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Journal of Clinical Oncology, Vol 25, No 31 (November 1), 2007: pp. 4993-4997 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.12.6649 Video-Assisted Thoracic Surgery Lobectomy: Report of CALGB 39802—A Prospective, Multi-Institution Feasibility Study
From the Surgery Committee of the Cancer and Leukemia Group B (CALGB), Statistics Office of CALGB, and Respiratory Committee of CALGB, Chicago, IL Address reprint requests to Scott J. Swanson, MD, Division of Thoracic Surgery, Mt Sinai Medical Center, 1190 5th Ave, New York, NY 10029; e-mail: Scott.Swanson{at}mountsinai.org
Purpose To evaluate the technical feasibility and safety of video-assisted thoracic surgery (VATS) lobectomy for small lung cancers.
Patients and Methods The Cancer and Leukemia Group B 39802 trial was a prospective, multi-institutional study designed to elucidate the technical feasibility of VATS in early non–small-cell lung cancer (NSCLC) using a standard definition for VATS lobectomy (one 4- to 8-cm access and two 0.5-cm port incisions) that mandated videoscopic guidance and a traditional hilar dissection without rib spreading. Between 1998 and 2001, 128 patients with peripheral lung nodules Results One hundred twenty-seven patients (66 males and 61 females; median age, 66 years; range, 37 to 86 years), with a performance status of 0 (74%) or 1 (26%), underwent surgery. Patients with lymph nodes more than 1 cm by computed tomography scan underwent mediastinal lymph node sampling to rule out N2 disease. One hundred eleven patients (87%) had stage I lung cancer, and 96 (86.5%) of these 111 patients underwent successful VATS lobectomies. The median procedure length was 130 minutes (range, 47 to 428 minutes), and median chest tube duration was 3 days (range, 1 to 14 days). Fifty-eight (60%) of 97 patients underwent diagnostic biopsy at lobectomy. Within 30 days, three (2.7%) of 111 patient deaths occurred, none of which were directly related to VATS technique; seven (7.4%) of 95 patients had grade 3 or greater complications, with only one case of bleeding. Conclusion A standardized approach to VATS lobectomy as specifically defined with avoidance of rib spreading is feasible.
Minimally invasive surgery has improved the treatment of surgical patients. These surgical techniques minimize trauma and optimize patient recovery without compromising the surgical outcome. Laparoscopic cholecystectomy is a prime example of a minimally invasive surgical procedure that has become the standard of care for the surgical treatment of gallbladder disease. With respect to thoracic surgery, video-assisted thoracic surgery (VATS) is preferred by most thoracic surgeons for procedures such as pleural biopsy, wedge resection, blebectomy, and lung biopsy. However, VATS anatomic lung resection for cancer is controversial. The definition of VATS lobectomy has been variable. The term can refer to a range of operations including a standard thoracotomy and lobectomy via a small skin incision or a giant wedge resection. We prefer to standardize the definition of a VATS lobectomy to encompass a true anatomic lobectomy with individual ligation of lobar vessels and bronchus as well as hilar lymph node dissection or sampling using the video screen for guidance, two or three ports, and no retractor use or rib spreading.1-3 To date, to our knowledge, there are no prospective studies that use a standardized definition to examine the utility of a VATS lobectomy. The oncologic efficacy of the VATS approach, which is of critical importance, has been questioned by some thoracic surgeons.4 Others have reported similar and improved survival relative to historical controls.5-7 With this background, the Cancer and Leukemia Group B (CALGB) 39802 prospective, multi-institutional study was designed to elucidate the technical feasibility and safety of VATS in early non–small-cell lung cancer (NSCLC) using a standardized definition for VATS lobectomy that mandated videoscopic guidance and a traditional hilar dissection without rib spreading.
We were primarily interested in the feasibility of performing VATS lobectomy in patients with peripheral NSCLC
Between 1998 and 2001, 128 patients with suspected or histologically documented clinical stage I NSCLC with solitary peripheral tumors  3 cm were registered. Preresectional biopsy was not required, but patients with enlarged (> 1 cm) mediastinal lymph nodes by computed tomography scan were required to undergo mediastinoscopy. All other patients underwent ipsilateral thoracoscopic mediastinal lymph node sampling or dissection for adequate staging. Patients with metastatic disease or a diagnosis of NSCLC or small-cell lung cancer within the past 5 years were also excluded. Patients who were included had an Eastern Cooperative Oncology Group performance status of 0 to 2. Participating surgeons were required to undergo a rigorous credentialing protocol that included registration in a course to review technique, submission of an unedited videotape, operative and pathology reports from a VATS lobectomy for central review, and participation in an animal laboratory. Surgeons were required to perform at least five VATS lobectomies before being credentialed. The technique was carefully outlined in the appendix of the protocol and mandated no rib spreading; a maximum length of 8 cm of the 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 bases for the study accrual goal. The study's sample size goal was chosen with the following issues in mind: the study was designed to have 80% power to 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 completely resected using VATS without conversion to a thoracotomy; the study was designed to have 80% power to differentiate between an 80% and 90% morbidity/complication rate, with safety defined as the in-house morbidity and 30-day or in-house mortality, whichever was longer; and approximately 20% of patients would not have stage T1N0 disease. The study's accrual goal was 135 patients, including 107 patients with T1N0 disease. The length of time of the surgical procedures, duration of chest tube, and other complications were recorded. Secondary end points included failure-free survival (FFS) and survival. FFS was defined as the time between surgery and initial failure (death, disease progression, or relapse); survival was defined as the time between surgery and death. The Kaplan-Meier product-limit estimator was used to graphically describe FFS and overall survival. A VATS lobectomy procedure form was required for each participant. The VATS procedure was defined as successfully completed, converted to a thoracotomy, or aborted because of an inability to perform either VATS or thoracotomy for the following specified reasons: bleeding, tumor larger than appreciated, tumor more central than appreciated, vascular anatomy not amenable to VATS, pleural adhesions, positive N2 nodes, tumors other than NSCLC, difficulty with one-lung ventilation, other anesthesia problems, or other technical or anatomic considerations.
One hundred twenty-eight patients were accrued to the study at six centers by 11 surgeons between 1998 and 2001. One patient who was registered to the study after undergoing surgical resection was excluded from the analyses. Another two patients who underwent successful surgery were included even though both had at least one lesion more than 3 cm on prestudy computed tomography scans. Therefore, analyses are based on 127 patients with a median age of 66 years (range, 37 to 86 years). Patient characteristics are listed in Table 1. One hundred eleven of the remaining 127 patients had stage T1N0 (1 to 3 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 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-one of 111 patients who had stage I NSCLC underwent lymph node sampling. The mean number of lymph nodes stations dissected was 4.2 (standard deviation, 2.2 stations). The lymph node distribution for lymph node stations is shown in Table 3.
There were three perioperative deaths (2.7%). Patient deaths were attributed to mesenteric ischemia (one patient, day 19), sudden cardiopulmonary arrest (one patient, day 7), and pulmonary embolus (one patient, day 7). None of these three patients had a complicated VATS lobectomy operation. Adverse events were evaluated for 95 of 96 patients who had successful VATS resection; no data were available for one patient. Nine severe or life-threatening complications occurred in seven patients (Table 4). There were five episodes of arrhythmias (supraventricular tachycardia or atrial fibrillation), one episode of hypotension, one episode of bleeding, one prolonged air leak, and one pleural effusion.
Twelve of 111 patients underwent conversion to open thoracotomy. The reasons for the conversions included bleeding (n = 2), dense lymphadenopathy (n = 1), calcified node adherent to pulmonary artery and bronchus (n = 1), history of tuberculosis with adhesions of pulmonary vein and artery with anthracotic adenopathy (n = 1), inability to tolerate single-lung ventilation (n = 1), near fusion of ribs rendering it difficult to pass instruments through a small space (n = 1), unsatisfactory orientation that did not permit stapler to be passed around the superior pulmonary vein (n = 1), abnormal bronchial anatomy (n = 1), pathology frozen section nondiagnostic for tumor (n = 2), need to fully palpate lungs to identify pathologic area in question (n = 1), and camera technology inadequate for visualization (n = 1). Among the 111 patients determined to have T1N0 NSCLC, the probability of FFS is 91% (95% CI, 85.9% to 96.9%) at 1 year and 78% (95% CI, 70% to 86%) at 2 years at a median follow-up time of 36 months (Fig 1).
The use of minimally invasive surgical techniques in thoracic surgery is now routine for biopsies and basic procedures such as drainage of pleural effusion and blebectomy. Although its use is still controversial, VATS lobectomy has been performed for the surgical treatment of lung cancer for more than 14 years by a limited number of surgeons.8 Single-institution retrospective series have reported favorable morbidity, mortality, and survival data.4-7,9,10 However, a standardized definition for VATS lobectomy has not been established, and a multi-institution study has not been conducted, so the benefits have not been well characterized. Like the proponents of laparoscopic cholecystectomy, advocates of VATS lobectomy have suggested that the advantages to patients are obvious. However, it is important to be certain that this technique preserves oncologic principles and, because it is technically more demanding, that it is beneficial to patients. To this end, the CALGB specifically defines VATS lobectomy as the same procedure performed via a thoracotomy but without the chest wall muscle division or rib spreading that are the key sources of postoperative pain and limitation of function. Eleven surgeons at six centers underwent credentialing to assure uniformity of procedure. The success rate, morbidity, and mortality of the procedure achieved or surpassed previous levels.1,11 Notably, more than one third of the patients in this study were older than 70 years of age, suggesting to investigators that VATS is better tolerated in the elderly than thoracotomy.12 Our results are in contrast to a recent series of patients older than age 70 years who underwent open thoracotomy for slightly more advanced-stage disease, in whom reported operative morbidity was 40% to 50%.13 Another study reported hospital mortality rates of 12.8% in patients older than 70 years compared with 4.7% in patients younger than 70 years.14 Also of interest is the finding that certain complications, such as arrhythmias and prolonged air leak, were observed at a lower frequency (5.6% and < 1%, respectively) with VATS procedures compared with lobectomy performed via a thoracotomy. The American College of Surgeons Oncology Group Z0030 trial reported atrial arrhythmias in 15% and prolonged air leak in 8% of patients who underwent open lobectomy.13 These findings may be related to reduced trauma and less direct manipulation of the lung and hilum. Various inflammatory mediators and cytokines, such as C-reactive protein, interleukin-6, and polymorphonuclear elastase, are less perturbed in VATS patients than in patients who undergo thoracotomy and may, in part, explain these observations.15-17 The length of chest tube duration and arrhythmia incidence observed in this study were noticeably lower than the 12% and 15% rates, respectively, reported in thoracotomy patients12,13 and should result in shorter hospital stays with consequent cost savings, as suggested by other authors,18 particularly because the average VATS operation in our study took just longer than 2 hours including a confirmational wedge biopsy. The secondary study end points were recurrence and survival. The finding of 78% FFS at 36 months for patients with stage I NSCLC suggests that the VATS operation yields results equal to those observed using a thoracotomy approach. Given that VATS was defined as a procedure identical to that performed by thoracotomy, the equivalent survival data are not surprising. In addition, lymph node clearance is quite effective using a VATS technique.19 Whether minimizing trauma will lead to improved survival, perhaps via improved immune surveillance, as noted in some reports,5-7,15,17 remains to be investigated. Ideally, the benefits of the VATS operation to the patient will be based on quality-of-life measures that currently are difficult to demonstrate. The existing data are sparse but favor the VATS approach with respect to postsurgical pulmonary function, pain, activity parameters, and overall well-being.20-27 Finally, the credentialing method used in this study may serve as a standard to facilitate the safe use of new technology in a surgical practice. CALGB 39802 is the first prospective, multi-institution study to examine a standardized, truly videoscopic, minimally invasive VATS lobectomy for early-stage lung cancer. The results demonstrate that a VATS lobectomy as defined herein (ie, a lobectomy performed with videoscopic guidance and anatomic hilar vascular, bronchial, and lymphatic dissection using two or three ports and 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 cooperative cancer group study to compare the outcome of a VATS approach with a thoracotomy for early-stage lung cancer has been proposed to further define the potential patient benefit.
Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors. Employment or Leadership Position: None Consultant or Advisory Role: Scott J. Swanson, Ethicon (C); Todd L. Demmy, US Surgical (U); Robert J. McKenna Jr, Ethicon (C) Stock Ownership: Mark R. Green, Johnson & Johnson Honoraria: Thomas A. D'Amico, US Surgical; Todd L. Demmy, US Surgical; Robert J. McKenna Jr, Ethicon Research Funding: None Expert Testimony: None Other Remuneration: Todd L. Demmy, US Surgical
Conception and design: Scott J. Swanson, James E. Herndon II, Thomas A. D'Amico, Todd L. Demmy, Robert J. McKenna Jr, Mark R. Green, David J. Sugarbaker Administrative support: David J. Sugarbaker Provision of study materials or patients: Todd L. Demmy, Robert J. McKenna Jr Collection and assembly of data: James E. Herndon II Data analysis and interpretation: Scott J. Swanson, James E. Herndon II, Mark R. Green Manuscript writing: Scott J. Swanson, James E. Herndon II, Thomas A. D'Amico, Todd L. Demmy, Robert J. McKenna Jr, David J. Sugarbaker Final approval of manuscript: Scott J. Swanson, James E. Herndon II, Todd L. Demmy, Robert J. McKenna Jr, Mark R. Green, David J. Sugarbaker
We thank Francine R. Dembitzer, MD, for assistance with this article.
Supported by the National Cancer Institute Grants No. UO1 CA65170 and U10 CA59594. Presented at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando FL. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
