title: Primary systemic treatment and concomitant low dose radiotherapy for breast cancer: final results of a prospective phase II study.
abstract: BACKGROUND
  To evaluate the efficacy of preoperative low dose fractionated radiotherapy (LD-FRT) and chemotherapy in breast cancer.
  
  
  METHODS
  Patients with stage IIA-IIIA breast cancer, received LD-FRT (0.40 Gy bid, on day 1 and 2, for 6 cycles) to primary tumor volume and concurrent chemotherapy with non-pegylated liposomal anthracycline and docetaxel. Pathological response was assessed by Mandard Tumor Regression Grade (TRG). We evaluated the pathological major response rate (PMRR) as TRG1 and TRG2. The expected outcome was a PMRR of 60%. The accrual was determined by the single proportion powered analysis (α = 0.05, power = 0.8).
  
  
  RESULTS
  Twentyone patients were enrolled. No grade 2-4 acute skin and hematological toxicity was observed. TRG1 was obtained in 3 patients (14.3%), TRG2 in 4 patients (19%). The PMRR was 33.3%; it does not concur with the expected result, but is similar to that of chemotherapy alone. According to molecular subtype, 2/11 luminal A patients and 4/6 luminal B patients obtained a PMRR to preoperative treatment (35.3%); 1/4 basal like patients reported TRG1 (25%).
  
  
  CONCLUSIONS
  LD-FRT concomitant with primary systemic treatment has a good toxicity profile. The response rate is consistent with that of chemotherapy alone, and suggests different interactions between low dose radiotherapy and molecular subtypes. Additional investigations are planned.
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Luigia
authors.initials: L
authors.lastname: Nardone
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy. Electronic address: diletto.b@gmail.com.
authors.forename: Barbara
authors.initials: B
authors.lastname: Diletto
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Maria Carmen
authors.initials: MC
authors.lastname: De Santis
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Giuseppe Roberto
authors.initials: GR
authors.lastname: D' Agostino
authors.affiliation: Department of Radiology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Belli
authors.affiliation: Department of Radiology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Enida
authors.initials: E
authors.lastname: Bufi
authors.affiliation: Department of Surgery, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Franceschini
authors.affiliation: Department of Pathology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Mulé
authors.affiliation: Department of Biomedical Science and Human Oncology, University of Torino, via Santena, 7, 10126 Torino, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Sapino
authors.affiliation: Department of Surgery, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Terribile
authors.affiliation: Department of Radiation Oncology, Catholic University of the Sacred Heart, Largo A. Gemelli, 1, 00168 Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000473:pathology / Q000628:therapy*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000628:therapy*; D018275:Carcinoma, Lobular / Q000473:pathology / Q000628:therapy*; D059186:Chemoradiotherapy, Adjuvant; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D043823:Taxoids; C506643:liposomal doxorubicin; D000077143:Docetaxel; D011092:Polyethylene Glycols; D004317:Doxorubicin
keywords: Breast cancer; Low dose radiotherapy; Preoperative treatment; Primary systemic therapy