DO GAPS IN TREATMENT CONTINUATION OF DOCETAXEL AFFECT OVERALL SURVIVAL? – RESULTS FROM A US LOCAL COMMUNITY PRACTICE
Author(s)
Zhao L1, Chen L2, Christiansen NP3, Sullivan SD41eTeam. Inc, South Plainfield, NJ, USA, 2Sanofi-Aventis, Bridgewater, NJ, USA, 3Medical University of South Carolina, Charleston, SC, USA, 4University of Washington, Pharmaceutical Outcomes Research and Policy Program, Seattle, WA, USA
OBJECTIVES: Docetaxel (D) is well recognized as first-line chemotherapy in patients with metastatic prostate cancer (PC). To what extent gaps in treatment impact overall survival (OS) remains unknown. This study aimed to investigate the relationship between treatment gap and OS in a community practice. METHODS: Using the Georgia Cancer Specialist Database (2003-2008), patients with initial stage IV PC receiving D were identified and followed from the date of first D use to the earlier of death or loss to follow-up. The three-month period prior to the first D use was the baseline. A gap in treatment continuation was defined as elapsed days between any adjacent treatment cycles of >60 days during follow-up. Kaplan-Meier curve was compared between patients with and without a gap using the log-rank test. The impact of treatment gap on OS was examined with multivariate Cox model by adjusting treatment cycles, age, comorbidity, baseline PSA, baseline bisphosphonate use, hormonal therapies and other chemotherapy during the follow-up. Sensitivity analysis (SA) was conducted with gap defined as 90, 120 and 180 days. RESULTS: The study sample contained 47 patients, with mean age 75, average baseline PSA 296 ng/ml, 48.9% treated with bisphosphonate at baseline, 53.3% treated with hormonal therapies, and 29.8% treated with other chemotherapies during follow-up. Patients on average completed 10 cycles of docetaxel, with 7 (15%) patients experienced a treatment gap. Median survival was 387 and 333 days for groups with and without gaps, respectively (P=0.1654). The Cox model found no increased risk of death for the group with gap (HR=0.80, P=0.7189). Consistent results were found in SA. CONCLUSIONS: This analysis implied that allowing treatment gap in docetaxel treatment did not appear to impair OS for metastatic PC. The results could be confounded by some unadjusted factors, e.g., ethnicity and patients’ disease characteristics.
Conference/Value in Health Info
2010-05, ISPOR 2010, Atlanta, GA, USA
Value in Health, Vol. 13, No. 3 (May 2010)
Code
PCN22
Topic
Clinical Outcomes
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Oncology