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S. Daher
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MA13 - Modern Technologies and Biological Factors in Radiotherapy (ID 395)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Radiotherapy
- Presentations: 1
- Moderators:M. Thomas, P. Mitchell
- Coordinates: 12/06/2016, 16:00 - 17:30, Stolz 1
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MA13.05 - Nivolumab in Non-Small Cell Lung Cancer (NSCLC): The Real-Life Data (ID 5582)
16:00 - 17:30 | Author(s): S. Daher
- Abstract
- Presentation
Background:
Nivolumab has been recently approved by the FDA as a 2[nd]-line treatment of NSCLC. The data regarding its efficacy in the real-life setting is lacking.
Methods:
260 consecutive patients with advanced NSCLC treated with nivolumab at five cancer centers in Israel between January 2015 and March 2016 were observed for OS and toxicity. OS was analyzed by the Cox proportional-hazards regression model.
Results:
Patient baseline characteristics: median age 67y (range 41-99); males 68%; smokers 76%; ECOG PS ≥2 46%; Non-sq/Sq/other 70%/23%/7%; KRASm/EGFRm/ALK+/other genetic aberration/none/NA 7%/5%/0%/4%/42%/42%; brain metastases 21%; liver metastases 21%; treatment (Tx) line: 1st/2nd/3rd+-line/NA 6%/64%/26%/4%. Median duration of follow-up was 4.3 mo (range 0.1-13.8); median Tx duration was 2.7 mo (range 0.1-15.5); median number of Tx cycles delivered was 6 (range 1-26). 130 (50%) patients died; median OS comprised 6.6 mo (95%CI 5.6-8.4). In univariate and multivariate analysis, the only variable which significantly correlated with OS was ECOG PS (table 1). Median OS of patients with ECOG PS 0/1 and ECOG PS ≥2 comprised 8.6 mo and 3.5 mo, respectively. Safety data is presented in table 2. Figure 1Figure 2
Conclusion:
Nivolumab has reasonable efficacy and good safety profile in the real-life setting. ECOG PS ≥2 is associated with poor prognosis.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-053 - Clinical and Plasma Biomarkers for Disease Control with Nivolumab Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 4715)
14:30 - 15:45 | Author(s): S. Daher
- Abstract
Background:
Anti-PD1 antibodies have become the treatment of choice for most advanced NSCLC patients after failure of first line platinum-based chemotherapy. Responses are seen in roughly 20% of treated patients. PDL1 expression level and mutational burden might be predictive factors but are not always available and their predictive accuracy is limited. Predictive biomarkers are urgently needed. We hypothesized that clinical data and baseline blood tests might be predictive for benefit from nivolumab.
Methods:
A chart review was performed of patients with advanced NSCLC who received at least one cycle of nivolumab, at one of three cancer centers during 2015-2016. Additional inclusion criteria were: available baseline clinical data, evaluation of response and availability of blood test results. Blood test results collected were: Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC), White Blood Cells (WBC), Hemoglobin (Hb), Platelets (PLT), Albumin (ALB), Lactate Dehydrogenase (LDH). Blood test results were collected at baseline and before the second and third treatment. Disease control (DC) was defined as any tumor shrinkage, or stable disease for at least 6 months, as assessed by the treating physician by computerized tomography scans. Patients with DC were compared with patients with progressive disease (PD, patients progressing within the first 6 months). Uni- and multivariate regression analyses were performed using Stata (version 11.2, StataCorp).
Results:
A total of 70 patients treated with nivolumab were included, median age 67 years, 66% males, 27% with DC. DC patients compared to PD patients were younger (61.6 vs 69.3 yr, p<0.001), more females (42% vs 27%, p<0.05), and had a lower baseline WBC (6.9 vs 9.2 K/microL, p<0.05). The difference in WBC between DC and PD patients increased during treatment (2.3 K/microL at baseline, 2.6 prior to third treatment). Lower baseline neutrophil count was associated with DC (p=0.02). Neither performance status nor LDH predicted outcome on uni-variate analysis. On multivariate analysis age (p=0.050) and baseline WBC (p=0.02) were associated with outcome. Patients less than 67 years of age with baseline WBC<8.04 K/microL (n=18) had DC rate of 50%, while DC rate was 4% in patients 67 years or more, with WBC >=8.04 K/microL (n=23).
Conclusion:
We have identified clinical biomarkers (age and baseline WBC) that are associated with DC under nivolumab treatment. Validation on an independent data set is warranted. The association of a low peripheral WBC/ANC with increased response rate raises the possibility that acute inflammatory responses are counteractive to anti-PD1 therapy.
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-004 - Nivolumab for Non-Small Cell Lung Cancer (NSCLC): An Economic Model for Risk Sharing Based on Real-Life Data (ID 5452)
14:30 - 15:45 | Author(s): S. Daher
- Abstract
Background:
Increasing costs of novel immunotherapy requires risk sharing between manufacturers and payers. Aside from the cost per dose of the compound, the total treatment cost (TTC) is affected by the duration of treatment (DOT). DOT in real life may differ significantly from that observed in the randomized clinical trials. The objective of this study was to develop a risk sharing strategy based on real world data for the use of nivolumab in NSCLC.
Methods:
We analyzed DOT for 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016. We developed a model to incorporate the number of cycles delivered and to calculate the TTC for each patient. We calculated the “mid-point” (MP) to estimate the number of cycles for all patients to comprise half of the TTC for the population.
Results:
Median age 67y (range 41-99); males 68%; ECOG PS ≥2 46%; Non-squamous (Non-sq)/Squamous(Sq)/other histology 70%/23%/7%; treatment line: 1[st]/2[nd]/3[rd]+-line/NA 6%/64%/26%/4%. All patients received nivolumab as standard of care or within the compassionate use program. Median duration of follow-up was 4.3 mo (range 0.1-13.8); 27% of patients continued the treatment at the time of data cut-off. Median DOT was 2.7 mo (range 0.1-15.5). Median number of treatment cycles delivered calculated from a total of 206 patients was 6 (range 1-26 and 1-23 for Sq and Non-sq NSCLC, respectively). TTC distribution according to the treatment cycle and MP for Non-sq and Sq NCSLC are presented in Figure 1 (A and B), respectively. Figure 1
Conclusion:
Based on current list prices in Israel, the estimated mid-point for total treatment cost is the 5[th] cycle for Non-Sq NSCLC and the 4[th] cycle for Sq NSCLC. Our data may represent a basis for risk sharing discussion between the payers and the manufacturers.
