Evidence-based treatment protocol (ETP) usage in community oncology clinics

Abstract

6621 Background: Clinical outcomes for patients (pts) treated in non-clinical trial settings have not been compared to clinical trial participant outcomes. Moreover, the degree to which reference regimens (Ref Reg) are utilized in actual clinical settings is not known. We created ETPs based on trial reports and guidelines and measured clinician compliance with regimens, degree of variance from Ref Reg, and outcomes in heterogenous community oncology practice settings. Methods: ETPs including Ref Reg were created for 1st and 2nd line therapy in metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and prostate cancer (PRC) based on review of published and presented Phase III trials and supplemented by NCCN guidelines when phase III data were not available. A range of acceptable regimens and a preferred regimen for each disease were identified, but clinicians were free to utilize any regimen of their choice after pt prospective registration with IRB approved informed consent on the ETP. Results: Five community oncology clinics with median (range) 13 (8–26) medical oncologists enrolled 169 pts as of 12/1/07: 64 CRC, 85 NSCLC, and 20 PRC. Pt demographics: 43% female, 14% African American, 50% Medicare primary payer, ECOG PS 0 31%, PS 1, 47% and > 2, 17%. Of 160 evaluable pts 67(41.9%) were treated identically to Ref Reg, 57 (35.6%) received a standard regimen with dose variation, 20 (12.5%) were enrolled on a research protocol and 11% received a non-ETP regimen. From time to event analysis, the estimated median (95%CI) duration of first line regimen ETP was 210 (98–322) days for CRC, 111 (86–135) days for NSCLC and 225 (181–268) days for PRC. There was no statistically significant difference in the duration of 1st line therapy for Ref Reg compared to dose variation/non-standard regimens. The ETP preferred regimen (± dose variation) was used in 30/54 CRC, 47/70 NSCLC, and 10/16 PRC pts. Accruals to all three ETPs are ongoing. Conclusions: ETPs can be created and utilized successfully in community oncology practice. Most patients received a Ref Reg although a priori dose modifications were common. Initial analysis indicates duration of 1st line therapy is similar in patients receiving clinical trial derived Ref Reg or alternative doses or regimens. No significant financial relationships to disclose.