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Ann Thorac Surg 2004;77:1878-1879
© 2004 The Society of Thoracic Surgeons

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Correspondence

Do we need more trials of postoperative radiotherapy after esophagectomy?

Division of Thoracic Surgery, Department of Surgical Oncology, Tata Memorial Hospital, Mumbai 400012, India

e-mail: cspramesh{at}vsnl.net

To the Editor:

We read with interest the article by Xiao and associates [1] on a randomized comparison of esophagectomy with or without postoperative radiotherapy. We agree with the editorial comment that the article breaches an important ethical standard regarding informed consent but that the information gained from this study addresses an important question, thus justifying its publication. Previous randomized trials [2, 3] evaluating the role of postoperative radiotherapy have suffered from a lack of adequate numbers. However, we take exception to the conclusions of the study on several counts. In a trial where the intervention is postoperative, we do not understand why the randomization was not performed after the operation. Postoperative randomization would have ensured that stratification into the 2 groups could have been performed while taking into consideration the pTNM staging. Failure to do so has resulted in a skewed distribution of patients, with significantly more lymph node–positive patients being randomized into the surgery plus radiotherapy arm. With lymph nodal positivity being a significant independent predictor of poor outcome, the effect of radiotherapy is expected to be diluted. This could have been easily prevented by stratifying patients on the basis of pTNM status after esophagectomy.

We also do not understand why 54 patients were excluded from the surgery plus radiotherapy arm because of low dosage of radiotherapy, poor health, leukopenia, and radiation reactions. We believe that patients should have been analyzed on an intention-to-treat basis (especially because most of the reasons for exclusion were related to the intervention itself) and included in the final statistical analysis. We wonder whether there still would be a significant difference between the 2 arms in patients with T3 tumors if these 54 patients were also included in the statistical analysis. Despite these methodologic and statistical flaws, the study still carries an important take-home message that postoperative radiotherapy may yield better locoregional control and, probably, overall survival in T3 cancers of the esophagus. The effect of postoperative radiotherapy in lymph node–positive patients probably did not reach statistical significance because of the relatively small numbers. We suggest that a prospective, multicenter trial of patients with T3 and N1 esophageal cancer, randomized after operation to receive or not to receive adjuvant radiotherapy, should be performed to resolve this issue. This trial should have a sample size adequate to detect a 10% improvement in survival, and randomization should be performed after operation and stratified on the basis of pTNM status.

References

1. Xiao Z.F., Yang Z.Y., Liang J., et al. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg 2003;75:331-336.[Abstract/Free Full Text]
2. Fok M., Sham J.S., Choy D., Cheng S.W., Wong J. Postoperative radiotherapy for carcinoma of the esophagus: a prospective randomized controlled study. Surgery 1993;113:138-147.[Medline]
3. Teniere P., Hay J.M., Fingerhut A., Fagniez P.L. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet 1991;173:123-130.[Medline]

This article has been cited by other articles:

				S. Jiwnani, G. Karimundackal, C. S. Pramesh, and S. G. Laskar Postoperative Radiotherapy After Esophagectomy: Ripe for a Randomized Trial Ann. Thorac. Surg., May 1, 2011; 91(5): 1652 - 1652. [Full Text] [PDF]

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted 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): Sanjay Sharma Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Pramesh, C.S. Articles by Sharma, S. Search for Related Content PubMed PubMed Citation Articles by Pramesh, C.S. Articles by Sharma, S.