Durvalumab after definitive chemoradiotherapy in locally advanced NSCLC: Data of the German EAP

Following the PACIFIC trial, durvalumab has been approved by the European Medicines Agency (EMA) for consolidation of locally advanced PD-L1-positive NSCLC after chemoradiotherapy (CRT). Patients were treated with durvalumab in the EAP from 22.11.2017 to 15.10.2018 allowing analysis of its efficacy and safety. 211 patients were registered by 90 German centres. Data were collected retrospectively by questionnaire and queries. 56 centres reported data on 126 patients who actually received at least one cycle of durvalumab. In contrast to the PACIFIC-trial population, some patients with oligometastatic disease and a history of autoimmune disease are included in the EAP population. Information on PD-L1 status was obtained for 111 patients. Baseline data include age, gender, ECOG, stage (IASLC 8th ed.), and smoking history. Treatment data include mode of chemoradiotherapy, used chemotherapy agent, and duration of durvalumab therapy. Adverse evants were documented according to CTAEC 5.0. Data were analysed for progression-free survival (PFS), overall survival (OS), and adverse events (AE). The results were published in Lung Cancer [1].


Keywords:
NSCLC PD-L1 Checkpoint inhibitor Survival Real world Oligometastatic Autoimmune 211 patients were registered by 90 German centres. Data were collected retrospectively by questionnaire and queries. 56 centres reported data on 126 patients who actually received at least one cycle of durvalumab. In contrast to the PACIFIC-trial population, some patients with oligometastatic disease and a history of autoimmune disease are included in the EAP population. Information on PD-L1 status was obtained for 111 patients. Baseline data include age, gender, ECOG, stage (IASLC 8th ed.), and smoking history. Treatment data include mode of chemoradiotherapy, used chemotherapy agent, and duration of durvalumab therapy. Adverse evants were documented according to CTAEC 5.0. Data were analysed for progression-free survival (PFS), overall survival (OS), and adverse events (AE). The results were published in Lung Cancer [1].
© 2020 The Author(s

Value of the Data
• The data describes the largest multicentric national cohort with detailed clinical characteristics and longest follow-up so far published. The national cohort comprises more patients than the German subgroup of the PACIFIC-trial. • The data is of interest for thoracic oncologists studying locally advanced or oligometastatic NSCLC • The data might be used for pooled analysis with data from other sources on rare subgroups (e. g. oligometastatic NSCLC) or subgroups not well represented in prospective trials (e. g. patients with autoimmune disease). for cross-country comparisons of treatment standards and outcome with data sets from other countries. • These data provide real world information on the use of durvalumab in Europe.
• These data provide real world information on the use of durvalumab in subgroups not included in clinical trials (oligometastatic stage-IVA patients, patients with stable autoimmune diseases). • The pooled analysis of rare subgroups could provide the basis for improved treatment of subgroups for which prospective trial data are lacking.

Data Description
The data describe overall survival of subgroups of patients treated with durvalumab consolidation after definitive chemoradiotherapy by age, gender, performance status (ECOG 0,1,2), histology (adenocarcinoma, squamous-cell carcinoma, other), mode of chemoradiotherapy (with or without induction chemotherapy), or chemotherapy used (cisplatin or carboplatin). Sites of recurrence are given in Data Table 1 . The survival data are summarized as Kaplan-Meier curves ( Data Fig. 1 ), baseline characteristics of each subgroup are provided in the respective tables ( Data Table 2A Table 2 Baseline characteristics and number of deaths of subgroups. There were no relevant differences among the subgroups with respect to smoking history or proportion of patients with a history of autoimmune diseases. All subgroups had a proportion of smokers of 94% -100% with mean PY of 37 -52, and a proportion of patients with an autoimmune disease of 0 -14%. For better clarity, these parameters were not included in the subgroup tables. A. Age. B. Gender. C. Performance status. D. Histology. E. Mode of CRT and prior chemotherapy of patients treated with simultaneous CRT with or without induction chemotherapy. Four patients (3.2%) had received chemotherapy and radiotherapy sequentially and were not analysed separately. Data Fig. 1 (pdf). Survival of subgroups of the EAP population from start of durvalumab.
F. Patients treated with cisplatin or carboplatin as part of the simultaneous CRT. Raw data file (MS excel) File: Faehling PACIFIC EAP Germany.xlsx Excel file with raw data which were used for the analysis published in lung cancer: Questionaire used to collect the data: File: Faehling CRF EAP Durvalumab final.docx

Experimental Design, Materials and Methods
German centres who registered patients for treatment with durvalumab in the Early Access Programme (EAP) were asked to report pseudonymized data on their patients using the questionnaire. The data were clarified using queries by mail. The data were transferred into the excel data file. The data were analysed using GraphPad Prism8. Kaplan-Meier plots were generated us-ing GraphPad Prism8. HRs and 95% confidence intervals (CIs) were calculated using the log-rank (Mantel-Cox) test-algorithm of GraphPad Prism8.