Dawn DePaolo

Prospective evaluation of low-dose warfarin for prevention of thalidomide associated venous thromboembolism

Venous thromboemobolism (VTE) is an important complication of thalidomide therapy especially when it is combined with steroids or chemotherapy. Currently there is no consensus on the most appropriate prophylactic approach. We prospectively investigated the use of low-dose warfarin sodium in prevention of thalidomide-associated VTE in patients receiving thalidomide-based combination therapies. Patients with multiple myeloma or chronic lymphocytic leukemia who were treated on thalidomide based-combination therapies were treated on low-dose warfarin (1 or 2 mg) continuously through the duration of their therapy. Among the 68 patients enrolled, four developed an episode of VTE, an overall incidence of 5.9% (odds = 0.063). Median duration of thalidomide therapy was 4 months. Low-does warfarin decreases the incidence of VTE compared to historical control and is an effective mechanism of prevention of VTE in thalidomide-based chemotherapy regimens.

Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

Background: Serious adverse events (SAEs) and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL) or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011–2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G), Medical Outcomes Study Social Support Survey (MOSSSS), Charlson comorbidity scores (CCS) and Royal Marsden scores (RMS) were obtained at baseline. Frequency of dose limiting toxicities (DLTs), subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher’s exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04). Conclusions: Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.