Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
America, 6 Pulmonary Medicine, Denver Veteran Affairs Medical Center, Denver/
United States of America
Background: Clinical Trial with Data Analysis in Progress Methods: Subjects
(n=90) were selected for the trial if they met one the following criteria:
current or former smoker (> 10 pack years); biopsy proven endobronchial
dysplasia; airflow obstruction (FEV1/FVC < 0.70); or at least mild sputum
cytologic atypia. Fluorescent bronchoscopy was performed at trial entry with
biopsy of 6 standard endobronchial sites and all other abnormally appearing
areas. Subjects also had pulmonary function testings and quantitative high
resolution CT scans at the start and completion of the trial. Subjects were
then randomized to oral pioglitazone or placebo for 6 months, followed by a
second fluorescent bronchoscopy with repeat biopsy of all the central airway
areas sampled on the first bronchoscopy. The endobronchial biopsies were
scored on a 1-8 scale based on WHO criteria. The primary endpoint for the
study is change in maximum (worst) endobronchial histology. Results: Final
data analysis is pending Conclusion: clinical trial with data analysis in progress
Keywords: chemoprevention, pioglitazone, endobronchial dysplasia
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/RESEARCH GROUPS
SUPPORTIVE, PREVENTIVE –
TUESDAY, DECEMBER 6, 2016
P2.06-033 LONG-TERM SAFETY AND EFFICACY OF DARBEPOETIN
ALFA IN SUBJECTS WITH ADVANCED STAGE NSCLC RECEIVING
MULTI-CYCLE CHEMOTHERAPY
Julia Gage 1 , Pere Gascón 2 , Rajnish Nagarkar 3 , Martin Šmakal 4 , Kostas Syrigos 5 ,
Carlos Barrios 6 , Jesús Cárdenas Sánchez 7 , Li Zhang 8 , David Henry 9 , Alex
Fleishman 10 , Cisio De Oliveira Brandao 10
1 Gage Medical Writing, Llc, Moorpark/CA/United States of America, 2 Hospital
Clinic, Barcelona University, Barcelona/Spain, 3 Curie Manavata Cancer Centre,
Nashik/India, 4 Nemocnice Horovice, Nh Hospital A.S., Prague/Czech Republic,
5 Sotira General Hospital, Athens School of Medicine, Athens/Greece, 6 Medicine,
Pucrs School of Medicine, Porto Alegre/Brazil, 7 Centro Medico de Colima, Colima/
Mexico, 8 Department of Medical Oncology, Sun Yat-Sen University Cancer Center,
Guangzhou/China, 9 University of Pennsylvania, Philadelphia/PA/United States of
America, 10 Amgen Inc., Thousand Oaks/CA/United States of America
Background: Darbepoetin alfa (DA) is an erythropoiesis-stimulating agent
(ESA) that has been shown to increase hemoglobin levels and reduce the rate
of transfusions in patients with chemotherapy-induced anemia (CIA). Most
studies have not shown an association between ESA use and poor outcomes,
but some clinical trials have reported increased mortality and/or tumor
progression. This trial was therefore designed to address the safety of DA
for CIA in patients with non-small cell lung cancer (NSCLC). Methods: Study
20070782 is a randomized, double-blind, noninferiority trial to compare DA
with placebo, and is enrolling patients with NSCLC with CIA. Eligible patients
are ≥ 18 years old with Eastern Cooperative Oncology Group (ECOG) status ≤
1, stage IV NSCLC, no prior adjuvant/neoadjuvant NSCLC therapy, ≥ 2 cycles
first-line chemotherapy planned (≥ 6 weeks total), and screening hemoglobin
≤ 11 g/dL. Approximately 3,000 patients from up to 500 global sites will
be randomized 2:1 to DA (500 mcg) or placebo every 3 weeks (Q3W) until
disease progression or end of chemotherapy. At hemoglobin > 12 g/dL, study
drug is withheld until hemoglobin ≤ 12 g/dL. Transfusions are allowed when
necessary. Endpoints include overall survival (OS; primary) and progressionfree
survival (PFS; secondary), and will be analyzed when ~2,700 deaths have
occurred. Additional safety endpoints include tumor response and rate of
thromboembolic events. Superiority of DA to placebo in transfusion rates
will be tested if noninferiority is achieved for OS and PFS. Results: As of
April 15, 2016, a total of 2,215 patients have enrolled. The independent data
monitoring committee has conducted 9 reviews of unblinded data (which
included a planned formal interim analysis at 40% of planned total number
of 2,700 deaths to test for harm), and has recommended continuation of
the trial without changes. Conclusion: Study 20070782 is the largest clinical
trial in NSCLC to date, and will provide comprehensive data on the safety and
efficacy of DA in patients with CIA.
Keywords: non-small cell lung cancer, Safety, darbepoetin alfa, chemotherapyinduced
anemia
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/
RESEARCH GROUPS
Radiotherapy, TT Fields –
TUESDAY, DECEMBER 6, 2016
P2.06-034 METIS: A PHASE 3 STUDY OF RADIOSURGERY WITH
TTFIELDS FOR 1-10 BRAIN METASTASES FROM NSCLC
Minesh Mehta 1 , Vinai Gondi 2 , Paul Brown 3
1 Miami Cancer Institute, Coral Gables/FL/United States of America, 2 Radiation
Oncology Consltants, Chicago/IL/United States of America, 3 Mayo Clinic,
Scottsdale/AZ/United States of America
Background: Tumor Treating Fields (TTFields) are non-invasive regional
anti-mitotic treatment modality, based on low intensity alternating electric
fields. Efficacy of TTFields in non-small cell lung cancer (NSCLC) has been
demonstrated in multiple in vitro and in vivo models, and in a phase I/II clinical
study. TTFields treatment to the brain was shown to be safe and to extend
overall survival in newly-diagnosed glioblastoma patients. Methods: 270
patients with 1-10 brain metastases (BM) from NSCLC will be randomized in
a ratio of 1:1 to receive stereotactic radio surgery (SRS) followed by either
TTFields or supportive care alone. Patients are followed-up every two months
until 2 nd cerebral progression. Patients in the control arm may cross over
to receive TTFields at the time of 2 st cerebral progression. Objectives: To
test the efficacy, safety and neurocognitive outcomes of TTFields in this
patient population. Endpoints: Time to 1 st cerebral progression based on the
RANO-BM Criteria or neurological death (primary); time to neurocognitive
failure based on the following tests: HVLT, COWAT and TMT; overall survival;
radiological response rate; quality of life; adverse events severity and
frequency (secondary). Main eligibility criteria: Karnofsky performance
status (KPS) of 70 or above, 1 inoperable or 2-10 brain lesions amenable to
SRS, optimal standard therapy for the extracranial disease, no brain-directed
therapy, no signs of significantly increased intracranial pressure, no electronic
implantable devices in the brain. Treatment: Continuous TTFields at 150
kHz for at least 18 hours per day will be applied to the brain within 7 days
of SRS. The treatment system is a portable medical device allowing normal
daily activities. The device delivers TTFields to the brain using 4 Transducer
Arrays, which may be covered by a wig or a hat for cosmetic reasons. Patients
will receive the best standard of care for their systemic disease. Statistical
Considerations: This is a prospective, randomized, multicenter study for
270 patients. The sample size was calculated using a log-rank test (based
on Lakatos 1988 and 2002) and has 80% power at a two sided alpha of 0.05
to detect a hazard ratio of 0.57. Results: Trial in progress Conclusion: Trial in
progress
Keywords: TTFields, Tumor Treating Fields, brain metastasis, METIS
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/RESEARCH GROUPS
RADIOTHERAPY, TT FIELDS –
TUESDAY, DECEMBER 6, 2016
P2.06-035 EXPLORING RECRUITMENT FACTORS IN A FEASIBILITY
TRIAL OF SABR VERSUS SURGERY
Janine Bestall 1 , Kevin Franks 2 , Fiona Collinson 3 , Catherine Lowe 4 , Lucy
Mcparland 5 , Walter Gregory 5 , David Sebag-Montifiore 6 , David Baldwin 7 , Jenny
Hewison 1 , Barbara Potrata 1
1 Centre for Health Services Research, Leeds Institute of Health Sciences, Leeds/
United Kingdom, 2 St James Institute of Oncology, Leeds Teaching Hospitals NHS
Trust, TF/United Kingdom, 3 Medical Oncology, Leeds Institute of Clinical Trials
Research, Nl/United Kingdom, 4 Trial Management, Leeds Institute of Clinical Trials
Research (LICTR), Leeds/United Kingdom, 5 Statistics, Leeds Institute of Clinical
Trials (LICTR), Nl/United Kingdom, 6 University of Leeds/ Leeds Cancer Centre, TF/
United Kingdom, 7 Nottingham University Hospitals NHS Trust, PB/United Kingdom
Background: The SABRTooth trial aims to assess the feasibility of recruiting
patients with stage I non-small cell lung cancer (NSCLC) to a study comparing
surgery to stereotactic ablative radiotherapy (SABR). Both trial treatments
were available outside of the trial. An embedded qualitative study aimed to
explore reasons for non-participation or refusal to take up the randomised
treatment arm in the SABRTooth trial to help identify factors that affect
recruitment. Methods: Using in-depth qualitative interviews we aimed
to interview sixteen patients not taking part in the trial across five sites
using a pre-defined topic guide. The data were thematically analysed using
a compare and contrast approach, identifying similarities and differences.
Results: Fifteen patients have been approached so far for interview, ten
opted out, five were interviewed. Although, from a limited sample there
were three key themes affecting patients decision making that are similar
to those reported in the literature. These were 1) treatment preferences 2)
influence of personal contacts 3) influence of professionals. We interviewed
patients about their experience of being offered the trial and reasons for their
treatment preference. Patients described existing treatment preferences
that were amenable to change in some cases. Their choice of treatment
was subject to change throughout the process of being of being offered
the trial and treatment options and was shaped by previous experience
and knowledge. Treatment decisions were influenced by people in their
close personal networks. Those that chose SABR had previous knowledge
or experience of this treatment. Professionals could influence decisions by
using specific phrases such as “surgery is your golden ticket” or comparing
S572 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017