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Eur J Cardiothorac Surg 2001;20:339-343
© 2001 Elsevier Science NL

Is lung cancer surgery justified in patients with direct mediastinal invasion?

Department of Thoracic Surgery, Sainte-Marguerite Hospital, Marseille, France

Received 9 October 2000; received in revised form 31 March 2001; accepted 6 April 2001.

Corresponding author. Tel.: +33-491-744741; fax: +33-491-744590
e-mail: cdoddoli{at}mail.ap-hm.fr

	Abstract

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Objective: To assess the results of the surgical treatment of patients with stage IIIB non-small cell lung carcinoma (NSCLC) invading the mediastinum (T4). Methods: Twenty-nine patients were operated on from 1986 to 1999. Histology was squamous cell carcinoma in 17 patients, adenocarcinoma in eight, large cell carcinoma in two and neuroendocrinal carcinoma in two. Three patients received a preoperative chemotherapy (n=2) or radiochemotherapy (n=1). The lung resection consisted of a pneumonectomy in 25 patients and a lobectomy in four. The procedure was extended to one of the following structures: superior vena cava (SVC) (n=17), aorta (n=1), left atrium (n=5) and carina (n=6). Seventeen patients had a postoperative regimen including radiochemotherapy (n=12), radiotherapy (n=4), or chemotherapy (n=1). Results: Complete R0 resection was achieved in 25 patients, whereas four patients had a microscopically (n=1) or macroscopically (n=3) residual disease. The operative mortality rate was 7% (n=2). Non-fatal major complications occurred in eight patients (28%). Overall 5-year survival rate was 28% (median 11 months), including the operative mortality. The median survival of the 18 patients with an N0 or N1 disease was 16 months whereas the median survival of the 11 patients with an N2 disease was 9 months. At completion of the study, 22 patients have died, two postoperatively and 10 from pulmonary causes without evidence of cancer. Conclusions: Surgical management of T4 NSC lung cancer invading the mediastinum should be considered, in the absence of N2 disease, when a complete resection is achievable.

Key Words: Lung cancer • Extended resection • Postoperative mortality • Survival

	1. Introduction

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
The treatment of patients with a non-small lung cancer invading mediastinal organs remains a challenge. These patients are usually considered as having a non-resectable tumour and/or a non-curable disease. However, almost all patients with a stage IIIB disease, present disabling symptoms justifying any effective treatment directed toward palliating the manifestations of the disease. From a surgical point of view, some individuals may receive extended surgery, but with an increased operative risk when compared to that of standard procedures that may adversely counterbalance the potential gain in long-term survival. From an oncological point of view, profound mediastinal invasion reasonably supposes the presence of occult metastatic disease that justifies adjunctive therapeutic programmes. Indeed, the literature of the last decade reports the 5-year survival rate to be under 10% worldwide. However, a more favourable prognosis can be expected nowadays by the means of judicious selection of candidates for surgery, improvement of perioperative care, and use of effective anticancerous agents for combined modality therapies.

This context led us to review our experience with 29 consecutive patients who underwent extended resection for lung cancer invading mediastinal organs in order to assess the current risk/benefit ratio of the surgical management of such patients

	2. Materials and methods

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
2.1. Inclusion criteria
A chart review was done of all patients surgically treated for a non-small cell lung carcinoma (NSCLC) at our institution for the period January 1986 to June 1999. During the study period, our policy was to consider the opportunity of surgery in any T4 patient with direct mediastinal involvement by the tumour, provided that the N2 disease was absent at the CT-scan.

In all cases, detectable extra thoracic disease on brain and abdominal CT-scan and bone scanning had been required preoperatively. Mediastinoscopy was not routinely performed as part of the preoperative work-up. Five patients had equivocal CT-scan findings and underwent a mediastinoscopy to rule out an N2 disease.

Preoperative work-up also included routine biochemical profile, chest roentgenogram, bronchoscopy, pulmonary function tests with spirometry and arterial blood gas analysis at rest, as well as quantitative ventilation and perfusion scans in patients in whom predicted postoperative FEV1 could be estimated lower than 1 l.

Twenty-nine individuals were identified from about 2600 patients. All these patients required extended resections to various mediastinal organs. However, those with T4 tumours invading the intrapericardial portion of the pulmonary artery were not included because all the patients operated on with this condition during the study period were amenable to a standard intrapericardial pneumonectomy with division of the ligamentum arteriosum, but without the adjunct of a cardiopulmonary by-pass to secure the control of the origin of the left pulmonary artery. The median age was 59 years (±9), ranging from 36 to 73, and all patients were males. Three patients had received a preoperative treatment (chemotherapy in two patients, radiochemotherapy in one). All patients were staged according to the 1997 International TNM staging system.

2.2. Surgical procedure
The routine surgical approach was a posterolateral thoracotomy. The lung resection consisted of pneumonectomy in 25 patients and lobectomy in four.

Six patients underwent a right pneumonectomy with a carinal resection and end-to-end tracheobronchial anastomosis with interrupted 3/0 absorbable sutures (Ethicon, Somerville, NJ). Partial resection of the left atrium was performed in five patients, after dissection of the inter-atrial septum and mechanical stapling using a TA55B device (USCC, Norwalk, CT). One patient required a lateral resection of the aorta in the subadventitial layer by the means of cross-clamping and controlled systemic hypotension without femoro-femoral by-pass. Among the patients who had a superior vena cava (SVC) resection, four underwent a complete venous resection with graft replacement. In these cases, the procedure required fluid implementation, short venous cross-clamping time and anticoagulation therapy (100 UI/kg) in order to avoid any internal or cardiopulmonary by-pass. The venous reconstruction was achieved by interposition of a large polytetrafluoroethylene (PTFE) graft between the proximal and distal ends of the SVC (n=2), or between one brachiocephalic vein and the right atrium (n=2). In these two last cases, a median sternotomy associated in one case with a cervicotomy was performed to allow an optimal access and control to the innominate veins. The sizes of the ringed PTFE grafts used were no. 14 (first and second cases), and no. 12 (third and fourth cases). Thirteen patients underwent partial lateral resection of the SVC; 11 patients had a direct running suture, whereas the remaining patient underwent a prosthetic (PTFE) patch. The anticoagulation regimen in the patient with PTFE graft included a week-course of continuous heparin relayed for at least 6 months with oral administration of vitamin K antagonist to maintain the prothrombin time at 35–45% of the normal serum level. Subcutaneous thrombosis prophylaxis with low molecular weight heparin was given to the other patients until they were discharged from the hospital. All resections included an extensive mediastinal lymph node dissection.

2.3. Statistical analysis
Survival was calculated by the Kaplan–Meier method and hospital deaths were included in the survival figures. Comparisons were made using the log-rank test. Probability (P) values of 0.05 or less were considered statistically significant. The follow up was complete for all patients.

	3. Results

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
3.1. Postoperative pathologic features
Complete R0 resection was achieved in 25 patients (86%) whereas a macroscopic residual R2 disease was left in place in three. The remaining patient was proved to have a residual R1 disease, at the analysis of the operative specimen.

Pathology disclosed a squamous cell carcinoma in 17 patients, an adenocarcinoma in eight, an undifferentiated carcinoma in two and a neuroendocrinal carcinoma in two. The lymph node status was N0 in 11 patients (38%), N1 in seven (24%) and N2 in 11 (38%).

3.2. Postoperative course
There were two early postoperative deaths (7%). One was related to adult respiratory distress syndrome and one to a bronchopleural fistula. Non-fatal major complications occurred in eight patients (28%). Table 1 shows the characteristics of these patients. No early SVC thrombosis was observed in the patients who underwent SVC resection.

Seventeen patients received adjuvant treatment (radiochemotherapy in 12, radiotherapy in four and chemotherapy in one). At completion of the study, seven patients (24%) were still alive. The median survival was 11.3 months (ranging from 0 to 129 months). As shown in Fig. 1 , the overall 5-year survival rate was 28% (confidence interval 95%: 21–61%). Causes of mid- and long-term deaths are given in Table 2.

View larger version (30K): [in this window] [in a new window]   Fig. 1. The 5-year probability of survival of 29 patients who underwent an aggressive resection.

View larger version (14K): [in this window] [in a new window]   Fig. 2. Survival curves of patients with N0–N1 lymph node involvement or N2 involvement. The 5-year probabilities of survival were 29 and 27%, respectively. The difference was not significant (P=0.48).

	4. Discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

At the same time, meta-analyses of randomised studies confirmed the survival benefit afforded by cisplatin-based induction chemotherapy followed by radiotherapy and helped to establish this as the new standard of care for locally advanced, unresectable NSCLC [11]. Finally, some phase II trials reported long-term survival outcome comparing favourably with that of multimodality trials including surgery [12,13]. These apparently contradictory therapeutic options are still associated with high local and distant failure rates, indicating that both local and systemic therapies need to be improved.

One of the main issues to be addressed is how to select candidates appropriately for surgery in this subgroup of patients. Modern imaging technologies certainly provide sufficient ground, particularly when a close collaboration is established among surgeons and radiologists [14]. Our 86% R0 resection rate as well as those reported by Takahashi et al. [9] (71%) or Spaggiari et al. [10] (80%) contrast with those around 20% reported in series including patients treated in the pre CT-scan era [15]. In our series, 38% of the patients were proved to have a pN2 disease. This fact clearly reflects the non-routine use of mediastinoscopy in the selection process. The potential of thoracoscopy is unclear. De Giacomo et al. demonstrate its diagnostic value [16]. To date, however, videothoracoscopic evaluation of tumour resectability has not been achievable [17]. Finally, one may suppose that positron emission tomography will probably reduce the role of those invasive surgical endoscopies in the near future.

The second matter of concern to be debated is the place and possible consequences of induction regimen in these particular patients. The value of preoperative radiochemotherapy is controversial. Most phase II studies showed modest efficacy and substantial toxicity leading to an increased operative risk [18–20]. Induction chemotherapy has been suggested to be effective for downstaging centrally located T4 non-small cell (NSC) lung cancer, with promising survival, especially in patients whose disease becomes resectable [21]. However, such encouraging results may be the results of an improved selection of ‘winners’ as well [22].

To minimise the operative risk is a constant concern of the surgeon. In our series, both operative mortality and morbidity rates ranged within reasonably estimated rates of surgical complication in the treatment of lung cancer [23]. It is of interest that 50% of the postoperative mortality and 80% of the morbidity in our experience were directly related to the surgical procedure. Compared with standard surgery, extended resections almost always lead to a higher percentage of patients requiring pneumonectomy and greater numbers of technical problems. The risks of postoperative complications and death can also be expected to be higher [1–10]. Our experience clearly illustrates this assertion since postoperative complications were observed after pneumonectomy only, a procedure performed in 86% of our patients.

Only three of our patients received induction therapy. Indeed, our policy regarding T4N0 cancer patients was to perform surgery on first intention, whenever a complete resection was thought to be technically possible. In our opinion, any attempt to downstage the disease in these particular patients introduced a new dilemma for the surgeon concerning the type of resection to be performed: the one that was required initially to remove all the disease, or the one dictated by the residual disease? As far as early morbidity is concerned, one may suppose that a non-dramatic difference could be anticipated following extended pneumonectomy performed on first intent, when compared with lobectomies associated with reconstruction of hilar-mediastinal structures performed after the induction therapy. Furthermore, to resect the residual disease leads to the consideration of surgery as an adjuvant modality treatment to oncological regimen, which is not the least of the paradoxes.

The relatively good 5-year survival rate (28%) that we observed reflect judicious patient selection, as it can be reported worldwide [1–10]. Logically, the median survival time of patients with N2 was two times lower than that of N0–N1 patients, even if the difference did not reach the statistical significance level because of the size of the subgroups. The place of adjuvant treatments following complete resection remains unclear. We have used adjuvant therapy in all patients with N2 disease and/or incomplete resection, whereas only four patients among seven with N1 disease had adjuvant radiotherapy. A surprising result of the present study was the fact that half of the late deaths were not disease-related, but due to respiratory failure and possibly in relation with this adjuvant therapy. Indeed, a detrimental effect of adjuvant radiotherapy has been demonstrated in the meta-analysis published in 1998 by the Port Meta-analysis Trialists Group [24].

Another matter of concern was the relatively high incidence of thromboembolic complications in the long-term outcome. None of our patients who underwent a lateral SVC resection received vitamin K antagonist in the long run. However, two of them died with an SVC syndrome and fatal pulmonary embolism, without evidence of disease recurrence. At the same time, a graft occlusion was observed in two of the four patients, due to a non-effective anticoagulation treatment. Obviously, this can be improved.

	5. Conclusions

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Surgical management of T4 NSC lung cancer invading the mediastinum remains anecdotal. However, surgery should be considered whenever a complete resection is thought to be technically possible, provided that the N2 disease is absent. The use of positron emission tomography in the pretherapeutic work-up, on the one hand, and the results of comparative studies including a radiochemotherapy arm, on the other hand, will probably better define the place of surgery for the treatment of those challenging patients in the near future.

	Footnotes

 
Presented at the 14th Annual Meeting of the European Association for Cardio-thoracic Surgery, Frankfurt, Germany, October 7–11, 2000.

	Appendix A. Conference discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Dr W. Klepetko (Vienna, Austria): First of all, we found that even with very modern imaging techniques, sometimes it's quite difficult to decide whether there is invasion or not of the mediastinum, so we went into investigations, like VATS procedures, before really defining the patient as a T3 invading the mediastinum. My question would be, do you do that? Do you have that in your protocol?

The second question is, what is your attitude towards preoperative mediastinoscopy? Do you apply that or not? A positive N2 lesion in these patients would give you a quite different situation, especially with regard to induction chemotherapy.

Third, what I would like to add is that since induction chemotherapy has shown us quite improved results and quite nice operative situations, at least in our department, we consider that it is crucial and important to be applied as a routine procedure in these patients.

Dr Thomas: For the first question, we are now experienced with 3D imaging and most of the indications are based upon this examination and with the very close collaboration that we have established with the radiologists.

Regarding our policy concerning mediastinoscopy, in this series only five patients had a preoperative mediastinoscopy because the indication in our department is the presence of enlarged lymph nodes on the CT-scan. In this series we considered only patients who had clinical T4-N0 disease after CT-scan examination.

Finally, in patients with suspected T4-N2 disease, these patients received preoperative mediastinoscopy and induction therapy, but in this particular subset of patients, in our experience, the postoperative morbidity is very high, and we will show a poster on it this afternoon.

Dr W. Hasse (Freiburg, Germany): I would like to add a plea for preoperative radiotherapy. I do not believe that irradiation really increases the risk, but it rather facilitates, in my opinion, to find a plane of dissection, in particular at the great vessels of the aortic arch. Thereby, we might also avoid spilling of cells in contrast to not having this pre-treatment.

Another short remark refers to the anticoagulation in SVC replacement or repair: for how long are you doing it? Just to add, in our experience, it is not necessary to apply permanent anticoagulation even after implantation of a prosthesis.

Dr Thomas: Concerning the anticoagulation therapy, I think in our experience, the fact that two patients died with graft thrombosis is of concern and our tendency is to propose thromboprophylaxis in all patients for their whole life.

Concerning preoperative radiotherapy, we completely agree with you concerning the technical ease of dissection that it gets. However, we are against postoperative radiotherapy, which is detrimental for the patients in our experience in terms of postoperative complications.

	References

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Pascal Thomas Roger Giudicelli Pierre Fuentes Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Doddoli, C. Articles by Fuentes, P. Search for Related Content PubMed PubMed Citation Articles by Doddoli, C. Articles by Fuentes, P. Related Collections Lung - cancer