Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
Conclusion: Only 45% of patients know their treatment is not curative,
although this study shows they should know the palliative intent. Patients
with advanced lung cancer who know they cannot be cured, are more aware of
the primary goal of a palliative treatment. 57% and 51% wants to have a
conversation about EoL care and their prognosis.
Keywords: prognostic understanding, Communication, lung cancer, early
palliative care
objectives include comparison of changes in immune responses and search
for prognostic biomarkers. Clinical trial information: EudraCT number
2014-003084-37. Results: Section is not applicable Conclusion: Section is not
applicable
Keywords: DCVAC/LuCa, Active cellular immunotherapy, dendritic cell vaccine,
NSCLC
POSTER SESSION 3 – P3.05: PALLIATIVE CARE/ETHICS
QUALITY OF LIFE, OTHERS –
WEDNESDAY, DECEMBER 7, 2016
P3.05-020 PATIENTS’ PERCEPTION OF RAPID ONSET OPIOIDS
Choonhee Son
Pulmonology, Dong-A University Hospital, Busan/Korea, Republic of
Background: Patients with lung cancer often complain of pain, and not
always controlled by maintenance managements. Rapid onset opioids
(ROO) are prescribed for breakthrough pain. Patients in Korea prefer to take
medicine orally. We evaluated patients’ preference of transmucosal ROO in
patients with lung cancer. Methods: One hundred and seventy seven patients
with lung cancer who complained of pain were interviewed and filled in a
questionnaire about perception of ROO before and after their use. Results:
Ninety three patients (53%) were older than 65 year old. Patients who cannot
classify maintenance drugs and ROO were 78(67%) and 35(20%) before and
after use of drugs. At the time of breakthrough pain, 66(37%) and 12(7%)
tolerated without ROO before and after use of them. Twenty five (14%) and
87(49%) patients were relieved from pain within 10 minutes with oral and
transmucosal drugs. Preference of transmucosal drugs were 48(27%) and
changed to 89(50%) after use them. Conclusion: Many patients tolerated
breakthrough pain without ROO. Preference to transmucosal drugs changed
after use of them. Physicians should educate ROO especially in older patients.
Keywords: Rapid onset opioid
POSTER SESSION 3 – P3.06: TRIAL DESIGN/STATISTICS
Clinical Studies –
WEDNESDAY, DECEMBER 7, 2016
P3.06-001 PHASE I/II STUDY TO EVALUATE SAFETY AND EFFICACY
DCVAC/LUCA WITH 1ST LINE CHEMOTHERAPY +/- IMMUNE
ENHANCERS VS CHEMOTHERAPY, STAGE IV NSCLC
Libor Havel 1 , Vitezslav Kolek 2 , Milos Pesek 3 , Milada Zemanová 4 , Jirina
Bartunkova 5 , Jan Fagerberg 6 , Radek Spisek 5 , Inna Krasnopolskaya 7
1 Thomayer Hospital, Prague/Czech Republic, 2 Respiratory Medicine, University
Hospital, Olomouc/Czech Republic, 3 Department of Pneumology, Charles
University in Prague, Plzen/Czech Republic, 4 Oncology Vfn, General University
Hospital in Prague, Prague/czech Republic; 1St Faculty of Medicine of Charles
University in Prague, Prague/Czech Republic, 5 Motol University Hospital, Prague/
czech Republic/sotioa.S., Prague/Czech Republic, 6 Sotio A.S., Prague/Czech
Republic, 7 Medical, Sotio, Prague/Czech Republic
Background: Lung cancer (LuCa) has been the most common cancer in the
world for several decades and also the most common cause of death from
cancer worldwide. Immunotherapy, for induction of tumor cell specific
immune responses destroying tumor cells, has emerged as a promising
treatment modality in solid malignant tumors. Studies have shown that
chemotherapy can be combined with vaccine without impairing the immune
response. Methods: SLU01 is a randomized, open, parallel-group, multicenter,
international phase I/II study to evaluate the efficacy and safety of DCVAC/
LuCa (active cellular immunotherapy based on dendritic cells) added to
standard first line chemotherapy with carboplatin and paclitaxel +/- immune
enhancers (interferon-α and hydroxychloroquine) vs chemotherapy alone
in patients with Stage IV NSCLC. The study was initiated in December 2014
and plans to enroll 105 patients at approximately 12 sites in Czech and Slovak
Republics. Eligible patients are required to present with metastatic NSCLC
defined by histologically or cytologically confirmation and ECOG score 0-1. All
patients will receive Standard of Care (SoC) carboplatin and paclitaxel, and
will be randomized 1:1:1 to DCVAC/LuCa or DCVAC/LuCa + immune enhancers
(pegylated IFN-α2b and hydroxychloroquine) or SoC only. Patients will be
stratified by histology subtype adenomatous or squamous cell carcinoma
and smoking history. The primary objective is to compare efficacy of DCVAC/
LuCa + chemotherapy +/- immune enhancers vs. chemotherapy alone in
patients with stage IV NSCLC, as measured by progression free survival (PFS).
Secondary objectives include assessments of safety, objective response
rate (ORR), duration of response (DoR) and overall survival (OS). Exploratory
POSTER SESSION 3 – P3.06: TRIAL DESIGN/STATISTICS
CLINICAL STUDIES –
WEDNESDAY, DECEMBER 7, 2016
P3.06-002 ATLANTIS TRIAL: PHASE III STUDY OF PM01183/
DOXORUBICIN VS. CAV OR TOPOTECAN IN SCLC AFTER ONE
PLATINUM-CONTAINING LINE
Anna Farago 1 , Martin Forster 2 , Luis Paz-Ares 3 , Carmen Puparelli 4 , Sergio
Szyldergemajn 5 , Jose Lopez-Vilarino 5 , Keren Moss 6 , Carmen Kahatt 5 , Arturo
Soto-Matos 5 , Maria Eugenia Olmedo 7
1 Massachusets General Hospital, Massachuset/United States of America, 2 Cancer
Division, University College Hospital London, Nw Bu/United Kingdom, 3 Hospital
Doce de Octubre, Madrid/Spain, 4 Instituto Alexander Fleming-Fuca, Buenos Aires/
Argentina, 5 Pharmamar, Colmenar Viejo, Madrid/Spain, 6 Inc Research, Kiryat-Ono/
Israel, 7 Medical Oncology Department, Hospital Universitario Ramón Y Cajal,
Madrid/Spain
Background: PM01183 (lurbinectedin) is a new anticancer drug that blocks
trans-activated transcription, induces DNA double-strand breaks and
modulates the tumor microenvironment. Synergism in combination with
doxorubicin with compelling overall response rates (~67%, including
approximately 10% complete responses) was reported in a phase I expansion
cohort in 21 second-line SCLC patients (pts) (ASCO 2015, abstract 7509). The
most common toxicity observed was hematologic. Methods: Multinational,
multicenter (>150 sites), open-label, randomized, phase III study of PM01183/
doxorubicin vs. a control arm with investigator choice of either standard CAV
or topotecan (1.5 mg/m 2 , D1-5 q3wk). A total of 600 pts will be randomized (1:1)
and stratified according to ECOG performance status (PS), chemotherapyfree
interval (CTFI), known CNS involvement, prior PD-1/PD-L1 based
immunotherapy and potential investigator’s control preference. Patients
with clinical benefit after 10 cycles of doxorubicin containing-combination
will continue on single agent PM01183 or CV, until PD or unacceptable toxicity.
Interim safety analysis will be performed after 150 pts by an independent data
monitoring committee. The most relevant inclusion criteria are: pts ≥18 years
old; confirmed diagnosis of SCLC (small-cell carcinomas from unknown site
are eligible provided ≥50% Ki-67 expression). One prior platinum containing
regimen is mandatory (additional immunotherapy is allowed provided that
it was not given in combination with CT); PS: 0-2 and adequate major organ
function, including normal LVEF ≥50% at baseline. Pts are excluded if pretreated
with PM01183, doxorubicin or topotecan; symptomatic or steroid
requiring CNS involvement or any serious medical condition that might
preclude safe compliance with study treatment. The primary objective is
to determine a difference in progression-free survival by an independent
review committee. Secondary endpoints are overall survival, survival rates
at 12/18/24 months, antitumor response (RECIST v1.1), duration of response,
QoL, safety, subgroup analyses and pharmacokinetics (PK) of PM01183/
doxorubicin arm. First patient is planned in JUL2016. Enrollment is expected
to be completed by 4Q17. Results: Section not applicable Conclusion: Section
not applicable
Keywords: phase III, Lurbinectedin, SCLC
POSTER SESSION 3 – P3.06: TRIAL DESIGN/STATISTICS
CLINICAL STUDIES –
WEDNESDAY, DECEMBER 7, 2016
P3.06-003 SARON: STEREOTACTIC ABLATIVE RADIOTHERAPY FOR
OLIGOMETASTATIC NON-SMALL CELL LUNG CANCER (NSCLC). A UK
RANDOMISED PHASE III TRIAL
Yenting Ngai 1 , Gerard Hanna 2 , John Conibear 3 , Nicholas Counsell 1 , Laura
Hughes 1 , Laura Farrelly 1 , David Landau 4
1 Cr Uk & UCL Cancer Trials Centre, London/United Kingdom, 2 Belfast City Hospital,
Belfast/United Kingdom, 3 St Bartholomew’S Hospital, London/United Kingdom,
4 Oncology, Guy’s and St Thomas’ NHS Foundation Trust, London/United Kingdom
Background: It has been theorised that local ablative therapy such as
stereotactic ablative radiotherapy (SABR) and stereotactic radiosurgery (SRS)
could improve outcomes for patients with oligometastatic disease. There is
now growing evidence to support the safety, local control effect and potential
improvement in overall survival (OS) for SABR/SRS to warrant a randomised
phase III trial. The SARON trial investigates the impact on OS of radiotherapy
S748 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017