title: Efficacy of six month neoadjuvant endocrine therapy in postmenopausal, hormone receptor-positive breast cancer patients--a phase II trial.
abstract: BACKGROUND
  Neoadjuvant hormonal therapy (NHT) is playing an increasing role in the clinical management of breast cancer (BC) and may improve surgical outcomes for postmenopausal, oestrogen receptor (ER)-positive BC patients. However, there is currently no consensus on the optimal duration of NHT before surgery. Here, we present the outcomes of the TEAM IIA trial, a multicentre, phase II trial investigating the efficacy of six months of neoadjuvant exemestane in postmenopausal, strong ER-positive (ER+, ⩾50%) BC patients.
  
  
  METHODS
  102 patients (stage T2-T4ac) were included in the study after exclusion of ineligible patients. Primary end-point was clinical response at 3 and 6 months as measured by palpation. Secondary end-point was radiological response as measured by magnetic resonance imaging (MRI), mammography and/or ultrasound. Linear mixed models (95% confidence interval (CI)) were used to compare changes in mean tumour size (in mm) between baseline, 3 and 6 months after the start of endocrine therapy. Conversion rates from mastectomy to breast conserving surgery (BCS) were evaluated.
  
  
  RESULTS
  Median age of all patients was 72 years (range 53-88). Overall response rate by clinical palpation was 64.5% in all patients with a final palpation measurement. Four patients had clinically progressive disease. 63 patients had both 3-month and >3-month palpation measurements. Overall response was 58.7% at 3 months and 68.3% at final palpation (>3 months). Mean tumour size by clinical palpation at T=0 was 39.1mm (95% CI 34.8-43.4mm), and decreased to 23.0mm (95% CI 18.7-27.2mm) and 16.7 mm (95% CI 12.6-20.8) at T=3 and T>3 months, respectively (p=0.001). Final radiological response rates at the end of treatment for MRI (n=37), ultrasound (n=77) and mammography (n=56) were 70.3%, 41.6% and 48.2%, respectively. Feasibility of BCS improved from 61.8% to 70.6% (McNemar p=0.012).
  
  
  CONCLUSIONS
  6 months of neoadjuvant exemestane therapy helps reduce mean tumour size further in strongly ER-positive BC patients without significant side-effects compared to 3 months. Nevertheless, some patients still experience disease progression under exemestane. Feasibility of breast conservation rates improved by almost 10%.
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
authors: Duveken B Y
authors: DB
authors: Fontein
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
authors: Ayoub
authors: A
authors: Charehbili
authors: Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
authors: Johan W R
authors: JW
authors: Nortier
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
authors: Elma
authors: E
authors: Meershoek-Klein Kranenbarg
authors: Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
authors: Judith R
authors: JR
authors: Kroep
authors: Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.
authors: H
authors: H
authors: Putter
authors: Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
authors: Yvonne
authors: Y
authors: van Riet
authors: Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
authors: Grard A P
authors: GA
authors: Nieuwenhuijzen
authors: Department of Medical Oncology, Spaarne Ziekenhuis, Hoofddorp, The Netherlands; Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors: Bart
authors: B
authors: de Valk
authors: Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors: Jetske M Meerum
authors: JM
authors: Terwogt
authors: Department of Surgery, MC Zuiderzee, Lelystad, The Netherlands.
authors: Gijs D
authors: GD
authors: Algie
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
authors: Gerrit-Jan
authors: GJ
authors: Liefers
authors: Department of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands; Department of Pathology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Sabine
authors: S
authors: Linn
authors: Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: c.j.h.van_de_velde@lumc.nl.
authors: Cornelis J H
authors: CJ
authors: van de Velde
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D047072:Aromatase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017698:Postmenopause / Q000378:metabolism; D011960:Receptors, Estrogen / Q000096:biosynthesis*; D021701:Sentinel Lymph Node Biopsy
chemical_list: D000730:Androstadienes; D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D011960:Receptors, Estrogen; C056516:exemestane
keywords: Breast cancer; Breast conserving surgery; Endocrine therapy; Exemestane; Neoadjuvant; Postmenopausal; Pre-operative