Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
with chemotherapy and other targeted agents is also an important area of
priority. The role of biomarkers to select therapy is another critical research
priority. We should also make efforts to improve the percentage of patients
enrolled to clinical trials. A major reason for this is the stringent eligibility
criteria that excludes a significant proportion of patients in order to select
the ‘fittest’ candidates for clinical trials. While this is certainly appropriate
in early phase drug development, if patients enrolled in clinical trials do not
represent the ‘real-world’ patient population, the applicability of the results
are limited. The next wave of clinical trials should also take into consideration
the impact of new treatments on the overall cost of care and the clinical
significance of improvements in efficacy. The national Cooperative groups in
the United States are committed to a collaborative approach to address key
research questions and improve outcomes for lung cancer.
Keywords: NSCLC, Adjuvant therapy, ALCHEMIST, immunotherapy
SC15: CLINICAL TRIALS: HOW TO SET PRIORITIES?
TUESDAY, DECEMBER 6, 2016 - 11:00-12:30
SC15.04 THE JAPANESE PERSPECTIVE
Yuichiro Ohe
Thoracic Oncology, National Cancer Center Hospital, Tokyo/Japan
In Japan, several cooperative study groups, such as Japan Clinical Oncology
Group (JCOG), West Japan Oncology Group (WJOG), North East Japan Study
Group (NEJ), Thoracic Oncology Research Group (TORG), Tokyo Cooperative
Cooperative Oncology Group (TCOG), Oncology Group in Kyushu (LOGiK),
Okayama Lung Cancer Study Group (OLCSG) and so on are conducting
investigator initiated cooperative clinical studies for lung cancer. Phase 3
studies are mainly conducted by JCOG, WJOG and NEJ. JCOG and WJOG are
conducting intergroup phase 3 studies for lung cancer. More recently, multigroup
phase 3 studies are also started. JCOG is a multicenter clinical study
group for cancer treatment fully funded by the national research grants in
Japan. The goal of the JCOG is to establish effective standard treatments for
various types of malignant tumors by conducting nationwide multicenter
clinical trials, and to improve the quality and outcome of the management of
cancer patients. JCOG consists of 16 subgroups and JCOG Lung Cancer Study
Group (JCOG-LCSG) consists of 44 institutions, was established in 1982. JCOG
also have JCOG Lung Cancer Surgical Study Group (JCOG-LCSSG) established
in 1986.
Only JCOG is supported by no industries but National Cancer Center and
grants of Japan Agency for Medical Research and Development (AMED). Thus,
JCOG studies are conducting completely independent from pharmaceutical
companies. Other groups are supported by mainly pharmaceutical companies
and grants of AMED. JCOG-LCSG has been conducting many randomized
trials for small cell lung cancer and elderly non-small cell lung cancer. In case
of JCOG-LCSG, protocol concepts are discussing in the group meeting held
every 3 months. The protocol concept agreed in the group meeting will discuss
in JCOG Protocol Review Committee and finally approved by JCOG Steering
Committee. Kawano Y, Okamoto I, Fukuda H, et al. Current status and future
perspectives of cooperative study groups for lung cancer in Japan. Respir
Investig 52: 339-347, 2014.
Keywords: Japan Clinical Oncology Group, West Japan Oncology Group,
Investigator initiated multicenter clinical study
SESSION SC16: SUPERIOR SULCUS TUMORS
TUESDAY, DECEMBER 6, 2016 - 14:30-15:45
SC16.03 RADIOTHERAPY FOR SULCUS SUPERIOR TUMORS
Maria Werner-Wasik
Radiation Oncology, Sidney Kimmel Cancer Center at Thomas Jefferson University,
Philadelphia/PA/United States of America
Superior sulcus tumors (SST) are unique among lung cancer in that they
have a tendency for the invasion into the chest wall and a spread superiorly
outside the lungs, namely into the brachial plexus and the sympathetic
chain, therefore causing a well-defined constellation of symptoms and
signs, such as chest wall/arm/shoulder pain, Horner’s syndrome, spinal cord
compression, upper extremity edema etc. A primary surgical resection is rarely
performed, and bi- or trimodality therapies are most often implemented,
depending on tumor stage. A comprehensive evaluation of the tumor extent
is mandatory before any intervention is undertaken. Following tumor biopsy
to establish a diagnosis of non-small cell lung cancer, standard lung cancer
staging studies need to be obtained, such as the chest and upper abdomen
computerized tomography (CT) scan with intravenous contrast, a PET CT
scan and contrast-enhanced brain imaging (CT or MRI). Routine blood work
and pulmonary function testing are standard as well. However, there are
two additional radiographic studies which are necessary for each superior
sulcus tumors: (1) MRI scan of the brachial plexus; (2) MRI scan of the cervical
and thoracic spine. The rationale for imaging of the brachial plexus is not to
confirm that the plexus is invaded (which is evident based on the presenting
symptoms and a physical examination), but rather to assess the degree of its
vertical involvement, since only the lowest trunks of the brachial plexus can
be safely resected without fear of causing paralysis of the upper extremity.
The MRI of the vertebral column serves a double purpose: (1) to assess the
degree (if any) of vertebral involvement and resulting resectability; (2) to
image the proximity of the tumor to the spinal cord, which is crucial for
radiation planning. SSTs can cause thecal sac or spinal cord compression by
extending into the spinal canal through neural foramina, without apparent
spine invasion, hence the need for the MRI, which provides a superior image
quality than a chest CT scan. The overall treatment strategy depends on the
nodal status (“N” stage). For those patients without nodal involvement (“N0”)
or with involvement only of the ipsilateral hilar lymph nodes (“N1”), a common
approach is to use concurrent induction chemo-radiotherapy, followed by the
surgical resection. If obvious mediastinal nodal involvement is seen (“N2 or
N3”), the recommendation is for definitive concurrent chemo-radiotherapy
without subsequent surgery. Therefore, invasive staging of the mediastinum,
either with mediastinoscopy or with EBUS, is mandatory, since it may result in
avoiding surgery as part of management. General thoracic radiation therapy
(RT) principles apply to the SSTs, such as: (1) use of the CT simulation for
tumor and normal tissue imaging; (2) use of 6-10 MV photon energies (unless
protons are applied); (3) careful definition of the GTV, Gross Tumor Volume, to
include the visible tumor on lung windows and the abnormal lymph nodes on
soft tissue windows; (4) adequate margins for the CTV, Clinical Target Volume,
and the PTV, Planning Target Volume. In particular, a tendency to have very
tight margins around the tumor which is in close proximity to the spinal cord
should be avoided at all cost, since this may result in a marginal tumor failure.
In comparison to lung cancers in other locations, local tumor progression of
a SST can have devastating clinical consequences, resulting in unmanageable
pain, limb paralysis and a low quality of life. The commonly used total RT
doses are: 45-60 Gy in trimodality therapy (chemo-RT, then surgery) or 60-70
Gy in bimodality therapy (chemo-RT) in 2 Gy daily fractions. The doselimiting
normal structures are usually the spinal cord and brachial plexus.
The maximum allowed dose to the spinal cord may need to be higher (54-55
Gy) in SSTs than in other lung cancers (50 Gy) in order not to compromise
the minimum dose prescribed to the PTV by attempting to “spare” spinal
cord. In patients presenting with severe pain, a simple field arrangement
(such as anterior and posterior opposed fields) treating the tumor with wide
margins is a good initial option allowing for a quick start, followed by a more
advanced planning technique, such as 3-dimensional RT, intensity modulated
RT (IMRT) or VMAT. The tolerance of brachial plexus was classically described
as a maximum dose of 65 Gy, with recent publications suggesting that higher
doses, up to 78 Gy result in 12% risk of Grade>3 radiation-related brachial
plexopathy, and that brachial plexopathy is more common as a result of tumor
progression than radiation damage. The most quoted prospective clinical trial
reporting on treatment outcomes of SSTs is a landmark Phase II SWOG 9416
study, in which 95/110 enrolled patients without disease progression (86%)
received thoracic RT to 45 Gy in 1.8 Gy fractions with concurrent cisplatin
and etoposide chemotherapy, followed by surgery and further adjuvant
chemotherapy. Eligible patients were those with T3-T4 primary tumors and N0
or N1 nodal status. The resection rate was 80% and 75% achieved a complete
(R0) resection. The pathologic response rate (no tumor in the specimen or
microscopic residual) was 56%; the overall 5 yr survival rate was 44% for all
patients and 54% for those with a complete tumor resection. Since then,
recognition in the surgical community that operating after RT doses higher
than 45 Gy is safe, led to a more common use of the full RT dose, i.e. 60 Gy. If
the patient initially planned for trimodality therapy is no longer a surgical
candidate or refuses surgery, thoracic RT should continue to definitive
dose without interruption. Therefore, it is crucial to perform re-imaging for
response assessment in the last week of chemo-RT (if doses of