Utilization of an audit tool to evaluate accuracy of treatment summary and survivorship care plans.

PURPOSE: A quality review process was implemented to determine compliance with the requirement from the Commission on Cancer to use the American Society of Clinical Oncology (ASCO) template as the minimum data set for Treatment Summary and Survivorship Care Plans (TS/SCP) provided to cancer survivors. METHODS: TS/SCPs generated during 2017 (N = 1257) were audited for concordance with each of the 66 TS/SCP line items on ASCO's template. Descriptive statistics and chi-square statistics were used to examine line item concordance, overall and by services groups (survivorship vs. other oncology service). Mixed-effects logistic regression was used to estimate the effects of service delivery group on the concordance. RESULTS: Institutional compliance with the ASCO template was very high; 76% of the 66 line items were present in at least 75% of the delivered TS/SCPs. There was a significantly higher rate of concordance for TS/SCPs provided by the survivorship service (83% vs. 66%, P = 0.006). TS/SCPs provided by the survivorship service were nearly twice as likely to be concordant with ASCO template (OR = 1.88, 95% CI = 1.77-2.00) compared to those by other service groups. CONCLUSIONS: Use of the electronic medical record to auto-populate information was instrumental in achieving a high rate of concordance. Institutions should consider providing training to improve or maintain quality of these documents. IMPLICATIONS FOR CANCER SURVIVORS: Ensuring that the information contained on the TS/SCP is consistently present is necessary for a high-quality survivorship visit between the clinician, PCP, and survivor and as a record of care for future health care encounters.

Multiparametric flow cytometric analysis of signal transducer and activator of transcription 5 phosphorylation in immune cell subsets in vitro and following interleukin-2 immunotherapy.

PURPOSE: Treatment with interleukin (IL)-2 (Proleukin) yields a 10% to 20% response rate in patients with metastatic melanoma or metastatic renal cell carcinoma. IL-2 is known to activate distinct signals within lymphocytes, including the Janus-activated kinase-signal transducer and activator of transcription (STAT) pathway. We examined the phosphorylation of STAT5 (P-STAT5) in IL-2-stimulated immune cells of normal subjects and in patients receiving IL-2 therapy using a novel flow cytometric assay to characterize the pattern and level of activation within immune subsets. EXPERIMENTAL DESIGN: Normal peripheral blood mononuclear cells (PBMC) were treated in vitro with IL-2 and analyzed for P-STAT5 using an intracellular flow cytometric assay. PBMC were simultaneously evaluated for the induction of STAT5-regulated genes at the transcript level. PBMC were also obtained from patients immediately before and 1 hour after treatment with high-dose IL-2 and analyzed for the presence of P-STAT5 within immune cell subsets by dual-variable intracellular flow cytometry. RESULTS: In vitro IL-2 treatment produced a rapid and dose-dependent increase in P-STAT5 within normal PBMC that correlated with the induction of transcript for the IL-2-responsive genes CIS, Pim-1, and SOCS1 (correlation coefficients 0.8628, 0.6667, and 0.7828, respectively). Dose-dependent induction of P-STAT5 was detected in PBMC for up to 18 hours following in vitro pulse stimulation with IL-2. P-STAT5 was detected within a subset of normal donor CD4(+) T cells (52.2 +/- 15.0%), CD8(+) T cells (57.6 +/- 25.8%), and CD56(+) natural killer (NK) cells (54.2 +/- 27.2%), but not CD14(+) monocytes or CD21(+) B cells, following in vitro IL-2 treatment. The generation of P-STAT5 within immune cell subsets after the therapeutic administration of IL-2 varied significantly between individuals. NK cells were noticeably absent in the posttreatment sample, a finding that was consistent for all patients examined. Surprisingly, activated STAT5 persisted within CD4(+) and CD8(+) T lymphocytes, as well as CD56(+) NK cells, for up to 3 weeks post-IL-2 treatment in three patients who exhibited a clinical response to therapy and in a fourth who exhibited a significant inflammatory response after 11 doses of therapy (first cycle). CONCLUSIONS: The flow cytometric assay described herein is a highly efficient and reliable method by which to assess the cellular response to IL-2 within PBMC and specific immune effector subsets, both in vitro and in the clinical setting. Assessment of P-STAT5 in patient PBMC in response to therapeutic IL-2 administration reveals disparate responses between immune cell subsets as well as interpatient variation. Persistent activation of STAT5 within NK and T cells was an unexpected observation and requires further investigation.