The Experts below are selected from a list of 17505 Experts worldwide ranked by ideXlab platform
Bernard Fisher - One of the best experts on this subject based on the ideXlab platform.
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twenty year follow up of a randomized trial comparing total mastectomy Lumpectomy and Lumpectomy plus irradiation for the treatment of invasive breast cancer
The New England Journal of Medicine, 2002Co-Authors: Bernard Fisher, Stewart J Anderson, John Bryant, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Jonghyeon Jeong, Norman WolmarkAbstract:Background In 1976, we initiated a randomized trial to determine whether Lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Methods A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, Lumpectomy alone, or Lumpectomy and breast irradiation. Kaplan–Meier and cumulative-incidence estimates of the outcome were obtained. Results The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent Lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent Lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease–free survival, or overall survival. The hazard ratio for death among the women who underwent Lumpectomy alone, as compared with those wh...
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tamoxifen in treatment of intraductal breast cancer national surgical adjuvant breast and bowel project b 24 randomised controlled trial
The Lancet, 1999Co-Authors: Bernard Fisher, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Lawrence D Wickerham, Roy E Smith, Mirsada Begovic, Nikolay V Dimitrov, Richard G MargoleseAbstract:Summary Background We have shown previously that Lumpectomy with radiation therapy was more effective than Lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether Lumpectomy, radiation therapy, and tamoxifen was of more benefit than Lumpectomy and radiation therapy alone for DCIS. Methods 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned Lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or Lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57–93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. Flndings Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8·2 vs 13·4%, p=0·0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4·1% at 5 years: 2·1% in the ipsilateral breast, 1·8% in the contralateral breast, and 0·2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. Interpretation The combination of Lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.
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Lumpectomy and radiation therapy for the treatment of intraductal breast cancer findings from national surgical adjuvant breast and bowel project b 17
Journal of Clinical Oncology, 1998Co-Authors: Bernard Fisher, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Joseph P Costantino, W Poller, D L Wickerham, Richard G MargoleseAbstract:PURPOSEIn 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after Lumpectomy concluded that the combination was more beneficial than Lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.PATIENTS AND METHODSWomen (N = 818) with localized DCIS were randomly assigned to Lumpectomy or Lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.RESULTSThe benefit of Lumpectomy plus radiation was virtually unchan...
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reanalysis and results after 12 years of follow up in a randomized clinical trial comparing total mastectomy with Lumpectomy with or without irradiation in the treatment of breast cancer
The New England Journal of Medicine, 1995Co-Authors: Bernard Fisher, Stewart J Anderson, Norman Wolmark, C Redmond, D L Wickerham, Walter M CroninAbstract:Background Previous findings from a clinical trial (Protocol B-06) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) indicated the worth of Lumpectomy and breast irradiation for treating breast cancer. After the discovery by NSABP staff members of falsified information on patients enrolled in the study by St. Luc Hospital in Montreal, separate audits were conducted at St. Luc Hospital and other participating institutions. We report the results of both audits and update the study findings through an average of 12 years of follow-up. Methods Patients with either negative or positive axillary nodes and tumors 4 cm or less in diameter were randomly assigned to one of three treatments: total mastectomy, Lumpectomy followed by breast irradiation, or Lumpectomy without irradiation. Three cohorts of patients were analyzed. The first cohort included all 2105 randomized patients, who were analyzed according to the intention-to-treat principle. The second cohort consisted of 1851 eligible ...
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pathologic findings from the national surgical adjuvant breast project nsabp protocol b 17 intraductal carcinoma ductal carcinoma in situ
Cancer, 1995Co-Authors: Edwin R Fisher, Bernard Fisher, Joseph P Costantino, Alka Palekar, Carol K. RedmondAbstract:Background. Controversy exists concerning the natural history of ductal carcinoma in situ (DCIS) of the breast, including its pathologic expression and treatment. This controversy has been fostered largely by the retrospective nature and limited sample sizes of extant studies. Method. Resolution of some of these issues was attempted by analyzing the pathologic features of 573 examples of DCIS obtained from a larger cohort of 790 women with DCIS enrolled in Protocol B-17 of the National Surgical Adjuvant Breast Project. This prospective randomized clinical trial was performed to assess the efficacy of local breast irradiation to reduce the incidence of second ipsilateral breast tumors (IBT) after Lumpectomy. Results. Tumor and patient characteristics, including significantly less IBT for those treated by Lumpectomy and irradiation than Lumpectomy alone, were almost identical for the subset comprising this analysis and the total B-17 cohort reported previously. The presence of moderate/marked comedo necrosis, which was evaluated as an independent parameter rather than as a specific histologic type of DCIS and uncertain/involved Lumpectomy margins were the only statistically significant independent predictors of IBT for patients treated by Lumpectomy as well as irradiation. The latter markedly reduced the annual hazard rates for the IBT associated with these indicators. Conclusions. Although not an endpoinl of this study, the authors' findings suggest that the beneficial effect of irradiation in reducing IBT after Lumpectomy for DCIS occurs with small (<1.0 cm.) and larger lesions. Moderate/marked comedo necrosis and uncertain/involved Lumpectomy margins represent independent predictors of IBT. Cancer 1995;75:1310-9.
Norman Wolmark - One of the best experts on this subject based on the ideXlab platform.
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twenty year follow up of a randomized trial comparing total mastectomy Lumpectomy and Lumpectomy plus irradiation for the treatment of invasive breast cancer
The New England Journal of Medicine, 2002Co-Authors: Bernard Fisher, Stewart J Anderson, John Bryant, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Jonghyeon Jeong, Norman WolmarkAbstract:Background In 1976, we initiated a randomized trial to determine whether Lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Methods A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, Lumpectomy alone, or Lumpectomy and breast irradiation. Kaplan–Meier and cumulative-incidence estimates of the outcome were obtained. Results The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent Lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent Lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease–free survival, or overall survival. The hazard ratio for death among the women who underwent Lumpectomy alone, as compared with those wh...
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tamoxifen in treatment of intraductal breast cancer national surgical adjuvant breast and bowel project b 24 randomised controlled trial
The Lancet, 1999Co-Authors: Bernard Fisher, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Lawrence D Wickerham, Roy E Smith, Mirsada Begovic, Nikolay V Dimitrov, Richard G MargoleseAbstract:Summary Background We have shown previously that Lumpectomy with radiation therapy was more effective than Lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether Lumpectomy, radiation therapy, and tamoxifen was of more benefit than Lumpectomy and radiation therapy alone for DCIS. Methods 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned Lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or Lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57–93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. Flndings Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8·2 vs 13·4%, p=0·0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4·1% at 5 years: 2·1% in the ipsilateral breast, 1·8% in the contralateral breast, and 0·2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. Interpretation The combination of Lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.
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Lumpectomy and radiation therapy for the treatment of intraductal breast cancer findings from national surgical adjuvant breast and bowel project b 17
Journal of Clinical Oncology, 1998Co-Authors: Bernard Fisher, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Joseph P Costantino, W Poller, D L Wickerham, Richard G MargoleseAbstract:PURPOSEIn 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after Lumpectomy concluded that the combination was more beneficial than Lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.PATIENTS AND METHODSWomen (N = 818) with localized DCIS were randomly assigned to Lumpectomy or Lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.RESULTSThe benefit of Lumpectomy plus radiation was virtually unchan...
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reanalysis and results after 12 years of follow up in a randomized clinical trial comparing total mastectomy with Lumpectomy with or without irradiation in the treatment of breast cancer
The New England Journal of Medicine, 1995Co-Authors: Bernard Fisher, Stewart J Anderson, Norman Wolmark, C Redmond, D L Wickerham, Walter M CroninAbstract:Background Previous findings from a clinical trial (Protocol B-06) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) indicated the worth of Lumpectomy and breast irradiation for treating breast cancer. After the discovery by NSABP staff members of falsified information on patients enrolled in the study by St. Luc Hospital in Montreal, separate audits were conducted at St. Luc Hospital and other participating institutions. We report the results of both audits and update the study findings through an average of 12 years of follow-up. Methods Patients with either negative or positive axillary nodes and tumors 4 cm or less in diameter were randomly assigned to one of three treatments: total mastectomy, Lumpectomy followed by breast irradiation, or Lumpectomy without irradiation. Three cohorts of patients were analyzed. The first cohort included all 2105 randomized patients, who were analyzed according to the intention-to-treat principle. The second cohort consisted of 1851 eligible ...
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Lumpectomy Compared with Lumpectomy and Radiation Therapy for the Treatment of Intraductal Breast Cancer
The New England journal of medicine, 1993Co-Authors: Bernard Fisher, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, Joseph P Costantino, D L Wickerham, Nikolay V Dimitrov, Carol K. Redmond, Liora OreAbstract:Background and Methods Women with ductal carcinoma in situ have been treated both by Lumpectomy and by Lumpectomy followed by radiation therapy, but the benefit of combined therapy is uncertain. A group of 818 women with ductal carcinoma in situ were randomly assigned to undergo Lumpectomy or Lumpectomy followed by breast irradiation (50 Gy). Sufficient tissue was removed that the margins of the resected specimens were histologically tumor-free. The mean duration of follow-up was 43 months (range, 11 to 86). The principal end point of the study was event-free survival, as defined by the presence of no new ipsilateral or contralateral breast cancers, regional or distant metastases, or other cancers and by no deaths from causes other than cancer. Results Five-year event-free survival was better in the women who received breast irradiation (84.4 percent, vs. 73.8 percent for the women treated by Lumpectomy alone; P = 0.001). The improvement was due to a reduction in the occurrence of second ipsilateral breas...
Richard G Margolese - One of the best experts on this subject based on the ideXlab platform.
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twenty year follow up of a randomized trial comparing total mastectomy Lumpectomy and Lumpectomy plus irradiation for the treatment of invasive breast cancer
The New England Journal of Medicine, 2002Co-Authors: Bernard Fisher, Stewart J Anderson, John Bryant, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Jonghyeon Jeong, Norman WolmarkAbstract:Background In 1976, we initiated a randomized trial to determine whether Lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Methods A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, Lumpectomy alone, or Lumpectomy and breast irradiation. Kaplan–Meier and cumulative-incidence estimates of the outcome were obtained. Results The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent Lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent Lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease–free survival, or overall survival. The hazard ratio for death among the women who underwent Lumpectomy alone, as compared with those wh...
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tamoxifen in treatment of intraductal breast cancer national surgical adjuvant breast and bowel project b 24 randomised controlled trial
The Lancet, 1999Co-Authors: Bernard Fisher, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Lawrence D Wickerham, Roy E Smith, Mirsada Begovic, Nikolay V Dimitrov, Richard G MargoleseAbstract:Summary Background We have shown previously that Lumpectomy with radiation therapy was more effective than Lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether Lumpectomy, radiation therapy, and tamoxifen was of more benefit than Lumpectomy and radiation therapy alone for DCIS. Methods 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned Lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or Lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57–93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. Flndings Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8·2 vs 13·4%, p=0·0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4·1% at 5 years: 2·1% in the ipsilateral breast, 1·8% in the contralateral breast, and 0·2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. Interpretation The combination of Lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.
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Lumpectomy and radiation therapy for the treatment of intraductal breast cancer findings from national surgical adjuvant breast and bowel project b 17
Journal of Clinical Oncology, 1998Co-Authors: Bernard Fisher, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Joseph P Costantino, W Poller, D L Wickerham, Richard G MargoleseAbstract:PURPOSEIn 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after Lumpectomy concluded that the combination was more beneficial than Lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.PATIENTS AND METHODSWomen (N = 818) with localized DCIS were randomly assigned to Lumpectomy or Lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.RESULTSThe benefit of Lumpectomy plus radiation was virtually unchan...
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Lumpectomy Compared with Lumpectomy and Radiation Therapy for the Treatment of Intraductal Breast Cancer
The New England journal of medicine, 1993Co-Authors: Bernard Fisher, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, Joseph P Costantino, D L Wickerham, Nikolay V Dimitrov, Carol K. Redmond, Liora OreAbstract:Background and Methods Women with ductal carcinoma in situ have been treated both by Lumpectomy and by Lumpectomy followed by radiation therapy, but the benefit of combined therapy is uncertain. A group of 818 women with ductal carcinoma in situ were randomly assigned to undergo Lumpectomy or Lumpectomy followed by breast irradiation (50 Gy). Sufficient tissue was removed that the margins of the resected specimens were histologically tumor-free. The mean duration of follow-up was 43 months (range, 11 to 86). The principal end point of the study was event-free survival, as defined by the presence of no new ipsilateral or contralateral breast cancers, regional or distant metastases, or other cancers and by no deaths from causes other than cancer. Results Five-year event-free survival was better in the women who received breast irradiation (84.4 percent, vs. 73.8 percent for the women treated by Lumpectomy alone; P = 0.001). The improvement was due to a reduction in the occurrence of second ipsilateral breas...
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Significance of ipsilateral breast tumour recurrence after Lumpectomy.
Lancet (London England), 1991Co-Authors: B Fisher, Stewart J Anderson, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, Eleftherios P Mamounas, Carol K. Redmond, D L Wickerham, Richard G MargoleseAbstract:Abstract Breast cancer treatment trials from the US National Surgical Adjuvant Breast and Bowel Project have established breast-conserving operations as a replacement for radical mastectomy (NSABP B-04), and have shown that in terms of survival free from distant disease there was no significant difference between Lumpectomy, Lumpectomy plus breast irradiation, and total mastectomy (NSABP B-06). 9-year follow-up data from B-06 are used here to address the issue of ipsilateral breast tumour recurrence (IBTR) and the development of distant disease, a question with important clinical and biological implications. A Cox regression model on fixed co-variates (ie, features such as tumour type or size present at surgery and not subsequently alterable) and on I BTR, which is time dependent and not fixed, revealed that the risk of distant disease was 3·41 times greater after adjustment for co-variates in patients in whom an IBTR developed. IBTR proved to be a powerful independent predictor of distant disease. However, it is a marker of risk for, not a cause of, distant metastasis. While mastectomy or breast irradiation following Lumpectomy prevent expression of the marker they do not lower the risk of distant disease. These findings further justify the use of Lumpectomy.
Varagur Venkatesan - One of the best experts on this subject based on the ideXlab platform.
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patterns of breast recurrence in a pilot study of brachytherapy confined to the Lumpectomy site for early breast cancer with six years minimum follow up
International Journal of Radiation Oncology Biology Physics, 2003Co-Authors: Francisco Perera, Frank Chisela, Jay Engel, Varagur Venkatesan, Ronald Holliday, Leslie ScottAbstract:Abstract Purpose In this pilot study of high-dose-rate brachytherapy to the Lumpectomy site as the sole radiation, ipsilateral and contralateral breast recurrences are documented with specific attention to the location of recurrence relative to the Lumpectomy site. Methods Between March 1992 and January 1996, 39 patients with T1 (32 patients) and T2 breast cancers received 37.2 Gy in 10 fractions (b.i.d.) over 1 week prescribed to a volume encompassing the surgical clips. Thirteen received adjuvant tamoxifen, and 4 received chemotherapy. Follow-up included annual bilateral mammograms and clinical breast examination every 3 to 6 months. Whereas 13 patients had intraoperative implantation of the Lumpectomy site, 26 had postoperative implantation. The latter group and 7 of the former group had surgical clips marking the Lumpectomy site, which allowed estimates of the distance of any ipsilateral breast recurrence from the Lumpectomy site, using the mediolateral and cranio-caudad mammographic views. Results At a median follow-up of 91 months, 33 women are alive, 4 have died of disease, and 2 have died of other causes. The 5-year actuarial rate of ipsilateral breast recurrence was 16.2%. Of 6 ipsilateral recurrences, 2 occurred within the Lumpectomy site (in-field recurrences). One of the 2 patients had a 1-mm microscopic margin at initial diagnosis; the recurrence was a 3.5-mm microscopic focus of duct carcinoma in situ . The other patient had a 1.5-cm, high-grade infiltrating mammary carcinoma with no residual at wider resection at first diagnosis; the 5-mm invasive recurrence was also of high grade. Four women developed invasive recurrences at least 1.6 cm or more from the Lumpectomy site (out-of-field recurrences). Two of these women had gross multifocal recurrences with two cancers in each patient; 1 of the 2 patients had an extensive intraductal component at initial diagnosis. The estimated nearest distances between the out-of-field recurrences and the surgical clips were 1.6, 5.5, 7.7, and 12.0 cm. All ipsilateral breast recurrences were salvaged by mastectomy (4 patients) or by repeat Lumpectomy (2 patients) and whole-breast radiation. The interval postdiagnosis to ipsilateral recurrence ranged from 20 months to 58 months. There were two contralateral breast recurrences at intervals of 34 and 36 months; 1 of these patients also had a multifocal, ipsilateral recurrence at 58 months, as previously described. Among patients with any breast recurrence, 1 patient had a family history of prostate cancer; there was no family history of breast or ovarian cancer. Of 17 patients who received adjuvant systemic therapy, only 1 had a breast recurrence. Conclusions In this pilot study, breast recurrences outside of the Lumpectomy site were the predominant pattern of recurrence.
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METHOD OF LOCALIZATION AND IMPLANTATION OF THE Lumpectomy SITE FOR HIGH DOSE RATE BRACHYTHERAPY AFTER CONSERVATIVE SURGERY FOR T1 AND T2 BREAST CANCER
International Journal of Radiation Oncology Biology Physics, 1995Co-Authors: Francisco Perera, Frank Chisela, Jay Engel, Varagur VenkatesanAbstract:Abstract Purpose : This article describes our technique of localization and implantation of the Lumpectomy site of patients with T1 and T2 breast cancer. Our method was developed as part of our Phase I/II pilot study of high dose rate (HDR) brachytherapy alone after conservative surgery for early breast cancer. Methods and Materials : In March 1992, we started a pilot study of HDR brachytherapy to the Lumpectomy site as the sole radiotherapy after conservative surgery for clinical T1 or T2 invasive breast cancer. Initially, the protocol required intraoperative placement of the interstitial needles at the time of definitive surgery to the breast. The protocol was then generalized to allow the implantation of the Lumpectomy site after definitive surgery to the breast, either at the time of subsequent axillary nodal dissection or postoperatively. To date, five patients have been implanted intraoperatively at the time of definitive breast surgery. Twelve patients were implanted after definitive breast surgery, with 7 patients being done at the time of axillary nodal dissection and 5 patients postoperatively. We devised a method of accurately localizing and implanting the Lumpectomy site after definitive breast surgery. The method relies on the previous placement of surgical clips by the referring surgeon to mark the Lumpectomy site. For each patient, a breast mold is made with radio-opaque angiocatheters taped onto the mold in the supero-inferior direction. A planning CT scan is then obtained through the Lumpectomy site. The volume of the Lumpectomy site, the number of implant planes necessary, and the orientation of the implants are then determined from the CT scan. The angiocatheters provide a reference grid on the CT films to locate the entry and exit points of the interstitial needles on the plastic mold. The entry and exit points for reference needles are then transferred onto the patient's skin enabling implantation of the Lumpectomy site. Needle positions with respect to the Lumpectomy site are then verified using simulator radiographs. Results : Eight double plane implants and four single plane implants have been done using this method. Five implants were done using direct visualization. It has not been necessary to reorient the implant in any of the patients. If not for the presence of surgical clips, the size of the Lumpectomy site cannot be separated from the surrounding normal breast tissue. Conclusion : This technique is an accurate way to localize the Lumpectomy site for HDR brachytherapy.
Edwin R Fisher - One of the best experts on this subject based on the ideXlab platform.
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twenty year follow up of a randomized trial comparing total mastectomy Lumpectomy and Lumpectomy plus irradiation for the treatment of invasive breast cancer
The New England Journal of Medicine, 2002Co-Authors: Bernard Fisher, Stewart J Anderson, John Bryant, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Jonghyeon Jeong, Norman WolmarkAbstract:Background In 1976, we initiated a randomized trial to determine whether Lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Methods A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, Lumpectomy alone, or Lumpectomy and breast irradiation. Kaplan–Meier and cumulative-incidence estimates of the outcome were obtained. Results The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent Lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent Lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease–free survival, or overall survival. The hazard ratio for death among the women who underwent Lumpectomy alone, as compared with those wh...
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tamoxifen in treatment of intraductal breast cancer national surgical adjuvant breast and bowel project b 24 randomised controlled trial
The Lancet, 1999Co-Authors: Bernard Fisher, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Lawrence D Wickerham, Roy E Smith, Mirsada Begovic, Nikolay V Dimitrov, Richard G MargoleseAbstract:Summary Background We have shown previously that Lumpectomy with radiation therapy was more effective than Lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether Lumpectomy, radiation therapy, and tamoxifen was of more benefit than Lumpectomy and radiation therapy alone for DCIS. Methods 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned Lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or Lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57–93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. Flndings Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8·2 vs 13·4%, p=0·0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4·1% at 5 years: 2·1% in the ipsilateral breast, 1·8% in the contralateral breast, and 0·2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. Interpretation The combination of Lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.
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Lumpectomy and radiation therapy for the treatment of intraductal breast cancer findings from national surgical adjuvant breast and bowel project b 17
Journal of Clinical Oncology, 1998Co-Authors: Bernard Fisher, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, James J Dignam, Eleftherios P Mamounas, Joseph P Costantino, W Poller, D L Wickerham, Richard G MargoleseAbstract:PURPOSEIn 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after Lumpectomy concluded that the combination was more beneficial than Lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.PATIENTS AND METHODSWomen (N = 818) with localized DCIS were randomly assigned to Lumpectomy or Lumpectomy plus radiation (50 Gy). Tissue was removed so that resected specimen margins were histologically tumor-free. Mean follow-up time was 90 months (range, 67 to 130). Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment. Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.RESULTSThe benefit of Lumpectomy plus radiation was virtually unchan...
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pathologic findings from the national surgical adjuvant breast project nsabp protocol b 17 intraductal carcinoma ductal carcinoma in situ
Cancer, 1995Co-Authors: Edwin R Fisher, Bernard Fisher, Joseph P Costantino, Alka Palekar, Carol K. RedmondAbstract:Background. Controversy exists concerning the natural history of ductal carcinoma in situ (DCIS) of the breast, including its pathologic expression and treatment. This controversy has been fostered largely by the retrospective nature and limited sample sizes of extant studies. Method. Resolution of some of these issues was attempted by analyzing the pathologic features of 573 examples of DCIS obtained from a larger cohort of 790 women with DCIS enrolled in Protocol B-17 of the National Surgical Adjuvant Breast Project. This prospective randomized clinical trial was performed to assess the efficacy of local breast irradiation to reduce the incidence of second ipsilateral breast tumors (IBT) after Lumpectomy. Results. Tumor and patient characteristics, including significantly less IBT for those treated by Lumpectomy and irradiation than Lumpectomy alone, were almost identical for the subset comprising this analysis and the total B-17 cohort reported previously. The presence of moderate/marked comedo necrosis, which was evaluated as an independent parameter rather than as a specific histologic type of DCIS and uncertain/involved Lumpectomy margins were the only statistically significant independent predictors of IBT for patients treated by Lumpectomy as well as irradiation. The latter markedly reduced the annual hazard rates for the IBT associated with these indicators. Conclusions. Although not an endpoinl of this study, the authors' findings suggest that the beneficial effect of irradiation in reducing IBT after Lumpectomy for DCIS occurs with small (<1.0 cm.) and larger lesions. Moderate/marked comedo necrosis and uncertain/involved Lumpectomy margins represent independent predictors of IBT. Cancer 1995;75:1310-9.
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Lumpectomy Compared with Lumpectomy and Radiation Therapy for the Treatment of Intraductal Breast Cancer
The New England journal of medicine, 1993Co-Authors: Bernard Fisher, Richard G Margolese, Melvin Deutsch, Edwin R Fisher, Norman Wolmark, Joseph P Costantino, D L Wickerham, Nikolay V Dimitrov, Carol K. Redmond, Liora OreAbstract:Background and Methods Women with ductal carcinoma in situ have been treated both by Lumpectomy and by Lumpectomy followed by radiation therapy, but the benefit of combined therapy is uncertain. A group of 818 women with ductal carcinoma in situ were randomly assigned to undergo Lumpectomy or Lumpectomy followed by breast irradiation (50 Gy). Sufficient tissue was removed that the margins of the resected specimens were histologically tumor-free. The mean duration of follow-up was 43 months (range, 11 to 86). The principal end point of the study was event-free survival, as defined by the presence of no new ipsilateral or contralateral breast cancers, regional or distant metastases, or other cancers and by no deaths from causes other than cancer. Results Five-year event-free survival was better in the women who received breast irradiation (84.4 percent, vs. 73.8 percent for the women treated by Lumpectomy alone; P = 0.001). The improvement was due to a reduction in the occurrence of second ipsilateral breas...
