Novartis, Lilly, Roche, Janssen-Cilag; Financial Interests, Institutional, Funding: AstraZeneca, BMS; Financial Interests, Personal, Other: GSK. F. Griesinger: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche; Financial Interests, Institutional, Funding: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Siemens. E. von der Heyde: Financial Interests, Personal, Member of the Board of Directors: Onkologische Praxis am Raschplatz; Financial Interests, Personal, Invited Speaker: BMS, Novartis, Boehringer Ingelheim, Ipsen, Pierre Fabre; Financial Interests, Personal and Institutional, Funding: Novartis, BMS, Boehringer Ingelheim, Ipsen. S. Dörfel: Financial Interests, Personal and Institutional, Ownership Interest: Onkozentrum Dresden/Freiberg; Financial Interests, Personal, Stocks/Shares: iOMEDICO. C. Schiefer: Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, Chiesi, GSK; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chiesi, GSK. C. Losem: Non-Financial Interests, Personal, Advisory Board: Amgen, AbbVie, BMS; Other, Personal, Stocks/Shares: iOMEDICO. A. Hipper: Financial Interests, Institutional, Funding: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Janssen-Cilag, MSD, Lilly, Novartis, Pfizer, Roche, Takeda. C. Dietel: Financial Interests, Institutional, Funding: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Janssen-Cilag, MSD, Lilly, Novartis, Pfizer, Roche, Takeda. A. Bleckmann: Financial Interests, Personal, Advisory Role: Alexion, Gilead, Novartis, BMS, Bayer, Servier, Roche, AstraZeneca, Takeda, Merck, BeiGene, MSD, Lilly, ArtTempi, Janssen-Cilag, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Alexion, Gilead, Novartis, BMS, Bayer, Servier, Roche, AstraZeneca, Takeda, Merck, BeiGene, MSD, Lilly, ArtTempi, Janssen-Cilag, Boehringer Ingelheim; Financial Interests, Institutional, Funding: Novartis. R. Benkelmann: Financial Interests, Personal, Advisory Role: Boehringer Ingelheim, Roche, Merck, Celgene, Novartis, BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Roche, Merck, Celgene, Novartis, BMS. M. Boesche: Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Roche. A. Müller: Financial Interests, Personal, Advisory Role: AstraZeneca, Roche, Boehringer Ingelheim, Lilly, MSD, Pfizer, Novartis, BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, Boehringer Ingelheim, Lilly, MSD, Pfizer, Novartis, BMS; Financial Interests, Institutional, Funding: BMS, Roche, Boehringer Ingelheim. W.E.E. Eberhardt: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, Pfizer, MSD/Merck, Novartis, BMS, Takeda, Boehringer Ingelheim, Bayer, Sanofi-Aventis, Eli Lilly, Amgen; Financial Interests, Institutional, Funding: AstraZeneca, Eli Lilly, BMS; Financial Interests, Personal, Other: Baumgart Consult, Onkowissen.de, ArtTempi. M. Thomas: Financial Interests, Personal, Advisory Board: AstraZeneca, BeiGene, BMS, Boehringer Ingelheim, Celgene, Chugai, Daichii Sankyo, GSK, Janssen-Cilag, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda; Financial Interests, Personal, Invited Speaker: AstraZeneca, BeiGene, BMS, Boehringer Ingelheim, Celgene, Chugai, Daichii Sankyo, GSK, Janssen-Cilag, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda; Financial Interests, Institutional, Funding: AstraZeneca, BMS, Merck, Roche, Takeda; Financial Interests, Personal, Other, travel reimbursement: AstraZeneca, BMS, Janssen-Cilag, MSD, Pfizer, Roche, Takeda. All other authors have declared no conflicts of interest.