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LETTER TO THE EDITOR |
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy
To the Editor:
I read with interest Dr. Weber’s editorial published in the July issue of the Annals of Surgical Oncology.1
Because my article2 has apparently represented the occasion for both general and specific comments reported in that editorial, I feel somewhat obliged to express my opinion to indicate to readers that starting from Dr. Weber’s same point, some different conclusions can be reached.
Everybody agrees that many aspects of therapy for rectal cancer are controversial, and preoperative chemoradiation (PreCR) is not an exception. This is due, as correctly stated by the editorialist, to the absence of randomized clinical trials (RCT) because both the Intergroup 0147 and the National Surgical Adjuvant Breast and Bowel Project R0-3 failed to accrue a sufficient number of patients. However, such a failure does not only reflect the passionate views of many surgeons that prevented them from randomizing patients but also the initial evidence that preoperative radiotherapy might be better than a postoperative one, as shown in a meta-analysis published in JAMA,3 and the growing awareness (by the patients) that preoperative therapy can sometimes avoid a permanent colostomy.
A recent article in BMJ4 illustrated how in many fields of surgery RCT are virtually impossible to be performed because of the lack of equipoise by the patients.
In the case of preoperative versus postoperative radiotherapy in patients with rectal cancer, it is obvious that randomization will be rejected by the majority of the patients if it is uncertain which of the two procedures will achieve a better oncologic outcome, being however, one less mutilating than the other.
The importance of avoiding a colostomy, at least for the population of southern Europe, is well illustrated in the recent article (and enclosed commentary) by Rouanet et al.5
The final obvious consequence is the proliferation in literature of small reports of prospective nonrandomized studies (the last of which6 appears in the same issue of the Annals of Surgical Oncology where the editorial is published).
None of them aim to "rebuild a consensus"1 on this controversial approach to rectal cancer but just to insert a piece in the mosaic of the research on the worth of preoperative therapy of this tumor.
I agree that "downsizing is not synonymous with downstaging"1 and this is the reason why we have reported both the changes in the T category as well as in the size of the tumor.
What matters more, I do not know; however, nobody can deny that there are reports which show excellent results obtained in patients rendered pT0 by preoperative therapy7–13 and that downsizing the tumor by centimeters or even millimeters can convert a R1 resection into a R0 one or make possible a sphincter-saving surgery.7,14–18
Coming back to our report, I think that Dr. Weber has overestimated the article. We never expressed the intention to "rebuild evidence-based consensus on optimal adjuvant therapy for rectal cancer"1 with our data!
On the contrary, both in the title and in the text we clearly reported that the end point of the study was to assess the response of the primary lesion to the PreCR. It is true that "the fact that rectal adenocarcinomas respond... to neoadjuvant chemoradiation is not a novel observation"1; however, very few reports have analyzed this event in a selected series of tumors staged before and after PreCR by endoscopic ultrasonography or have quantitatively assessed the reduction of size and invasion. Virtually none have prospectively analyzed the specimen by the pathologic classification of Mandard.19
I would not excessively mind the comparisons on tumor regression and sphincter preservation rates. Due to their retrospective nature, we clearly defined the first one as "tentative" and the second one was simply solicited by the reviewer’s request and in any case, it is only mentioned in the Discussion.2
Even if I am sure that the only difference between the groups we compared is the period of study, I anticipate and accept the criticism of biostatisticians who would refuse to analyze differences of data from nonrandomized samples. For such a reason, we omitted all details (which are available in our previous articles9,20) and we only reported the crude data without emphasizing our findings.
Unfortunately, it is not possible to prospectively assess the potential gain in sphincter-saving rate with PreCR because in cancer of the lower rectum the decision regarding conservative surgery is usually intraoperative and any judgment before chemoradiation is barely accurate.
In conclusion, regardless of the possible discrepancy of opinions among surgeons on the value of PreCR in the approach to rectal cancer, we think that our study is simply a step forward in the lengthy way into research of rectal cancer therapy and as such the article should be read.
In 2002, bioethicists and biostatisticians accept that small underpowered RCT be done provided that some conditions are respected,21 why surgeons should a priori refuse that, in absence of large RCT, a future consensus may be reached if a core of multiple small studies will show a common agreement on the efficacy of a therapy?
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