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2–44 Full-Dose Intraoperative Radiotherapy With Electrons During Breast-Conserving Surgery: Experience With 590 Cases
2–43
Breast Conserving Surgery and Accelerated Partial Breast Irradiation Using the MammoSite System: Initial Clinical Experience DiFronzo LA, Tsai PI, Hwang JM, et al (Kaiser West Los Angeles Med Ctr) Arch Surg 140:787-794, 2005
Hypothesis.—Balloon catheterbased accelerated partial breast irradiation (APBI) may result in desirable short-term outcomes in patients undergoing breast conserving surgery. Design.—Prospective consecutive case series. Setting.—Tertiary multidisciplinary referral center. Patients.—Forty selected patients with invasive breast carcinoma undergoing breast conserving surgery and MammoSite device placement. Interventions.—Breast conserving surgery, sentinel and/or axillary node dissection, placement of the new balloon catheter applicator (MammoSite device), and APBI. Main Outcome Measures.—Infection, early and late seroma, device explantation, time to initiating APBI, acute toxic effects on the skin, and cosmesis using the Harvard Scale.
2–44
Full-Dose Intraoperative Radiotherapy With Electrons During Breast-Conserving Surgery: Experience With 590 Cases Veronesi U, Orecchia R, Luini A, et al (Istituto Europeo di Oncologia, Milan, Italy; Univ of Milan, Italy) Ann Surg 242:101-106, 2005
Background.—Previous studies show that local recurrences after breastconserving treatment occur in the site of
Results.—Thirty-nine patients underwent MammoSite device placement at the time of lumpectomy; 1 patient underwent percutaneous device placement after lumpectomy. Nineteen patients (49%) had drainage catheters placed in the breast cavity at the time of lumpectomy. Wound infection developed in 3 patients (8%). Five devices (12%) were explanted because of unfavorable final pathological findings or infection. The mean time to the start of APBI in patients who did not undergo simultaneous drain placement was 7.2 days (range, 5-12 days), compared with 5.1 days (range, 3-8 days) in patients who did (P = .008). With a mean follow-up of 13.3 months (range, 2-28 months), patients completing APBI had limited toxic effects on the skin, with excellent or good cosmetic results in 39 patients (97%). Conclusions.—Use of the MammoSite system in APBI has favorable short-term outcomes. Infection and radiation treatment delay are common and may warrant use of perioperative antibiotics and drain placement, respectively. A small number of patients who have device placement at the time of lumpectomy will require explantation because of unfavorable final pathological findings. Short-term outcomes of MammoSite brachytherapy support further studies comparing APBI with standard whole
breast irradiation in patients undergoing breast conserving surgery.
the primary tumor. The need for postoperative radiotherapy on the whole breast is challenged in favor of radiotherapy limited to the area of the breast at high risk of recurrence. The new mobile linear accelerators easily moved close to the operating table to allow the full-dose irradiation during surgery. Patients and Methods.—From July 1999 to December 2003, 590 patients affected by unifocal breast carcinoma up to a diameter of 2.5 cm received wide resection of the breast followed by intraoperative radiotherapy with electrons (ELIOT). Most patients received 21 Gy
intraoperatively, biologically equivalent to 58 to 60 Gy in standard fractionation. Patients were evaluated 1, 3, 6, and 12 months after surgery, and thereafter every 6 months, to look for early, intermediate, late complications, and other events. Results.—After a follow-up from 4 to 57 months (mean, 24 months; median, 20 months), 19 patients (3.2%) developed breast fibrosis, mild in 18, severe in 1, which resolved within 24 months. Three patients (0.5%) developed local recurrences, 3 patients ipsilateral carcinomas in other quadrants and other 5 patients contralateral breast carcinoma.
The authors described their initial experience with the MammoSite balloon brachytherapy catheter. As was true for many of the early articles on this technique, a risk of infection was noted and the importance of excellent catheter care was stressed. In a large group of patients (more than 1,550) treated on the American Society of Breast Surgeons registry trial, the catheter-related infection rate was 5%. Most practitioners who are experienced with this technique (ie, have used it for more than 100 patients) find that meticulous catheter care can reduce that rate to less than 3%. The authors recommended using a drain to keep serous fluid from soaking the dressings for patients undergoing intraoperative placement of the catheter. In my practice I have not found that necessary, preferring instead to change dressings twice daily. I consider it better to avoid placing an additional foreign object in the patient, especially adjacent to the balloon where it might cause a balloon rupture. M. E. Keisch, MD
®
Breast Diseases: A Year Book Quarterly Vol 17 No 2 2006
183 183
One patient (0.2%) died of distant metastases. Conclusions.—ELIOT is a safe method for treating conservatively operated breasts, avoids the long period of postoperative radiotherapy, and reduces drasti-
cally the cost of radiotherapy. ELIOT reduces radiation to normal tissues and organs. Results on short-term and middleterm toxicity up to 5 years of follow-up are good. Data on local control are encouraging.
A comment on this and the following abstract appears after the following abstract.
2–45
lae, and local or systemic events were noted in these patients after a mean follow-up of 27.3 months. Conclusions.—In appropriated selected patients, when it is critical to perform PFR after breast-conserving therapy, a single dose of ELIOT may be considered to avoid mastectomy, reduce potential treatment toxicity, improve quality of life, and resolve logistic problems. The long-term results of ongoing clinical trials will further delineate patients in whom ELIOT may replace PFR.
ELIOT to most patients was 21 Gy, which according to the authors was equivalent to about 60 Gy given in 2-Gy fractions over a period of 6 weeks. Although patient age or tumor histology did not seem to have been selection factors, the fact that 90% of the tumors were smaller than 2.5 cm is important to note. Because an extensive intraductal component was an exclusion criterion and because most patients underwent wide local excision or quadrantectomy, presumably most patients had negative surgical margins. Initially, the authors considered involvement of the axillary lymph nodes as a possible contraindication to the use of this procedure but now, based on their experience, they state “. . . that there are no logical reasons for this position,” assuming that axillary involvement, if any, “may be of very limited dimension and therefore may be resolved with conserving surgery and local radiotherapy.” Incidentally, 394 patients (82%) had negative findings on sentinel node biopsy and did not undergo axillary dissection, whereas 66 patients (14%) with sentinel node metastases underwent axillary dissection. An additional 100 patients underwent wide excision quadrantectomy with complete axillary dissection because of clinical suspicion of axillary node metastasis; disease in 68 of these patients was histologically confirmed. At a mean follow-up time of 24 months (range, 4-57 months) only 3 patients (0.5%) had developed local recurrence and another 3 patients experienced ipsilateral second primary breast
Full-Dose Intraoperative Radiotherapy With Electrons in Breast Surgery Intra M, Leonardi C, Luini A, et al (European Inst of Oncology, Milan, Italy; Univ of Milan School of Medicine, Italy) Arch Surg 140:936-939, 2005
Hypothesis.—Although postoperative fractionated radiotherapy (PFR) remains the standard method for conservative treatment of breast carcinomas, widespread experience in the use of fulldose intraoperative radiotherapy with electrons (ELIOT) merits its application in novel clinical situations, although longterm results of ongoing clinical trials have not been fully reported. Design.—Retrospective case series. Setting.—Division of breast surgery in a comprehensive cancer center. Patients.—From June 1999 to September 2003 ELIOT was used as the sole radiotherapy in 355 patients with unifocal invasive carcinoma who were candidates for breast-conserving surgery and most of whom were participating in an ongoing institutional trial. In a group of patients in whom PFR was not considered safe or feasible (because of previous mantle field irradiation for Hodgkin disease, cosmetic breast augmentation, severe cardiopathy, large hypertrophic scarring from skin burns, vitiligo, and geographic or social obstacles), ELIOT was performed outside of the ongoing trial. Results.—No particular adverse effects, unusual acute reactions, late seque-
184 184
®
Recent years have seen increased interest in the clinical application of partial breast irradiation, delivered by a variety of methods, in the context of breast conservation therapy for patients with invasive breast cancer at suitable stages. The range of techniques used includes brachytherapy (either with interstitial implants or MammoSite catheters), intraoperative low-kV x-rays, external-beam irradiation (of the 3-dimensional conformal or intensity-modulated types), or intraoperative electron beam, as reported here. The group at the European Institute of Oncology in Milan have pioneered postoperative radiotherapy approaches and have accumulated substantial experience with various techniques. In the first article abstracted here (Abstract 2–44), Veronesi and colleagues discussed results from 590 patients, most of whom had invasive unifocal ductal carcinoma, with tumors smaller than 2.5 cm. The single radiation dose given by
Breast Diseases: A Year Book Quarterly Vol 17 No 2 2006
Breast Conserving Surgery and Accelerated Partial Breast Irradiation Using the MammoSite System: Initial Clinical Experience DiFronzo LA, Tsai PI, Hwang JM, et al (Kaiser West Los Angeles Med Ctr) Arch Surg 140:787-794, 2005
Hypothesis.—Balloon catheterbased accelerated partial breast irradiation (APBI) may result in desirable short-term outcomes in patients undergoing breast conserving surgery. Design.—Prospective consecutive case series. Setting.—Tertiary multidisciplinary referral center. Patients.—Forty selected patients with invasive breast carcinoma undergoing breast conserving surgery and MammoSite device placement. Interventions.—Breast conserving surgery, sentinel and/or axillary node dissection, placement of the new balloon catheter applicator (MammoSite device), and APBI. Main Outcome Measures.—Infection, early and late seroma, device explantation, time to initiating APBI, acute toxic effects on the skin, and cosmesis using the Harvard Scale.
2–44
Full-Dose Intraoperative Radiotherapy With Electrons During Breast-Conserving Surgery: Experience With 590 Cases Veronesi U, Orecchia R, Luini A, et al (Istituto Europeo di Oncologia, Milan, Italy; Univ of Milan, Italy) Ann Surg 242:101-106, 2005
Background.—Previous studies show that local recurrences after breastconserving treatment occur in the site of
Results.—Thirty-nine patients underwent MammoSite device placement at the time of lumpectomy; 1 patient underwent percutaneous device placement after lumpectomy. Nineteen patients (49%) had drainage catheters placed in the breast cavity at the time of lumpectomy. Wound infection developed in 3 patients (8%). Five devices (12%) were explanted because of unfavorable final pathological findings or infection. The mean time to the start of APBI in patients who did not undergo simultaneous drain placement was 7.2 days (range, 5-12 days), compared with 5.1 days (range, 3-8 days) in patients who did (P = .008). With a mean follow-up of 13.3 months (range, 2-28 months), patients completing APBI had limited toxic effects on the skin, with excellent or good cosmetic results in 39 patients (97%). Conclusions.—Use of the MammoSite system in APBI has favorable short-term outcomes. Infection and radiation treatment delay are common and may warrant use of perioperative antibiotics and drain placement, respectively. A small number of patients who have device placement at the time of lumpectomy will require explantation because of unfavorable final pathological findings. Short-term outcomes of MammoSite brachytherapy support further studies comparing APBI with standard whole
breast irradiation in patients undergoing breast conserving surgery.
the primary tumor. The need for postoperative radiotherapy on the whole breast is challenged in favor of radiotherapy limited to the area of the breast at high risk of recurrence. The new mobile linear accelerators easily moved close to the operating table to allow the full-dose irradiation during surgery. Patients and Methods.—From July 1999 to December 2003, 590 patients affected by unifocal breast carcinoma up to a diameter of 2.5 cm received wide resection of the breast followed by intraoperative radiotherapy with electrons (ELIOT). Most patients received 21 Gy
intraoperatively, biologically equivalent to 58 to 60 Gy in standard fractionation. Patients were evaluated 1, 3, 6, and 12 months after surgery, and thereafter every 6 months, to look for early, intermediate, late complications, and other events. Results.—After a follow-up from 4 to 57 months (mean, 24 months; median, 20 months), 19 patients (3.2%) developed breast fibrosis, mild in 18, severe in 1, which resolved within 24 months. Three patients (0.5%) developed local recurrences, 3 patients ipsilateral carcinomas in other quadrants and other 5 patients contralateral breast carcinoma.
The authors described their initial experience with the MammoSite balloon brachytherapy catheter. As was true for many of the early articles on this technique, a risk of infection was noted and the importance of excellent catheter care was stressed. In a large group of patients (more than 1,550) treated on the American Society of Breast Surgeons registry trial, the catheter-related infection rate was 5%. Most practitioners who are experienced with this technique (ie, have used it for more than 100 patients) find that meticulous catheter care can reduce that rate to less than 3%. The authors recommended using a drain to keep serous fluid from soaking the dressings for patients undergoing intraoperative placement of the catheter. In my practice I have not found that necessary, preferring instead to change dressings twice daily. I consider it better to avoid placing an additional foreign object in the patient, especially adjacent to the balloon where it might cause a balloon rupture. M. E. Keisch, MD
®
Breast Diseases: A Year Book Quarterly Vol 17 No 2 2006
183 183
One patient (0.2%) died of distant metastases. Conclusions.—ELIOT is a safe method for treating conservatively operated breasts, avoids the long period of postoperative radiotherapy, and reduces drasti-
cally the cost of radiotherapy. ELIOT reduces radiation to normal tissues and organs. Results on short-term and middleterm toxicity up to 5 years of follow-up are good. Data on local control are encouraging.
A comment on this and the following abstract appears after the following abstract.
2–45
lae, and local or systemic events were noted in these patients after a mean follow-up of 27.3 months. Conclusions.—In appropriated selected patients, when it is critical to perform PFR after breast-conserving therapy, a single dose of ELIOT may be considered to avoid mastectomy, reduce potential treatment toxicity, improve quality of life, and resolve logistic problems. The long-term results of ongoing clinical trials will further delineate patients in whom ELIOT may replace PFR.
ELIOT to most patients was 21 Gy, which according to the authors was equivalent to about 60 Gy given in 2-Gy fractions over a period of 6 weeks. Although patient age or tumor histology did not seem to have been selection factors, the fact that 90% of the tumors were smaller than 2.5 cm is important to note. Because an extensive intraductal component was an exclusion criterion and because most patients underwent wide local excision or quadrantectomy, presumably most patients had negative surgical margins. Initially, the authors considered involvement of the axillary lymph nodes as a possible contraindication to the use of this procedure but now, based on their experience, they state “. . . that there are no logical reasons for this position,” assuming that axillary involvement, if any, “may be of very limited dimension and therefore may be resolved with conserving surgery and local radiotherapy.” Incidentally, 394 patients (82%) had negative findings on sentinel node biopsy and did not undergo axillary dissection, whereas 66 patients (14%) with sentinel node metastases underwent axillary dissection. An additional 100 patients underwent wide excision quadrantectomy with complete axillary dissection because of clinical suspicion of axillary node metastasis; disease in 68 of these patients was histologically confirmed. At a mean follow-up time of 24 months (range, 4-57 months) only 3 patients (0.5%) had developed local recurrence and another 3 patients experienced ipsilateral second primary breast
Full-Dose Intraoperative Radiotherapy With Electrons in Breast Surgery Intra M, Leonardi C, Luini A, et al (European Inst of Oncology, Milan, Italy; Univ of Milan School of Medicine, Italy) Arch Surg 140:936-939, 2005
Hypothesis.—Although postoperative fractionated radiotherapy (PFR) remains the standard method for conservative treatment of breast carcinomas, widespread experience in the use of fulldose intraoperative radiotherapy with electrons (ELIOT) merits its application in novel clinical situations, although longterm results of ongoing clinical trials have not been fully reported. Design.—Retrospective case series. Setting.—Division of breast surgery in a comprehensive cancer center. Patients.—From June 1999 to September 2003 ELIOT was used as the sole radiotherapy in 355 patients with unifocal invasive carcinoma who were candidates for breast-conserving surgery and most of whom were participating in an ongoing institutional trial. In a group of patients in whom PFR was not considered safe or feasible (because of previous mantle field irradiation for Hodgkin disease, cosmetic breast augmentation, severe cardiopathy, large hypertrophic scarring from skin burns, vitiligo, and geographic or social obstacles), ELIOT was performed outside of the ongoing trial. Results.—No particular adverse effects, unusual acute reactions, late seque-
184 184
®
Recent years have seen increased interest in the clinical application of partial breast irradiation, delivered by a variety of methods, in the context of breast conservation therapy for patients with invasive breast cancer at suitable stages. The range of techniques used includes brachytherapy (either with interstitial implants or MammoSite catheters), intraoperative low-kV x-rays, external-beam irradiation (of the 3-dimensional conformal or intensity-modulated types), or intraoperative electron beam, as reported here. The group at the European Institute of Oncology in Milan have pioneered postoperative radiotherapy approaches and have accumulated substantial experience with various techniques. In the first article abstracted here (Abstract 2–44), Veronesi and colleagues discussed results from 590 patients, most of whom had invasive unifocal ductal carcinoma, with tumors smaller than 2.5 cm. The single radiation dose given by
Breast Diseases: A Year Book Quarterly Vol 17 No 2 2006