The phase 2 LYSA study of prednisone, vinblastine, doxorubicin, and bendamustine for untreated Hodgkin lymphoma in older patients.

ABSTRACT: Older patients with classical Hodgkin lymphoma (cHL) require more effective and less toxic therapies than younger patients. In this multicenter, prospective, phase 2 study, we investigated a new firstline therapy regimen comprising 6 cycles of prednisone (40 mg/m2, days 1-5), vinblastine (6 mg/m2, day 1), doxorubicin (40 mg/m2, day 1), and bendamustine (120 mg/m2, day 1) (PVAB regimen) every 21 days for patients with newly diagnosed cHL aged ≥61 years with an advanced Ann Arbor stage. A Mini Nutritional Assessment score ≥17 was the cutoff value for patients aged ≥70 years. The primary end point was the complete metabolic response (CMR) rate after 6 cycles. The median age of the 89 included patients was 68 years (range, 61-88 years), with 35 patients (39%) aged ≥70 years. Seventy-eight patients (88%) completed the 6 cycles. The toxicity rate was acceptable, with a 20% rate of related serious adverse events. CMR was achieved by 69 patients (77.5%; 95% confidence interval [CI], 67-86). After a median follow-up of 42 months, 31 patients progressed or relapsed (35%), and 24 died (27%) from HL (n = 11), toxicity during treatment (n = 4), secondary cancers (n = 6), or other causes (n = 3). The 4-year progression-free survival (PFS) and overall survival rates were 50% and 69%, respectively. Multivariate analysis showed that liver involvement (P = .001), lymphopenia (P = .001), CRP (P = .0005), and comedications (P = .003) were independently associated with PFS. The PVAB regimen yielded a high CMR rate with acceptable toxicity. Over long-term follow-up, survival end points were influenced by unrelated lymphoma events. This trial was registered at www.clinicaltrials.gov as #NCT02414568 and at EudraCT as 2014-001002-17.

Toward A Serious Game to Help Future Military Doctors Face Mass Casualty Incidents.

INTRODUCTION: To prepare military doctors to face mass casualty incidents (MCIs), the French Army Health Service contributed to the development of TRAUMASIMS, a serious game (SG) for training medical responders to MCIs. METHODS: French military doctors participated in a three-phase training study. The initial war trauma training was a combination of didactic lectures (Phase 1), laboratory exercises (Phase 2), and situational training exercises (STX) (Phase 3). Phase 1 lectures reviewed French Forward Combat Casualty Care (FFCCC) practices based on the acronym MARCHE (Massive bleeding, Airway, Respiration, Circulation, Head, hypothermia, Evacuation) for the detection of care priorities and implementation of life-saving interventions, triage, and medical evacuation (MEDEVAC) requests. Phase 2 was a case-control study that consisted of a traditional text-based simulation of MCIs (control group) or SG training (study group). Phase 3 was clinical: military students had to simultaneously manage five combat casualties in a prehospital setting. MCI management was evaluated using a standard 20-item scale of FFCCC benchmarks, 9-line MEDEVAC request, and time to evacuate the casualty collection point (CCP). Emotional responses of study participants were secondarily analyzed. RESULTS: Among the 81 postgraduate military students included, 38 took SG training, and 35 trained with a text-based simulation in Phase 2. Regarding the error rates made during STX (Phase 3), SG improved FFCCC compliance (11.9% vs. 23.4%; p < .001). Additionally, triage was more accurate in the SG group (93.4% vs. 88.0%; p = .09). SG training mainly benefited priority and routine casualties, allowing faster clearance of the CCP (p = .001). Stress evaluations did not demonstrate any effect of immersive simulation. CONCLUSION: A brief SG-based curriculum (2 hours) improved FFCCC performance and categorization of casualties in MCI STX.