title: Phase II study of lapatinib in combination with vinorelbine in patients with HER2 positive recurrent or metastatic breast cancer: a multicentric Turkish Oncology Group (TOG) trial.
abstract: BACKGROUND
  The aim of this explorative phase II study was to evaluate the activity and safety of lapatinib in combination with intravenous vinorelbine in women with HER2 positive metastatic or recurrent breast cancer.
  
  
  METHODS
  Twenty-nine patients were enrolled. The primary objectives were response and clinical benefit (CB) rates, secondary objectives were toxicity, response duration and progression free survival. Patients received 1250 mg oral lapatinib continuously once daily and intravenous vinorelbine 20-25 mg/m(2) on days 1 and 8, every 3 weeks.
  
  
  RESULTS
  Although 25 patients were evaluable for response, according to intend to treat analysis of 28 patients; 14% had confirmed partial response (PR) and 36% had stable disease more than 24 weeks with a CB rate of 50%. Sixty four percent of the patients suffered from grade 3-4 hematologic and 18% from grade 3 extra-hematologic toxicities.
  
  
  CONCLUSIONS
  The results of this trial provide evidence to further investigate the potential of this combination for patients unsuitable for trastuzumab or who become refractory to trastuzumab.
authors: Department of Medical Oncology, Institute of Oncology, Istanbul University, Capa, Istanbul 34390, Turkey. Electronic address: pinarsaip@gmail.com.
authors: P
authors: P
authors: Saip
authors: Y
authors: Y
authors: Eralp
authors: F
authors: F
authors: Sen
authors: H
authors: H
authors: Karaca
authors: M
authors: M
authors: Ozkan
authors: B
authors: B
authors: Cetin
authors: M
authors: M
authors: Benekli
authors: M
authors: M
authors: Kucukoner
authors: A
authors: A
authors: Isikdogan
authors: O
authors: O
authors: Un
authors: G
authors: G
authors: Basaran
authors: H
authors: H
authors: Onur
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D000077341:Lapatinib; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011799:Quinazolines / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D013997:Time Factors; D014421:Turkey; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D014747:Vinblastine; D000077235:Vinorelbine; C508053:ERBB2 protein, human
keywords: HER2 positive; Lapatinib; Metastatic breast cancer; Vinorelbine