Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
(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. (See Table next page)
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.
POSTER SESSION 3 – P3.07: REGIONAL ASPECTS/HEALTH POLICY/PUBLIC HEALTH
THERAPY AND ECONOMICS –
WEDNESDAY, DECEMBER 7, 2016
P3.07-009 USE OF ADJUVANT CHEMOTHERAPY FOR NON-SMALL
CELL LUNG CANCER: THE REAL-WORLD CLINICAL PRACTICE IN
TAIWAN
Bin-Chi Liao 1 , Yu-Yun Shao 1 , James Chih-Hsin Yang 1 , Ho-Min Chen 1 , Ann-Lii
Cheng 1 , Mei-Shu Lai 2
1 Department of Oncology, National Taiwan University Hospital, Taipei/Taiwan,
2 Institute of Epidemiology and Preventive Medicine, College of Public Health,
National Taiwan University, Taipei/Taiwan
Background: Adjuvant chemotherapy is the standard treatment for selected
patients with non-small cell lung cancer (NSCLC) following curative surgery.
This study evaluated the use of adjuvant chemotherapy for these cases among
the general population in Taiwan. Methods: A population-based cohort was
established by searching the database of the Taiwan Cancer Registry System
to identify patients newly diagnosed with NSCLC for the period covering
2005 to 2009. Our target was patients with stage I, II and IIIA NSCLC who had
undergone curative surgery. Medication prescription data were retrieved from
the National Health Insurance Research Database, Taiwan. Chemotherapy
administered within 3 months after the surgery was defined as adjuvant
chemotherapy. Results: A total of 5789 patients received curative surgery for
NSCLC, and the 1277 (22.1%) who had undergone adjuvant chemotherapy were
included in this study. Overall, the most common adjuvant chemotherapy
regimen was platinum plus gemcitabine (P + G) (25.7%), followed by platinum
plus vinorelbine (P + V) (18.4%). For patients with stage II or IIIA disease, P
+ G remained the most common regimen, respectively (29.0% and 29.0%).
However, for patients with stage I disease, the most common regimen was
tegafur/uracil (30.7%). Analyzed by the diagnosis year, P + G was the most
common adjuvant chemotherapy regimen until overtaken by P + V in 2009.
Conclusion: Platinum plus gemcitabine regimen was the most commonly used
adjuvant chemotherapy regimen in patients with operated stage II and IIIA
NSCLC in Taiwan from 2005 to 2009.
Keywords: Gemcitabine, vinorelbine, non-small cell lung cancer, adjuvant
chemotherapy
Keywords: Compassionate use program, osimertinib, lung cancer, Nivolumab
POSTER SESSION 3 – P3.07: REGIONAL ASPECTS/HEALTH POLICY/PUBLIC HEALTH
THERAPY AND ECONOMICS –
WEDNESDAY, DECEMBER 7, 2016
P3.07-008 METASTATIC NSCLC: TREATMENT REALITY FROM 182
CASES OF LUNG ADENOCARCINOMA IN A BRAZILIAN PUBLIC
CANCER HEALTH SERVICE
Leonardo Lago 1 , Bruna Da Silva 2 , Gabriel Lenz 2 , Fernanda Bruzzo 2 , Vinicius
Da Silva 3
1 Oncology, Hospital Sao Lucas Da Pucrs, Porto Alegre/Brazil, 2 Faculdade de
Medicina Da Pucrs, Porto Alegre/Brazil, 3 Professor of Pathology, Faculdade de
Medicina Da Pucrs, Porto Alegre/Brazil
Background: In Brazil, lung cancer is a public health problem as in the world.
The national Incidence in 2016 is estimated in 28.220 new cases 1 . In Rio
Grande do Sul, an etimated number of new cases is 4.240 1 . Is well estabilished
molecular testing for EGFR, ALK mutations are mandatory to treat metastatic
adenocarcinomas to indicate target therapy, or not. Prevalence of EGFR
mutations in adenocarcinomas, for example, are estimeted from 25,5%
to 30,4% 2,3 . Although many guidelines advocates to use a TKI as first line
therapy, in Brazil is difficult becouse nor the drugs, nor the assays are
available to public health service, except by legal measures 4 , or support
from pharmaceutical industry Methods: We made a cross-sectional study
from january 2013 to may 2016, collecting data from medical records in our
institution, to evaluate our population and how we are handling advanced
and metastatic adenocarcinomas in NSCLC patients. Results: We found 182
patients with NSCLC (adenocarcinoma), from those 72 was in stage IIIB-IV or
with relapsed disease. In 37/72 (51,38%) cases some molecular testing was
done (EGFR, ALK); EGFR 26 (36,1%) WT: 9/26 (34,6%), mut: 9/26 (34.6%)(in
confirmation), UK (data in confirmation): 8/26 (30,7%); ALK: 10 (13,8%), w-o
transloc.: 6/10 (60%); wtransloc: 1/10 (10%); UK (data in confirmation)3/10
(30%). From 72 patients, nine (12,5%) was included in clinical trials; 6/72
(8.33%) recived TKI out of a trial. From these just 2/6 received TKI as first
line, and 4/6 as a second line and beyond. Conclusion: It will be done after our
sample, and assay tests results review.
Keywords: EGFR, ALK, PUBLIC HEALTH SERVICE, Metastatic NSCLC
POSTER SESSION 3 – P3.07: REGIONAL ASPECTS/HEALTH POLICY/PUBLIC HEALTH
THERAPY AND ECONOMICS –
WEDNESDAY, DECEMBER 7, 2016
P3.07-010 ECONOMIC EVALUATION OF GEFITINIB VS. ERLOTINIB
FOR FIRST LINE IN NSCLC EGFRM UNDER THE PERSPECTIVE OF
BRAZILIAN HEALTH SYSTEM
Adriana De Carvalho 1 , Alisson Matsuo 2 , Marcelo Custodio 3 , Andre Sasse 1
1 Cevon, Campinas/Brazil, 2 Market Access, Astrazeneca, Cotia/Brazil, 3 Medical
Department, Astrazeneca, Cotia/Brazil
Background: About 28,220 new cases of lung cancer are going to be
diagnosed in Brazil in 2016. The epidermal growth factor receptor (EGFR)
is a transmembrane protein with tyrosine kinase activity associated with
growth, survival, proliferation and differentiation in different human cells.
Approximately 25.5% of patients with non-small lung cancer cells (NSCLC) in
Brazil present activating mutations in EGFR gene, which confers sensitivity
to tyrosine kinase inhibitors (gefitinib and erlotinib). Methods: Given the
similarity in efficacy observed in RCTs, an economic evaluation under the
perspective of the public and private sectors in Brazil was performed using
a Markov model. Estimation of direct medical costs was calculated in a
group of advanced NSCLC patients with EGFR mutations, undergoing first
line treatment with one of the target therapies. A discount rate of 5% was
applied on future costs/benefits and the rate of adverse events was extracted
from a meta-analysis to estimate its costs. Results: According to the model,
patients with locally advanced or metastatic NSCLC who have EGFR activating
mutations undergoing treatment firstline with gefitinib required less
resource versus erlotinib in both perspectives as shown in Table 1, mainly due
to the price difference between the drugs (USD 984.22 versus USD 2,033.15
in the public and USD 1,440.31 versus USD 2,439.78 in the private). Table 1.
Estimated total costs for first line treatment with gefitinib or erlotinib
Strategy
Treatment Costs
(USD)
Incremental Costs
(USD)
Private Sector Gefitinib 26,637.12 -
Erlotinib 42,110.00 15,472.88
Public Sector Gefitinib 16,134.00 -
Erlotinib 32,045.40 15,911.40
Exchange rate 1 USD = 3.30 BRL (July/2016) Regarding costs related only to
S754 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017