Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
3 pts 10, 25, or 50 × 10 6 DC were administered IV and intradermally, 3 times
at a bi-weekly interval and after 3 and 6 months. Primary endpoint was
toxicity occurring within 8 weeks after the first vaccination. Secondary
endpoints were response rate (RR), progression free survival (PFS) and
overall survival (OS). PFS and OS were determined from time of registration
in the trial. Immunological read-outs were performed (DTH skin testing,
peripheral blood testing). Results: Nine pts (median age 69yrs, 8 male, 1
female) were included. All patients developed transient grade 1-fever and a
grade 1-2 injection site reaction. No dose limiting toxicities or autoimmunity
signs were observed. In 2 pts (22%), both treated with 25 ×10 6 cells, a partial
response (PR) was observed, the other 7 pts had stable disease as best overall
response. All patients are alive with a median follow up of 11.9 months after
trial inclusion(range 7.6-16.5 months). Median PFS was 8.3 months (95%
confidence interval (CI) 3.7-not yet reached), PFS at 12 months was 33% (95%
CI 8%-62%). Data on immunological read outs are pending. Conclusion: DC
immunotherapy with allogenic tumor cell lysate is safe and clinically active.
Data on PFS and OS are promising and still maturing. The recommended dose
for future studies will be 25 * 10 6 cells based on the responses and logistic
reasons (the number of monocytes obtained during leucapheresis to generate
5 vaccinations). A randomized trial comparing DC therapy with Pheralys
versus best supportive care as maintenance treatment after chemotherapy is
planned to start in Q1 2017.
Keywords: vaccination, Mesothelioma, Immunotherapy, dendritic cell
OA13: IMMUNOTHERAPY IN MALIGNANT PLEURAL MESOTHELIOMA: CURRENT STATUS
OF TRIALS AND NEW APPROACHES
TUESDAY, DECEMBER 6, 2016 - 14:15-15:45
OA13.07 INTRAPLEURAL MODIFIED VACCINE STRAIN MEASLES
VIRUS THERAPY FOR PATIENTS WITH MALIGNANT PLEURAL
MESOTHELIOMA
Tobias Peikert 1 , Sumithra Mandrekar 1 , Aaron Mansfield 1 , Virginia Van
Keulen 1 , Steven Albelda 2 , Sandra Aderca 1 , Stephanie Carlson 1 , Allen Dietz 1 ,
Mike Gustafson 1 , Robert Kratzke 3 , Val Lowe 1 , Fabien Maldonado 4 , Julian
Molina 5 , Manish Patel 3 , Anja Roden 1 , Jin Sun 2 , Angelina Tan 1 , Maja Tippmann-
Peikert 1 , Evanthia Galanis 1
1 Mayo Clinic, Rochester/MN/United States of America, 2 Medicine, University of
Pennsylvania, Philadelphia/PA/United States of America, 3 University of Minnesota,
Minneapolis/MN/United States of America, 4 Pulmonary and Critical Care Medicine,
Vanderbilt University, Nashville, Tn/MN/United States of America, 5 Mayo Clinic,
Rochester/United States of America
Background: Malignant pleural mesothelioma (MM) remains an almost
universally fatal disease with limited treatment options. Preclinical models
indicate the preferential oncolytic activity of the modified vaccine strain
measles virus carrying the gene for the human sodium-iodine symporter (NIS)
– MV-NIS. Intraperitoneal and intravenous administration of MV-NIS was
recently found to be potentially effective in patients with refractory ovarian
cancer and multiple myeloma. However, whether MV-NIS is directly oncolytic
or triggers an anti-tumor immune response remains unclear. Methods: We
conducted a phase I dose escalation study with 3+3 design and ongoing
maximal tolerated dose (MTD) expansion cohort. MV-NIS was administered
as first or second line therapy via a tunneled intrapleural catheter to patients
with MM. MV-NIS dose ranged from 10 8 TICID 50
to 9 x 10 9 TICID 50
. In the
absence of dose limiting toxicity and disease progression, patients received
up to 6 cycles of MV-NIS therapy (Phase I). Currently additional patients are
being randomized between a single and multiple cycles. MV-NIS infection
and replication are monitored by Iodine 123 SPECT/CT (Phase I only) as well
as by RT-PCR and/or plaque-assay. Anti-tumor immunity is monitored in the
blood and pleural fluid and patients are followed clinically by chest CT using
the modified RECIST criteria. Results: Twelve patients (3/dose level) received
MV-NIS therapy. There were no dose limiting adverse events and therapy
was well tolerated. The best therapeutic response was stable disease, which
was achieved at 1 month by 8/12 evaluable patients (67%). Median overall
survival was 449 days (95%CI: 221, 484) (~15 months) (4/12 patients remain
alive), and median progression free survival was 63 days (95% CI: 33, 174) (~2
months). MV infection and replication were detectable by RT-PCR and plaque
assay in the pleural fluid between 24-72 hours after treatment. I 123 SPECT-CT
demonstrated only marginal viral gene expression in a single patient treated
with the highest dose level. MV-NIS therapy effectively boosted pre-existing
anti-MV neutralizing antibody responses in the plasma and pleural fluid of
most patients. We observed a transient inflammatory response in the pleural
space after MV-NIS administration. In addition, induction or boosting of
anti-tumor antibody responses was observed. Conclusion: The intrapleural
administration of MV-NIS is safe, resulted in stable disease for 67% of
patients and may be associated with favorable overall survival in MM. While
there was only transient infection and viral replication, we observed the
induction of anti-tumor immune responses supportive of potential long-term
therapeutic impact. The study continues with the MTD expansion cohort.
Keywords: Measles Virus, Intrapleural therapy, Virotherapy, Mesothelioma
SESSION OA14: NURSES IN CARE FOR LUNG CANCER
AND IN RESEARCH
TUESDAY, DECEMBER 6, 2016 - 16:00-17:30
OA14.01 ACCEPTABILITY OF AN ADVANCED PRACTICE NURSE IN
LUNG CANCER BY HEALTH PROFESSIONALS AND PATIENTS: A
QUALITATIVE EXPLORATION
Andrea Serena, Andrew Dwyer, Manuela Eicher
Institute of Higher Education and Research in Healthcare, Faculty of Biology and
Medicine, University of Lausanne, Lausanne/Switzerland
Background: The advanced practice nurse in lung cancer (APNLC) has shown
to play a key role in meeting the complex supportive care needs of patients
with lung cancer. Nurses working in novel advanced practice nursing (APN)
roles encounter a range of barriers to effective practice particularly in
countries without an existing regulation of these novel roles. Being accepted
by patients and healthcare professionals (HCPs) is fundamental for successful
role implementation. The University Hospital of Lausanne (CHUV) was the
first comprehensive cancer center in Switzerland to integrate an APNLC
into the specialized multidisciplinary team (MDT) of the thoracic cancer
center. To overcome barriers to implementing the APNLC role and promote
its long-term viability, we aimed to explore the acceptability of this novel
APNLC role from the perspective of the MDT and the patients cared for by the
APNLC. Methods: This qualitative study was part of a larger implementation
study (ClinicalTrials.gov, Number: NCT02362204). During summer 2015,
we conducted focus groups and semi-structured interviews in the thoracic
cancer center of CHUV. Participants were purposefully sampled and included
patients with lung cancer (n=4) and HCPs from the MDT [physicians (n=6),
nurses (n=5)], a social worker and the APNLC. Semi-structured individual
interviews were conducted to examine the perspectives of patients and the
APNLC alike. Focus groups were employed to gather perspectives from the
MDT. Data were analyzed using thematic content analysis. Results: Three
main themes emerged describing the acceptability of the APNLC: “role
identification”, “role-specific contribution” and “flexible service provision”.
Physicians and patients identified the specific APNLC role within the MDT.
In particular, they valued specific contributions to continuity of care,
psychosocial support and self-management of symptoms. Nurses perceived
the APNLC role as overlapping with the traditional oncology nurse role.
They were concerned about losing part of their traditional role. Flexibility
in service provision was seen as strength of the APNLC role yet also posed
organizational challenges related to the work-load. Conclusion: The new
APNLC role appears to be well-accepted by patients and physicians. Barriers
identified during the implementation of the APNLC role were primarily related
to intra-professional and organizational challenges. The intra-professional
role tension could challenge effective role implementation. To maximize the
acceptability of a new APNLC role - particularly in countries that are in an
early stage of APN role development - we recommend formalizing nursing
role expectations, providing appropriate support/resources and promoting a
national plan for APN accreditation and certification.
Keywords: Lung cancer nurse, Advanced practice nursing, Multidisciplinary
team
OA14: NURSES IN CARE FOR LUNG CANCER AND IN RESEARCH
TUESDAY, DECEMBER 6, 2016 - 16:00-17:30
OA14.02 NURSING AND ALLIED HEALTHCARE PRACTITIONER
DRIVEN INITIATIVE TO DEVELOP AN INTEGRATED EDUCATIONAL
AND ASSESSMENT PROGRAM FOR IMMUNOTHERAPY
Marianne Davies 1 , Lisa Barbarotta 2 , Rebecca Abramovitz 2 , Lauren Cardone 2 ,
Felicia Corolla 2 , Michelle Randall-Doran 2 , Monica Fradkin 2 , Stephanie
Kulakowski 2 , Kelly Guttmann 2 , Susan Okon 2 , Laura Tuttle 2 , Emily Duffield 1
1 Medical Oncology, Yale Cancer Center, New Haven/CT/United States of America,
2 Education, Yale New Haven Hospital, New Haven/United States of America
Background: Immunotherapy is rapidly becoming recognized as the fourth
pillar of treatment for lung cancer. As an academic center of excellence, our
staff have developed expertise with immune-oncology (I-O) agents though
clinical trials. Currently two agents (Nivolumab and Pembrolizumab) have
been FDA-approved for the treatment of lung cancer. Variability existed in
patient assessment, patient education and staff education regarding how to
identify and manage immune-related adverse events (IrAEs). Methods: Initial
evaluation consisted of an online staff survey and interviews to assess the
educational materials available for instruction of both patients and staff.
A review of existing educational materials was conducted to determine the
breadth of information available as well as knowledge gaps. The evaluation
revealed a lack of standardization, with inconsistency in the educational
messages being delivered. A focused working group including CNS, APRNs,
Pharmacists and RNs from the academic hub and broader community care
Copyright © 2016 by the International Association for the Study of Lung Cancer
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