AIM: To investigate the efficacy and safety of @entity136 and @entity902 salt, with or without trastuzumab, in @entity1 with locally advanced or metastatic @entity189 overexpressing @entity1722 . METHODS: The main eligibility criterion was @entity1722 overexpression on immunohistochemistry (IHC 2+ or 3+) of primary @entity5 tissue confirmed by fluorescence in situ hybridisation (FISH). @entity1 were randomised to Arm A: @entity136 1000mg/m(2) (days 1 and 8) plus either @entity900 (70mg/m(2)) or @entity3003 (AUC=5) (day 1 every 3weeks) or Arm B: added trastuzumab (8mg/kg loading dose, then 6mg/kg every 21days until progression). The primary end-point was progression-free survival (PFS). RESULTS: Among 563 screened @entity1 , 75 (13.3%) were @entity1722 positive (IHC 2+/3+ and FISH+) and 61 met all eligibility criteria (median age, 64years; 54/61 males; 50/61 baseline ECOG-PS 0-1; 11 locally advanced and 50 metastatic). There was no significant difference between Arms A and B in median PFS (10.2 versus 8.2months, respectively, p=0.689), objective response rate (65.5% versus 53.2%, p=0.39), and median overall survival (15.7 versus 14.1months, respectively, p=0.684). In an exploratory analysis, trastuzumab-treated @entity1 receiving @entity900 rather than @entity3003 -based chemotherapy fared better (PFS: 10.6 versus 8.0; OS: 33.1 versus 9.5months). Myelosuppression was the main grade 3/4 @entity137 . A case of grade 3 @entity1370 and one death from @entity1398 occurred in arm B. CONCLUSION: The unexpectedly low incidence of @entity1722 overexpression precluded the detection of a significant difference in efficacy on addition of trastuzumab to @entity902 -based chemotherapy with @entity136 . However, the satisfactory tolerance of the combination warrants further studies, especially of the @entity900 -based combination, in well-defined @entity1 subsets.

Multicentre randomised phase II trial of @entity136 + @entity902 , with or without trastuzumab, in advanced or metastatic XXXX overexpressing @entity1722 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity902 :: ('MESH:D010984', 'Chemical') :: ['platinum'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity189 :: ('MESH:D002277', 'Disease') :: ['urothelial carcinoma'] @entity1370 :: ('MESH:D066126', 'Disease') :: ['cardiotoxicity'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['febrile neutropenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1722 :: ('2064', 'Gene') :: ['Her2']
@entity189 :: (MESH:D002277,Disease) :: ['urothelial carcinoma']
