Virtual Library
Start Your Search
John R. Penrod
Author of
-
+
OA05 - Clinical Trials in IO (ID 899)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
-
+
OA05.06 - CheckMate 227: Patient-Reported Outcomes of First-Line Nivolumab + Ipilimumab in High Tumor Mutational Burden Advanced NSCLC (ID 13450)
14:25 - 14:35 | Author(s): John R. Penrod
- Abstract
- Presentation
Background
The randomized, open-label, multipart phase 3 study CheckMate 227 (NCT02477826) demonstrated a significant progression-free survival benefit (co-primary endpoint) with first-line nivolumab+ipilimumab versus histology-based, platinum-doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) and high tumor mutational burden (TMB; ≥10 mutations/Mb). Patient-reported outcomes (PROs) for this population within CheckMate 227 are presented.
a9ded1e5ce5d75814730bb4caaf49419 Method
Eligible chemotherapy-naïve patients had stage IV or recurrent NSCLC, ECOG performance status 0−1, and no known sensitizing EGFR/ALK alterations. PROs were assessed as an exploratory endpoint; this analysis included patients with high TMB randomized to nivolumab+ipilimumab or chemotherapy; specific outcomes included proportion of patients with disease-related symptom deterioration by 12 weeks and time to deterioration in symptoms (by Lung Cancer Symptom Scale [LCSS] Average Symptom Burden Index [ASBI]), and assessment of quality of life and overall health status (by EuroQoL-5 Dimension [EQ-5D] utility index [UI] and visual analog scale [VAS]). PROs were evaluated each cycle (Q2W, nivolumab+ipilimumab; Q3W, chemotherapy) for the first 6 months, every 6 weeks thereafter during treatment, and at follow-up visits 1/2. EQ-5D was also assessed during survival follow-up.
4c3880bb027f159e801041b1021e88e8 Result
PRO completion rates were ~90% at baseline and >80% for nearly all on-treatment assessments. Among patients with high TMB, fewer patients in the nivolumab+ipilimumab (n=139) versus chemotherapy (n=160) groups reported symptom deterioration by week 12, irrespective of whether they were still on therapy or had discontinued (22.3% versus 35.0%; absolute risk reduction: 12.7% [95% CI: 2.4–22.5]). Time to first deterioration (TTD) using common assessment time points (on/off treatment) was delayed with nivolumab+ipilimumab versus chemotherapy for the LCSS ASBI (hazard ratio [HR]: 0.40; 95% CI: 0.26–0.63) and 3-Item Global Index (3-IGI; HR: 0.56; 95% CI: 0.38–0.82). The estimated benefit in TTD generally favored nivolumab+ipilimumab for individual symptoms in the ASBI and each item in the 3-IGI (HRs: 0.48–0.74), except for hemoptysis (HR: 1.20), which exhibited very low burden; an advantage for nivolumab+ipilimumab was also seen in the EQ-5D VAS (HR: 0.62; 95% CI: 0.42–0.92) and UI (HR: 0.50; 95% CI: 0.34–0.73). Mean changes from baseline with nivolumab+ipilimumab showed early and clinically meaningful improvements in LCSS ASBI/3-IGI and EQ-5D VAS/UI; for patients treated with chemotherapy, symptoms and quality of life remained stable (LCSS ASBI/3-IGI, EQ-5D UI) or improved following completion of chemotherapy (EQ-5D VAS).
8eea62084ca7e541d918e823422bd82e Conclusion
Nivolumab+ipilimumab demonstrated early and sustained improvements in health-related quality of life versus chemotherapy in patients with advanced NSCLC and high TMB.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
-
+
P2.01-91 - Treatment Patterns in Patients with Stage IIIB-IV NSCLC in Clinical Practice: Retrospective Analysis of a UK Trust Database (ID 13261)
16:45 - 18:00 | Author(s): John R. Penrod
- Abstract
Background
I-O Optimise is a new pan-European data platform developed to enable real-world insights into the management of thoracic malignancies. As part of this initiative, the current analysis reports the characteristics and treatment patterns for adult patients diagnosed with stage IIIB or IV NSCLC at Leeds Teaching Hospitals Trust (LTHT), hosting one of the largest integrated cancer centres in the UK.
a9ded1e5ce5d75814730bb4caaf49419 Method
Retrospective cohort study using longitudinal data already collected from electronic medical records at LTHT, including all adult patients diagnosed with stage IIIB-IV NSCLC between January 2007 and August 2017. Minimum follow-up was 6 months. Distinct lines of therapy (LoT) were identified using a clinically-verified algorithm based on the name and date of systemic anti-cancer therapy (SACT) administered and the gap between two treatments.
4c3880bb027f159e801041b1021e88e8 Result
Overall, 2119 patients were included. Mean age at diagnosis was 71.4 ± 11.2 years. Nearly one-third (32.7%) were clinically diagnosed without pathological confirmation (TABLE) and very few of these patients have SACT administration recorded. Following diagnosis, 648 patients (30.6%) received ≥1 LoT, 223 (10.5%) ≥2 LoT and 60 (2.8%) ≥3 LoT. Proportions of patients treated decreased with age (73.5% [25/34] aged 18-44 years; 52.7% [267/507] aged 45-64 years; 29.8% [310/1040] aged 65-79 years; 8.6% [46/538] aged 80+ years) and performance score (58.5% [387/662] PS0-1; 38.2% [158/414] PS2; 6.1% [52/848] PS3-4). Between the periods 2007-2011 and 2012-2017, increased proportions were treated (28.2% [263/933] and 32.5% [385/1186] respectively). Patient characteristics of the treated cohort and regimens administered for 1st and 2nd LoT are shown (TABLE).
8eea62084ca7e541d918e823422bd82e Conclusion
Around 70% of this real-world cohort did not receive any SACT, and the administration of treatment was strongly associated with age and performance status. The changing availability of treatment options over time (including the emergence of immunotherapy) and survival outcomes by LoT will be presented in more detail for the cohort described.
6f8b794f3246b0c1e1780bb4d4d5dc53
