Transcript LAPAROSCOPIC GASTRIC CONDITIONING FOR ESOPHAGECTOMY

Sublobar Resection and Intraoperative
Brachytherapy for Lung Cancer:
ACOSOG Update
Rodney J. Landreneau, MD
Professor of Surgery
The Heart Lung and Esophageal Surgery
Institute
University of Pittsburgh Medical Center
Surgical Treatment of Lung Cancer
Radiofrequency Ablation to VATS Lobectomy
November 13-14, 2008
Pittsburgh, Pennsylvania
Surgical Resection of the Lung
Standard of Care for Peripheral
Nodules
1940’s
Pneumonectomy
1960’s
Lobectomy
1990’s
? Segmentectomy/Wedge (and
adjuvant local/systemic Rx)
Background
● Non-small cell lung carcinoma (NSCLC)
identified in patients with impaired
cardiopulmonary reserve creates important
therapeutic challenges.
● Sublobar pulmonary resection is often
utilized in these patients, however, local
recurrence is high (15-25%).
How Can Therapy to Customized for Patients
with Poor Cardiopulmonary Reserve?
● Primary external beam radiation therapy
- ? survival
● Chemotherapy
- no defined role as primary therapy
● Radiofrequency Ablation
- ? survival
● Sublobar resection
● Sublobar resection with adjuvant radiation therapy
Background
● Postoperative (postop) external
radiotherapy following sublobar resection is
time consuming and can result in additional
loss of pulmonary function.
● We review our experience using intraoperative 125I lodine brachytherapy following
sublobar resection of stage I NSCLC in
patients with impaired cardiopulmonary
reserve.
Methods
● From 1/1989 to 7/1994, 102 patients (mean age
69.5 years) with pathologic stage I NSCLC and
poor cardiopulmonary reserve (mean % predicated
FEV 1 preop = 65%) underwent sublobar resection
as primary therapy.
● We have since (1/1997 to 6/2002) introduced
adjunctive intraoperative brachytherapy with 125I to
sublobar resection among 96 stage I patients with
similar cardiopulmonary compromise (mean %
predicted FEV1 preop = 53%).
Methods
● After resection, a vicryl™ implant containing 125I
seeds, sewn at 1cm² intervals, was placed over the
resection staple line covering a 2cm lateral margin.
A local radiation does of 10,000 cGy was delivered.
● No post-op patient isolation was required per
national radiation safety guidelines
● Mortality and morbidity, local recurrence and
disease free survival have been compared.
Results
Sublobar Resection
(n=102)
Sublobar Resection
With Brachy (n=96)
Local Recurrence
19 (18.6%)
1 (1%) p=.0001
Hospital Mortality
0 (0%)
3 (3%) p=ns
Hospital Stay
7 days
8 days p=ns
93, 73, 68, 60%
96, 82, 70, 67% p=ns
29 (28.4)
22 (23%) p=ns
65%
53% p=ns
Survival %
1, 2, 3 and 4 year
Systemic Recurrence
Pre-op FEV 1%
predicted
● The FEV 1 did not change postoperatively in the sublobar
resection with brachytherapy group in the interval of follow-up
Conclusions
●
Local recurrence of NSCLC following
sublobar resection with intra-operative
125Ibrachytherapy (1%) appears to be less
than following sublobar resection alone
(18.6%).
●
This safe, pulmonary function preserving,
and practical intra-operative brachytherapy
method may be considered when sublobar
resection is utilized as compromise therapy
of stage I NSCLC.
ACOSOG Z4032
Sublobar Resection vs.
Sublobar Resection with
Intraoperative Brachytherapy for
High Risk Stage IA Non Small Cell
Lung Cancer Patients
SCHEMA
R
E
G
High risk
patients with
suspected or
proven NSCLC
Pre-Registration
and
Randomization
to Z4032
Histological
confirmation
NSCLC and
confirmation
N2/N3
negative lymph
nodes
(if necessary)
**
I
S
T
F
ARM 1:
Sublobar
Resection
(SR)
O
L
R
L
A
O
T
I
O
N
ARM 2:
Sublobar
Resection +
Brachytherapy
(SRB)
W
U
P
Patient Selection
Eligibility Criteria
Part I: Pre-Operative Criteria (Pre-Registration/Randomization):
● Patients must have a suspicious lung nodule for clinical
Stage I NSCLC.
● Patient must have a mass ≤ 3cm maximum diameter by CT
size estimate: Clinical stage Ia or selected Ib (i.e., with
visceral pleural involvement.
● Patient must have a CT scan of the chest with upper
abdomen within 60 days prior to date of pre-registration.
Eligibility Criteria
Part I: Pre-Operative Criteria (Pre-Registration/Randomization):
●
Patient must meet at least one major criteria or meet a minimum of
two minor criteria as described below:
Major Criteria
-
FEV1 ≤ 50% predicted
DLCO ≤ 50% predicted
Eligibility Criteria
Part I: Pre-Operative Criteria (Pre-Registration/Randomization):
Minor Criteria
-
Age ≥ 75
FEV1 51-60% predicated
DLCO 51-60% predicated
Pulmonary hypertension (defined as a pulmonary artery
systolic pressure greater than 40mmHg) as estimated by
echocardiography or right heart catheterization
Eligibility Criteria
Part I: Pre-Operative Criteria (Pre-Registration/Randomization):
Minor Criteria
-
Poor left ventricular function (defined as an ejection fraction of
40% or less)
Resting or Exercise Arterial pO2 ≤55mm Hg or SpO2 ≤88%
pCO2 45mm Hg
Modified Medical Research Council (MMRC) Dyspnea Scale ≥3
Eligibility Criteria
Modified Medical Research Council Scale
Grade
Description
0
No breathlessness except with strenuous exercise
1
Breathlessness when hurrying on the level or walking up a slight hill
2
Walks slower than people of the same age on the level because of
breathlessness or has to stop for breath when walking at own pace on the level
3
Stops for breath after walking about 100 yards or a few minutes on the level
4
Too breathless to leave the house or breathless when dressing or undressing
Eligibility Criteria
Part I: Pre-Operative Criteria (Pre-Registration/Randomization):
● Patient must not have had previous intra-thoracic radiation
therapy.
● Women of child-bearing potential must have negative serum
or urine pregnancy test.
● No prior invasive malignancy, unless disease-free for ≥ 5
years prior to pre-registration (Exceptions: non-melanoma
skin cancer, in-situ cancers).
Eligibility Criteria
Part II: Intra-Operative Criteria (Registration):
● Patient must have biopsy-proven NSCLC.
● Patient must have all suspicious mediastinal lymph (>1 cm
short-axis dimension on CT scan or positive on PET scan)
assessed by one of the following methods to confirm negative
involvement with NSCLC (Mediastinoscopy, endoesophageal ultrasound guided needle aspiration, CT-guided,
video-assisted thoracoscopic or open lymph node biopsy).
ACOSOG Z4032
Accrual Summary
● 174 Patients Accrued Nationally
● Accrual Goal is 226 Patients
● Estimated Study Closure - November 2009
Thank You