Citations

ZUMA-12 is a multicenter phase 2 study evaluating axicabtagene ciloleucel (axi-cel) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy as part of first-line treatment for high-risk large B-cell lymphoma (LBCL). In the primary efficacy analysis (n = 37; median follow-up, 15.9 months), axi-cel demonstrated a high rate of complete responses (CR; 78%) and a safety profile consistent with prior experience. Here, we assessed updated outcomes from ZUMA-12 in 40 treated patients after ≥3 years of follow-up. Eligible adults underwent leukapheresis, lymphodepleting chemotherapy, and axi-cel infusion (2 × 106 CAR T cells/kg). Investigator-assessed CR, objective response, survival, safety, and CAR T-cell expansion were assessed. The CR rate among response-evaluable patients (n = 37) increased after the primary analysis to 86% (95% confidence interval [CI], 71%-95%), with a 92% objective response rate. After a median follow-up of 47.0 months (range, 37.1-57.8 months), 36-month estimates (95% CI) of duration of response and event-free, progression-free, and overall survival were 81.8% (63.9%-91.4%), 73.0% (55.6%-84.4%), 75.1% (57.5%-86.2%), and 81.1% (64.4%-90.5%), respectively. In total, 4 patients had new malignancies, 2 occurring after the data cutoff of the primary analysis; none were axi-cel–related. Eight patients died on study, 2 of whom died from nonrelapse mortality causes. After long-term follow-up, axi-cel demonstrated a high durable response rate, with no new safety signals after the primary analysis, suggestive of an effective first-line therapy with curative intent in high-risk LBCL. Further assessments are needed to determine its benefit vs standard of care. This trial was registered at clinicaltrials.gov, as NCT03761056.

Abstract Winters, JD, Heebner, NR, Johnson, AK, Poploski, KM, Royer, SD, Nagai, T, Randall, CA, Abt, JP, and Lephart, SM. Altered physical performance following advanced special operations tactical training. J Strength Cond Res 35(7): 1809–1816, 2021—The purpose of this study was to determine how the unique challenges of specific military tactical training phases influence overall physical performance characteristics. Broad jump, 5-10-5, 300-yd shuttle, percent body fat (%BF), anaerobic power (AP) and anaerobic capacity (AC), maximal oxygen uptake (V̇ o 2 max), isokinetic knee extension/flexion strength, shoulder internal/external rotation strength, and trunk extension/flexion strength were collected on 73 United States Marine Corps Forces Special Operations Command (MARSOC) students (age: 27.4 ± 3.8 years, height: 178.7 ± 6.6 cm, and body mass: 85.8 ± 9.4 kg) at the beginning of (P1), in between (P2), and at the completion of 2 distinct tactical training phases (P3). Linear mixed models were used to analyze within-subject performance changes over the 3 time points, and post hoc Bonferroni pairwise comparisons analyzed performance changes between each testing time point. There were significant changes in broad jump ( p < 0.0001), 5-10-5 agility time ( p < 0.001), %BF ( p = 0.011), AP ( p < 0.0001), V̇ o 2 max ( p = 0.001), and both right and left shoulder internal rotation strength ( p = 0.004 and p = 0.015, respectively) between P1 and P2. There were also significant changes in 300-yd shuttle run time ( p = 0.001), AP ( p < 0.0001), AC ( p < 0.0001), left knee extension strength ( p = 0.006), trunk flexion strength ( p < 0.0001), and left shoulder external rotation strength (0.027) between P2 and P3. Identifying the effect that specific tactical training phases may have on physical performance will allow for the development of effective phase-specific evidence-based human performance programs, reducing performance deficits and thereby reducing the risk of injury.