Summary:therapy. It is postulated that immunotherapy with interleukin-2 (IL-2), administered early after ASCT, at a time of minimal residual disease, may reduce the relapse rate. The success of autologous stem cell transplantation (ASCT) for hematologic malignancy is limited largelyAn earlier phase I trial with IL-2 (Hoffman LaRoche, Nutley, NJ, USA) administered early after ABMT for hemby a high relapse rate. It is postulated that IL-2 administered after ASCT may eliminate minimal residual disatologic malignancies identified a tolerable regimen which induced immunomodulatory effects. 10 The encouraging ease and thereby reduce relapses. A phase I/II study was performed to identify a regimen of IL-2 (Chiron) that clinical results observed in the course of that phase I trial 11,12 stimulated the design of phase III trials. However, could be given early after ASCT in phase III trials. In the phase I study, beginning a median of 46 days after since Roche IL-2 became unavailable, the current phase I/II trial was performed to identify an equitoxic regimen of IL-ASCT for hematologic malignancy, cohorts of three to four patients received escalating doses of 'induction' IL-2 provided by Chiron which could then be used in randomized trials to determine whether post-transplant IL-2 2 of 9, 10, or 12 × 10 6 IU/m 2 /day for 4 or 5 days by continuous i.v. infusion (CIV), followed by a 4-day rest therapy will reduce relapses in patients with AML and NHL. period, and then 1.6 × 10 6 IU/m 2 /day of maintenance IL-2 by CIV for 10 days. The maximum tolerated dose (MTD) of induction IL-2 was 9 × 10 6 IU/m 2 /day × 4. In the phase II study, 52 patients received the MTD. Eighty Materials and methods percent of patients completed induction IL-2. Most patients exhibited some degree of capillary leak. OnePatient characteristics patient died of CMV pneumonia and one died of ARDS.Between November 1992 and April 1995, 67 patients with Maintenance IL-2 was well tolerated. In the phase I/II a median age of 44 (range 1-63) were treated with highstudy, 16 of 31 patients with non-Hodgkin lymphoma dose chemotherapy, with or without fractionated total body (NHL), 3/8 with Hodgkin disease (HD), 4/17 with AML, irradiation, plus an infusion of autologous stem cells from and 4/5 with ALL remain in CR. Two of six multiple peripheral blood (PB; n = 34), bone marrow (BM; n = 23), myeloma (MM) patients remain in PR. Although the or BM and PB (n = 10) followed by IL-2 therapy. Patients regimen of IL-2 identified had significant side-effects in were treated at the University of Washington Medical some patients, it was well tolerated in the majority of Center, the Fred Hutchinson Cancer Research Center patients. Phase III prospectively randomized clinical (FHCRC) or the Seattle Veteran's Administration Medical trials are in progress to determine if this IL-2 regimen Center. Patients were treated for NHL (31), AML (17), will decrease the relapse rate after ASCT for AML Hodgkin's disease (HD; eight), MM (six), or acute lymand NHL.phoblastic leukemia (ALL; fou...
Allogeneic bone marrow transplantation (BMT) for advanced acute leukemia is associated with a high risk of relapse. It is postulated that interleukin-2 (IL-2) administered after BMT might induce or amplify a graft-versus-leukemia effect and thereby reduce the relapse rate. To identify an IL-2 regimen for testing this hypothesis, a phase I trial of IL-2 (Roche) was performed in children in complete remission (CR) without active graft-versus-host disease (GVHD) off immunosuppressive agents after unmodified allogeneic matched-sibling BMT for acute leukemia beyond first remission. Beginning a median of 68 days after BMT, 17 patients received escalating doses of induction IL-2 (0.9, 3.0, or 6.0 x 10(6) IU/m2/d representing levels I, II, and III) for 5 days by continuous intravenous infusion (CIV). After 6 days of rest, they received maintenance IL-2 (0.9 x 10(6) IU/m2/d) for 10 days by CIV infusion. Levels I and II were well-tolerated, but, of 6 patients at level III, 1 developed pulmonary infiltrates, 1 developed hypotension (both resolved), and 1 died of bacterial sepsis and acute respiratory distress syndrome. Grade II acute GVHD developed in 1 patient at level I and 1 at level III. The maximum tolerated dose of induction IL-2 was level II. IL-2 induced lymphocytosis, with an increase in CD56+ and CD8+ cells. Ten patients remain in CR at 5+ to 67+ months. Thus, a regimen of IL-2 has been identified that did not induce a high incidence of acute GVHD when administered to children after unmodified allogeneic BMT. Its clinical activity will be assessed in a phase II trial.
80 Background: High quality and safe medical care has been a consistent goal of the medical community at Virginia Mason Medical Center (VMMC). The Am Soc of Clinical Oncology (ASCO) has set out a list of criteria as part of Its Quality Oncology Practice Initiative (QOPI), which are increasingly being adopted as standards for quality measurement in the Oncology community. Our practice at VMMC participated in the QOPI quality metric survey, with the intent of measuring and enhancing cancer care delivery. Methods: We participated in the web-based QOPI quality metric during the September, 2013 and April, 2014 sessions. Chart abstraction was shared by the providers. Following the Sept session, our performance was analyzed, and targeted areas of improvement were collectively identified by all providers. Following the April session, the clinical note format was changed to incorporate a standard template, addressing areas of underperformance. Results: In the September 2013 session, the primary areas of underperformance were assessment of: a) pain, b) emotional distress, c) performance status (PFS), and d) documentation of staging. Following the April 2014 session, we noted improved performance in all these assessments. Thus, pain reporting rates improved from 40.6 to 61.2%; emotional distress screening from 37.3% to 42.8%; PFS documentation from 42.6 to 53.7%; and staging at initial diagnosis from 74.6% to 80.9%. However our areas of underperformance continued to lag 10 to 30% behind QOPI aggregate reporting rates. With the introduction of a structured note in the electronic medical record (EMR), further improvements are expected the results of which will be reported at the time of the meeting. On the positive side, chemotherapy education and discussion of risk/benefit were consistently areas of superior performance in our practice with our reporting rates being 10 to 40% higher than the QOPI aggregate. Conclusions: QOPI participation is a useful tool for improving and sustaining a high level of practice performance in oncology. Structured notes in the EMR maybe indispensable for maintaining a high level of compliance with performance measures.
94 Background: A common symptom in patients being treated with opioid analgesics is constipation, which is often underreported by patients and therefore undertreated by providers. The Quality Oncology Project Initiative (QOPI) has identified constipation as one of the benchmark symptoms to be monitored in order to obtain certification. At Virginia Mason Medical Center, we had previously identified constipation as a symptom which was not adequately addressed in the medical record, and implemented a template-based initiative to increase its evaluation. Methods: We identified consecutive patients with advanced cancer undergoing systemic therapy who were also receiving opioid analgesic treatments. These patients were surveyed for constipation, and answered a questionnaire regarding its severity and whether they felt it was adequately handled. We then reviewed the encounter notes for the visit to correlate the provider’s documentation of constipation and its treatment and the patient experience. Results: Results will be presented at the symposium. Conclusions: We aim to describe whether or not the symptom of constipation was adequately captured and/or treated in patients receiving opioid therapy.
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