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Ann Thorac Surg 1995;60:1382-1389
© 1995 The Society of Thoracic Surgeons
McMaster University, Hamilton; The University of Toronto, Toronto; Laval University, Sainte-Foy; the University of Western Ontario, London; the University of Ottawa, Ottawa; and Hotel Dieu, Windsor Western Hospital Centre, Windsor, Canada
Accepted for publication June 24, 1995.
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Abstract |
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 TopFootnotes Abstract IntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Methods. We conducted a randomized, controlled trial in thoracic surgery services at mainly academic tertiary and secondary care general hospitals. We recruited 685 patients with apparently operable, suspected or proven, non–small cell carcinoma of the lung who underwent either mediastinoscopy or computed tomography. Depending on the apparent presence or absence of mediastinal nodes of greater than 1 cm, patients undergoing computed tomography either underwent mediastinoscopy or went directly to thoracotomy. The primary outcome was thoracotomy without cure, defined as resection with recurrence. Secondary outcomes included thoracotomies undertaken in patients with benign disease and costs of the two strategies.
Results. The relative risk of thoracotomy without cure in patients in the computed tomography group was 0.95 (95% confidence interval, 0.75 to 1.19). The relative risk of thoracotomy without cure or thoracotomy in patients with benign disease was 0.88 (95% confidence interval, 0.71 to 1.10). The mediastinoscopy strategy cost $708 more per patient (95% confidence interval, -$723 to $2,140).
Conclusions. The computed tomography strategy is likely to produce the same number of or fewer unnecessary thoracotomies in comparison with doing mediastinoscopy on all patients, and is also likely to be as or less expensive.
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Introduction |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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A metaanalysis of 42 studies examining the accuracy of CT in detecting mediastinal nodes found a sensitivity of 0.79 and specificity of 0.78 [1], and subsequent investigations have produced consistent findings [2–4]. These results suggest that some patients with negative CT findings (no nodes greater than 1 cm) who proceed to thoracotomy may in fact have N2 disease that could have been detected by mediastinoscopy, thus avoiding an inappropriate thoracotomy. However, mediastinoscopy itself may be inaccurate. Because CT scanning may detect occult metastatic disease outside the mediastinum, and information from CT may help guide the mediastinoscopist, the diagnostic strategy of using CT to decide on the necessity for mediastinoscopy is widespread [5]. This latter approach deems that N2 disease not apparent on CT scan is resectable with up to 30% five-year survival.
Because of the continuing controversy and varying clinical practice [6], we decided to conduct an investigation to try to resolve this issue. The ultimate test of the two diagnostic strategies is their ability to prevent thoracotomy without cure: that is, thoracotomies in which resection is incomplete and thoracotomies that are followed by recurrence. The strongest study design to compare the relative success of the two strategies in preventing thoracotomy without cure is a randomized trial. Given the increasing importance of cost-effectiveness considerations in health care delivery, we also examined the costs of the alternate strategies as part of our randomized trial.
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Material and Methods |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Study Design
After obtaining informed consent and confirming eligibility, we stratified patients according to clinical center and whether their lesions were central (no air between mediastinum and lesion) or noncentral tumours. Within each stratum we randomly allocated patients to be investigated according to mediastinoscopy alone or CT approaches in blocks of 4 such that of every 4 patients, 2 were randomized to CT and 2 to mediastinoscopy. Patients were randomized by the methods center when clinical centers called to report an eligible patient from whom consent had been obtained.
Figure 1
summarizes the study design. In the mediastinoscopy arm, we considered those in whom the test was ``positive'' (metastatic nodes found) to have ``unresectable'' disease unless the nodes were single station ipsilateral and intracapsular, when, at the discretion of the surgeon, patients were offered a primary operation. If patients who underwent thoracotomy had recurrence, they were classified as having thoracotomy without cure; if they did not have recurrence, they were classified as having been cured by thoracotomy. In the CT arm, patients with a ``negative'' scan proceeded to a primary operation. Those with a ``positive'' scan, indicating mediastinal lymphadenopathy, underwent mediastinoscopy.
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COMPUTED TOMOGRAPHY.
All centers used third- and fourth-generation scanners with rapid scan times and good resolution at narrow cut widths. Radiologists measured all N2 nodes in the shortest transverse axis and commented on whether there were any such nodes greater than 1 cm in size accessible to mediastinoscopy. In patients who went on to mediastinoscopy, the protocol called for surgeons to perform biopsy of all enlarged nodes, as well as those specified for routine sampling. We have previously reported on the reproducibility of our radiologists' assessment of nodal size [10].
Ascertainment of Outcome
We reviewed patients in follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year after randomization and then every 6 months for a total of 3 years. At each follow-up we documented whether patients were free of tumor, whether recurrence was suspected, or whether there was definite evidence of recurrence. At the 3-year follow-up we conducted a search for metastatic disease, which included a history, physical examination, chest radiograph, and measurement of alkaline phosphatase and serum calcium levels.
An adjudication committee reviewed all clinical data collected at each follow-up including clinical notes, reports of investigations, and, where available, autopsy reports. An internist from the methods center, two thoracic surgeons, and the study statistician reviewed each file. We resolved disagreements by consensus. The committee also classified the cause of death in each patient who died.
Our primary end point, chosen before the study began, was thoracotomy without cure. We defined thoracotomy without cure as including patients who were found to have unresectable disease at the time of thoracotomy, who underwent incomplete resections, or in whom recurrent disease developed. If a surgeon designated a patient as having unresectable disease at the time of thoracotomy but the patient was disease-free at 3 years, the designation was changed to complete resection at the time of thoracotomy. Reasoning that patients with benign disease would be better off without a thoracotomy, as a secondary end point we included all patients who had thoracotomy without cure and all patients with benign disease who had thoracotomy, and classified such patients as having had an ``unnecessary thoracotomy.''
Economic Analysis
Adopting a similar analytic framework as an earlier cost-effectiveness model of CT scanning compared with mediastinoscopy in the preoperative staging of lung cancer [11], we determined the cost per patient by prospective collection of data on the type and quantity of services used by each patient. These resource items were then multiplied by the unit price of each service and summed across all services. We documented duration of stay in the hospital, both before and after surgical procedures, and time in thoracic surgical wards, intensive care units, and step-down units. We documented all major procedures. We adopted a restricted viewpoint for economic analysis of hospital costs within 3 months after randomization, anticipating that this period and perspective would be responsible for all major cost differences between the two approaches. We determined the unit price of each service using a model of full allocation of costs conducted for one of the participating hospitals. These costs are in Canadian dollars, and we provide an indication of the magnitude of Canadian costs by showing our cost estimates for the following: a day on a surgical ward, $370; a day in the intensive care unit $1,653; professional fee for CT scan, $62; total cost of CT, $200; surgical professional fee for a mediastinoscopy, $172; total cost of a mediastinoscopy, $930.
Data Analysis
We calculated the relative risks of thoracotomy without cure and mortality and confidence intervals around the relative risks. We conducted both univariable analyses and analyses adjusted for center, location of lesion, patient age, sex, histologic diagnosis, presence of symptoms, and Karnofsky performance status. In addition, we examined the number of thoracotomies in patients with benign disease and calculated the relative risk of thoracotomy in such patients. Finally, we calculated the relative risk of either thoracotomy without cure or thoracotomy in patients with benign disease.
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Results |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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. Because patients often had more than one reason for being ineligible, the number in Table 1 is greater than the number of ineligible patients. Of the remaining 789 patients, 104 were eligible but not recruited, usually due to administrative oversight. We randomized the remaining 685 patients, 343 to CT and 342 to mediastinoscopy. The two groups were similar on all key variables (Table 2). We achieved complete follow-up to 3 years or death in all but 2 patients. We lost 1 patient randomized to the CT group to follow-up at 9 months, and that patient is not included in the outcome data. A second patient was disease-free when lost to follow-up at 2 years; we assumed that patient remained disease-free, and included him in the analysis.
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According to protocol, surgeons conducting mediastinoscopy were to sample four ipsilateral nodal stations and one contralateral nodal station. Of the 315 mediastinoscopies, the surgeons sampled no nodal stations in 11, 1 station in 18, 2 stations in 37, 3 stations in 61, and 4 or more stations in 188. Of the 11 instances in which no nodes were sampled, the reasons were that the left main pulmonary artery was involved with tumor and any resection was judged hazardous in 1 patient; a large atheromatous plaque in the innominate artery made biopsy dangerous in 1 patient; there was gross tumor involvement, which made the surgeon judge biopsy unnecessary in 1 patient; and there was no adequate reason in 8 patients. One reason for only a limited number of nodes being sampled would be if one of the first sampled nodes were positive. In patients whose mediastinoscopy was ultimately negative 10 had no nodes sampled, 13 had one node sampled, 32 had two nodes sampled, 50 had three nodes sampled, and 149 had four or more nodes sampled.
Among the 315 patients who underwent mediastinoscopy, 11 complications occurred in 9 patients, including pneumothorax in 3, recurrent laryngeal nerve damage in 1, hemorrhage in 4, and arrhythmia in 3. Of the 315 mediastinoscopies in the mediastinoscopy group, 61 (19%) were positive. Of the 342 patients randomized to mediastinoscopy, 14 ultimately had a CT scan of the thorax as part of their initial investigation.
OUTCOME OF PATIENTS IN THE COMPUTED TOMOGRAPHY GROUP.
Of the 343 patients randomized to CT, 338 actually were scanned. For those who did not receive a CT scan, the reasons were as follows: 2 patients proved to have benign disease; through protocol violations 2 patients went straight to mediastinoscopy (1 of whom eventually had thoracotomy and was disease-free at 3 years and 1 who did not have thoracotomy); and 1 patient refused investigation (and never had thoracotomy). Of the 338 patients who had a CT scan, 159 were CT positive, and of these, 23 did not have a mediastinoscopy. The reasons were as follows: in 12, investigation revealed metastatic disease precluding resection; 4 had small cell tumor; in 4 patients, the surgeon disagreed with the radiologist's interpretation of the CT scan and went straight to thoracotomy; 2 proved to have benign lesions; and 1 patient had medical contraindications to operation.
Of the 179 patients who were CT negative, mediastinoscopy was undertaken in 17, and the reasons were as follows: the surgeons were suspicious that the histology might be small cell in 5; the surgeons were suspicious that the lesions might be benign in 2; 2 patients were at high operative risk and surgeons therefore thought all efforts should be made to exclude metastatic disease; and the surgeon disagreed with the radiologists' interpretation and thought the findings on CT scan warranted mediastinoscopy in 8.
Thus, in comparison with the 315 patients in the mediastinoscopy group who underwent mediastinoscopy, 155 in the CT group underwent mediastinoscopy. Among the 155 patients who underwent mediastinoscopy, 7 complications occurred, including recurrent laryngeal nerve damage in 1, hemorrhage in 4, tracheal injury in 1, and postoperative infection in 1. Of the 155 mediastinoscopies in the CT group, 66 (43%) were positive. Among a total of 470 mediastinoscopies there were no postoperative deaths and 18 complications.
ACCURACY OF COMPUTED TOMOGRAPHY.
One conventional way of examining the results of CT scanning of the mediastinum is to examine the accuracy of CT in terms of the results in patients who undergo a CT scan and then have either a mediastinoscopy or go to thoracotomy. Of the 103 patients in the CT group who had a positive mediastinoscopy or N2 disease at thoracotomy, 80 (78%) had a positive CT scan. Of the 195 patients who had a negative mediastinoscopy or were free of N2 disease at thoracotomy, 134 (69%) had a negative CT. These estimates of sensitivity and specificity are in keeping with prior estimates of the test properties.
PRIMARY COMPARISONS OF COMPUTED TOMOGRAPHY AND MEDIASTINOSCOPY STRATEGIES.
Table 3 summarizes the patients in both groups who did not have non–small cell carcinoma of the lung.
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Of 342 patients in the mediastinoscopy group, 248 went to thoracotomy. Of these, 107 (31%) had no N2 nodes sampled at thoracotomy. Of the 141 patients who had N2 nodes sampled at thoracotomy, 33 (10% of all patients in the mediastinoscopy group and 23% of those who had nodes sampled) had N2 disease at thoracotomy. In 8 of these patients, the only positive nodes were subcarinal nodes.
Of the patients in whom N2 disease was found at thoracotomy, 15 in the CT group and 16 in the mediastinoscopy group had incomplete resection and ultimate recurrence, 12 in the CT group and 8 in the mediastinoscopy group had complete resection and recurrence, and 16 in the CT group and 14 in the mediastinoscopy group had complete resection and no recurrence. Thus, 27 of 343 patients in the CT group and 24 of 342 in the mediastinoscopy group had N2 disease found at thoracotomy and associated with a poor outcome.
We present the number of deaths and thoracotomies, and the primary outcome, thoracotomy without cure, in Table 4. In the table and in the text, we present the all relative risks in the CT group relative to the mediastinoscopy group. Thus, relative risks greater than 1 suggest an increased risk in the CT group, whereas relative risks less than 1 suggest a decreased risk in the CT group. The adjusted and unadjusted estimates were very similar, and we therefore present only the unadjusted relative risks. The relative risk of death from any cause associated with being in the CT group was 1.05 (p = 0.27; 95% confidence interval, 0.91 to 1.22), and the relative risk of death from lung cancer was 1.05 (p = 0.30; 95% confidence interval, 0.89 to 1.25). The relative risk for thoracotomy without cure associated with being in the CT group was 0.95 (p = 0.34; 95% confidence interval, 0.75 to 1.19). The relative risk of having a thoracotomy among patients who ultimately proved to have benign disease was 0.42 (p = 0.05; 95% confidence interval, 0.12 to 1.13). The relative risk of ``unnecessary'' thoracotomies (thoracotomies without cure and thoracotomies in those who proved to have benign disease) was 0.88 (p = 0.15; 95% confidence interval, 0.71 to 1.1).
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. Of the 4 patients in the mediastinoscopy group who did not have thoracotomy because of extrathoracic metastases, 1 had metastases detected by scalene node biopsy and 1 by supraclavicular node biopsy, 1 had liver metastases, and 1 had brain metastases. Our protocol did not include determination of the reason for extra tests being done, and the deductions we can make in this regard are limited. For example, we do not know the reason that, in the patient in whom liver metastases were found, the ultrasound that detected the liver metastases was ordered.
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COMPARISON OF COSTS.
We summarize the costs comparison in Table 6. Professional fees were higher for the mediastinoscopy group (p < 0.05), but the trend toward higher overall costs in the mediastinoscopy group did not reach conventional levels of statistical significance.
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Comment |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Although we were interested in patients with non–small cell carcinoma of the lung, approximately 10% of those enrolled either had small cell carcinoma or did not have cancer at all. In a study that was designed to reflect standard clinical practice, this was inevitable. Patients often present to thoracic surgeons with radiographic lesions but without a histologic diagnosis, and surgeons choose their diagnostic approach before obtaining the histology. We randomized patients at the point of presentation, the juncture at which surgeons choose their approach to investigation. It is possible that the approach to diagnosis might influence the fate of the patients who did not have non–small cell lung cancer; indeed, the data suggest that patients without cancer may have less risk of thoracotomy if randomized to the CT approach.
Our estimates of cost may be sensitive to a number of assumptions. Mediastinoscopy may be less costly if routinely conducted as an outpatient procedure [12] or at the time of thoracotomy, whereas Canadian costs of a variety of procedures are likely to be lower than American costs. None of these differences are, however, likely to make a major difference in the direction or magnitude of difference in costs in the two groups.
This study showed that the relative risk of thoracotomy without cure in patients in the CT group was 95% of that in the mediastinoscopy group; that is, patients in the CT group were 5% less likely to experience thoracotomy without cure (a reduction in relative risk of 5%) (see Table 4
). Despite this trend in favor of CT, the result does not exclude a clinically important reduction in thoracotomies without cure if all patients were to undergo the mediastinoscopy approach (the extreme confidence limit favoring mediastinoscopy represents an increase in risk with the CT approach of 19%). If one considers needless thoracotomies (thoracotomies without cure and thoracotomies in patients who proved to have benign disease), the trend in favor of CT is stronger, with a relative risk of 88%, corresponding to a reduction in risk of 12%. This difference still fails to reach conventional levels of statistical significance, and the results are compatible with an increase in risk with CT of 10%. The level of uncertainty is emphasized by consideration of overall mortality and mortality due to lung cancer, both of which showed a nonsignificant trend toward a greater number of deaths in the CT arm.
A conservative interpretation of the results is that an important difference in thoracotomies without cure or costs between the two approaches is unlikely. However, because of the trend in favor of CT in thoracotomies without cure, and the parallel trend in the economic analysis (see Table 6), we suggest that clinicians should adopt the CT approach as the standard strategy for investigation of patients with non–small cell carcinoma of the lung.
Aside from the strategies we have investigated, one alternative approach to management of these patients would be to go straight to thoracotomy in all patients with a negative chest radiograph. The large number of positive N2 nodes we found in both groups excludes this approach. Another alternative would be to do both CT and mediastinoscopy on all patients. This approach would be more expensive than either one we have investigated. If the optimal approach were to do both procedures, one might expect to detect a higher number of positive N2 nodes with mediastinoscopy, and to detect additional patients with contraindications to primary operation with the CT scan.
Theoretically, one could examine this issue in two ways. First, one could examine the number of positive N2 nodes found at thoracotomy. There were 5 more patients who had positive N2 nodes at thoracotomy (43/343) in the CT group than in the mediastinoscopy group (38/342). Although one possible explanation for this difference is the efficacy of mediastinoscopy in detecting nodes before thoracotomy, this difference may also be easily explained by chance, or by the fact that 9% more of the patients in the CT group than in the mediastinoscopy group had mediastinal nodes sampled at thoracotomy.
Second, one could examine the number of patients in the two groups in whom mediastinoscopic findings had precluded resection (expecting to find a larger number in the mediastinoscopy group), and see if this is balanced by additional patients in the CT group who had been spared fruitless resection as a result of CT discovery of intrapulmonary or extrapulmonary tumor spread. Table 5, however, shows that the number of patients in the CT group in whom positive mediastinoscopy was the reason for not having a thoracotomy was actually greater than in the mediastinoscopy group. The results of the current study, therefore, provide limited support for a policy of both CT and mediastinoscopy in all patients.
Some surgeons would currently treat patients with preoperatively identified positive N2 nodes with neoadjuvant strategies involving chemotherapy or chemoradiation. Our study does not directly address the impact of CT or mediastinoscopy strategies in implementing such a management approach. However, it is likely that our finding of no benefit for universal mediastinoscopy without CT would also apply to this alternative management strategy.
In summary, we have demonstrated that diagnostic approaches to patients with non–small cell carcinoma without obvious mediastinal involvement on chest radiograph lead to similar rates of thoracotomy without cure and similar costs, with trends in both thoracotomy without cure and costs in favor of the CT approach, but a trend toward increased numbers of deaths. Although these results are not definitive, they support use of the CT approach for the investigation of intrathoracic tumor spread. At the same time, they justify the use of the mediastinoscopy approach in settings, such as less industrialized countries, where CT may be unavailable. This is particularly so because we identified only 4 patients in whom CT clearly was the only investigation that led to a patient with disseminated disease avoiding thoracotomy.
For patients in more industrialized countries, on the basis of current evidence, patients with apparently operable lung cancer should all have CT scan of the chest, and those with nodes greater than 1 cm should undergo mediastinoscopy, whereas the remainder can proceed directly to thoracotomy. There is limited evidence that a combined approach, CT scan plus mediastinoscopy in all patients, might further diminish the number of ``unnecessary'' thoracotomies, although total costs might increase.
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Appendix 1. Members of the Canadian Lung Oncology Group Who Participated in This Study, and Their Roles |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Study Coordination: Gordon H. Guyatt, MD, Deborah J. Cook, MD, Michael S. Lefcoe, MD, Timothy L. Winton, MD, Jean Deslauriers, MD, Richard I. Inculet, MD, Farid M. Shamji, MD, Michael Coughlin, MD, and Susan M. Troyan, BA.
Writing: Gordon H. Guyatt, MD, Deborah J. Cook, MD, Stephen Walter, PhD, Robert J. Ginsberg, MD, Bernie J. O'Brien, PhD, Thomas R. J. Todd, MD, and Richard J. Eddy, MD.
Economic Analysis: Ron A. Goeree, MA, and Bernie J. O'Brien, PhD.
Adjudication: W. Fred Bennett, MD, Stephen Walter, PhD, Jemi Olak, MD, Deborah J. Cook, MD, Gordon H. Guyatt, MD, Farid M. Shamji, MD, Gail E. Darling, MD, and Susan M. Troyan, BA.
Methods Center: Deborah J. Cook, MD, Gordon H. Guyatt, MD, Stephen Walter, PhD, Susan M. Troyan, BA, Lauren E. Griffith, MS, Deborah L. Maddock, Suzanne J. Duchesne, Barbara Jedrzejowski, and Sandi M. Harper.
Radiology Coordination: Michael S. Lefcoe.
Clinical Centers: Hamilton: Geoffrey Evans, MD, W. Fred Bennett, MD, Carl J. Zylak, MD, and Susan M. Troyan, BA.
Toronto: Timothy J. Winton, MD, Robert J. Ginsberg, MD, Melvyn Goldberg, MD, G. Alexander Patterson, MD, F. Griffith Pearson, MD, Donald P. Jones, MD, Robert A. Zeldin, MD, Gary L. Stoik, MD, Hensley A. B. Miller, MD, Glen A. Taylor, MD, Martin F. McKneally, MD, PhD, Stephen J. Herman, MD, Gordon L. Weisbrod, MD, Marvin Steinhardt, MD, Robert Bruce, MD, Susan M. Rosgen, BScN, Jane Flett, RN, Leslie Steward-Pichette, BScN, Anne Fedyk, RN, and Kathie Roche, BScN.
Quebec City: Jean Deslauriers, MD, Michel Piraux, MD, Guy Carrier, MD, Sylvie Ferland, MD, Brigitte Fournier, BScN, Carolle St. Pierre, BScN, and Pierre Bedard, BScN.
London: Richard I. Inculet, MD, Richard J. Finley, MD, Michael S. Lefcoe, MD, and Natalie Zankowicz, BScN.
Ottawa: Farid M. Shamji, MD, Harold J. Sachs, MD, Thomas R. J. Todd, MD, Rebecca Peterson, MD, Nancy M. Hickey, MD, and Diane C. Lister, RNA.
Windsor: Michael Coughlin, MD, Craig R. Pearce, MD, Dermot R. Feore, MD, Peter Tadros, MD, and Judy Imeson, BScN.
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Acknowledgments |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Doctors Guyatt and Cook are Career Scientists of the Ontario Ministry of Health. This study was supported by the Ontario Ministry of Health. Doctor Walter holds a National Health Scientist award from Health Canada.
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Footnotes |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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Address reprint requests to Dr Guyatt, Department of Clinical Epidemiology and Biostatistics, McMaster University Health Sciences Center, Rm 2C12, 1200 Main St W, Hamilton, ON, Canada L8N 3Z5.
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAppendix 1. Members of...AcknowledgmentsReferences |
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