Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
50% had had partial response as the best response to first-line treatment. The
objective response rate was 53%, stable disease 26.5%, disease progression
16.3%, non-evaluable 4% and disease control rate of 79.6%. The combination
had an adequate tolerance, mostly toxicities grades 1-2. Toxicities grade 3-4
were mainly fatigue (14%), diarrhea (13%), hiporexia (7%), neutropenia (7%),
nausea (6%), vomiting (1%). Nintedanib dose was reduced in 27 patients
(27%). The median duration of the treatment with nintedanib was 6.7 months.
Conclusion: Overestimated responses may be related to the retrospective
desing of the study and due to that were valued by investigator wich could
influence the results. The Safety of nintedanib in real-life patients was
demostrated and not very different from the results in the LUME-Lung 1
trial. Gastrointestinal toxicity were the most frequent side effects, mostly
toxicities grades 1-2.
Keywords: Metastatic NSCLC, nintedanib, second line treatment,
compassionate-use program in Mexico
POSTER SESSION 3 – P3.02A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
MISCELLANEOUS –
WEDNESDAY, DECEMBER 7, 2016
P3.02A-033 THE HUMANISTIC BURDEN ASSOCIATED WITH CARING
FOR ADVANCED NSCLC PATIENTS IN EUROPE - A REAL WORLD
SURVEY OF CAREGIVERS
Robert Wood 1 , Gavin Taylor-Stokes 1 , Bill Malcolm 2 , Michael Lees 3 , Oana
Chirita 2
1 Adelphi Real World, Bollington/United Kingdom, 2 Bristol-Myers Squibb, Uxbridge/
United Kingdom, 3 Bristol-Myers Squibb, Rueil-Malmaison/France
Background: While the financial aspects of the burden on caregivers for
patients with advanced Non-Small Cell Lung Cancer (aNSCLC) have been
estimated, limited published information exists on the humanistic burden
incurred by these caregivers. Methods: Data were taken from a multi-center,
cross-sectional study of aNSCLC patients and their caregivers conducted in
France, Germany and Italy. The study consisted of three components: medical
chart review, patient questionnaire and caregiver questionnaire. Overall,
683 consulting patients and 277 accompanying informal caregivers were
recruited via treating physicians. The impact on health related quality of life
was measured using the EuroQoL-5D (EQ-5D-3L) while caregiver burden was
quantified using the Zarit Burden Interview (ZBI), which consists of 22 items,
each rated 0-4. ZBI scores were grouped into: little/no burden (0-20), mild/
moderate (21-40), moderate/severe (41-60) and severe burden (61-88). Scores
of 24+ were assumed to identify caregivers at risk of depression. Analysis,
conducted on 277 matched patient and caregiver forms, was stratified by
country and by patients’ line of therapy. Statistical significance was assessed
using Mann-Whitney U tests. Results: Caregivers’ mean (SD) age was 55.2
(13.0) years; 78.6% were female and 62.3% were the patient’s partner/spouse.
Patients’ mean (SD) age was 66.2 (9.7); 73.6% were male and 91.0% had Stage
IV NSCLC. Over two-thirds (70.4%) of patients were receiving 1 st line advanced
therapy, while 29.6% were receiving later lines of therapy. The mean (SD)
EQ-5D-3L index for caregivers was 0.87 (0.19). Differences in EQ-5D-3L were
observed between carers of 1 st line patients and later line patients (0.89 v 0.83
p=0.003). The mean ZBI score for caregivers was 32.1 (15.6); A quarter (24.0%)
of caregivers had little/no burden, 44.6% mild/moderate, 28.8% moderate/
severe and 2.6% severe burden; 69.7% of caregivers were identified as at risk
of depression. Differences in ZBI were observed between carers of 1 st line
patients and later line patients (30.9 v 34.9 p=0.099). Conclusion: Comparing
these results with other published ZBI data, the burden suffered by aNSCLC
patient caregivers appears to be higher than other conditions studied in
Europe, namely, Parkinson’s disease (25.8) another study conducted across
advanced cancer (18.5). Caregivers for aNSCLC patients suffer significant
humanistic burden in addition to the overall burden faced by patients and is
likely to result in additional costs. When assessing the impact of a treatment,
the potential to improve the impact on caregivers should also be included.
Keywords: NSCLC, humanistic burden, caregiver burden
POSTER SESSION 3 – P3.02A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
MISCELLANEOUS –
WEDNESDAY, DECEMBER 7, 2016
P3.02A-034 VEMURAFENIB IN PATIENTS WITH NON-SMALL
CELL LUNG CANCER (NSCLC) HARBORING BRAF MUTATION.
PRELIMINARY RESULTS OF THE ACSÉ TRIAL
Julien Mazieres 1 , Claire Cropet 2 , Fabrice Barlesi 3 , Pierre Jean Souquet 4 ,
Virginie Avrillon 2 , Bruno Coudert 5 , Jacques Le Treut 6 , Frederique Orsini
Piocelle 7 , Gilles Quere 8 , Elizabeth Fabre 9 , Jean Tredaniel 10 , Marie Wislez 11 ,
Olivier Huillard 12 , Eric Dansin 13 , Denis Moro-Sibilot 14 , Helene Blons 15 , Gilbert
Ferretti 14 , Etienne Lonchamp 16 , Natalie Hoog Labouret 16 , Veronica Pezzella 17 ,
Céline Mahier Ait Oukhatar 17 , Jean-Yves Blay 2
1 CHU de Toulouse Hôpital Larrey, Toulouse/France, 2 Centre Leon Berard, Lyon/
France, 3 Hôpital Nord, Marseille/France, 4 Centre Hospitalier Lyon Sud, Pierre
Bénite/France, 5 Département Oncologie Médicale, Centre Georges François Leclerc,
Dijon/France, 6 Chi Aix Pertuis, Aix En Provence/France, 7 Chr Annecy, Pringy/
France, 8 Chru de Brest - Hôpital Morvan, Brest/France, 9 Medical Oncology, Hôpital
Européen Georges Pompidou (Hegp), Assistance Publique Hôpitaux de Paris (Ap-
Hp), Paris, France, Paris/France, 10 Gh Paris Saint Joseph, Paris/France, 11 Service
de Pneumologie, Aphp Hôpital Tenon, Paris/France, 12 CHU Paris Centre - Hôpital
Cochin, Paris/France, 13 Centre Oscar Lambret, Lille/France, 14 CHU de Grenoble,
Grenoble/France, 15 Hôpital Européen Georges Pompidou (Hegp), Assistance
Publique Hôpitaux de Paris (Ap-Hp), Paris, France, Paris/France, 16 French National
Cancer Institute Inca, Boulogne Billancourt/France, 17 Unicancer, Paris/France
Background: BRAF is found mutated in 2-3% of stage IV NSCLC. BRAF
inhibitors have been reported to have antitumor activity. A nationwide
access to vemurafenib for cancer patients with tumors presenting with BRAF
mutations was launched by the French National Cancer Institute (INCa)
providing free access to tumor molecular diagnosis. The AcSé-Vemurafenib
study is the 2 nd exploratory multi-tumor 2-stage design phase II trial of
AcSé program. We report the preliminary results of the NSCLC cohort in this
nationwide program. Methods: BRAF mutational status was assessed on INCa
molecular genetic platforms by either direct sequencing or NGS. Patients with
BRAF mutation (including BRAF V600E and others less common mutations),
progressing after at least one standard treatment (including a platinumbased
doublet, unless pts were considered as unfit for chemotherapy) were
proposed to receive vemurafenib 960 mg BID. Responses were centrally
assessed using RECIST v1.1 every 8 weeks. Results: From Oct. 13, 2014 to June
15, 2016, 65 patients were enrolled including 55 NSCLC harboring BRAF V600E
and 10 pts with other activating mutations (2 G466, 3 G469, 1 G596, 3 K601 and
1 N581). 55 patients received vemurafenib and had at least one post-baseline
assessment. Median age: 67 years (range 40–84), 51% females and 100% nonsquamous
histology. Median number of prior chemotherapy lines: 1 (0 –5).
Most frequent grade ≥3 adverse events (AEs) were skin (18% of patients) and
gastrointestinal toxicities (16%). Among the 39 BRAF V600E NSCLC patients
evaluable for the best overall response (BOR) with a minimum follow-up of
4 months, 15 PR, 8 SD, 10 PD, 5 deaths before assessment and 1 missing were
observed. The objective response rate was 38.5% [95% CI:23.4-55.4], and the
disease control rate 59% [42.1-74.4]. Median duration of response was 5.1
months [1.8-9.2]. Progression-free survival (PFS) at 4 months was 48.2% [31.8-
62.8]. No response was reported among the 7 evaluable patients with other
BRAF mutations with 5 PD, 1 death before assessment and 1 missing as BOR
; PFS at 4 months was 14.3% [0.7-46.5]. 18 patients were still on treatment
at the cut-off date, 47 have stopped vemurafenib (25 PD, 15 AEs, 1 death, 1
doctor’s decision, 5 patient’s decisions). Conclusion: Vemurafenib provided
response rate and DCR in BRAF V600E pretreated NSCLC but was not found
efficient in NSCLC with other BRAF mutations. These results underline the
interest of integrating BRAF V600E in biomarkers routine screening.
Keywords: BRAF mutation, Vemurafenib, NSCLC, AcSé
POSTER SESSION 3 – P3.02A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
MISCELLANEOUS –
WEDNESDAY, DECEMBER 7, 2016
P3.02A-035 CAN AIRWAY STENTING AVOID SUFFOCATION DEATHS
CAUSED BY MALIGNANT AIRWAY OBSTRUCTION?
Naofumi Miyahara 1 , Takeshi Shiraishi 2 , Toshiro Oobuchi 3 , Akinori Iwasaki 1
1 General Thoracic, Breast, and Pediatric Surgery, Fukuoka University Hospital,
Fukuoka/Japan, 2 Dept. of General Thoracic, Breast, and Pediatric Surgery, Fukuoka
University School of Medicine, Fukuoka City/Japan, 3 Thoracic Surgery, Saint Maria
Hospital, Fukuoka City/Japan
Background: Airway stenting is undoubtedly the mainstay procedure for
treating patients with malignant airway stenosis to prevent a variety of
airway symptoms. Suffocation death is the most painful ending for those
patients. The impact of airway stent treatment to avoid this tragic event
was investigated. Methods: Between 2000 and 2014, 57 patients underwent
airway stenting in our department for malignant airway stenosis. They
included 25 lung cancer cases, 15 esophageal cancer cases and 7 thyroid cancer
cases. The location of the stenosis was the carina for 31 cases, the right or left
main bronchus in 12, and the trachea 14. Either Dumon silicon (n=50) or selfexpandable
metallic stents (n=7) were used. The effect of airway stenting to
prevent suffocation death, and the factors for predicting the prognosis were
analyzed. Results: There were no cases of in-hospital death. An improvement
in airway symptoms was achieved in 54 patients (94.7%) and the median
survival after stenting was 3.7 months. At death, only 8 (14%) of those
patients died due to direct airway symptoms, including respiration difficulty,
even when their general condition was good (Suffocation death group).
Copyright © 2016 by the International Association for the Study of Lung Cancer
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