- Email: [email protected]
T2 breast cancer
Proceedings of the 43rd Annual ASTRO Meeting
Materials and Methods: The institutional prospective breast cancer database was searched by patient age, date of birth, date of first diagnosis between January 1, 1992 and December 31, 1995, tumor size, Scarff-Bloom-Richardson (SBR) grade, number of lymph nodes removed, number of lymph nodes positive, and estrogen and progesterone receptor status. Last known patient status was censored from this list. Of the 840 patients, 39 were matched exactly with a corresponding brachytherapy patient for high SBR grade (7/group), nodal status (6 node positive/group), and the use of chemotherapy (4/group). The pairs were also matched as closely as possible by date of diagnosis (⫹/- 2 years), age (⫹/- 5 years), and tumor size (⫹/- 0.5 cm). All patients had non-lobular histology and no patient had known positive margins. Three patients in each group had extensive intraductal component (EIC) positive cancers. Paired comparison of outcomes was done using McNemar’s Chi-square. Breast radiation was 37.2 Gy (minimum peripheral dose to the lumpectomy site) in 10 fractions bid over 5 to 7 days in group B and either 40 Gy in 16 fractions over 3 1⁄2 weeks with a lumpectomy boost of 12.5 Gy in 5 fractions over 1 week or 50 Gy in 25 fractions over 5 weeks with a lumpectomy boost of 10 Gy in 5 fractions over 1 week in Group C. Results: Median age was 59 years for both groups and median follow-up was similar at 60 months. Thirteen women in the brachytherapy group B and 10 in the control group C received tamoxifen. Margin status was ⱕ 2 mm, ⬎ 2 mm, and unknown in 12, 21 and 6 patients in group B and in 8, 10 and 11 patients in group C, respectively (p not significant). There were no significant differences in patient age, tumor size, and use of systemic therapy. Six patients in group C, and none in group B, had lymphatic vessel invasion in the primary tumor (p⫽0.014). One patient in group C and 1 in group B were lost to follow-up after 2 years and 5 years, respectively. One in group C and 5 patients in group B have died of any cause. There were six ipsilateral breast recurrences in group B versus 1 in group C with a trend towards significance (p⫽0.059). Four of the 6 recurrences in group B were outside the lumpectomy site. There were 2 contralateral breast recurrences in group B versus 1 in group C. The comparison of any breast recurrence (8 versus 2) also had a trend towards significance (p⫽0.058). There were significantly more total recurrences (local and distant) in group B 14 versus group C 3 (p⫽0.008) but only one patient in group B with breast recurrence has developed distant metastases. Conclusion: This study suggests that HDR brachytherapy to the lumpectomy site and without the routine use of systemic therapy, is less effective than conventional whole breast radiation. A randomized clinical trial would be more definitive.
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A Phase I/II Study of HDR Brachytherapy Alone for T1/T2 Breast Cancer 1
L. Berle , D. Lowther1, T. DiPetrillo1,2,3, B. Cady3, R. Graham1, J. Rothschild1, T. Graves2, M. Chung3, R. Ruthazer1, D. Wazer1,2,3 1 Radiation Oncology, Surgery, and Medicine, New England Medical Center, Tufts University School of Medicine, Boston, MA, 2Radiation Oncology and Surgery, Rhode Island Hospital, Brown University School of Medicine, Providence, RI, 3 Breast Health Center, Women and Infants Hospital, Providence, RI Purpose: To investigate the feasibility, toxicity, cosmetic outcome and local control of HDR brachytherapy alone for early stage breast carcinoma. Materials and Methods: From 6/97 until 8/99, 34 breasts in 33 women with stage I/II carcinoma had surgical excision and post-operative irradiation via HDR brachytherapy implant as part of a multi-institutional clinical phase I/II protocol. Patients eligible included those with T1/T2, N0, N1 (ⱕ3 nodes (⫹)), tumors of non-lobular histology with negative surgical margins, and no extra-capsular nodal extension. Brachytherapy catheters were placed at the initial excision, re-excision, or at the time of sentinel/full axillary node sampling. The target volume was defined as the excision cavity plus 2 cm margin. High activity 192 Ir (3-10 Ci) was used to deliver 340 cGy per fraction BID, for five consecutive days to a total dose of 34 Gy. Results: The median follow-up of all patients was 26 months (range: 9-44 months). The median patient age was 65 years, the median tumor size was 12 mm (range: 5-25mm) and 55% had an extensive intraductal component. Three patients had positive axillary lymph nodes. There were no peri- or post-operative infections. There were no wound healing problems and no significant skin reactions related to the implant. In the assessment of late skin toxicity, 31 cases were RTOG grade 0-1 and 3 cases were grade 2. Subcutaneous toxicity was scored as 13 cases grade 0, 3 cases grade 1, 8 cases grade 2, 2 cases grade 3, and 8 cases grade 4. Clinically evident fat necrosis occurred in 8 cases at a median of 7.5 months after completion of HDR brachytherapy. The only variables significantly associated with grade 3/4 toxicity were the number of source dwell positions and the volume of tissue encompassed by the prescription isodose shell. Cosmetic scoring after a minimum of 18 months follow-up was: 3 fair, 5 good, 22 excellent. There has been one case of ipsilateral breast failure diagnosed 24 months after HDR brachytherapy. This failure appeared to be a new primary tumor as it was histologically distinct from the initial tumor and was located 9 cm from the initial tumor bed and 3 cm from the implant volume. Conclusions: Treatment of the tumor bed alone with HDR interstitial brachytherapy is associated with a 29% incidence of grade 3/4 subcutaneous toxicity, though with generally favorable overall cosmetic outcomes. The risk of toxicity appears to be primarily related to implant volume. With limited follow-up, there is a low incidence of ipsilateral breast tumor recurrence.
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Materials and Methods: The institutional prospective breast cancer database was searched by patient age, date of birth, date of first diagnosis between January 1, 1992 and December 31, 1995, tumor size, Scarff-Bloom-Richardson (SBR) grade, number of lymph nodes removed, number of lymph nodes positive, and estrogen and progesterone receptor status. Last known patient status was censored from this list. Of the 840 patients, 39 were matched exactly with a corresponding brachytherapy patient for high SBR grade (7/group), nodal status (6 node positive/group), and the use of chemotherapy (4/group). The pairs were also matched as closely as possible by date of diagnosis (⫹/- 2 years), age (⫹/- 5 years), and tumor size (⫹/- 0.5 cm). All patients had non-lobular histology and no patient had known positive margins. Three patients in each group had extensive intraductal component (EIC) positive cancers. Paired comparison of outcomes was done using McNemar’s Chi-square. Breast radiation was 37.2 Gy (minimum peripheral dose to the lumpectomy site) in 10 fractions bid over 5 to 7 days in group B and either 40 Gy in 16 fractions over 3 1⁄2 weeks with a lumpectomy boost of 12.5 Gy in 5 fractions over 1 week or 50 Gy in 25 fractions over 5 weeks with a lumpectomy boost of 10 Gy in 5 fractions over 1 week in Group C. Results: Median age was 59 years for both groups and median follow-up was similar at 60 months. Thirteen women in the brachytherapy group B and 10 in the control group C received tamoxifen. Margin status was ⱕ 2 mm, ⬎ 2 mm, and unknown in 12, 21 and 6 patients in group B and in 8, 10 and 11 patients in group C, respectively (p not significant). There were no significant differences in patient age, tumor size, and use of systemic therapy. Six patients in group C, and none in group B, had lymphatic vessel invasion in the primary tumor (p⫽0.014). One patient in group C and 1 in group B were lost to follow-up after 2 years and 5 years, respectively. One in group C and 5 patients in group B have died of any cause. There were six ipsilateral breast recurrences in group B versus 1 in group C with a trend towards significance (p⫽0.059). Four of the 6 recurrences in group B were outside the lumpectomy site. There were 2 contralateral breast recurrences in group B versus 1 in group C. The comparison of any breast recurrence (8 versus 2) also had a trend towards significance (p⫽0.058). There were significantly more total recurrences (local and distant) in group B 14 versus group C 3 (p⫽0.008) but only one patient in group B with breast recurrence has developed distant metastases. Conclusion: This study suggests that HDR brachytherapy to the lumpectomy site and without the routine use of systemic therapy, is less effective than conventional whole breast radiation. A randomized clinical trial would be more definitive.
4
A Phase I/II Study of HDR Brachytherapy Alone for T1/T2 Breast Cancer 1
L. Berle , D. Lowther1, T. DiPetrillo1,2,3, B. Cady3, R. Graham1, J. Rothschild1, T. Graves2, M. Chung3, R. Ruthazer1, D. Wazer1,2,3 1 Radiation Oncology, Surgery, and Medicine, New England Medical Center, Tufts University School of Medicine, Boston, MA, 2Radiation Oncology and Surgery, Rhode Island Hospital, Brown University School of Medicine, Providence, RI, 3 Breast Health Center, Women and Infants Hospital, Providence, RI Purpose: To investigate the feasibility, toxicity, cosmetic outcome and local control of HDR brachytherapy alone for early stage breast carcinoma. Materials and Methods: From 6/97 until 8/99, 34 breasts in 33 women with stage I/II carcinoma had surgical excision and post-operative irradiation via HDR brachytherapy implant as part of a multi-institutional clinical phase I/II protocol. Patients eligible included those with T1/T2, N0, N1 (ⱕ3 nodes (⫹)), tumors of non-lobular histology with negative surgical margins, and no extra-capsular nodal extension. Brachytherapy catheters were placed at the initial excision, re-excision, or at the time of sentinel/full axillary node sampling. The target volume was defined as the excision cavity plus 2 cm margin. High activity 192 Ir (3-10 Ci) was used to deliver 340 cGy per fraction BID, for five consecutive days to a total dose of 34 Gy. Results: The median follow-up of all patients was 26 months (range: 9-44 months). The median patient age was 65 years, the median tumor size was 12 mm (range: 5-25mm) and 55% had an extensive intraductal component. Three patients had positive axillary lymph nodes. There were no peri- or post-operative infections. There were no wound healing problems and no significant skin reactions related to the implant. In the assessment of late skin toxicity, 31 cases were RTOG grade 0-1 and 3 cases were grade 2. Subcutaneous toxicity was scored as 13 cases grade 0, 3 cases grade 1, 8 cases grade 2, 2 cases grade 3, and 8 cases grade 4. Clinically evident fat necrosis occurred in 8 cases at a median of 7.5 months after completion of HDR brachytherapy. The only variables significantly associated with grade 3/4 toxicity were the number of source dwell positions and the volume of tissue encompassed by the prescription isodose shell. Cosmetic scoring after a minimum of 18 months follow-up was: 3 fair, 5 good, 22 excellent. There has been one case of ipsilateral breast failure diagnosed 24 months after HDR brachytherapy. This failure appeared to be a new primary tumor as it was histologically distinct from the initial tumor and was located 9 cm from the initial tumor bed and 3 cm from the implant volume. Conclusions: Treatment of the tumor bed alone with HDR interstitial brachytherapy is associated with a 29% incidence of grade 3/4 subcutaneous toxicity, though with generally favorable overall cosmetic outcomes. The risk of toxicity appears to be primarily related to implant volume. With limited follow-up, there is a low incidence of ipsilateral breast tumor recurrence.
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