Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma.

This phase 1/2 study was the first to evaluate the safety and efficacy of the cyclin-dependent kinase (CDK) 4/6-specific inhibitor palbociclib (PD-0332991) in sequential combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. The recommended phase 2 dose was palbociclib 100 mg orally once daily on days 1-12 of a 21-day cycle with bortezomib 1.0 mg/m2 (intravenous) and dexamethasone 20 mg (orally 30 min pre-bortezomib dosing) on days 8 and 11 (early G1 arrest) and days 15 and 18 (cell cycle resumed). Dose-limiting toxicities were primarily cytopenias; most other treatment-related adverse events were grade≤3. At a bortezomib dose lower than that in other combination therapy studies, antitumor activity was observed (phase 1). In phase 2, objective responses were achieved in 5 (20%) patients; 11 (44%) achieved stable disease. Biomarker and pharmacodynamic assessments demonstrated that palbociclib inhibited CDK4/6 and the cell cycle initially in most patients.

Impact of patient navigation from diagnosis to treatment in an urban safety net breast cancer population.

BACKGROUND: Disparities between U.S. population groups in cancer incidence, treatment and outcome have been well documented. Literature evidence is scarce regarding the impact of patient navigator programs on elimination of these differences. METHODS: This is a retrospective case series analysis .The pre -navigation group included patients diagnosed between January 1, 1997 and December 31, 1999. The post -navigation group included patients diagnosed between January 1, 2000 and December 31, 2003. Cancer stage, time from presentation to treatment and treatment outcome were compared by review of medical records. RESULTS: Three hundred and thirty five women were diagnosed between January 1, 1997 and December 31, 2003. Thirteen patients were ineligible, 103 women in the pre- navigation group, and 219 women in the post-navigation group. 157 (72%) received navigation services. The median time to first treatment was decreased by 9 days (42 days in pre -navigation group compared to 33 days in post -navigator group). Race, insurance and clinical presentation did not influence the time to treatment. CONCLUSIONS: Navigation program did not influence the stage of presentation or the overall survival of women. There was a modest decrease in the time between initial presentation and definitive therapy. The utility of navigator programs is likely to vary with each institution.