A new perspective in cancer treatment: Low dose metronomic chemotherapy with old known drugs in advanced breast cancer patients—Phase II clinical trial.

• DOI: 10.1200/jco.2015.33.15_suppl.e13500
• Publication Date: 2019-03-07T22:16:39Z
• Authors: Herman Andres Per...; Carlos Maria Alasino; Maria Jose Rico; Mauricio Ariel Me...; Leandro Ernesto M...; Stella Maris Pezz...; Francisco Nestor ...; Viviana Rosa Rozados; Olga Graciela Sch...
• Keywords: Clinical endpoint

e13500 Background: The oral administration of Cyclophosphamide (Cy) and Celecoxib (Cel) encourage the use low-dose metronomic chemotherapy (MC) to treat heavily pretreated, multidrug resistant, advanced breast cancer patients (ABCP). Methods: Study design: Single arm, mono-institutional, nonrandomized, phase II, two steps clinical trial (Approved by Bioethics Committee #5732/2007 ANMAT-Argentine Regulatory Authority- #4596/09). 15 were enrolled in first stage, 5 additional second one (β error = 0.10-0.20; α 0.05). Treatment plan: Cy 50 mg po.d+Cel 200 p.o bid. Patient eligibility criteria: 21-80 years old, ≥ than 3 month life expectancy, ABCP progressed anthracyclines, taxanes capecitabine, ≤ 4 schemes, at least 1 measurable lesion (RESIST 1.1), ECOG scale 2, appropriate bone marrow renal function. Informed consent signed. Primary endpoint: Progression free survival (PFS) benefit (CB). Results: main outcomes prolonged disease stabilization (SD > 24 weeks) 10/20 (50%) partial remission (PR) 1/20 (5%). No complete remissions (CR) observed. Response rate was 5% (CR+PR: 1/20). CB 55% (PR+SD weeks: 11/20). TTP 21.1 weeks (median: 15.5, range: 3-81). Median who achieved 35.6 27, 24-81). PFS 50%. Overall (OS) year after enrollment 25%. Mean OS 44.20 36 5.14-232.14 weeks). There no grade 3/4 toxicities associated treatment. Quality did not change or improved transiently a high proportion patients. Conclusions: effective control this group patients, with low toxicity profile excellent tolerability. These results MC scheme pretreated ABCP, as well development new schemes that do affect quality life. Although objective evaluation effectiveness elderly due lack benefit, kind treatment could be valid option for Clinical information: 4596/09.