A Randomized Phase II Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab in Patients with Advanced Gastrointestinal Stromal Tumors.

PURPOSE: Most gastrointestinal stromal tumors (GIST) are driven by KIT/PDGFRa mutations. Tyrosine kinase inhibitor benefit is progressively less after imatinib failure. This phase II trial analyzed the efficacy of nivolumab (N) or nivolumab + ipilimumab (N + I) in patients with refractory GIST. PATIENTS AND METHODS: Patients with advanced/metastatic GIST refractory to at least imatinib were randomized 1:1 in a noncomparative, parallel group, unblinded phase II trial of N (240 mg every 2 weeks) or N + I (240 mg every 2 weeks + 1 mg/kg every 6 weeks). The primary endpoint was the objective response rate of N alone or N+I by RECIST 1.1 in the intent-to-treat population. RESULTS: A total of 36 patients with a median of 3 (1-6) prior lines of therapies were enrolled. Ten of 19 (52.6%) patients had stable disease (SD) for a clinical benefit rate (CBR) of 52.6% in the N arm and the median progression-free survival (PFS) was 11.7 weeks [95% confidence interval (CI), 7.0-17.4]. In the N+I arm, 1 of 16 (6.7%) patients had a complete response (CR) and 4/16 (25.0%) had SD for a CBR of 31.3% and a median PFS of 8.3 weeks (95% CI, 5.6-22.2). The 4- and 6-month PFS were 42.1% and 26.3%, respectively for N, and 31.3% and 18.8%, respectively for N+I. The most common adverse events (AE) attributed to N and N+I were fatigue: 13.9% and 22.2%, respectively. There were nine total attributable grade 3-4 AEs. CONCLUSIONS: The primary endpoint of response rate > 15% was not observed for N or N + I. In a heavily pretreated GIST population, responses and long-term disease control with both N and N+I were observed. No new safety signals have been observed.

Busy therapists: Examining caseload as a potential factor in outcome.

As demand increased for mental health services, especially in university counseling centers, providers have seen increasing numbers of clients. The effect of this increase on therapist caseloads is explored, with a recognition that past research on therapist caseloads lacks direct and fluctuating measures of caseload that reflect practice in naturalistic settings. Using a large dataset from a counseling center (N = 18,322), therapist caseload was conceptualized dynamically over rolling 30-day periods, using within-therapist counts of therapy sessions, unique clients seen, and the proportion of unique clients to sessions. Analysis of variance was used first to test for differences in caseload between months, years, then to test for differences between therapists (n = 173). Hierarchical linear models were constructed to examine the relationship between changes in therapist caseload across time and client outcome. Logistic and ordinal regression approaches were used to further examine this relationship for clinically significant change. Results included finding a small, but significant, effect of therapist caseload on outcome, with this finding discussed in the context of the effect sizes in the literature on therapist effects. (PsycInfo Database Record (c) 2021 APA, all rights reserved).