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E. Dudnik
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OA21 - Palliative and Supportive Care for Lung Cancer Patients (ID 405)
- Event: WCLC 2016
- Type: Oral Session
- Track: Palliative Care/Ethics
- Presentations: 1
- Moderators:C.A. Silva, H. Watzke
- Coordinates: 12/07/2016, 11:00 - 12:30, Schubert 5
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OA21.02 - ALK-Rearranged Non-Small Cell Lung Cancer is Associated with a High Rate of Venous Thromboembolism (ID 4290)
11:00 - 12:30 | Author(s): E. Dudnik
- Abstract
- Presentation
Background:
Patients with lung cancer are at increased risk for venous thromboembolism (VTE), particularly those receiving chemotherapy. It is estimated that 8-15% of patients with advanced non-small cell lung cancer (NSCLC) experience a VTE in the course of their disease. The incidence in patients with specific molecular subtypes of NSCLC is unknown. We undertook this review to determine the incidence of VTE in patients with ALK-rearranged NSCLC.
Methods:
We identified all patients with ALK-rearranged NSCLC, diagnosed and/or treated at the Princess Margaret Cancer Centre (PM CC) in Canada between July 2012 and January 2015. Retrospective data were extracted from electronic medical records. We then included a validation cohort comprising all consecutive patients with ALK-rearranged NSCLC treated in two tertiary centers in Israel.
Results:
Within the PM CC cohort, of 55 patients with ALK-rearranged NSCLC, at a median follow-up of 22 months, 23 (42%) experienced VTE. Patients with VTE were more likely to be Caucasian (p=0.006). The occurrence of VTE was associated with a trend towards worse prognosis (overall survival HR=2.88, p=0.059). Within the validation cohort (N=43), VTE rate was 28% at a median follow-up of 13 months. Combining the cohorts (N=98) the VTE rate was 36%. Patients with VTE were younger (age 52 vs 58, p=0.04) and had a worse ECOG performance status (p=0.04). VTE was associated with shorter OS (HR=5.71, p=0.01)Figure 1.
Conclusion:
We found the rate of VTE in our ALK-rearranged cohort is 3-5-fold higher than previously reported for the general NSCLC population. This warrants confirmation in larger cohorts.
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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): E. Dudnik
- 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: 2
- 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): E. Dudnik
- 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.
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P3.07-007 - Compassionate Use Program for New Cancer Drugs in Israel - Shortcut for Reimbursement Approval (ID 4873)
14:30 - 15:45 | Author(s): E. Dudnik
- Abstract
Background:
Drug accessibility and reimbursement remains a major challenge across the globe. The Israeli Ministry of Health (MOH) approves drugs based on previous approval by the FDA and EMA-EU. Compassionate use programs (CPU) represent the use of a compound approved by the FDA/EMA-EU before its approval by local regulatory authorities. CPU provides accelerated access to novel compounds to patients otherwise unable to get the treatment.
Methods:
This is a retrospective analysis of 102 patients treated with nivolumab, osimertinib, or nintedanib within a CPU in a single tertiary Israeli cancer center. Basic patient demographics, different logistic treatment aspects and the time from FDA/EMA-EU approval to reimbursement approval for these compounds in Israel were analyzed.
Results:
We started Nintedanib program by July 2014 when the official MOH approval was 16 months later in Nov 2015. Osimertinib program was started a year before the official approval by MOH and was approved for reimbursement 4 months prior to drug registration. Nivolumab for Non-squamous was started 6 months before approval, while for Squamous the label was approved by MOH 2 months after starting the compassionate program. Reimbursement approval was received 6 months thereafter for nivolumab (Squamous NSCLC). Two out of the three drugs in the program were approved for reimbursement, one of them even before MOH registration. Figure 1
Conclusion:
Compassionate use programs allow access to new cancer drugs prior to their approval by the regulatory authorities, increases physicians' experience with novel compounds and may affect reimbursement approval.
