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Session Item

RTT track: Risk management/quality management
9350
Poster
RTT
12:00 - 12:10
APBI with 3D-CRT vs. WBI: cosmetic and toxicity results of the prospective randomised IRMA trial
OC-0611

Abstract

APBI with 3D-CRT vs. WBI: cosmetic and toxicity results of the prospective randomised IRMA trial
Authors: MEDURI|, BRUNO(1)*[brunomeduri@gmail.com];BALDISSERA|, ANTONELLA(2);STAM|, MARCEL(3);BLANDINO|, GLADYS(4);BOERSMA|, LIESBETH(5);PARISI|, SALVATORE(6);VALLI|, MARIACARLA(7);KOITER|, EVELINE(8);FRASSINELLI|, LUCA(1);CIABATTI|, SELENA(2);GIACOBAZZI|, PATRIZIA(1);MORGANTI|, ALESSIO G.(9);D'AMICO|, ROBERTO(10);IOTTI|, CINZIA(4);BERTONI|, FILIPPO(11);POORTMANS|, PHILIP M.P.(12);FREZZA|, GIOVANNI P.(2);
(1)AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, ONCOLOGY DEPARTMENT - RADIATION ONCOLOGY UNIT, MODENA, ITALY;(2)OSPEDALE BELLARIA – AUSL DI BOLOGNA, RADIOTHERAPY UNIT, BOLOGNA, ITALY;(3)RADIOTHERAPIEGROEP, RADIOTHERAPIEGROEP ARNHEM, ARNHEM, THE NETHERLANDS;(4)AUSL-IRCCS DI REGGIO EMILIA, RADIOTHERAPY UNIT, REGGIO EMILIA, ITALY;(5)MAASTRICHT UNIVERSITY MEDICAL CENTRE + MUMC+, DEPARTMENT OF RADIATION ONCOLOGY MAASTRO, MAASTRICHT, THE NETHERLANDS;(6)CASA DEL SOLLIEVO DELLA SOFFERENZA, RADIOTHERAPY UNIT, S. GIOVANNI ROTONDO FOGGIA, ITALY;(7)OSPEDALE REGIONALE BELLINZONA E VALLI, ISTITUTO ONCOLOGICO DELLA SVIZZERA ITALIANA, BELLINZONA, SWITZERLAND;(8)MEDISCH SPECTRUM TWENTE, RADIOTHERAPY UNIT, ENSCHEDE, THE NETHERLANDS;(9)UNIVERSITY OF BOLOGNA, RADIATION ONCOLOGY CENTER-DEPARTMENT OF EXPERIMENTAL- DIAGNOSTIC AND SPECIALTY MEDICINE, BOLOGNA, ITALY;(10)UNIVERSITÀ DI MODENA E REGGIO EMILIA, DEPARTMENT OF MEDICAL STATISTIC, MODENA, ITALY;(11)AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, EMERITUS CHAIR OF RADIOTHERAPY UNIT, MODENA, ITALY;(12)PARIS SCIENCES ET LETTRES UNIVERSITY, MARIE CURIE PROFESOR, PARIS, FRANCE;
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Purpose or Objective

To report cosmetic and toxicity results in all patients enrolled in the multicentric prospective randomised phase 3 IRMA trial

Material and Methods

Women aged ≥ 49 years with invasive breast cancer< 3 cm, pN0-1, were randomly assigned after breast-conserving surgery to 3D-CRT accelerated partial breast irradiation (APBI) (38,5 Gy in 10 fractions twice daily) or whole breast irradiation (WBI). Patients received adjuvant systemic therapy according to institutional guidelines. Cosmetic results were assessed according to IRMA protocol parameters by both the patient and the physician. Toxicity was scored according to RTOG tables. We performed the analysis according to the treatment received

Results

From March 2007 to March 2019, 3309 patients were enrolled by 35 European centres. Median follow-up was 5 years. Acute G3-4 skin toxicity was rare in both treatment arms (0% PBI vs. 1,07% WBI), no further G3-4 acute toxicities were observed. Late G2-4 skin toxicity was 7,02% (APBI) vs. 8,68% (WBI) (p=0,08); G2-4 late subcutaneous tissue toxicity was 43,93% (APBI) vs 28,89% (WBI) (p<0,01) (G3-4: 2,57% vs 1%; p<0,01); G3-G4 bone toxicity was 1,03% (APBI) vs 0% (WBI) (p<0,01); further G3-4 late toxicities were rare (<0,2%). Axillary lymph node dissection (vs. sentinel node) increased G3-4 late skin toxicity (2,46% vs. 0,47%, p<0,01); no correlation of toxicity with adjuvant chemotherapy was observed. At 5 years, adverse cosmetic results (fair/poor) were: physician-reported 18,45% (APBI) vs. 15,01% (WBI) (p=0,1); patient-reported 15,1% (APBI) vs. 10,86% (WBI) (p=0,02)

Conclusion

APBI with 3D-CRT was associated with an increased rate of moderate to late subcutaneous tissue and bone toxicity and with a slight decrease in patient-reported cosmetic outcome at 5 years. Longer follow-up is needed to confirm these results