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P. Bonomi
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.12 - Discussant for MA06.09, MA06.10, MA06.11 (ID 6976)
16:00 - 17:30 | Author(s): P. Bonomi
- Abstract
- Presentation
Abstract not provided
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OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:O.T. Brustugun, S. Lu
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 2
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OA23.02 - Efficacy and Safety of Necitumumab Continuation Monotherapy in Patients with EGFR-Expressing Tumors in SQUIRE, a Phase 3 Study (ID 4283)
14:20 - 15:50 | Author(s): P. Bonomi
- Abstract
- Presentation
Background:
SQUIRE (NCT00981058) demonstrated adding necitumumab (N) to gemcitabine/cisplatin (GC) improved survival in patients with Stage IV squamous NSCLC (SQ-NSCLC). Retrospective analysis revealed consistent treatment effect in favor of patients receiving N monotherapy as continuation after chemotherapy (CT) (GC+N continuation patients) versus continuation therapy-eligible GC arm patients (GC non-progressors). In the EU, N is approved for patients with EGFR-expressing tumors. We repeated the analysis in this patient population.
Methods:
Patients with Stage IV SQ-NSCLC were randomized 1:1 for ≤6 cycles of G (1250 mg/m[2] iv, Days [d] 1,8) and C (75 mg/m[2] iv, d1) either with or without N (800 mg iv, d1,8). Patients in GC+N without progression continued N until progressive disease (PD). SQUIRE included mandatory tissue collection. EGFR protein expression was assessed by IHC in a central lab (Dako EGFR PharmDx kit). Analyses were done in EGFR-expressing patients (EGFR >0). Patients who received ≥4 cycles of CT without PD were included. Overall survival (OS) and progression-free survival (PFS) were calculated by Kaplan-Meier method. 95% CIs and hazard ratios estimated using stratified Cox proportional hazards model.
Results:
Of 1093 patients (ITT population), 982 patients (89.8%) had evaluable IHC assay results; 935/982 (95.2%) had EGFR>0. GC+N arm continuation therapy patients included 228 patients with EGFR>0 and 194 patients (EGFR>0) were GC arm non-progressors. Baseline characteristics were similar except gender (Males: 81% in GC+N vs 91% in GC arm). CT exposure was balanced. Median OS from randomization in GC+N vs GC was 16.1 vs 14.9 months; HR 0.76 (95% CI, 0.61, 0.95). Median PFS in GC+N vs GC was 7.4 vs 6.9 months; HR 0.81 (95% CI, 0.66, 1.00). Figure 1
Conclusion:
In patients with EGFR-expressing tumors, a consistent treatment effect in favor of GC+N continuation maintenance compared to GC non-progressors was observed, similar to ITT population with no unexpected increases in AEs.
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-006 - Frequency of 2 Year PFS Milestone in Stage IV NSCLC Patients Treated with First Line Pemetrexed/Platinum and Pemetrexed Maintenance (ID 6288)
14:30 - 15:45 | Author(s): P. Bonomi
- Abstract
Background:
Focusing on median progression free and overall survival does not fully inform us, or our patients, of the maximum achievable benefit found at the tail end of the survival curve (Hellman M, JAMA Oncology 2016). Milestone metrics in this context may be more informative; however, mature data are scarce. Our anecdotal observations suggested that some of our non-squamous NSCLC pts treated with pemetrexed continuation maintenance had long-term disease control beyond the reported median PFS. The objective of our single institution retrospective study was to determine the % of patients who reach the 2 year PFS milestone in patients whose treatment plan included continuation pemetrexed maintenance. Evaluation of the potential predictive value of clinical parameters was a secondary objective.
Methods:
Pts with stage IV NSCLC who received at least once cycle of pemetrexed/platinum with planned pemetrexed maintenance (N = 241) between May 2010 and December, 2013 were included in this retrospective analysis. Minimum follow up for every patient was > 24 months. Patient demographics, routine laboratory values, first and last dates of pemetrexed therapy, and date of progression were collected. Pts were grouped according to duration of disease control ≥24 months vs < 24 months. Potential associations between patient demographics and comparison of laboratory values for the two groups were assessed using a Mann-Whitney-Wilcoxon test.
Results:
Median age 66, male/female 40.25%/59.75%, 21% never smoker. The median progression free survival was 6.2 months. 34 pts (14.1%) had no progression of disease at ≥24 months since starting treatment with pemetrexed/platinum followed by pemetrexed maintenance. A PFS ≥24 months was associated with a lower baseline neutrophil/lymphocyte ratio (NLR) (median 3.3 vs 4.55; 25-75 percentile 2.32-3.94 vs 2.8-7.89; p=0.0011). PS at baseline was also significantly associated with a PFS≥24 months (p=0.02). Long term PFS was not significantly related to gender, age, sites of metastases, or number of disease sites.
Conclusion:
Considering that the two year OS rate for first line chemotherapy in clinical trials is approximately 25%, the 2 year PFS milestone rate of 14.1% patients is encouraging. Significantly lower baseline NLR, was observed in patients who reached the two year PFS milestone. Studies evaluating the potential predictive value of other clinical and molecular parameters are ongoing.
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-060 - Baseline Skeletal Muscle Index (SMI) Values Are Associated with Biomarkers of Insulin Resistance in Stage IV Non-Small Cell Lung Cancer (ID 5286)
14:30 - 15:45 | Author(s): P. Bonomi
- Abstract
Background:
The aim of this project was to correlate pretreatment levels of circulating biomarkers of insulin resistance with computed tomography measured evidence of sarcopenia in stage IV NSCLC patients receiving platinum doublet chemotherapy.
Methods:
Pretreatment serum from 93 patients with frontline stage IV NSCLC was evaluated for 13 metabolism biomarkers with the Bio-Plex Pro Human Diabetes Assay Panel and 20 inflammation-related biomarkers using the Milliplex Human High Sensitivity T Cell Panel. All patients were treated with standard platinum doublet based chemotherapy. All patients had skeletal muscle index (SMI) calculated from baseline CT images using the Slice-O-Matic software package (Tomovision); where SMI = (muscle cross sectional area in cm2) / height in m2. Associations of biomarkers with SMI were assessed using a Spearman’s Rank Correlation Coefficient. The Log-Rank test was performed to evaluate the association of individual biomarkers with overall survival (OS).
Results:
High levels of adiponectin (with low levels of adiponectin being correlating with obesity in the literature) were associated with good OS (p=0.036) and low baseline SMI value specifically for males (p=0.00029). High levels adipsin was associated with favorable OS (p=0.015) and a higher baseline SMI specifically for females (p=0.66 x10-5). Low levels of ghrelin were associated with favorable OS (p=0.005) and were inversely associated with SMI values for both genders (p=0.021).
Conclusion:
Altered values of several biomarkers of insulin resistance were associated with inferior survival and a greater degree of sarcopenia in frontline NSCLC patients receiving platinum double therapy. These findings suggest a certain subset of patients that may have improvements in cancer cachexia by targeting insulin resistance.
