Preliminary results of @entity416 metronomic chemotherapy in operable XXXX after standard adjuvant therapy - A single-arm phase II study.

@entity1 @entity137 @entity0 @entity416 @entity294
PURPOSE: The aim of this study is to investigate efficacy and @entity137 of 1year of @entity416 metronomic therapy preceded by standard adjuvant chemotherapy in @entity0 ( @entity0 ) @entity1 . METHODS: Between June 2010 and February 2012, 19 @entity1 with pathologically proven operable @entity0 , who had received standard adjuvant chemotherapy before were enrolled. @entity1 received 1year of oral @entity416 metronomic therapy (650mg/m(2), twice every day), after standard adjuvant chemotherapy and radiotherapy if indicated. The primary endpoints of this study were disease-free survival rates (DFS) and safety profile. Secondary end point was overall survival (OS). RESULTS: The maximal follow-up was 46.6months with a median of 30.1months   11.525 (95% CI; 28.5-33.5months). The median DFS was 41.7months   2.7 (95% CI; 36.5-46.9). No one developed locoregional recurrence. The actuarial rate of DFS was 88.8% and 82.05% at 2 and 3years, respectively. At the time of the analyses, no @entity1 had died and the median OS was not reached. Treatment-related adverse events were manageable with only 1 @entity1 (5.3%) suffering from Grade 3/4 hand-foot syndrome and another 1 @entity1 (5.3%) suffering from Grade 3 @entity294 . No Grade 3/4 hematologic @entity137 was recorded. All @entity1 received full doses of @entity416 throughout the study and dose reduction was not required in any of our @entity1 . CONCLUSION: One year of @entity416 metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in @entity0 @entity1 previously treated with standard adjuvant chemotherapy.
