Surgery in early NSCLC and co-morbidity
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《胸》
1 Section of General Surgery, Department of Surgical, Anaesthesiological and Radiological Sciences, University of Ferrara, Ferrara, Italy
Correspondence to:
Dr D Sortini
Sezione di Chirurgia Generale, Dipartimento di Scienze Chirurgiche, Anestesiologiche e Radiologiche, Università di Ferrara, 44100 Ferrara, Italy; sors@libero.it
Keywords: non-small cell lung cancer; surgery
We would like to congratulate Janssen-Heijnen et al1 on their well performed study and on their significant contribution to resolving the problem of treatment in patients with non-small cell lung cancer (NSCLC) and co-morbidity. However, we could not find a description of the surgical approach used and would like to ask the authors to provide details of the surgical procedures adopted and the accompanying survival rates. We think,2 in agreement with other authors3 that, for patients with early stage NSCLC and co-morbidity, a less invasive surgical approach should be used. This view is supported by studies in elderly patients or in patients with co-morbidity showing that a less invasive approach does not influence survival rates. Only the recurrence rate seems to be increased by a less invasive surgical approach such as segmentectomy or pulmonary wedge resection.3–5
Several factors determine whether conservative or invasive resection should be used for NSCLC. We think that a less invasive approach should be chosen as the first therapeutic step, even for early stage NSCLC, and that elderly patients should be treated less aggressively than younger patients.
Figure 1 Surgical approach for surgically resected localised NSCLC according to age and co-morbidity.
References
Janssen-Heijnen MLG, Smulders S, Lemmens VEPP, et al. Effect of comorbidity on the treatment and prognosis of elderly patients with non-small cell lung cancer. Thorax 2004;59:602–7.
Sortini D, Feo C, Carcoforo P, et al. Thoracoscopic localization techniques for patients with solitary pulmonary nodule and history of malignancy. Ann Thorac Surg 2005;79:258–62.
Sugarbaker DJ. Lung cancer. 6: The case for limited surgical resection in non-small cell lung cancer, Thorax 2003;58:639–41.
Kodama K, Doi O, Higashiyama M, et al. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg 1997;114:347–53.
Landreneau RJ, Sugarbaker DJ, Mack MJ, et al. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg 1997;113:691–8.
Authors’ reply
M L G Janssen-Heijnen2, H J A A van Geffen2, V E P P Lemmens2, F W J M Smeenk2, S A Smulders2 and J W W Coebergh2
2 Eindhoven Cancer Registry, The Netherlands
Correspondence to:
Dr M L G Janssen-Heijnen
P O Box 231, 5600 AE Eindhoven, The Netherlands; research@ikz.nl
We agree with Sortini and colleagues that the type of surgical procedure may influence survival. Several studies have shown that less invasive resections might be a good alternative for the elderly and those with co-morbidity because postoperative mortality and complications are rather high in these patients.1–5 We did not present survival rates for the different surgical approaches because the numbers of patients in the subgroups were rather small, especially for the less invasive resections like sleeve resection, segmentectomy, and wedge resection. However, at the request of Sortini and colleagues, we here present the results for the different surgical approaches.
Figure 1 shows the proportional distribution of surgical approaches in resected patients with stage I and II NSCLC according to age and number of co-morbid conditions. Elderly patients received a pneumonectomy less often, while the proportion of lobectomies and less invasive resections increased with age. In age groups <60 years and 70–79 years patients with co-morbidity received pneumonectomy less often and a lobectomy/less invasive resections more often than those without co-morbidity. In patients older than 80 years the number of patients was too small to draw any conclusions.
In the multivariate survival analysis of resected stage I and II NSCLC patients, those treated with bilobectomy (HR = 0.70, p = 0.08) or lobectomy (HR = 0.70, p = 0.003) had a significantly better survival than those treated with pneumonectomy, adjusted for age, sex, tumour size, histological subtype, and co-morbidity. Survival in patients treated with less invasive resections was not significantly different. The absence of a difference might be explained by the small number of patients in this subgroup (n = 47).
We want to emphasise that this is an observational population based study and not a randomised controlled trial. Among the elderly, probably only the fittest patients were selected for surgery. Although we adjusted for the above mentioned patient related and tumour related factors in the multivariate survival analysis, other selection factors for surgery such as performance status, ASA score, forced expiratory volume in 1 second, and patient’s choice might have confounded the results.
Since the recurrence rate has been shown to be higher in patients who underwent less invasive surgery (such as wedge resection), lobectomy or pneumonectomy remain the surgical approaches of first choice in patients who are fit enough to undergo invasive surgery.4 Since it is still not clear what assessment is necessary in order to assess whether an older patient is fit enough for invasive surgery, future studies should focus on this topic.
References
Recruitment of ethnic minorities to asthma studies
J C van der Wouden1
1 Department of General Practice, Erasmus MC University Medical Center Rotterdam, P O Box 1738, 3000 DR Rotterdam, The Netherlands; j.vanderwouden@erasmusmc.nl
Keywords: asthma; ethnicity
The research letter by Sheikh and co-authors1 addresses an important area but, regrettably, does not hit the nail on the head. Information on ethnicity of study participants is often missing in asthma studies, as the authors clearly show. However, presenting this information—for example, in the table of baseline characteristics when reporting a clinical trial—is only a first step. Much more important is the inclusion of this characteristic in the analysis of effect modification or subgroup analysis. Only then will we know whether ethnicity really matters when applying a certain intervention.
I would welcome a further report from the authors giving details about the actual incorporation of ethnicity in data analysis.
Reference
Sheikh A, Panesar SS, Lasserson T, et al. Recruitment of ethnic minorities to asthma studies. Thorax 2004;59:634.[Free Full Text]
Authors’ reply
G Netuveli2, S S Panesar2, T Lasserson3 and A Sheikh4
2 Division of Primary Care and Population Health Sciences, Imperial College, London, UK
3 Cochrane Airways Group, St George’s Hospital Medical School, London, UK
4 Department of Primary Care Research and Development, Division of Community Health Sciences: GP Section, University of Edinburgh, UK
Correspondence to:
Professor A Sheikh
Department of Primary Care Research and Development, Division of Community Health Sciences: GP Section, University of Edinburgh, UK; aziz.sheikh@ed.ac.uk
We are grateful to Dr van der Wouden for raising the important point of ensuring that ethnicity data are used when analysing trial results. Of the 23/70 studies (32.8%) reporting information on ethnicity in the trial report, all confined mention of ethnicity only to baseline characteristics of included participants. Thus, none of these 23 studies factored ethnicity into the analysis of results. A possible explanation for this rather disappointing observation is that the number of subjects recruited from minority ethnic groups tended to be small, thereby precluding any meaningful ethnic-specific subgroup analysis. Unfortunately, this is a problem not solely confined to asthma studies; for example, less than 30% of clinical trials on epilepsy which reported ethnicity used the information in the analysis.1
In designing clinical trials, pragmatic and cost considerations often force investigators to focus on the main objectives of the study, forcing considerations concerning subgroup analyses onto the back burner during trial planning. Most clinical trials therefore lack sufficient power for subgroup analyses;2 however, this appears to be a problem that is particularly common in relation to subgroup analysis by ethnicity.3
Our motivation for undertaking this study was to highlight the disparity in recruitment between ethnic minorities and the majority into trials in a disease where ethnic considerations may be relevant. Asthma is one such area, but there are also others.4 van der Wouden is entirely correct in asserting that improving recruitment of minority ethnic groups is only half the battle; at least equally important—if not more so—is ensuring that information on ethnicity is meaningfully and competently used when analysing data and presenting results.5 Both issues should now be prioritised by the respiratory research community.(D Sortini1, E Pozza1, K M)
Correspondence to:
Dr D Sortini
Sezione di Chirurgia Generale, Dipartimento di Scienze Chirurgiche, Anestesiologiche e Radiologiche, Università di Ferrara, 44100 Ferrara, Italy; sors@libero.it
Keywords: non-small cell lung cancer; surgery
We would like to congratulate Janssen-Heijnen et al1 on their well performed study and on their significant contribution to resolving the problem of treatment in patients with non-small cell lung cancer (NSCLC) and co-morbidity. However, we could not find a description of the surgical approach used and would like to ask the authors to provide details of the surgical procedures adopted and the accompanying survival rates. We think,2 in agreement with other authors3 that, for patients with early stage NSCLC and co-morbidity, a less invasive surgical approach should be used. This view is supported by studies in elderly patients or in patients with co-morbidity showing that a less invasive approach does not influence survival rates. Only the recurrence rate seems to be increased by a less invasive surgical approach such as segmentectomy or pulmonary wedge resection.3–5
Several factors determine whether conservative or invasive resection should be used for NSCLC. We think that a less invasive approach should be chosen as the first therapeutic step, even for early stage NSCLC, and that elderly patients should be treated less aggressively than younger patients.
Figure 1 Surgical approach for surgically resected localised NSCLC according to age and co-morbidity.
References
Janssen-Heijnen MLG, Smulders S, Lemmens VEPP, et al. Effect of comorbidity on the treatment and prognosis of elderly patients with non-small cell lung cancer. Thorax 2004;59:602–7.
Sortini D, Feo C, Carcoforo P, et al. Thoracoscopic localization techniques for patients with solitary pulmonary nodule and history of malignancy. Ann Thorac Surg 2005;79:258–62.
Sugarbaker DJ. Lung cancer. 6: The case for limited surgical resection in non-small cell lung cancer, Thorax 2003;58:639–41.
Kodama K, Doi O, Higashiyama M, et al. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg 1997;114:347–53.
Landreneau RJ, Sugarbaker DJ, Mack MJ, et al. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg 1997;113:691–8.
Authors’ reply
M L G Janssen-Heijnen2, H J A A van Geffen2, V E P P Lemmens2, F W J M Smeenk2, S A Smulders2 and J W W Coebergh2
2 Eindhoven Cancer Registry, The Netherlands
Correspondence to:
Dr M L G Janssen-Heijnen
P O Box 231, 5600 AE Eindhoven, The Netherlands; research@ikz.nl
We agree with Sortini and colleagues that the type of surgical procedure may influence survival. Several studies have shown that less invasive resections might be a good alternative for the elderly and those with co-morbidity because postoperative mortality and complications are rather high in these patients.1–5 We did not present survival rates for the different surgical approaches because the numbers of patients in the subgroups were rather small, especially for the less invasive resections like sleeve resection, segmentectomy, and wedge resection. However, at the request of Sortini and colleagues, we here present the results for the different surgical approaches.
Figure 1 shows the proportional distribution of surgical approaches in resected patients with stage I and II NSCLC according to age and number of co-morbid conditions. Elderly patients received a pneumonectomy less often, while the proportion of lobectomies and less invasive resections increased with age. In age groups <60 years and 70–79 years patients with co-morbidity received pneumonectomy less often and a lobectomy/less invasive resections more often than those without co-morbidity. In patients older than 80 years the number of patients was too small to draw any conclusions.
In the multivariate survival analysis of resected stage I and II NSCLC patients, those treated with bilobectomy (HR = 0.70, p = 0.08) or lobectomy (HR = 0.70, p = 0.003) had a significantly better survival than those treated with pneumonectomy, adjusted for age, sex, tumour size, histological subtype, and co-morbidity. Survival in patients treated with less invasive resections was not significantly different. The absence of a difference might be explained by the small number of patients in this subgroup (n = 47).
We want to emphasise that this is an observational population based study and not a randomised controlled trial. Among the elderly, probably only the fittest patients were selected for surgery. Although we adjusted for the above mentioned patient related and tumour related factors in the multivariate survival analysis, other selection factors for surgery such as performance status, ASA score, forced expiratory volume in 1 second, and patient’s choice might have confounded the results.
Since the recurrence rate has been shown to be higher in patients who underwent less invasive surgery (such as wedge resection), lobectomy or pneumonectomy remain the surgical approaches of first choice in patients who are fit enough to undergo invasive surgery.4 Since it is still not clear what assessment is necessary in order to assess whether an older patient is fit enough for invasive surgery, future studies should focus on this topic.
References
Recruitment of ethnic minorities to asthma studies
J C van der Wouden1
1 Department of General Practice, Erasmus MC University Medical Center Rotterdam, P O Box 1738, 3000 DR Rotterdam, The Netherlands; j.vanderwouden@erasmusmc.nl
Keywords: asthma; ethnicity
The research letter by Sheikh and co-authors1 addresses an important area but, regrettably, does not hit the nail on the head. Information on ethnicity of study participants is often missing in asthma studies, as the authors clearly show. However, presenting this information—for example, in the table of baseline characteristics when reporting a clinical trial—is only a first step. Much more important is the inclusion of this characteristic in the analysis of effect modification or subgroup analysis. Only then will we know whether ethnicity really matters when applying a certain intervention.
I would welcome a further report from the authors giving details about the actual incorporation of ethnicity in data analysis.
Reference
Sheikh A, Panesar SS, Lasserson T, et al. Recruitment of ethnic minorities to asthma studies. Thorax 2004;59:634.[Free Full Text]
Authors’ reply
G Netuveli2, S S Panesar2, T Lasserson3 and A Sheikh4
2 Division of Primary Care and Population Health Sciences, Imperial College, London, UK
3 Cochrane Airways Group, St George’s Hospital Medical School, London, UK
4 Department of Primary Care Research and Development, Division of Community Health Sciences: GP Section, University of Edinburgh, UK
Correspondence to:
Professor A Sheikh
Department of Primary Care Research and Development, Division of Community Health Sciences: GP Section, University of Edinburgh, UK; aziz.sheikh@ed.ac.uk
We are grateful to Dr van der Wouden for raising the important point of ensuring that ethnicity data are used when analysing trial results. Of the 23/70 studies (32.8%) reporting information on ethnicity in the trial report, all confined mention of ethnicity only to baseline characteristics of included participants. Thus, none of these 23 studies factored ethnicity into the analysis of results. A possible explanation for this rather disappointing observation is that the number of subjects recruited from minority ethnic groups tended to be small, thereby precluding any meaningful ethnic-specific subgroup analysis. Unfortunately, this is a problem not solely confined to asthma studies; for example, less than 30% of clinical trials on epilepsy which reported ethnicity used the information in the analysis.1
In designing clinical trials, pragmatic and cost considerations often force investigators to focus on the main objectives of the study, forcing considerations concerning subgroup analyses onto the back burner during trial planning. Most clinical trials therefore lack sufficient power for subgroup analyses;2 however, this appears to be a problem that is particularly common in relation to subgroup analysis by ethnicity.3
Our motivation for undertaking this study was to highlight the disparity in recruitment between ethnic minorities and the majority into trials in a disease where ethnic considerations may be relevant. Asthma is one such area, but there are also others.4 van der Wouden is entirely correct in asserting that improving recruitment of minority ethnic groups is only half the battle; at least equally important—if not more so—is ensuring that information on ethnicity is meaningfully and competently used when analysing data and presenting results.5 Both issues should now be prioritised by the respiratory research community.(D Sortini1, E Pozza1, K M)