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Yong Yuan
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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
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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): Yong Yuan
- 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.
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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
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P2.01-36 - Real-World Treatment Patterns in Treatment-Naïve Advanced NSCLC Patients in North America: A Systematic Literature Review (ID 12796)
16:45 - 18:00 | Presenting Author(s): Yong Yuan
- Abstract
Background
Clinical practice guidelines in North America for first-line (1L) treatment of advanced NSCLC (aNSCLC) include a range of systemic therapy combinations, with consideration given to patient and disease characteristics. As the aNSCLC treatment landscape evolves, it is relevant to understand which combinations are routine in clinical practice. We aimed to characterize treatment patterns in real-world (RW) practice in the US and Canada.
a9ded1e5ce5d75814730bb4caaf49419 Method
A systematic literature review of RW observational studies was conducted using EMBASE and MEDLINE (January 2012 to March 2018), alongside searches of conference proceedings (2015 to 2018). Two reviewers assessed eligibility and included studies that described treatment patterns among treatment-naïve patients with aNSCLC. Studies focusing exclusively on sub-populations, e.g. EGFR+ or ALK+ were excluded. Data regarding the study’s sampling frame and the frequency and type of therapies received (1L systemic regimens, other 1L treatment modalities, maintenance therapy, subsequent lines of systemic therapy) were extracted and validated.
4c3880bb027f159e801041b1021e88e8 Result
From 4600 abstracts, 18 studies met inclusion criteria (n=14 US; n=4 Canada). All studies used a retrospective design; patient sample sizes ranged from 147 to 55,189 and study periods ranged from 2000 to 2015. Six studies (n=5 US; n=1 Canada) applied a sampling frame that captured all regimens available in 1L and provided breakdowns by 1L regimen (Figure 1). Eight studies (n=8 US) applied a sampling frame restricted to a pre-defined subset of 1L regimens. Among these, five were restricted to those receiving bevacizumab-based regimens; the remaining three restricted to those on specific platinum doublet regimens. Four studies (n=1 US; n=3 Canada) provided breakdowns only by treatment modality (surgery, radiation, best supportive care or no systemic therapy).
8eea62084ca7e541d918e823422bd82e Conclusion
The identified studies capture treatment patterns primarily in an era when immunotherapy was unavailable in the 1L setting and reflect the prevalent use of platinum doublets as the mainstay of 1L treatment.
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