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Impact of Margin Status on Laser Surgery for Early Glottic Cancer—Reply

Impact of Margin Status on Laser Surgery for Early Glottic Cancer—Reply In reply We thank Wang for his interest in our article. The “anomalies” he points out are attributable to the fact that 30 (10.9%) patients were not treated as per protocol. This unfortunately is a fact of life. As stated in the article, we included all patients in the multivariate analysis, erecting a complex “margin variable” defined by 3 characteristics: margin status, whether second surgery was performed, and whether RT was administered. This approach was adopted to enable inclusion of all recruited patients. Wang refers to the “confusing” fact that the 33 patients with close or positive margins, no radicalization, but given RT also included 5 patients with negative margins. These 5 patients were in fact protocol violators and were overtreated. Contrary to Wang's assertion, our article was concerned with the influence of margin status on local control only. We defined disease-free survival as “time from surgery to recurrence or last follow-up”; we should have specified “local” recurrence. The labeling of the disease-free survival curve should also have specified “local relapse-free survival.” We apologize for the lack of clarity. We presented the hazard ratio of 2.53 (95% confidence interval [CI], 0.97-6.59) with P = .06, not claiming that it was statistically significant. We maintain, however, that, together with other data, patients with positive margins of 1 mm or less who did not receive radicalization or RT did worse than patients with negative margins. This result is further supported by a new multivariate analysis that includes 2 patients with regional recurrence only who were not mentioned in the article because we were concerned about the impact of margin status on local failure. For patients with close or positive margins who received no further treatment, the hazard ratio of local or regional recurrence was 3.06 (95% CI, 1.22-7.67; P = .02), compared with patients with negative margins. Wang complains that we neglected to address the influence of margin status on organ preservation. We agree that we omitted this aspect because only 8 patients lost their larynx as follows: Negative margins: 2/175 (1.1%) Close/positive radicalization: 1/33 (3.0%) Close/positive RT: 3/33 (9.1%) Close/positive (no radicalization, no RT): 2/30 (6.7%) True positive: 0/3 Wang argues that our use of only RT in patients with close margins “seems unreasonable” and that most patients benefit from radicalization, as also proposed by Jäckel et al.1 We wish to clarify that for T2-3 disease, we never planned RT but offered it when the lesion turned out to be pT2-3 and, for anatomical reasons, could not be radicalized endoscopically (open surgery would have been possible): all of this is clearly stated in the “Procedures” section of the article. From our experience (including organ preservation rates), we also believe that positive margins should be radicalized. However, when the margin is the thyroid cartilage (cT1 cases become pT2-3), it is preferable to offer RT, as also suggested by Jäckel et al.1 We conclude by emphasizing that among our 8 patients with positive margins, no radicalization, and no RT, there were 6 local recurrences: a second operation if feasible should therefore be performed; if not, RT should be administered. Correspondence: Dr Ansarin, Istituto Europeo di Oncologia, Via Ripamonti 435, 20141 Milano, Italy (mohssen.ansarin@ieo.it). Author Affiliations: Department of Head and Neck Surgery, European Institute of Oncology, Milan, Italy. References 1. Jäckel MCAmbrosch PMartin ASteiner W Impact of re-resection for inadequate margins on the prognosis of upper aerodigestive tract cancer treated by laser microsurgery. Laryngoscope 2007;117 (2) 350- 356PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Otolaryngology - Head & Neck Surgery American Medical Association

Impact of Margin Status on Laser Surgery for Early Glottic Cancer—Reply

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Publisher
American Medical Association
Copyright
Copyright © 2010 American Medical Association. All Rights Reserved.
ISSN
0886-4470
eISSN
1538-361X
DOI
10.1001/archoto.2009.222
Publisher site
See Article on Publisher Site

Abstract

In reply We thank Wang for his interest in our article. The “anomalies” he points out are attributable to the fact that 30 (10.9%) patients were not treated as per protocol. This unfortunately is a fact of life. As stated in the article, we included all patients in the multivariate analysis, erecting a complex “margin variable” defined by 3 characteristics: margin status, whether second surgery was performed, and whether RT was administered. This approach was adopted to enable inclusion of all recruited patients. Wang refers to the “confusing” fact that the 33 patients with close or positive margins, no radicalization, but given RT also included 5 patients with negative margins. These 5 patients were in fact protocol violators and were overtreated. Contrary to Wang's assertion, our article was concerned with the influence of margin status on local control only. We defined disease-free survival as “time from surgery to recurrence or last follow-up”; we should have specified “local” recurrence. The labeling of the disease-free survival curve should also have specified “local relapse-free survival.” We apologize for the lack of clarity. We presented the hazard ratio of 2.53 (95% confidence interval [CI], 0.97-6.59) with P = .06, not claiming that it was statistically significant. We maintain, however, that, together with other data, patients with positive margins of 1 mm or less who did not receive radicalization or RT did worse than patients with negative margins. This result is further supported by a new multivariate analysis that includes 2 patients with regional recurrence only who were not mentioned in the article because we were concerned about the impact of margin status on local failure. For patients with close or positive margins who received no further treatment, the hazard ratio of local or regional recurrence was 3.06 (95% CI, 1.22-7.67; P = .02), compared with patients with negative margins. Wang complains that we neglected to address the influence of margin status on organ preservation. We agree that we omitted this aspect because only 8 patients lost their larynx as follows: Negative margins: 2/175 (1.1%) Close/positive radicalization: 1/33 (3.0%) Close/positive RT: 3/33 (9.1%) Close/positive (no radicalization, no RT): 2/30 (6.7%) True positive: 0/3 Wang argues that our use of only RT in patients with close margins “seems unreasonable” and that most patients benefit from radicalization, as also proposed by Jäckel et al.1 We wish to clarify that for T2-3 disease, we never planned RT but offered it when the lesion turned out to be pT2-3 and, for anatomical reasons, could not be radicalized endoscopically (open surgery would have been possible): all of this is clearly stated in the “Procedures” section of the article. From our experience (including organ preservation rates), we also believe that positive margins should be radicalized. However, when the margin is the thyroid cartilage (cT1 cases become pT2-3), it is preferable to offer RT, as also suggested by Jäckel et al.1 We conclude by emphasizing that among our 8 patients with positive margins, no radicalization, and no RT, there were 6 local recurrences: a second operation if feasible should therefore be performed; if not, RT should be administered. Correspondence: Dr Ansarin, Istituto Europeo di Oncologia, Via Ripamonti 435, 20141 Milano, Italy (mohssen.ansarin@ieo.it). Author Affiliations: Department of Head and Neck Surgery, European Institute of Oncology, Milan, Italy. References 1. Jäckel MCAmbrosch PMartin ASteiner W Impact of re-resection for inadequate margins on the prognosis of upper aerodigestive tract cancer treated by laser microsurgery. Laryngoscope 2007;117 (2) 350- 356PubMedGoogle ScholarCrossref

Journal

Archives of Otolaryngology - Head & Neck SurgeryAmerican Medical Association

Published: Feb 15, 2010

References