Swanson 2007
Swanson 2007
4993
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Swanson et al
With this background, the Cancer and Leukemia Group B as the time between surgery and death. The Kaplan-Meier product-limit
(CALGB) 39802 prospective, multi-institutional study was designed estimator was used to graphically describe FFS and overall survival.
to elucidate the technical feasibility and safety of VATS in early non– A VATS lobectomy procedure form was required for each participant.
The VATS procedure was defined as successfully completed, converted to a
small-cell lung cancer (NSCLC) using a standardized definition for thoracotomy, or aborted because of an inability to perform either VATS or
VATS lobectomy that mandated videoscopic guidance and a tradi- thoracotomy for the following specified reasons: bleeding, tumor larger than
tional hilar dissection without rib spreading. appreciated, tumor more central than appreciated, vascular anatomy not
We were primarily interested in the feasibility of performing amenable to VATS, pleural adhesions, positive N2 nodes, tumors other than
VATS lobectomy in patients with peripheral NSCLC ⱕ 3 cm in size. NSCLC, difficulty with one-lung ventilation, other anesthesia problems, or
Feasibility was defined as the ability to successfully perform a lobec- other technical or anatomic considerations.
tomy via a VATS approach without significant morbidity or periop-
erative mortality (death within 30 days of the VATS procedure). RESULTS
Significant morbidity included bleeding that required greater than
two transfusion units, pneumonia that required antibiotic treatment,
One hundred twenty-eight patients were accrued to the study at six
cardiac arrhythmias that required treatment, supraventricular ar-
centers by 11 surgeons between 1998 and 2001. One patient who was
rhythmia that required cardioversion, deep vein thrombosis, pulmo-
registered to the study after undergoing surgical resection was ex-
nary embolus, myocardial infarction, wound infection that required
cluded from the analyses. Another two patients who underwent suc-
either antibiotic therapy or wound opening, empyema, bronchopleu-
cessful surgery were included even though both had at least one lesion
ral fistula, and prolonged air leak. If, despite the various retrospective
more than 3 cm on prestudy computed tomography scans. Therefore,
reports, VATS lobectomy, as carefully defined, was not feasible (ie, analyses are based on 127 patients with a median age of 66 years
successful and safe), then there would be little point in further exam- (range, 37 to 86 years). Patient characteristics are listed in Table 1. One
ining this technically advanced approach to lobectomy for early-stage hundred eleven of the remaining 127 patients had stage T1N0 (1 to 3
lung cancer. cm) NSCLC. VATS lobectomy was performed successfully in 96 of
111 patients, for a success rate of 86.5%. The median length of the
successfully completed procedures was 130 minutes (range, 47 to 428
PATIENTS AND METHODS
minutes). The median length of chest tube duration was 3 days (range,
1 to 14 days). Additional operative data are listed in Table 2. Ninety-
Between 1998 and 2001, 128 patients with suspected or histologically docu-
mented clinical stage I NSCLC with solitary peripheral tumors ⱕ 3 cm were one of 111 patients who had stage I NSCLC underwent lymph node
registered. Preresectional biopsy was not required, but patients with enlarged sampling. The mean number of lymph nodes stations dissected was
(⬎ 1 cm) mediastinal lymph nodes by computed tomography scan were 4.2 (standard deviation, 2.2 stations). The lymph node distribution for
required to undergo mediastinoscopy. All other patients underwent ipsilateral lymph node stations is shown in Table 3.
thoracoscopic mediastinal lymph node sampling or dissection for adequate There were three perioperative deaths (2.7%). Patient deaths
staging. Patients with metastatic disease or a diagnosis of NSCLC or small-cell were attributed to mesenteric ischemia (one patient, day 19), sudden
lung cancer within the past 5 years were also excluded. Patients who were cardiopulmonary arrest (one patient, day 7), and pulmonary embolus
included had an Eastern Cooperative Oncology Group performance status of
0 to 2.
(one patient, day 7). None of these three patients had a complicated
Participating surgeons were required to undergo a rigorous credentialing VATS lobectomy operation. Adverse events were evaluated for 95 of
protocol that included registration in a course to review technique, submission 96 patients who had successful VATS resection; no data were available
of an unedited videotape, operative and pathology reports from a VATS for one patient. Nine severe or life-threatening complications oc-
lobectomy for central review, and participation in an animal laboratory. Sur- curred in seven patients (Table 4). There were five episodes of arrhyth-
geons were required to perform at least five VATS lobectomies before being mias (supraventricular tachycardia or atrial fibrillation), one episode
credentialed. The technique was carefully outlined in the appendix of the of hypotension, one episode of bleeding, one prolonged air leak, and
protocol and mandated no rib spreading; a maximum length of 8 cm of the
one pleural effusion.
access incision for removal of the lobectomy specimen; individual dissection of
the vein, arteries, and airway for the lobe in question; and standard node
sampling or dissection (identical to an open thoracotomy). All specimens were
placed in an impermeable bag and removed through the access incision.
The two primary end points, technical feasibility and safety, were the Table 1. Patient Characteristics
bases for the study accrual goal. The study’s sample size goal was chosen with
No. of Patients
the following issues in mind: the study was designed to have 80% power to Characteristic (N ⫽ 127) %
differentiate between a 75% and 85% success rate for a test conducted at the
0.05 level of significance, where success was defined as a patient who can be Sex
completely resected using VATS without conversion to a thoracotomy; the Male 66 52
study was designed to have 80% power to differentiate between an 80% and Female 61 48
90% morbidity/complication rate, with safety defined as the in-house morbid- Age, years
ity and 30-day or in-house mortality, whichever was longer; and approxi- Median 66
mately 20% of patients would not have stage T1N0 disease. The study’s accrual Range 37-86
goal was 135 patients, including 107 patients with T1N0 disease. 70⫹ 44 35
Performance status
The length of time of the surgical procedures, duration of chest tube, and
0; normal activity 94 74
other complications were recorded. Secondary end points included failure-
1; fully ambulatory 33 26
free survival (FFS) and survival. FFS was defined as the time between surgery
and initial failure (death, disease progression, or relapse); survival was defined
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Swanson et al
Table 4. Complications Among Patients Who Underwent Successful Resection With Video-Assisted Thoracic Surgery
Grade of Complications
Grade 4: Life
Grade 3: Severe Threatening Grade 5: Lethal
Total No. of
No. of No. of No. of Patients
Complication Patients % Patients % Patients % Evaluated
Cardiovascular: arrhythmia
Arrhythmia, other 3 3 1 1 0 0 95
Supraventricular arrhythmias 1 1 0 0 0 0 95
Cardiovascular: general
Hypotension 1 1 0 0 0 0 95
Cardiac ischemia/infarction 0 0 0 0 0 0 95
Thrombosis/embolism 0 0 0 0 0 0 95
Operative injury of vein/artery 0 0 0 0 0 0 95
Dermatology/skin
Wound infection 0 0 0 0 0 0 95
Hemorrhage
Hemorrhage/bleeding associated 0 0 1 1 0 0 95
Infection/febrile neutropenia
Infection without neutropenia 0 0 0 0 0 0 95
Catheter-related infection 0 0 0 0 0 0 95
Infection/other 0 0 0 0 0 0 95
Pulmonary
Pleural effusion 1 1 0 0 0 0 95
Adult respiratory distress syndrome 0 0 0 0 0 0 95
Pneumothorax 0 0 0 0 0 0 95
Pulmonary, other 0 0 1 1 0 0 95
Summary
Maximum toxicity 4 4 3 3 0 0 95
NSCLC suggests that the VATS operation yields results equal to with respect to postsurgical pulmonary function, pain, activity param-
those observed using a thoracotomy approach. Given that VATS eters, and overall well-being.20-27 Finally, the credentialing method
was defined as a procedure identical to that performed by thora- used in this study may serve as a standard to facilitate the safe use of
cotomy, the equivalent survival data are not surprising. In addi- new technology in a surgical practice.
tion, lymph node clearance is quite effective using a VATS CALGB 39802 is the first prospective, multi-institution study
technique.19 Whether minimizing trauma will lead to improved to examine a standardized, truly videoscopic, minimally invasive
survival, perhaps via improved immune surveillance, as noted in VATS lobectomy for early-stage lung cancer. The results demon-
some reports,5-7,15,17 remains to be investigated. strate that a VATS lobectomy as defined herein (ie, a lobectomy
Ideally, the benefits of the VATS operation to the patient will be performed with videoscopic guidance and anatomic hilar vascular,
based on quality-of-life measures that currently are difficult to dem- bronchial, and lymphatic dissection using two or three ports and
onstrate. The existing data are sparse but favor the VATS approach without rib spreading) is feasible. The low complication rate and
short chest tube duration suggest there may be a benefit to the
patient; furthermore, at early follow-up, the secondary survival
end point compares favorably to open series. A follow-up cooper-
1.0 ative cancer group study to compare the outcome of a VATS
approach with a thoracotomy for early-stage lung cancer has been
0.8 proposed to further define the potential patient benefit.
Probability
0.6
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS
0.4
OF INTEREST
Employment or Leadership Position: None Consultant or Advisory Administrative support: David J. Sugarbaker
Role: Scott J. Swanson, Ethicon (C); Todd L. Demmy, US Surgical (U); Provision of study materials or patients: Todd L. Demmy, Robert J.
Robert J. McKenna Jr, Ethicon (C) Stock Ownership: Mark R. Green, McKenna Jr
Johnson & Johnson Honoraria: Thomas A. D’Amico, US Surgical; Todd Collection and assembly of data: James E. Herndon II
L. Demmy, US Surgical; Robert J. McKenna Jr, Ethicon Research Data analysis and interpretation: Scott J. Swanson, James E. Herndon II,
Funding: None Expert Testimony: None Other Remuneration: Todd L. Mark R. Green
Demmy, US Surgical Manuscript writing: Scott J. Swanson, James E. Herndon II, Thomas A.
D’Amico, Todd L. Demmy, Robert J. McKenna Jr, David J. Sugarbaker
AUTHOR CONTRIBUTIONS Final approval of manuscript: Scott J. Swanson, James E. Herndon II,
Todd L. Demmy, Robert J. McKenna Jr, Mark R. Green, David J.
Conception and design: Scott J. Swanson, James E. Herndon II, Thomas Sugarbaker
A. D’Amico, Todd L. Demmy, Robert J. McKenna Jr, Mark R. Green,
David J. Sugarbaker
long-term prognosis in patients with clinical stage IA lung cancer by video-assisted thoracic surgery: Can
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Acknowledgment
We thank Francine R. Dembitzer, MD, for assistance with this article.
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Copyright © 2007 American Society of Clinical Oncology. All rights reserved.
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