BACKGROUND: @entity136 (G) and @entity1206 (V) have favorable safety profile and antitumor activity in metastatic @entity0 . To exploit their different mechanism of action and lack of overlapping @entity137 , we performed a phase I and II study of G and V in combination. @entity1 AND METHODS: Fifty-three @entity1 with metastatic @entity0 were treated. In the dose-finding phase, seven cohorts of @entity1 (22 @entity1 ) received increasing doses to determine the dose limiting @entity137 (DLT) and maximum tolerated dose (MTD) of the combination. @entity1 recruited in the phase II portion of the study (31 @entity1 ) received the dose level immediately below the one defined as MTD (i.e., G 1200 mg/m2, V 30 mg/m2, on day 1 and day 8, every 3 weeks). RESULTS: Dose escalation was discontinued at G 1400mg/m2 and V 30 mg/m2 because of @entity137 due to @entity882 and CNS hemorrage. No other limiting @entity137 were observed, and tolerability was similar at all dose levels studied in the escalation portion of the study. The main @entity137 was @entity3028 of grade 3/4 in 36 and 48% of the @entity1 on phase I and II respectively, without @entity2749 of @entity221 . @entity882 was uncommon. Other side effects were usually mild to moderate. In 46 evaluable @entity1 , the response rate was 24% (complete response 7%, partial response 17%). Disease stabilization was observed in further 17%. The median duration of response was 12 months (range 5-14) and the median survival was 20 months (range 1 to 45+). CONCLUSIONS: G and V, on day 1 and 8 of 3-weekly cycles, can safely be administered to @entity1 with metastatic @entity0 at the dose of 1200 and 30 mg/m2, respectively. The antitumor activity of G and V in combination was similar to that reported when using either drug as single agent.

Phase I/II study of @entity136 in association with XXXX for metastatic @entity0 .

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxic death', 'toxicities'] @entity2749 :: ('MESH:C580065', 'Disease') :: ['episodes'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity882 :: ('MESH:D013921', 'Disease') :: ['Thrombocytopenia', 'thrombocytopenia'] @entity221 :: ('MESH:D005334', 'Disease') :: ['neutropenic fever'] @entity1206 :: ('MESH:C030852', 'Chemical') :: ['vinorelbine'] @entity3028 :: ('MESH:D000380', 'Disease') :: ['granulocytopenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine']
@entity1206 :: (MESH:C030852,Chemical) :: ['vinorelbine']
