LETTERS TO THE EDITOR
Vol. 2 15 No. I -
November 27, 1990 Dear Editor: Stotter et al. studied the survival risk of local recurrence after preservation surgery.' Most of the patients returned with recurrences that were larger than their primary lesions. Was the survival hazard of local recurrence confined to this group of patients? Over the past 10 years, I have suggested that patients who survive their first breast cancer without developing distant disease can be expected to survive a similar volume of tumor in adjacent breast or lymphatic tissue.2'3 Stotter's data are consistent with this thesis. The authors cite the second Guy's Hospital trial in which patients with stage I disease benefitted from mastectomy. The survival benefit was actually confined to patients with Tl lesions.4 The surgical practice at M. D. Anderson Hospital is the opposite of that concluded by this trial. The authors did not explain this paradox, for which I have previously offered an explanation.5 Do Balch and his co-authors find any fault with my explanation? They concluded that 10,000 patients would have to be monitored for more than 10 years to detect the survival hazard of locoregional recurrence. Because no consistent survival advantage has been shown for adjuvant radiation, patients should be informed that the survival benefit of radiation is negligible or very small indeed.
References 1. Stotter A, Atkinson EN, Fairston A, et al. Survival following locoregional recurrence after breast conservation therapy for cancer. Ann Surg 1990; 212:166-172. 2. Evans R. Host resistance to carcinoma of the breast. South Med J
1980; 73:1261-1263. 3. Evans R. The "seed and soil" hypothesis and the decline radical surgery: a surgeon's opinion. Tex Med 1990; 86:85-89. 4. Hayward J, Caleffi M. The significance of local control in the primary treatment of breast cancer: Lucy James Wortham Clinical Research Award. Arch Surg 1987; 122:1244-1247. 5. Evans R. Natural killer cells and the Guy's Hospital trials [letter]. Arch Surg 1988; 123:914-915. RICHARD A. EVANS, M.D.
Houston, Texas January 12, 1991 Dear Editor: One of the most important points we wished to make in our paper was that it was not possible to prove, or disprove, a survival hazard due to local recurrence. This is partly because local recurrence is not a frequent event; partly because the likely effect, if any, is relatively small; and partly because of insufficient numbers of patients in the relevant randomized trials, followed for insufficient time. There is therefore no question, at present, of identifying a subgroup of those patients developing local recurrence to which a survival hazard is confined. We predict that patients with small recurrences have a higher chance of survival than those with large recurrences, just as those with small primaries are known to do better than those with large primaries. Dr. Evans has proposed the mechanism for this being that each patient can tolerate a certain tumor burden (perhaps related to natural killer cell activity), constant over the years, and clinical metastasis only develops when that threshold is exceeded. In our model, we postulated that the chance of tumor emboli surviving and growing increased continuously with increasing tumor burden, with no critical cutoff. Both theories imply that local tumor is a source of metastatic disease, and that
91
the less there is of it over the years, the greater the chance of patient survival. The results of the second Guy's Hospital trial can be interpreted as indicating that more radical surgery resulted in improved survival for those women with stage I as compared with stage II disease. This was not shown in the first Guy's trial, however, and has not been supported by other randomized controlled trials of mastectomy compared with breast conservation therapy. The M. D. Anderson, like every other major center worldwide, considers breast conservation therapy as an alternative to mastectomy predominantly for women with early stage disease. Considerable data support the statement that adjuvant radiotherapy conveys no survival benefit after mastectomy. We cannot necessarily extrapolate from this to the situation where the breast has been preserved. We know that in breast conservation therapy there is a tradeoff between surgery and radiotherapy in achieving local control, whereby higher radiation doses can compensate for closer surgical margins. Dr. Evans has himself emphasized that local recurrence after mastectomy behaves like metastatic disease, whereas local recurrence after breast conservation therapy is different. He has proposed that the latter be termed "local persistence" to emphasize the fact that it behaves more like primary tumor. The results of the NSABP B-06 trial show that if we use breast-conserving surgery without adjuvant radiotherapy, we can expect a much higher local recurrence rate, itself unacceptable, regardless of the survival risks. The fact that patients in this arm of the trial have not fared significantly worse to date is to be expected from the numbers in the trial, the duration of follow-up, and the likely size of any resultant survival deficit. As we indicated in our paper, the likely survival deficit is small when considered in relation to the patient population as a whole, most of whom will not develop local recurrence. For the individual who does, we predicted approximately a doubling of her risk of dying of the disease. ANNE STOTTER, PH.D., F.R.C.S. Leicester, England February 19, 1991 Dear Editor: I read with interest the article by Peters et al., "Safety and Efficacy of Laparoscopic Cholecystectomy." Having performed over 100 laparoscopic cholecystectomies, I was pleased to finally see information reaching the journals regarding this procedure. I cannot help but to point out an absurdity in the article. Under unresolved issues, the authors state "can this procedure be performed safely by the average general surgeon in the community and/or rural hospital?" The authors should be reminded that this procedure was developed by the average general surgeon in a community hospital. Furthermore, in the south, this procedure has been performed in almost every hospital for approximately 6 months. I agree that there are many unresolved issues. However, most general surgeons that wish to take the time to learn this procedure and have appropriate equipment will be capable of safely performing laparoscopic cholecystectomies. The surgeons who are just beginning to gain experience with laparoscopic cholecystectomy should not think that this procedure needs to be limited to a few surgeons. I believe the emphasis should be based on properly training any general surgeon who wishes to learn this procedure. Perhaps a demonstration of competence in this procedure by limited preceptorship would be wise. The current emphasis by certain
92
Ann. surg. . January 1992
LETTERS TO THE EDITOR
to apparently accrue large sums of money by charging inordinate fees for preceptorship should be discouraged. If one has experience with laparoscopic cholecystectomy, he should share this experience with the fledgling laparoscopic surgeon for free (or at the very most, have his incurred expenses covered). JOSEPH F. UDDO, JR., M.D. Metairie, Louisiana
April 29, 1991
surgeons
April 22, 1991 Dear Editor: We would like to thank Dr. Uddo for his kind comments regarding the paper "Safety and Efficacy of Laparoscopic Cholecystectomy." We think he has pointed out some very accurate issues with regard to training and credentialling of surgeons in this area and we wholeheartedly agree with much that he says. We might remind him that the manuscript was prepared very early in the history of laparoscopic cholecystectomy. As he points out, and as has become clear over the ensuing months, this is a procedure that can be performed safely by the average general surgeon and, thus, we agree with his assessment. Nevertheless, we might also add that we are becoming more convinced that it is a more dangerous procedure, however, than open cholecystectomy. We think the procedure is generally safe, given appropriate training, caution, and an accepting attitude toward conversion to open cholecystectomy, but it may represent an inherently increased risk over open cholecystectomy. Time will allow us the answer. The issue of whether this procedure was actually devised by "average" general surgeons is certainly open to debate. As he knows, it originated in French clinics, and Dr. Mouret, who pioneered the procedure in France, is a clinical laparoscopist with extensive experience. Describing his laparoscopic abilities as average would be inadequate to say the least. In addition, although it was indeed developed at many community hospitals within the United States, we would also question whether the surgeons involved in such innovative endeavors could be described as average. We have had the opportunity to participate in training courses for laparoscopic cholecystectomy involving several hundreds of surgeons, and it has been our observation that there are many that find it difficult. It is by no means a natural extension of our usual surgical abilities. Dr. Uddo seems offended by the assertion that we should question whether the average general surgeon is capable of performing new procedures. He also suggests that implied in our statement is an argument for limiting the procedure to a limited group of surgeons. The authors clearly did not intend any such meaning by posing the question. We think it would be inappropriate for us not to question whether any new procedure, especially one that is as technologically different as laparoscopic cholecystectomy, can be taken from the laboratory into the clinical realm with training that would be available and reasonable to the majority of surgeons and then could be applied safely. Thus, the intent of the question was exactly the opposite of Dr. Uddo's suggestions. We believe it would be highly inadequate to develop procedures that could not be easily expanded to the realm of the majority of surgeons quickly. We agree with his assessment that the emphasis should be placed on proper training, including a demonstration of competence. The entrepreneurism that has been associated with this procedure is an unfortunate consequence of the realities of the 1990s marketplace and should be discouraged. JEFFREY H. PETERS, M.D. Columbus, Ohio
Dear Editor: Dr. Simons' excellent letter describes the treatment of a young girl who presented with extrusion of a free fragment or "remnants" of spleen through a shrapnel wound in the left flank. Extrusion of a free fragment of liver or spleen devoid of blood supply is not unique, especially in patients with large wounds and significant intraperitoneal injury that leads to an elevated intraperitoneal pressure. The extrication of such exteriorized fragments from clothing, dressing, the cart, or from the wound edge bears no resemblance to the historical external splenectomies described by our forbears who identified ligation and division of the externalized splenic blood supply. The word laparotomy is derived from the Greek word "lapara," which means loin or flank. Had Dr. Simons explored this patient through her flank wound, this "laparotomy" approach would have permitted safe vascular division with extrication of the fragmented spleen and repair of the injured diaphragm. Indeed, extension of a flank wound into a formal "laparotomy" is my preferred approach in a few carefully selected patients with a close-range shotgun blast that is clearly confined to the flank area. The decision by Dr. Simons to obtain intraperitoneal vascular pedicle control though the traditional anterior celiotomy permitted a more thorough inspection of the pancreas, which was normal. The fine result achieved by Dr. Simons reflects his decision to perform the traditional open approach by one of the many different anatomic pathways to achieve complete safe splenectomy. Dr. Simons' description of this girl's presentation, her interoperative findings, and the subsequent photograph of her flank wound on postoperative day 4 reinforce my conclusion that the beginning ofthe modern era of splenic surgery for trauma should be the splenectomy performed by Riegner, who, in 1893, performed an anterior celiotomy to remove the fractured spleen of a young man who had fallen from a scaffold.' John Hunter, the renowned 18th century anatomist and surgeon, would have recognized the distinct differences from the presentation of Dr. Simons' patient and the formal flank exposures by myself as compared with the historical splenectomies with extraperitoneal division of the vascular pedicle reported by his predecessors. John Hunter also would have recognized that deviation from the traditional historical concept invites excited commentary. Reference 1. Riegner 0. Ueber einen Fall Von Exstirpation der Traumatisch Zerrissenen Milz. Berl Klin Wochnschr 1893; 30:177-181.
CHARLES E. LUCAS, M.D. Detroit, Michigan March 7, 1991 Dear Editor: It was with great interest that I read Dr. Lucas's article "Splenic Trauma, Choice of Management" (Ann Surg 1991; 213:98-112). His dismissal of the historical accounts of splenectomy, performed by detaching the spleen as it presented in the wound, is made on the basis of a lack of documented contemporary descriptions of spleens prolapsing from wounds. His conclusions, however, may be somewhat premature. One of the first patients I saw as a Red Cross surgeon in Thailand was a 12-year-old girl who presented with a through-andthrough shrapnel injury of the left flank in whom the remnants of her injured spleen were seen to be prolapsing from her wound.
Vol. 2 15 No. I -
November 27, 1990 Dear Editor: Stotter et al. studied the survival risk of local recurrence after preservation surgery.' Most of the patients returned with recurrences that were larger than their primary lesions. Was the survival hazard of local recurrence confined to this group of patients? Over the past 10 years, I have suggested that patients who survive their first breast cancer without developing distant disease can be expected to survive a similar volume of tumor in adjacent breast or lymphatic tissue.2'3 Stotter's data are consistent with this thesis. The authors cite the second Guy's Hospital trial in which patients with stage I disease benefitted from mastectomy. The survival benefit was actually confined to patients with Tl lesions.4 The surgical practice at M. D. Anderson Hospital is the opposite of that concluded by this trial. The authors did not explain this paradox, for which I have previously offered an explanation.5 Do Balch and his co-authors find any fault with my explanation? They concluded that 10,000 patients would have to be monitored for more than 10 years to detect the survival hazard of locoregional recurrence. Because no consistent survival advantage has been shown for adjuvant radiation, patients should be informed that the survival benefit of radiation is negligible or very small indeed.
References 1. Stotter A, Atkinson EN, Fairston A, et al. Survival following locoregional recurrence after breast conservation therapy for cancer. Ann Surg 1990; 212:166-172. 2. Evans R. Host resistance to carcinoma of the breast. South Med J
1980; 73:1261-1263. 3. Evans R. The "seed and soil" hypothesis and the decline radical surgery: a surgeon's opinion. Tex Med 1990; 86:85-89. 4. Hayward J, Caleffi M. The significance of local control in the primary treatment of breast cancer: Lucy James Wortham Clinical Research Award. Arch Surg 1987; 122:1244-1247. 5. Evans R. Natural killer cells and the Guy's Hospital trials [letter]. Arch Surg 1988; 123:914-915. RICHARD A. EVANS, M.D.
Houston, Texas January 12, 1991 Dear Editor: One of the most important points we wished to make in our paper was that it was not possible to prove, or disprove, a survival hazard due to local recurrence. This is partly because local recurrence is not a frequent event; partly because the likely effect, if any, is relatively small; and partly because of insufficient numbers of patients in the relevant randomized trials, followed for insufficient time. There is therefore no question, at present, of identifying a subgroup of those patients developing local recurrence to which a survival hazard is confined. We predict that patients with small recurrences have a higher chance of survival than those with large recurrences, just as those with small primaries are known to do better than those with large primaries. Dr. Evans has proposed the mechanism for this being that each patient can tolerate a certain tumor burden (perhaps related to natural killer cell activity), constant over the years, and clinical metastasis only develops when that threshold is exceeded. In our model, we postulated that the chance of tumor emboli surviving and growing increased continuously with increasing tumor burden, with no critical cutoff. Both theories imply that local tumor is a source of metastatic disease, and that
91
the less there is of it over the years, the greater the chance of patient survival. The results of the second Guy's Hospital trial can be interpreted as indicating that more radical surgery resulted in improved survival for those women with stage I as compared with stage II disease. This was not shown in the first Guy's trial, however, and has not been supported by other randomized controlled trials of mastectomy compared with breast conservation therapy. The M. D. Anderson, like every other major center worldwide, considers breast conservation therapy as an alternative to mastectomy predominantly for women with early stage disease. Considerable data support the statement that adjuvant radiotherapy conveys no survival benefit after mastectomy. We cannot necessarily extrapolate from this to the situation where the breast has been preserved. We know that in breast conservation therapy there is a tradeoff between surgery and radiotherapy in achieving local control, whereby higher radiation doses can compensate for closer surgical margins. Dr. Evans has himself emphasized that local recurrence after mastectomy behaves like metastatic disease, whereas local recurrence after breast conservation therapy is different. He has proposed that the latter be termed "local persistence" to emphasize the fact that it behaves more like primary tumor. The results of the NSABP B-06 trial show that if we use breast-conserving surgery without adjuvant radiotherapy, we can expect a much higher local recurrence rate, itself unacceptable, regardless of the survival risks. The fact that patients in this arm of the trial have not fared significantly worse to date is to be expected from the numbers in the trial, the duration of follow-up, and the likely size of any resultant survival deficit. As we indicated in our paper, the likely survival deficit is small when considered in relation to the patient population as a whole, most of whom will not develop local recurrence. For the individual who does, we predicted approximately a doubling of her risk of dying of the disease. ANNE STOTTER, PH.D., F.R.C.S. Leicester, England February 19, 1991 Dear Editor: I read with interest the article by Peters et al., "Safety and Efficacy of Laparoscopic Cholecystectomy." Having performed over 100 laparoscopic cholecystectomies, I was pleased to finally see information reaching the journals regarding this procedure. I cannot help but to point out an absurdity in the article. Under unresolved issues, the authors state "can this procedure be performed safely by the average general surgeon in the community and/or rural hospital?" The authors should be reminded that this procedure was developed by the average general surgeon in a community hospital. Furthermore, in the south, this procedure has been performed in almost every hospital for approximately 6 months. I agree that there are many unresolved issues. However, most general surgeons that wish to take the time to learn this procedure and have appropriate equipment will be capable of safely performing laparoscopic cholecystectomies. The surgeons who are just beginning to gain experience with laparoscopic cholecystectomy should not think that this procedure needs to be limited to a few surgeons. I believe the emphasis should be based on properly training any general surgeon who wishes to learn this procedure. Perhaps a demonstration of competence in this procedure by limited preceptorship would be wise. The current emphasis by certain
92
Ann. surg. . January 1992
LETTERS TO THE EDITOR
to apparently accrue large sums of money by charging inordinate fees for preceptorship should be discouraged. If one has experience with laparoscopic cholecystectomy, he should share this experience with the fledgling laparoscopic surgeon for free (or at the very most, have his incurred expenses covered). JOSEPH F. UDDO, JR., M.D. Metairie, Louisiana
April 29, 1991
surgeons
April 22, 1991 Dear Editor: We would like to thank Dr. Uddo for his kind comments regarding the paper "Safety and Efficacy of Laparoscopic Cholecystectomy." We think he has pointed out some very accurate issues with regard to training and credentialling of surgeons in this area and we wholeheartedly agree with much that he says. We might remind him that the manuscript was prepared very early in the history of laparoscopic cholecystectomy. As he points out, and as has become clear over the ensuing months, this is a procedure that can be performed safely by the average general surgeon and, thus, we agree with his assessment. Nevertheless, we might also add that we are becoming more convinced that it is a more dangerous procedure, however, than open cholecystectomy. We think the procedure is generally safe, given appropriate training, caution, and an accepting attitude toward conversion to open cholecystectomy, but it may represent an inherently increased risk over open cholecystectomy. Time will allow us the answer. The issue of whether this procedure was actually devised by "average" general surgeons is certainly open to debate. As he knows, it originated in French clinics, and Dr. Mouret, who pioneered the procedure in France, is a clinical laparoscopist with extensive experience. Describing his laparoscopic abilities as average would be inadequate to say the least. In addition, although it was indeed developed at many community hospitals within the United States, we would also question whether the surgeons involved in such innovative endeavors could be described as average. We have had the opportunity to participate in training courses for laparoscopic cholecystectomy involving several hundreds of surgeons, and it has been our observation that there are many that find it difficult. It is by no means a natural extension of our usual surgical abilities. Dr. Uddo seems offended by the assertion that we should question whether the average general surgeon is capable of performing new procedures. He also suggests that implied in our statement is an argument for limiting the procedure to a limited group of surgeons. The authors clearly did not intend any such meaning by posing the question. We think it would be inappropriate for us not to question whether any new procedure, especially one that is as technologically different as laparoscopic cholecystectomy, can be taken from the laboratory into the clinical realm with training that would be available and reasonable to the majority of surgeons and then could be applied safely. Thus, the intent of the question was exactly the opposite of Dr. Uddo's suggestions. We believe it would be highly inadequate to develop procedures that could not be easily expanded to the realm of the majority of surgeons quickly. We agree with his assessment that the emphasis should be placed on proper training, including a demonstration of competence. The entrepreneurism that has been associated with this procedure is an unfortunate consequence of the realities of the 1990s marketplace and should be discouraged. JEFFREY H. PETERS, M.D. Columbus, Ohio
Dear Editor: Dr. Simons' excellent letter describes the treatment of a young girl who presented with extrusion of a free fragment or "remnants" of spleen through a shrapnel wound in the left flank. Extrusion of a free fragment of liver or spleen devoid of blood supply is not unique, especially in patients with large wounds and significant intraperitoneal injury that leads to an elevated intraperitoneal pressure. The extrication of such exteriorized fragments from clothing, dressing, the cart, or from the wound edge bears no resemblance to the historical external splenectomies described by our forbears who identified ligation and division of the externalized splenic blood supply. The word laparotomy is derived from the Greek word "lapara," which means loin or flank. Had Dr. Simons explored this patient through her flank wound, this "laparotomy" approach would have permitted safe vascular division with extrication of the fragmented spleen and repair of the injured diaphragm. Indeed, extension of a flank wound into a formal "laparotomy" is my preferred approach in a few carefully selected patients with a close-range shotgun blast that is clearly confined to the flank area. The decision by Dr. Simons to obtain intraperitoneal vascular pedicle control though the traditional anterior celiotomy permitted a more thorough inspection of the pancreas, which was normal. The fine result achieved by Dr. Simons reflects his decision to perform the traditional open approach by one of the many different anatomic pathways to achieve complete safe splenectomy. Dr. Simons' description of this girl's presentation, her interoperative findings, and the subsequent photograph of her flank wound on postoperative day 4 reinforce my conclusion that the beginning ofthe modern era of splenic surgery for trauma should be the splenectomy performed by Riegner, who, in 1893, performed an anterior celiotomy to remove the fractured spleen of a young man who had fallen from a scaffold.' John Hunter, the renowned 18th century anatomist and surgeon, would have recognized the distinct differences from the presentation of Dr. Simons' patient and the formal flank exposures by myself as compared with the historical splenectomies with extraperitoneal division of the vascular pedicle reported by his predecessors. John Hunter also would have recognized that deviation from the traditional historical concept invites excited commentary. Reference 1. Riegner 0. Ueber einen Fall Von Exstirpation der Traumatisch Zerrissenen Milz. Berl Klin Wochnschr 1893; 30:177-181.
CHARLES E. LUCAS, M.D. Detroit, Michigan March 7, 1991 Dear Editor: It was with great interest that I read Dr. Lucas's article "Splenic Trauma, Choice of Management" (Ann Surg 1991; 213:98-112). His dismissal of the historical accounts of splenectomy, performed by detaching the spleen as it presented in the wound, is made on the basis of a lack of documented contemporary descriptions of spleens prolapsing from wounds. His conclusions, however, may be somewhat premature. One of the first patients I saw as a Red Cross surgeon in Thailand was a 12-year-old girl who presented with a through-andthrough shrapnel injury of the left flank in whom the remnants of her injured spleen were seen to be prolapsing from her wound.
