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Long-Term Results of Transanal Excision After Neoadjuvant Chemoradiation for T2 and T3 Adenocarcinomas of the Rectum

  • 2008 plenary presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Introduction

Traditionally, selected early distal rectal cancers have been considered for treatment by transanal excision (TAE) with acceptable oncologic results. With the frequent use of neoadjuvant chemoradiation (NCR) for the treatment of locally advanced rectal cancer, there is growing interest in the application of TAE for such lesions. We report our experience of TAE for T2 and T3 rectal cancers following NCR.

Material and Methods

Between July 1994 and August 2006, 44 patients were identified as having undergone full-thickness TAE of pretreatment ultrasound-staged T2 and T3 rectal cancers that were treated with NCR. Fifteen patients were deemed medically unfit for radical resection, and 29 would have required abdominoperineal resection but were opposed to colostomy.

Results

Our patient population consisted of 26 men and 18 women, with a median age of 69 (range, 43–89) and a median follow up of 64 months (6–153). Thirty-one patients had a clinical complete response (cCR) to NCR of which 19 (61%) had a pathologic CR (pCR). Seven (16%) of 44 patients sustained disease recurrence of which two were local only, two local and systemic, and three systemic only. Only four (9%) patients had died of disease at current follow up. Overall 5-year survival rates for T2/T3N0 and T2/T3N1 patients were 84% and 81%, respectively. Five patients underwent radical resection immediately following TAE for either positive margins or residual cancer. There was minimal morbidity with no perioperative mortality associated with TAE.

Conclusions

TAE of T2 and T3 rectal cancers following NCR is a safe alternative to radical resection in a highly select group of patients for which recurrence and survival rates comparable to radical resection can be achieved. This study supports ongoing efforts to assess this approach in prospective, multi-center trials.

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Alessandro Fichera, M.D. (Chicago, IL): The group from Moffitt really needs to be congratulated for a very provoking study, a timely study as well. They have reviewed a large series of patients with T2/T3 rectal cancer that underwent transanal excision after combined modality therapy at their institution in the neoadjuvant setting. As I said, this is a very timely study, since this is a topic of prospective, randomized evaluations at this point.

To take a little bit of a step back and give you a little bit of an historical background, the Memorial Sloan-Kettering and the University of Minnesota group have shown that the recurrence rate after local excision alone for T2 rectal cancer could be as high as 47%, obviously not an acceptable rate. In the CALGB 8984 trial, chemoradiation therapy was utilized in the adjuvant setting after local excision for patients found to have a T2/T3 lesion with a significant improvement in local recurrence rate. Now, with the results of the German rectal cancer trial that was presented during the talk, it is clear that neoadjuvant chemoradiation therapy offers significant advantages and should be considered the treatment of choice for locally advanced rectal cancer. The authors have applied this approach to T2 and T3 lesions in their series. The study I thought was very well presented, and their pathologic complete response rate of 25 out of 44 patients is quite impressive.

There are some limitations to the study. Obviously, this is a retrospective evaluation, and there is obviously a selection bias inherent to the group of 29 patients that were opposed to a colostomy. Furthermore, during the 20 years of the study, our ability to stage rectal cancers and to deliver radiation therapy has changed dramatically. Notwithstanding these limitations, their results are very impressive. I would like to ask the authors a few questions.

Although the numbers are small, it appears that disease-free survival is somewhat reduced, 79% versus 88% at 5 years and 92% at 3 years, in the groups with positive lymph nodes. Should a local excision be offered to these patients at all, accepting a failure rate of 21%? On the same line, we do know that the risk of local recurrence is delayed by radiation therapy. The Brazilian study has also shown a slight increase in the number of recurrences as the follow-up continues. Even though your disease-free survival changes only slightly between 3 and 5 years, what are you expecting to see 5 years from now, and how are you going to follow these patients up? In view of the results of the study, what options are you offering to a patient that presents to your clinic with a T3 N0 rectal lesion at the dentate line at this point?

I truly enjoyed your presentation that was kindly provided to me ahead of schedule. Thank you also for the opportunity to discuss the paper.

Rajesh Nair, M.D. (Tampa, FL):Dr. Fichera, thank you very much for your review of our study and your critical appraisal. I will try and answer the questions in order.

In terms of patients with node-positive disease, the setup of the current prospective trial with ACOSOG includes patients with early stage, T2 node-negative cancers, and we agree, ideally, that this approach should be limited to node-negative patients. As we and others have demonstrated, the rates of recurrence with node-positive disease are too high. I think attempts at local excision can be made in patients, again, who are completely opposed to radical surgery and/or colostomy or are medically unfit for surgery. However, they need to understand that they will be accepting a higher rate of recurrence utilizing this approach.

In terms of long-term follow-up, the data from the Memorial group has clearly shown that local recurrences can occur more than 5 years beyond the initial time of treatment. Therefore, we will need to change our approach in follow-up, especially if this approach becomes utilized, extending from 5 to 10 years and maybe longer.

And in terms of a patient who presents to us with a T3 N0 cancer, our approach, again, would be to offer them neoadjuvant chemoradiation and then make a decision based upon the clinical response. In a patient who has a complete clinical response, our recommendation would still be to tell them that the standard of care is to undergo full radical surgical resection. However, if they are, again, opposed to colostomy and/or radical surgery or are medically unfit, we can offer this procedure, again, with the understanding that there may be an increased rate of local recurrence with this technique.

Bruce A. Orkin, M.D. (Washington, DC): I enjoyed your presentation very much. This is actually a very critical area that we are trying to evaluate ourselves. I have probably done over 200 of these cases, about a third of them for malignancies. Our experience has been that those patients who have had preoperative radiation and chemotherapy have a much, much higher complication rate. We primarily use transanal endoscopic microsurgery, and we have seen a lot of failures in terms of the wounds falling apart. I actually had a discussion about that with one of our colleagues yesterday.

Are you seeing such an increase in complications? Are you using TEM for any of these cases now? If so, are you prospectively evaluating it?

Dr. Nair: In terms of TEM, none of the patients in this particular study underwent TEM. However, within the last 12 months, almost all of the patients who have undergone local excision have been treated using TEM. In terms of complications, we have not noticed a significant change in our overall morbidity rate. In this current cohort, there was one patient who had a disruption of their suture line and subsequently required dilatation for an anorectal stenosis.

In a group of patients treated too recently to have been included in this study, we have seen two patients with rectal drainage secondary to minor suture line dehiscence. In both of these cases, symptoms were self-limited and completely resolved.

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Nair, R.M., Siegel, E.M., Chen, DT. et al. Long-Term Results of Transanal Excision After Neoadjuvant Chemoradiation for T2 and T3 Adenocarcinomas of the Rectum. J Gastrointest Surg 12, 1797–1806 (2008). https://doi.org/10.1007/s11605-008-0647-z

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