title: Cisplatin-ifosfamide combination chemotherapy in metastatic triple-negative, anthracycline- and taxane-pretreated breast cancer patients; a phase II study.
abstract: OBJECTIVE
  The purpose of this study was to prospectively evaluate the efficacy and toxicity of cisplatin and ifosfamide combination chemotherapy in metastatic triple negative breast cancer (TNBC) previously treated with anthracyclines and taxanes.
  
  
  METHODS
  Patients were treated with cisplatin 20 mg/ m2 iv, days 1-5, over 30 min and ifosfamide 1200 mg/m(2) iv, days 1-5 over 2 h with mesna uroprotection. Therapy was repeated every 3 weeks. Responding patients received a maximum of 6 cycles of chemotherapy. Treatment was delayed in the event of grade 3 or higher hematologic or non hematologic toxicity until resolution to grade 2 or less. Treatment then proceeded as scheduled but with 20% dose reduction of both drugs.
  
  
  RESULTS
  40 TNBC patients were enrolled. Median age was 43 years (range 37-49). Thirty (75%) patients had visceral involvement. Fourteen (35%) patients achieved objective response, disease stabilization occurred in 2 (5%) patients, while disease progression occurred in 24 (60%) patients. Grade 3/4 neutropenia occurred in 11 (27.5%) patients, while grade 3/4 thrombocytopenia was registered in 9 (22.5%) patients. Neurosensory toxicity was the commonest non hematologic acute severe toxicity (10%). With a median follow up of 14 months the median time to progression was 6 months and the median overall survival 12 months. Survival of responding patients was significantly better compared with non responders (p=0.000).
  
  
  CONCLUSIONS
  Our outpatient cisplatin / ifosfamide regimen displayed reasonable efficacy and toxicity in TNBC. However, the outcome did not differ from relevant studies in the literature. Further molecular studies and phase III trials are still needed to further improve treatment strategies in TNBC.
authors: Department of Clinical Oncology and Nuclear Medicine, Mansoura University, Mansoura, Egypt. amalsalahm@yahoo.com
authors: A
authors: A
authors: Halim
authors: H
authors: H
authors: Wahba
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D011960:Receptors, Estrogen / Q000378:metabolism*; D011980:Receptors, Progesterone / Q000378:metabolism*; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D002945:Cisplatin; D007069:Ifosfamide; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D043823:Taxoids; C508053:ERBB2 protein, human