Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: Five‐year results of a phase I–II study and initial findings of a randomized phase III trial

Journal of Surgical Oncology - Tập 80 Số 3 - Trang 121-128 - 2002
Csaba Polgár1, Zoltán Sulyok2, János Fodor1, Zsolt Horváth3, Tibor Major1, Zoltán Takácsi‐Nagy1, László Mangel1, A. Somogyi1, Miklós Kásler4, György Németh1
1Department of Radiotherapy, National Institute of Oncology, Budapest, Hungary
2Department of General and Thoracic Surgery, National Institute of Oncology, Budapest, Hungary
3Department of Human and Experimental Tumor Pathology, National Institute of Oncology, Budapest, Hungary
4Chair of Oncology, Semmelweis University, Budapest, Hungary

Tóm tắt

AbstractBackground and ObjectivesThe objectives of this study were to test the feasibility of sole interstitial high‐dose‐rate brachytherapy (HDR‐BT) after breast‐conserving surgery (BCS) for T1 breast cancer in a phase I–II study, and to present the initial findings of a phase III trial comparing the efficacy of tumor bed radiotherapy (TBRT) alone with conventional whole breast radiotherapy (WBRT).MethodsForty‐five prospectively selected patients with T1 breast cancer undergoing BCS were enrolled into a phase I–II study of TBRT alone, using interstitial HDR implants. HDR‐BT of 7 × 4.33 Gy (n = 8) and 7 × 5.2 Gy (n = 37) was delivered to the tumor bed. Based on the results of this phase I–II study, a further 126 patients were randomized to receive 50 Gy WBRT (n = 63) or TBRT alone (n = 63); the latter consisted of either 7 × 5.2 Gy HDR‐BT (n = 46) or 50‐Gy wide‐field electron irradiation (n = 17). Breast cancer related events and side effects were assessed.ResultsIn the phase I–II study, at a median follow‐up of 57 months, 2 (4.4%) local, 3 (6.7%) axillary, and 3 (6.7%) distant failures were observed. Two patients (4.4%) died of breast cancer. The 5‐year probability of cancer‐specific, relapse‐free and local recurrence‐free survival was 90.0%, 85.9%, and 95.6%, respectively. The cosmetic results were judged to be excellent in 44 of 45 patients (97.8%). Severe (higher than grade 2) skin sequelae or fibrosis was not found. Symptomatic fat necrosis occurred in one patient (2.2%). In the phase III study, at a median follow‐up of 30 months, the locoregional tumor control was 100% in both arms. The 3‐year probability of cancer‐specific and relapse‐free survival was 98.1% and 98.4% in the WBRT group and 100% and 94.4% in the TBRT group, respectively (P = NS). There was no significant difference between the two treatment arms regarding the incidence of radiation side effects.ConclusionsFive‐year results of our phase I–II study prove that sole HDR‐BT of the tumor bed with careful patient selection and adequate quality assurance is a feasible alternative to WBRT. However, long‐term results of phase III trials are required to determine the equivalence of TBRT alone, compared with WBRT in the management of selected patients with early breast cancer. J. Surg. Oncol. 2002;80:121–128. © 2002 Wiley‐Liss, Inc.

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Tài liệu tham khảo

10.1200/JCO.1996.14.5.1558

10.1056/NEJM199511303332203

10.1016/0277-5379(90)90113-8

10.1093/jnci/88.22.1659

10.1200/JCO.1999.17.8.2326

10.1016/0959-8049(95)00271-J

Fisher ER, 1992, Ipsilateral breast tumor recurrence and survival following lumpectomy and irradiation: Pathological findings from NSABP Protocol B‐06, Semin Surg Oncol, 8, 161

10.1016/0360-3016(93)90378-9

Clarke DH, 1994, “High Dose Rate Brachytherapy: A Textbook.” Armonk, 321

10.1016/0959-8049(95)00639-7

10.1016/S0002-9610(00)00454-2

10.1016/0167-8140(96)01747-1

10.1016/0360-3016(94)00576-1

10.1002/(SICI)1096-9098(199708)65:4<263::AID-JSO7>3.0.CO;2-3

Polgár C, 1999, Sole brachytherapy of the tumour bed after breast conserving surgery: A new radiotherapeutic strategy for patients at low risk of local relapse, Neoplasma, 46, 182

10.1016/S0936-6555(05)80900-8

10.1016/S0960-9776(99)90007-3

10.1016/S0360-3016(97)00035-7

10.1002/(SICI)1096-9098(199901)70:1<33::AID-JSO6>3.0.CO;2-O

10.1200/JCO.2001.19.7.1993

W.H.O, 1981, Histological Typing of Breast Tumors

10.1111/j.1365-2559.1991.tb00229.x

10.1007/PL00002336

10.3109/02841867809127689

10.1093/jnci/90.21.1587

10.1016/0360-3016(95)00060-C

10.1080/01621459.1958.10501452

10.1002/1097-0142(19850901)56:5<979::AID-CNCR2820560502>3.0.CO;2-N

Gump FA, 1992, Multicentricity in early breast cancer, Semin Surg Oncol, 8, 117

10.1002/1097-0142(20010215)91:4<647::AID-CNCR1053>3.0.CO;2-Z

Johansson B, 2000, Program and Abstracts, 127

Kuske RR, 2000, Program and Abstracts, 117

McCormick B, 2001, Radiation Therapy Oncology Group research plan 2002–2006: Breast Cancer Working Group, Int. J Radiat Oncol Biol Phys, 51, 56

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Journal of Surgical Oncology

Tập 80 Số 3

121-128

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