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0116 Intra-operative radiotherapy for breast cancer in patients where external beam radiation was not possible - results after 3 years of follow-up
S48
Poster Session I. Radiotherapy/IORT
survival with PMRT in T1 or T2 breast cancer patients with 1−3 positive axillary nodes. Deprivation of adjuvant radiotherapy for this subset of patients appears to be unjustified.
0115
Intraoperative radiotherapy in early breast cancer − preliminary experience
M. Steiner1 , R. Rubinov2 , J. Goldman3 , M. Cederbaum4 , A. Front5 , P. Zeevi3 , A. Kremer6 , Y. Salit7 , A. Biterman7 , E. Shiloni6 . 1 Oncology, Carmel medical center, 2 Oncology, Lin Medical Center, 3 Radiology, 4 Oncology, 5 Nuclear Medicine, 6 Surgical Dep B, 7 Surgery Dep A, Carmel medical center, Haifa, Israel Goals: From September 2006 we introduced intraoperative radiotherapy as the only post lumpectomy breast irradiation in selected early breast cancer patients. Treatment was offered as an alternative to the standard post-operative whole breast external irradiation to patients older than 60 years with clinical tumors up to 2 cm and clinically negative axillary nodes. It was offered too to younger patients or patients with bigger tumors if they were not candidate for standard radical therapy. Methods: Intrabeam System was used giving 20 Gy at the surface of surgical cavity. 88 patients were treated with median age of 70 years (55−87). Median clinical tumor size was 10 mm (5−28). Results: Median pathologic tumor size was 13 mm (9−23). 62% of patients underwent immediate wider excision and pathologic free margins >2 mm were obtained in all patients. 10 pts (12%) were found to have positive axillary l-nodes involved (seven patient one node, two had two nodes and one had three involved nodes). Five patients had additional local breast therapy: two had EBRT (one due to extensive l-vascular involvement and one because of three positive l-nodes with extracapsular extension), one had wide local reexcision due to uncertain DCIS at surgical margins and two patients were recommended mastectomy due to diffuse DCIS and precancerous lesions. 27/88 patients (32%) had local complications, 3 wound infection (3.6%), 20 seromas (23%), 8 of them complicated, 3 (3.6%) had local bleeding or hematoma and one patient had a small skin necrosis. During the short follow up period (2−25 month, median 5, mean 6), no local or systemic failure were observed. Patients satisfaction is very high. Conclusion: We conclude that intraoperative radiotherapy using the Intrabeam system is feasible and may offer an alternative to post operative external whole breast irradiation in selected low risk early breast cancer patients. The rate of post operative seroma is higher than expected. Further follow up is necessary including cosmetic evaluation.
0116
Intra-operative radiotherapy for breast cancer in patients where external beam radiation was not possible − results after 3 years of follow-up
M. Keshtgar1 , J.S. Vaidya2 , A. Keller3 , F. Wenz3 , T. Corica4 , D. Joseph4 , C. Stacey5 , J.S. Tobias6 , N.R. Williams7 , M. Baum7 . 1 Department of Surgery, Royal Free Hospital, London, 2 Department of Surgery, ¨ Ninewells Hospital, Dundee, United Kingdom, 3 Universitatsklinik fur ¨ ¨ Strahlentherapie und Radioonkologie, Universitatsmedizin Mannheim, Mannheim, Germany, 4 Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia, 5 Radiotherapy Physics Group, 6 Department of Oncology, UCLH, 7 Clinical Trials Group, UCL, London, United Kingdom Goals: Intra-operative radiotherapy (IORT) with Intrabeam® (Carl Zeiss, Germany) has been used since 2000 in the international randomised TARGIT Trial, which is being run to determine if there is equivalence between the novel technique of IORT and conventional external beam radiotherapy (EBRT) in women with early breast cancer. The main outcome objective is risk of local relapse. Some patients were unsuitable for inclusion in the trial for a number of reasons (e.g. previous radiotherapy, co-morbidities, personal reasons) and were given IORT as a single treatment off-trial. Methods: Patients with invasive breast cancer underwent wide local excision followed by IORT (n = 74) using the Intrabeam® system containing a miniature electron gun and accelerator. Low energy x-rays (50kV) are emitted from the point source, delivering 20Gy to the breast tissue at the surface of the tumour bed using a spherical applicator. Radiotherapy is delivered directly into the area of interest, following which women can then proceed to have chemotherapy and/or adjuvant hormonal therapy as required. In addition, patients who were deemed unfit for surgery (n = 3)
Thursday, 12 March 2009 received interstitial radiotherapy alone using Intrabeam® , with only the point source placed at the centre of the tumour under stereo-guidance under local anaesthetic, and were followed up with serial MRI scans. Women were followed-up for local recurrence. Results: Over the past 7 years in centres in 3 countries (UK, Germany and Australia), 77 patients have been treated in this way, of median age 66 (56−77 IQR) years and with a median follow-up of 37 (25−54 IQR) months. To date there have been two local recurrences, which gives an estimated annual local recurrence rate of 0.78% (95 CI 0.09% to 2.77%). Conclusion: This cohort adds to the evidence that targeted radiotherapy using Intrabeam® could offer a safe and effective method of delivering radiotherapy to breast cancer patients in whom EBRT is not feasible or is not an option.
0117
Radiofrequency ablation of early breast cancer followed by delayed surgical resection
S. Ohtani1 , K. Higaki1 , M. Itoh1 , Y. Araki2 , S. Takada3 , H. Matsuura3 , T. Moriya4 . 1 Breast Surgery, 2 Hapatology, 3 Pathology, Hiroshima City Hospital, Hiroshima, 4 Pathology 2, Kawasaki Medical University, Kurashiki, Japan Goals: Radiofrequency ablation (RFA) is gaining acceptance as a treatment modality for several tumor types. However, its use in breast cancer remains investigational. The current study was undertaken to determine the feasibility of treating early breast cancer with RFA and to evaluate the cancer cell death and marginal clearance of ablation area by pathological study. Goals of this study were to examine the possibility of RFA as a local treatment option in early breast cancer patients instead of breast conserving surgery. Methods: Patients with core-needle biopsy-proven breast carcinoma (<1.5 cm in greatest dimension) underwent ultrasound-guided RFA under local anaesthesia. Surgical resection was undertaken 1−2 months later. MRI scans were performed before ablation and repeated before resection. Results: 35 patients completed the treatment and experienced minimal or no discomfort. The mean tumor size was 1.2 cm. The mean time required for ablation was 10.5 minutes. There were no treatment-related complications other than one low-grade skin burn. The Post-RFA MRI scan revealed no residual lesion enhancement in 29 of 30 (96%) patients who had enhancing tumor in pre-RFA MRI scan. One patient had residual enhancement consistent with residual tumor, which was confirmed histologically. Evaluation of ablated area could not revealed pathological complete cell death only by hematoxylin and eosin staining. On the other hand, histochemical analysis of tumor viability using the nicotinamide adenine dinucleotide-diaphorase (NADH) staining showed pathological complete cell death in whole ablated area including surgical margin. Conclusion: In this study, we found that RFA of breast cancer could be safely applied in an outpatient setting with good patient tolerance, and that RFA could kill the cancer cell in whole ablated area. Therefore RFA would be minimally invasive modality for the local treatment of early breast cancer instead of breast conserving surgery.
0118
A preliminary report of a phase I study of intraoperative radiotherapy (IORT) for early breast cancer in Japan
M. Sawaki1 , S. Sato1 , C. Kagawa1 , T. Yamada1 , H. Takada1 , T. Kikumori1 , K. Oda1 , S. Ishihara2 , Y. Ito2 , T. Imai1 . 1 Breast and Endocrine Surgery, 2 Radiology, Nagoya University School of Medicine, Nagoya, Japan Goals: To identify the IORT dose for early breast cancer in Japanese women Methods: A dose-finding phase I study was designed according to the principles of Veronesi (Milan) radiotherapy. The study used a scheme of dose-escalation from 19, 20, and 21 Gy at 90% isodose. Primary endpoint is early toxicity (within 3 months). Secondary endpoints are efficacy for a long period and late toxicity. Inclusion criteria: (1) T < 2.5 cm, (2) age > 50 years, (3) surgical margin >1 cm, (4) intraoperative pathologically free margins, (5) written informed consent. Exclusion criteria: (1) contraindications to radiation therapy, (2) extensive intraductal component. Procedures: Resection was performed in the same manner as in our standard breast conservative surgery, keeping at least a 1 cm-margin around the tumor. The status of the margins was assessed microscopically by frozen sections.
Poster Session I. Radiotherapy/IORT
survival with PMRT in T1 or T2 breast cancer patients with 1−3 positive axillary nodes. Deprivation of adjuvant radiotherapy for this subset of patients appears to be unjustified.
0115
Intraoperative radiotherapy in early breast cancer − preliminary experience
M. Steiner1 , R. Rubinov2 , J. Goldman3 , M. Cederbaum4 , A. Front5 , P. Zeevi3 , A. Kremer6 , Y. Salit7 , A. Biterman7 , E. Shiloni6 . 1 Oncology, Carmel medical center, 2 Oncology, Lin Medical Center, 3 Radiology, 4 Oncology, 5 Nuclear Medicine, 6 Surgical Dep B, 7 Surgery Dep A, Carmel medical center, Haifa, Israel Goals: From September 2006 we introduced intraoperative radiotherapy as the only post lumpectomy breast irradiation in selected early breast cancer patients. Treatment was offered as an alternative to the standard post-operative whole breast external irradiation to patients older than 60 years with clinical tumors up to 2 cm and clinically negative axillary nodes. It was offered too to younger patients or patients with bigger tumors if they were not candidate for standard radical therapy. Methods: Intrabeam System was used giving 20 Gy at the surface of surgical cavity. 88 patients were treated with median age of 70 years (55−87). Median clinical tumor size was 10 mm (5−28). Results: Median pathologic tumor size was 13 mm (9−23). 62% of patients underwent immediate wider excision and pathologic free margins >2 mm were obtained in all patients. 10 pts (12%) were found to have positive axillary l-nodes involved (seven patient one node, two had two nodes and one had three involved nodes). Five patients had additional local breast therapy: two had EBRT (one due to extensive l-vascular involvement and one because of three positive l-nodes with extracapsular extension), one had wide local reexcision due to uncertain DCIS at surgical margins and two patients were recommended mastectomy due to diffuse DCIS and precancerous lesions. 27/88 patients (32%) had local complications, 3 wound infection (3.6%), 20 seromas (23%), 8 of them complicated, 3 (3.6%) had local bleeding or hematoma and one patient had a small skin necrosis. During the short follow up period (2−25 month, median 5, mean 6), no local or systemic failure were observed. Patients satisfaction is very high. Conclusion: We conclude that intraoperative radiotherapy using the Intrabeam system is feasible and may offer an alternative to post operative external whole breast irradiation in selected low risk early breast cancer patients. The rate of post operative seroma is higher than expected. Further follow up is necessary including cosmetic evaluation.
0116
Intra-operative radiotherapy for breast cancer in patients where external beam radiation was not possible − results after 3 years of follow-up
M. Keshtgar1 , J.S. Vaidya2 , A. Keller3 , F. Wenz3 , T. Corica4 , D. Joseph4 , C. Stacey5 , J.S. Tobias6 , N.R. Williams7 , M. Baum7 . 1 Department of Surgery, Royal Free Hospital, London, 2 Department of Surgery, ¨ Ninewells Hospital, Dundee, United Kingdom, 3 Universitatsklinik fur ¨ ¨ Strahlentherapie und Radioonkologie, Universitatsmedizin Mannheim, Mannheim, Germany, 4 Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia, 5 Radiotherapy Physics Group, 6 Department of Oncology, UCLH, 7 Clinical Trials Group, UCL, London, United Kingdom Goals: Intra-operative radiotherapy (IORT) with Intrabeam® (Carl Zeiss, Germany) has been used since 2000 in the international randomised TARGIT Trial, which is being run to determine if there is equivalence between the novel technique of IORT and conventional external beam radiotherapy (EBRT) in women with early breast cancer. The main outcome objective is risk of local relapse. Some patients were unsuitable for inclusion in the trial for a number of reasons (e.g. previous radiotherapy, co-morbidities, personal reasons) and were given IORT as a single treatment off-trial. Methods: Patients with invasive breast cancer underwent wide local excision followed by IORT (n = 74) using the Intrabeam® system containing a miniature electron gun and accelerator. Low energy x-rays (50kV) are emitted from the point source, delivering 20Gy to the breast tissue at the surface of the tumour bed using a spherical applicator. Radiotherapy is delivered directly into the area of interest, following which women can then proceed to have chemotherapy and/or adjuvant hormonal therapy as required. In addition, patients who were deemed unfit for surgery (n = 3)
Thursday, 12 March 2009 received interstitial radiotherapy alone using Intrabeam® , with only the point source placed at the centre of the tumour under stereo-guidance under local anaesthetic, and were followed up with serial MRI scans. Women were followed-up for local recurrence. Results: Over the past 7 years in centres in 3 countries (UK, Germany and Australia), 77 patients have been treated in this way, of median age 66 (56−77 IQR) years and with a median follow-up of 37 (25−54 IQR) months. To date there have been two local recurrences, which gives an estimated annual local recurrence rate of 0.78% (95 CI 0.09% to 2.77%). Conclusion: This cohort adds to the evidence that targeted radiotherapy using Intrabeam® could offer a safe and effective method of delivering radiotherapy to breast cancer patients in whom EBRT is not feasible or is not an option.
0117
Radiofrequency ablation of early breast cancer followed by delayed surgical resection
S. Ohtani1 , K. Higaki1 , M. Itoh1 , Y. Araki2 , S. Takada3 , H. Matsuura3 , T. Moriya4 . 1 Breast Surgery, 2 Hapatology, 3 Pathology, Hiroshima City Hospital, Hiroshima, 4 Pathology 2, Kawasaki Medical University, Kurashiki, Japan Goals: Radiofrequency ablation (RFA) is gaining acceptance as a treatment modality for several tumor types. However, its use in breast cancer remains investigational. The current study was undertaken to determine the feasibility of treating early breast cancer with RFA and to evaluate the cancer cell death and marginal clearance of ablation area by pathological study. Goals of this study were to examine the possibility of RFA as a local treatment option in early breast cancer patients instead of breast conserving surgery. Methods: Patients with core-needle biopsy-proven breast carcinoma (<1.5 cm in greatest dimension) underwent ultrasound-guided RFA under local anaesthesia. Surgical resection was undertaken 1−2 months later. MRI scans were performed before ablation and repeated before resection. Results: 35 patients completed the treatment and experienced minimal or no discomfort. The mean tumor size was 1.2 cm. The mean time required for ablation was 10.5 minutes. There were no treatment-related complications other than one low-grade skin burn. The Post-RFA MRI scan revealed no residual lesion enhancement in 29 of 30 (96%) patients who had enhancing tumor in pre-RFA MRI scan. One patient had residual enhancement consistent with residual tumor, which was confirmed histologically. Evaluation of ablated area could not revealed pathological complete cell death only by hematoxylin and eosin staining. On the other hand, histochemical analysis of tumor viability using the nicotinamide adenine dinucleotide-diaphorase (NADH) staining showed pathological complete cell death in whole ablated area including surgical margin. Conclusion: In this study, we found that RFA of breast cancer could be safely applied in an outpatient setting with good patient tolerance, and that RFA could kill the cancer cell in whole ablated area. Therefore RFA would be minimally invasive modality for the local treatment of early breast cancer instead of breast conserving surgery.
0118
A preliminary report of a phase I study of intraoperative radiotherapy (IORT) for early breast cancer in Japan
M. Sawaki1 , S. Sato1 , C. Kagawa1 , T. Yamada1 , H. Takada1 , T. Kikumori1 , K. Oda1 , S. Ishihara2 , Y. Ito2 , T. Imai1 . 1 Breast and Endocrine Surgery, 2 Radiology, Nagoya University School of Medicine, Nagoya, Japan Goals: To identify the IORT dose for early breast cancer in Japanese women Methods: A dose-finding phase I study was designed according to the principles of Veronesi (Milan) radiotherapy. The study used a scheme of dose-escalation from 19, 20, and 21 Gy at 90% isodose. Primary endpoint is early toxicity (within 3 months). Secondary endpoints are efficacy for a long period and late toxicity. Inclusion criteria: (1) T < 2.5 cm, (2) age > 50 years, (3) surgical margin >1 cm, (4) intraoperative pathologically free margins, (5) written informed consent. Exclusion criteria: (1) contraindications to radiation therapy, (2) extensive intraductal component. Procedures: Resection was performed in the same manner as in our standard breast conservative surgery, keeping at least a 1 cm-margin around the tumor. The status of the margins was assessed microscopically by frozen sections.