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Dillman R.O.,Caladrius Biosciences Inc. | McClay E.F.,Institute for Melanoma Research and Education | Barth N.M.,Genomics Usa, Inc. | Amatruda T.T.,Minnesota Oncology | And 5 more authors.
Cancer Biotherapy and Radiopharmaceuticals | Year: 2015

In patients with metastatic melanoma, sequential single-arm and randomized phase II trials with a therapeutic vaccine consisting of autologous dendritic cells (DCs) loaded with antigens from self-renewing, proliferating, irradiated autologous tumor cells (DC-TC) showed superior survival compared with similar patients immunized with irradiated tumor cells (TC). We wished to determine whether this difference was evident in cohorts who at the time of treatment had (1) no evidence of disease (NED) or (2) had detectable disease. Eligibility criteria and treatment schedules were the same for all three trials. Pooled data confirmed that overall survival (OS) was longer in 72 patients treated with DC-TC compared with 71 patients treated with TC (median OS 60 versus 22 months; 5-year OS 51% versus 32%, p=0.004). Treatment with DC-TC was associated with longer OS in both cohorts. Among 70 patients who were NED at the time that treatment was started, OS was better for DC-TC: 5-year OS 73% versus 43% (p=0.015). Among 73 patients who had detectable metastases, OS was better for DC-TC: median 38.8 months versus 14.7 months, 5-year OS 33% versus 20% (p=0.025). This approach is promising as an adjunct to other therapies in patients who have had metastatic melanoma. © Copyright 2015, Mary Ann Liebert, Inc. 2015. Source

Dillman R.O.,Hoag Institute for Research and Education | Dillman R.O.,Hoag Family Cancer Institute | McClure S.E.,Hoag Institute for Research and Education
Clinical Lung Cancer | Year: 2014

Background National data demonstrate minimal improvement in survival for patients diagnosed with lung cancer despite a number of apparent advances during the past 3 decades. We wished to know how demographic characteristics, staging, therapy, and survival have changed over time for patients with lung cancer who were accessioned to the cancer registry of a large community hospital in southern California.Patients and Methods Clinical features and survival data were collected on patients diagnosed during each of the successive 6-year eras of 1986 to 1991 (n = 812), 1992 to 1997 (n = 1072), 1998 to 2003 (n = 1209), and 2004 to 2009 (n = 1365).Conclusion Survival has steadily improved for patients in this community who were diagnosed with lung cancer. The explanations for this improvement are multifactorial, but include earlier stage at diagnosis, decreases in histologic types associated with active smoking, and increased use of systemic therapies.Results Median survival improved from 11 to 13 to 16 to 26 months and overall 5-year survival steadily improved from 16.5% to 19.1% to 24.0% to 31.1%. The proportion of patients with localized disease at diagnosis increased from 18.4% to 24.1% to 24.9% to 31.6%. Improvements in relative survival were much greater than have occurred nationally. Other obvious trends over time were increasing age of patients, increasing proportions with diagnoses of adenocarcinoma with concomitant decreases in squamous cell and small cell histologies, and decreases in the proportion of large cell carcinoma with reciprocal increases in neuroendocrine diagnoses. The use of chemotherapy for patients with local disease tripled in the most recent era. © 2014 Elsevier Inc. Source

Dillman R.O.,Hoag Institute for Research and Education | Dillman R.O.,Hoag Family Cancer Institute | Dillman R.O.,Cancer Biotherapy Research Group | Depriest C.,Cancer Biotherapy Research Group | And 2 more authors.
Cancer Biotherapy and Radiopharmaceuticals | Year: 2014

Various published data show that in patients with metastatic melanoma, high-dose interleukin-2 (IL2) is associated with 5-year survival rates of 15% from treatment initiation. We previously reported a median survival of 15.6 months, and a 20% 5-year survival rate for 150 patients who were treated with inpatient IL2 (Cancer Biother Radiopharm 2012;27:337). In the current study, we sought to determine whether treatment with active specific immunotherapy (ASI) with patient-specific tumor stem cell vaccines derived from autologous tumor cell (TC) lines contributed to the survival result. Existing databases revealed that 32/149 IL2-treated patients also received ASI, while 117 did not. ASI was given within 12 months of IL2 therapy in 19/32 patients. Patients who received IL2 plus ASI had better overall survival (p<0.001) with longer median survival (39.5 vs. 12.0 months) and a higher 5-year survival rate (39% vs. 13%). Survival was better even after exclusion of 55 IL2-alone patients who died before 12 months of follow-up (p=0.12). In subset analyses, survival was longer for 25 patients who received ASI after IL2 than for 7 who received ASI before IL2 (5-year survival 46% vs. 14%, p<0.001) and for 16 patients who received a dendritic cell/TC-based ASI compared with 16 injected with irradiated TC (p=0.17). This retrospective study suggests that receipt of IL2 followed by a patient-specific melanoma stem cell vaccine is associated with better survival than IL2 alone. © Mary Ann Liebert, Inc. Source

Dillman R.O.,Hoag Institute for Research and Education | Cornforth A.N.,California Stem Cell | Nistor G.,California Stem Cell
Expert Opinion on Biological Therapy | Year: 2013

Introduction: There are now two chemotherapy agents, one tyrosine kinase inhibitor and three immunotherapy products approved for the treatment of metastatic melanoma, but an unmet need persists because these options are toxic and of limited therapeutic benefit. Active specific immunotherapy with therapeutic vaccines could be a useful addition to the therapeutic armamentarium, especially in patients whose tumor burden has been reduced by other treatment modalities. Areas covered: This article reviews various sources of melanoma antigens, such as peptides, gangliosides, autologous tumor and cancer stem cells including allogeneic and autologous cell lines. The advantages and disadvantages of various antigen sources and allogeneic and autologous approaches are discussed with an emphasis on the theoretical benefits of immunizing against cancer stem cells. The results from published randomized trials testing the benefit of various vaccine approaches are summarized, as well as promising results from three Phase II trials (one randomized) of patient-specific stem cell antigen-based products. Expert opinion: Immune responses directed toward the unique neoantigens and stem cell antigens expressed on continuously proliferating, self-renewing, autologous tumor cells could potentially overcome the limitations inherent in these other antigen-based approaches, that to date, have yielded disappointing results in randomized trials. © 2013 Informa UK, Ltd. Source

Epstein M.,Hoag Institute for Research and Education | Silverstein M.,Hoag Memorial Hospital Presbyterian | Silverstein M.,University of Southern California | Lin K.,Hoag Memorial Hospital Presbyterian | And 10 more authors.
Annals of Surgical Oncology | Year: 2016

Introduction: Intraoperative radiation therapy (IORT) permits the delivery of radiation therapy directly to the tumor bed at the time of surgery. Minimal data are available about the complications associated with this modality of treatment using the Xoft® Axxent Electronic Brachytherapy (Axxent) System. Methods: A total of 702 patients who received IORT using the Xoft® Axxent System at Hoag Memorial Hospital Presbyterian between June 2010-February 2016 were accrued in an IORT data registry study. The prospective and retrospective protocols were approved by the institutional review board and met the guidelines of their responsible governmental agency. Data were collected at 1 week, 1 month, 3 months, 6 months, 1 year, and thereafter yearly. Acute complications were defined as those occurring within the first month. Chronic complications were those that persisted beyond 6 months. Results: Acute complications were observed in 21 % of patients and included hematomas that required drainage, seromas requiring drainage more than 3 times, infections treated with antibiotics or surgery, necrosis requiring surgery, and erythema. Chronic complications were observed in 13 % of patients and included seromas, fibrosis, and hyperpigmentation. The majority of acute and chronic problems from IORT were mild. If grade I erythema, fibrosis, and hyperpigmentation were removed, only 32 of 702 (4.6 %) had significant complications. Our complication rates were comparable to those of the TARGIT trial. Conclusions: IORT is a modality that safely delivers radiation therapy to patients diagnosed with breast cancer. This technique allows women who cannot (or decline to) undergo whole breast radiation to consider breast-conserving therapy rather than mastectomy. © 2016 Society of Surgical Oncology Source

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