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R. Ramlau
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ORAL 32 - EGFR WT and MT Targeting (ID 144)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:K.J. O'Byrne, D.R. Gandara
- Coordinates: 9/09/2015, 16:45 - 18:15, Four Seasons Ballroom F3+F4
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ORAL32.03 - Efficacy and Safety of Necitumumab Continuation Therapy in Phase 3 SQUIRE Study (ID 1391)
17:07 - 17:18 | Author(s): R. Ramlau
- Abstract
- Presentation
Background:
The SQUIRE study demonstrated that the addition of necitumumab (N) to gemcitabine-cisplatin (GC) improved survival in patients with stage IV sq-NSCLC. This retrospective analysis compares efficacy and safety outcomes for patients who received single-agent N as continuation therapy after completion of chemotherapy treatment (CT) in GC+N arm to the continuation therapy-eligible population of the GC arm.
Methods:
Patients were randomized 1:1 to GC (G=1250 mg/m² iv, days 1 and 8; C=75 mg/m² iv, day 1) plus N (800 mg iv, days 1 and 8), or GC alone every 21 days up to 6 cycles. Patients in GC+N with no progression continued on N alone until progressive disease. In this analysis, we consider patients in GC+N arm who were alive and progression-free before the start of N single-agent therapy (GC+N arm continuation therapy patients) and patients in GC arm who were alive, progression-free after completion of CT and did not discontinue treatment due to adverse event (AE) (GC arm non-progressor patients). This analysis included patients in both arms who received ≥4 cycles of CT. Overall survival (OS) and progression-free survival (PFS) were measured from the date of randomization, with parameters estimated using the Kaplan-Meier method. Hazard ratios and 95% CIs between subgroups were estimated from stratified Cox proportional hazards models. OS and PFS for post-induction period were measured from the completion of CT + 21 days. Selected treatment-emergent AEs (TEAEs) for patients in each arm are presented in the table.
Results:
261 patients were progression-free, received ≥4 cycles of CT, and received ≥1 dose of N alone in GC+N arm. 215 pts in GC arm completed ≥4 cycles of CT, were progression-free, and did not discontinue due to AE. Patient baseline characteristics and exposure to CT were well balanced between GC+N and GC arms. Median OS from randomization in GC+N vs GC was 15.9 vs 15.0 months; HR 0.85 (95% CI, 0.69, 1.05). Median OS for post-induction period in GC+N vs GC was 11.5 vs 10.9 months; HR 0.84 (95% CI, 0.68; 1.04). Median PFS from randomization in GC+N vs GC was 7.4 vs 6.9 months; HR 0.86 (95% CI, 0.70, 1.06). Median PFS from post-induction period in GC+N vs GC was 3.2 vs 2.3 months; HR 0.85 (95% CI, 0.70, 1.04). Selected TEAEs (Overall):GC+N Continuation PatientsN = 261, % GC Non-ProgressorsN = 215, % Category Any Grade Grade ≥3 Any Grade Grade ≥3 Neutropenia 55.9 34.1 57.7 33.0 Anemia 46.7 10.0 49.3 8.8 Thrombocytopenia 26.1 9.6 29.3 12.6 Hypomagnesemia 42.1 14.9 18.6 0.9 Conjunctivitis 11.9 0.8 3.3 0 Rash 87.4 8.8 10.2 0.5 Arterial thromboembolic event 5.7 3.1 0.5 0 Venous thromboembolic event 9.2 3.8 4.2 0.9
Conclusion:
There was a consistent treatment effect in favor of GC+N continuation patients as compared to GC non-progressors with no unexpected increases in AEs.
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ORAL 34 - Quality/Survival/Prognosis in Localized Lung Cancer (ID 153)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:B.C. Cho, R.L. Keith
- Coordinates: 9/09/2015, 16:45 - 18:15, 201+203
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ORAL34.03 - Prognostic Factors in Early Stage NSCLC: Analysis of the Placebo Group in the MAGRIT Study (ID 24)
17:07 - 17:18 | Author(s): R. Ramlau
- Abstract
- Presentation
Background:
The MAGRIT study was a worldwide, multicenter, phase-3 double-blind, randomized trial evaluating efficacy of the MAGE-A3 Cancer Immunotherapeutic in resected non-small cell lung cancer (NSCLC) (www.clinicaltrials.gov NCT00480025). We examined baseline patient and disease characteristics associated with overall survival (OS) and disease-free survival (DFS) among patients assigned to placebo.
Methods:
Study participants were ≥18 years, with histologically proven, MAGE-A3-positive stage IB, II or IIIA NSCLC (AJCC 6.0). Participants had undergone complete anatomical resection of the tumor (lobectomy or pneumectomy) with mediastinal lymph node (LN) dissection or sampling according to standard of care. Up to four cycles of platinum-based adjuvant chemotherapy were allowed. Cox regression models were used to explore characteristics that could predict DFS and OS. Factors statistically significant in univariate analysis (p<0.05) were included in multivariate models using a stepwise approach (p<0.05 to enter/remain in the model).
Results:
There were 757 placebo patients in the total treated population; median age 63 years, 76% male, 53% with squamous cell carcinoma (SCC), 34% with adenocarcinoma, 98% with performance status 0-1, 52% had received adjuvant chemotherapy.In univariate analyses, SCC, lower N-category and earlier disease stage were associated with improved DFS. Lower N-category, earlier stage and smaller tumor size were associated with improved OS. In multivariate analysis, N-category (HR 1.34, 95%CI [1.16-1.55]) and histological type (HR for SCC vs non-SCC 0.64, 95%CI [0.51-0.81]) remained significant for DFS. N-category (HR 1.47, 95%CI [1.21-1.79]) and tumor size (HR by unit increase 1.08, 95%CI [1.01-1.15]) did so for OS. No association was found between DFS or OS and age, gender, race, region, baseline performance status, quantitative MAGE-A3 expression, chemotherapy administration or type of chemotherapy, smoking status or type of LN sampling (minimal/systematic). Among patients with SCC, univariate analysis identified increased number of chemotherapy cycles and operative technique (pneumectomy) as associated with improved DFS (p<0.05). Only operative technique remained in the multivariate model. When including N-category (p<0.10 in univariate analysis) in the multivariate model, N-category and number of chemotherapy cycles were also selected. Lower N-category and smaller tumor size were significantly associated with improved OS, in univariate and multivariate analyses. Among patients with non-SCC, univariate analysis identified younger age, being female, lower N-category and earlier disease stage with improved DFS, and lower N-category, earlier disease stage and region (East Asia) with improved OS. N-category and gender, and N-category and region remained significant in the multivariate analysis for DFS and OS, respectively.
Conclusion:
This is the first prognostic factor analysis in resected NSCLC performed on data from a large, prospective randomized study. It highlighted that in terms of DFS, SCC patients have a better prognosis than non-SCC patients. N-category plays a major role in determining prognosis. Operative technique (pneumectomy), number of chemotherapy cycles (SCC) and gender (non-SCC) are also associated with outcome. Variables predictive for OS are N-category and tumor size (all) and region (non-SCC). These results confirm retrospective studies done within the context of TNM classification, but add that histopathology subtype is a strong determinant for DFS in resected NSCLC.
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