ABSTRACT
WHAT IS THIS SUMMARY ABOUT?: This is a plain language summary of a publication describing long-term results from the RESONATE-2 study with up to 8 years of follow-up. The original paper was published in Blood Advances in June 2022. WHAT WERE THE RESULTS?: Researchers looked at 269 adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had not received any treatment for their CLL/SLL. Study participants were randomly divided into two groups: 136 participants received treatment with a drug called ibrutinib, and 133 participants received treatment with a drug called chlorambucil. Participants in the study were treated and followed for up to 8 years, with results showing that more participants who took ibrutinib (59%) were alive without worsening of their disease at 7 years after starting treatment than participants who took chlorambucil (9%). Almost half of the participants (42%) were able to stay on ibrutinib treatment for up to 8 years. WHAT DO THE RESULTS OF THE STUDY MEAN?: In people with CLL or SLL, more participants who were taking ibrutinib were alive without worsening of their disease after 7 years compared with participants who took chlorambucil. Clinical Trial Registration: NCT01722487 (ClinicalTrials.gov) Clinical Trial Registration: NCT01724346 (ClinicalTrials.gov).
ABSTRACT
Primary results from the phase 3 RESONATE-2 study demonstrated superior efficacy and tolerability with ibrutinib versus chlorambucil in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Here, we describe characteristics and outcomes of patients who received ibrutinib treatment for ≥5 years in RESONATE-2. Patients aged ≥65 years with previously untreated CLL/SLL, without del(17p), were randomly assigned 1:1 to once-daily ibrutinib 420 mg until disease progression/unacceptable toxicity (n = 136) or chlorambucil 0.5−0.8 mg/kg for ≤12 cycles (n = 133). Baseline characteristics in ibrutinib-randomized patients (n = 136) were generally similar between patients on ibrutinib treatment for ≥5 years (n = 79) versus those on treatment for <5 years (n = 57). In patients on ibrutinib treatment for ≥5 years, complete response rates improved over time, reaching 42% by 5 years. Estimated 7-year progression-free survival and overall survival rates were 82% and 94%, respectively. Adverse events (AEs) led to dose reductions in 16/79 patients (20%); these AEs were resolved for 13/16 patients (81%). AEs led to dose holds (≥7 days) in 45/79 patients (57%); these AEs were resolved for 43/45 patients (96%). More than half (58%) of ibrutinib-randomized patients benefitted from ibrutinib treatment for ≥5 years regardless of baseline characteristics. Dose modification resolved AEs for most patients, thereby facilitating continued treatment.
ABSTRACT
Objective. To assess the impact of a pilot advanced pharmacy practice experience (APPE) on fourth-year (P4) Doctor of Pharmacy (PharmD) students' knowledge and confidence related to substance use disorder, harm reduction, and co-occurring psychiatric conditions.Methods. Beginning in 2020, a 62-item assessment was developed and administered to P4 students at the beginning and end of the six-week APPE. The assessment tested knowledge in 10 content areas related to substance use disorder, harm reduction, and co-occurring disorders. Students also ranked their confidence in providing care related to each content area. The post-assessment included a free-text (open-ended) item to provide feedback on the APPE experience. Descriptive statistics and paired t tests were used to analyze the data.Results. Complete pre- and post-assessments were obtained from all participating students (N=7). The mean cumulative knowledge score increased from 55.2% to 81.5%, and the mean cumulative confidence score improved from 34.2% to 81.8%. Free-text responses garnered positive feedback from students, who indicated that the APPE allowed them to immerse themselves in all stages of the recovery process, gain confidence in presentation skills with patients, and solidify their passion for addiction medicine.Conclusion. A novel APPE in addiction medicine addressed a current gap in pharmacy education, earned positive evaluations from student pharmacists, increased student knowledge and confidence related to substance use disorder, harm reduction, and co-occurring disorders, and supported the development of new interprofessional collaborations. United States colleges of pharmacy that do not yet offer APPEs in this clinical domain should consider this model.
