Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST): Refining Guidelines to Assess the Clinical Benefit of Cancer Immunotherapy.

Purpose Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods Atezolizumab data from clinical trials in non-small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1.1 included allowance for best overall response after progressive disease (PD) and changes in PD definitions per new lesions (NLs) and nontarget lesions. imRECIST progression-free survival (PFS) did not count initial PD as an event if the subsequent scan showed disease control. OS was evaluated using conditional landmarks in patients whose PFS differed by imRECIST versus RECIST v1.1. Results The best overall response was 1% to 2% greater, the disease control rate was 8% to 13% greater, and the median PFS was 0.5 to 1.5 months longer per imRECIST versus RECIST v1.1. Extension of imRECIST PFS versus RECIST v1.1 PFS was associated with longer or similar OS. Patterns of progression analysis revealed that patients who developed NLs without target lesion (TL) progression had a similar or shorter OS compared with patients with RECIST v1.1 TL progression. Patients infrequently experienced a spike pattern (TLs increase, then decrease) but had longer OS than patients without TL reversion. Conclusion Evaluation of PFS and patterns of response and progression revealed that allowance for TL reversion from PD per imRECIST may better identify patients with OS benefit. Progression defined by the isolated appearance of NLs, however, is not associated with longer OS. These results may inform additional modifications to radiographic criteria (including imRECIST) to better reflect efficacy with CIT agents.

Implementation of a screening, brief intervention, and referral to treatment program using the electronic medical record in a pediatric trauma center.

The purpose of this project was to develop and implement a consistent process for (1) screening adolescents by history for alcohol and substance abuse and (2) providing a motivational interview for change and appropriate referrals as needed. In the 18 months since we implemented the program, 534 patients were eligible for screening. Of these, 442 actually underwent screening and of these, 32 screened positive, thus receiving a brief intervention by social work and referral for further treatment. Use of the electronic medical record was key to the implementation and sustainability of this project.

Diagnostic and therapeutic laparoscopy in pediatric abdominal trauma.

PURPOSE: The purpose of this study is to assess the role of emergent laparoscopy as a diagnostic and potentially therapeutic modality in pediatric trauma. We hypothesize that diagnostic laparoscopy provides important information for the treatment of children with abdominal trauma and is accompanied by improved diagnostic accuracy, reduction of nontherapeutic laparotomy rates, and a reduction of morbidity. METHODS: A 5-year (January 2000-December 2004) retrospective review of a pediatric level I trauma center database was performed after institutional review board approval was obtained, and information regarding patients who had operations for abdominal trauma was abstracted. Demographic variables, mechanism of injury, operative interventions, and patient outcomes were examined. Statistical analysis was performed using descriptive statistics and Student's t test (P < .05). RESULTS: There were 7127 trauma admissions, of which 113 had abdominal explorations for blunt (88%) and penetrating (12%) trauma. Thirty-two (28%) patients had laparoscopy performed. Laparotomy was avoided in 56% of these patients. Laparoscopic therapeutic interventions were performed in 6 (19%) patients. Laparoscopy assisted in the diagnosis and subsequent conventional repair of perforated viscera in 10, diaphragmatic rupture in 3, and distal pancreatic injury in 1. Patients who had a laparoscopic procedure of any kind were less severely injured leading to significantly lower number of intensive care unit (0.6 +/- 1.6, P = .0004) and hospital days (7.4 +/- 5.6, P = .002) than patients who had a laparotomy (3.7 +/- 7.1 and 12.5 +/- 11.4). No injuries were missed, or technical complications occurred, as a result of laparoscopic explorations. There were 6 deaths in the laparotomy group. No patients who underwent laparoscopy died. CONCLUSION: Laparoscopy in pediatric trauma is a safe method for the evaluation and treatment of selective blunt and penetrating abdominal injuries in hemodynamically stable patients. Laparoscopy serves as a diagnostic tool in abdominal trauma, which reduces the morbidity of a negative laparotomy.