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.

Polgar, C ✉ [Polgár, Csaba (Sugárterápia, kli...), szerző] Országos Onkológiai Intézet; Sulyok, Z; Fodor, J [Fodor, János (Orvosi tudomány), szerző] Országos Onkológiai Intézet; Orosz, Z [Orosz, Zsolt (Pathológia), szerző] Országos Onkológiai Intézet; Major, T [Major, Tibor (klinikai sugárfizika), szerző] Országos Onkológiai Intézet; Takacsi-Nagy, Z [Takácsi-Nagy, Zoltán (Sugárterápia), szerző] Országos Onkológiai Intézet; Mangel, LC [Mangel, László Csaba (Sugárterápia), szerző]; Somogyi, A; Kasler, M [Kásler, Miklós (Klinikai onkológia), szerző] Országos Onkológiai Intézet; Nemeth, G [Németh, György (sugárterápia), szerző] Országos Onkológiai Intézet

Angol nyelvű Tudományos Szakcikk (Folyóiratcikk)
Megjelent: JOURNAL OF SURGICAL ONCOLOGY 0022-4790 1096-9098 80 (3) pp. 121-128 2002
  • SJR Scopus - Medicine (miscellaneous): Q1
    BACKGROUND AND OBJECTIVES: The 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). METHODS: Forty-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 x 4.33 Gy (n = 8) and 7 x 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 x 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. RESULTS: In 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. CONCLUSIONS: Five-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.
    Hivatkozás stílusok: IEEEACMAPAChicagoHarvardCSLMásolásNyomtatás
    2021-10-17 08:22