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Intravenous immunoglobulin with prednisone and risk-adapted chemotherapy for children with opsoclonus myoclonus ataxia syndrome associated with neuroblastoma (ANBL00P3): a randomised, open-label, phase 3 trial
de Alarcon P A, Matthay K K, London W B, Naranjo A, Tenney S C, Panzer J A, Hogarty M D, Park J R, Maris J M, Cohn S L
The Lancet Child & Adolescent Health. 2018;2((1)):25-34.
Abstract
Purpose: No previous clinical trial has been conducted for patients with neuroblastoma associated opsoclonus myoclonus ataxia syndrome (OMA), and current treatment is based on case reports. To evaluate the OMA response to prednisone and risk-adapted chemotherapy and determine if the addition of intravenous gammaglobulin (IVIG) further improves response, the Children's Oncology Group designed a randomized therapeutic trial. Patient and Methods: Eligible subjects were randomized to receive twelve cycles of IVIG (IVIG+) or no IVIG (NO-IVIG) in addition to prednisone and neuroblastoma risk-adapted chemotherapy. All low-risk patients were treated with cyclophosphamide. The severity of OMA symptoms was evaluated at 2, 6, and 12 months using a scale developed by Mitchell and Pike and baseline versus best response scores were compared. A single patient who did not undergo neurologic assessment was excluded from OMA response analysis. This study is registered with Clinical Trials.gov (identifier NCT00033293). Results: Of the 53 patients enrolled in the study, 62% (33/53) were female. There were 44 low-risk, 7 intermediate-risk, and 2 high-risk neuroblastoma patients. Twenty-six subjects were randomized to receive IVIG+ and 27 were randomized to NO-IVIG. The neuroblastoma 3-year event-free survival (95% confidence interval (CI)) was 94.1% (87.3%, 100%) and overall survival was 98.0% (94.1%, 100%). Significantly higher rates of OMA response were observed in patients randomized to IVIG+ compared to NO-IVIG [21/26=80.8% for IVIG+; 11/27=40.7% for NO-IVIG (odds ratio=6.1; 95% CI: (1.5, 25.9), p=0.0029)]. For the majority of patients, the IVIG+ OMA regimen combined with cytoxan or other risk-based chemotherapy was well tolerated, although there was one toxic death in a high-risk subject. Conclusion: This is the only randomized prospective therapeutic clinical trial in children with neuroblastoma-associated OMA. The addition of IVIG to prednisone and risk-adapted chemotherapy significantly improves OMA response rate. IVIG+ constitutes a back-bone upon which to build additional therapy.
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Intravenous immune globulin (IGIV) therapy reduces infectious complications in a dose-dependent manner
Sacher RA, Hanna K
Journal of Clinical Oncology. 2003;22:779. Abstract No. 3130.
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Prophylaxis of postoperative infections: immunoglobulins or antibiotics? Italian
Catania G, Salanitri T, Zamboni V
Minerva Chirurgica. 1993;48((19):):1083-90.
Abstract
Authors report the preliminary results of their experience in the infections prophylaxis treatment on the operated oncologic patient, with a particular care for immunoprophylaxis aiming to improve the immune defenses. 89 patients have been considered, dividing them into three groups according to the therapy carried out: e.v. immunoglobulins (300 mg/kg per day, for three days), e.v. immunoglobulins associated with routine antibiotic prophylaxis, routine antibiotic prophylaxis. The results show a remarkable reduction both of the period of postoperative bedridding in the group treated with e.v. immunoglobulins only, and of the infective complications in the patients treated with e.v. immunoglobulins (alone or in association with antibiotic prophylaxis), compared with the check group (antibiotic prophylaxis only).
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Immunoprophylaxis in "septic risk" patients undergoing surgery for gastrointestinal cancer. Results of a randomized, multicenter clinical trial
Gipponi M, Canova G, Bonalumi U, Bertoglio S, Corbetta G, Sguotti C, Cafiero F
International Surgery. 1993;78((1):):63-7.
Abstract
The results of a randomized, multicenter clinical trial of immunoprophylaxis of post-operative infections with intravenous Immunoglobulins (IVIG) (Sandoglobulin) in "septic-risk" patients undergoing surgery for gastrointestinal cancer are presented. "Septic-risk" patients were selected by an original multiparametric test based on delayed hypersensitivity skin testing and serum protein electrophoretic sub-fractions. This screening test had shown 76% positive predictivity in a previous validation assessment. In the present study, 159 "septic-risk" patients were selected prospectively from 369 patients undergoing colo-rectal (colon) and other kinds of gastrointestinal (non-colon) oncologic surgery: 80 "septic-risk" patients were included in the colon and 79 in the non-colon group. Immunoprophylaxis with IVIG (15 g on the day prior to operation, on the 1st and 5th postoperative days) was randomly associated with antibiotic prophylaxis (cefoxitin: 2 g one hour prior to, followed by 2 g at the end of operation plus 2 g every six hours for 24 hours) in colon surgery while the prophylactic schedule in non-colon surgery was only based on random administration of IVIG, at the same dosage as in the colon group. There was a clear-cut reduction of post-operative infections both in colon and non-colon "septic-risk" patients who had IVIG prophylaxis; in the colon group, 37 and 21 infections (P < 0.004) in antibiotic (A) versus IVIG plus antibiotic (IVIG + A) subset, respectively; in the non-colon group, 33 and 19 infections (P < 0.01) in control (C) versus (IVIG) subset, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
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Prophylaxis of infection with intravenous immunoglobulins plus antibiotic for patients at risk for sepsis undergoing surgery for colorectal cancer: results of a randomized, multicenter clinical trial
Cafiero F, Gipponi M, Bonalumi U, Piccardo A, Sguotti C, Corbetta G
Surgery. 1992;112((1):):24-31.
Abstract
BACKGROUND The results of a randomized, multicenter clinical trial with perioperative short-term antibiotic plus intravenous immunoglobulins (IVIG + A) versus antibiotic alone (A) for prevention of postoperative infections in patients at risk for sepsis undergoing surgery for colorectal cancer are presented. METHODS The patients at risk for sepsis were selected by an original multiparametric test based on delayed-hypersensitivity skin testing and serum protein electrophoretic subfractions. This screening had shown 76% positive predictability in a previous validation assessment. Eighty patients at risk for sepsis were selected prospectively from 210 patients undergoing surgery for colorectal cancer; 43 patients were randomly assigned to the IVIG + A group and 37 to the A group. IVIG was administered on the day before operation, on the first and fifth postoperative days. RESULTS There was a clear-cut reduction of postoperative infections in the IVIG + A group: 21 infections in 20 patients versus 37 infections in 29 patients in the A group (p less than 0.004). With regard to serum immunoglobulin (Ig) G monitoring, basal IgG levels were significantly lower in patients given IVIG + A who had postsurgical infections (p less than 0.005) compared with patients with a regular outcome, whereas the same was not true in the A group of patients. CONCLUSIONS A significant decrease (p less than 0.001) of postoperative IgG was evidenced in the A group of patients who had infections as opposed to a significant increase (p less than 0.001) of postoperative IgG in IVIG + A patients with a normal outcome.
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Immunoglobulins for the prevention of radiation pneumonitis following large-volume irradiation in bronchial carcinoma . German
Seibel RM, Wendt BK
Onkologie. 1986;9((1):):43-7.
Abstract
In a randomized study 20 patients with non small cell lung cancer were treated for cure at a linear accelerator. Before, during and after treatment levels of immunoglobulins were measured. At the end of radiation therapy levels of IgA, IgG and IgM decreased. After therapy they increased slowly. 3 months after irradiation the average immunoglobulin levels showed a reduction of 16%. After substitution of immunoglobulins no decrease of the levels was seen. After substitution of immunoglobulins the Karnofsky index was significantly higher. Substituted patients showed a lower rate of radiation pneumonitis.
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Reduction of infection frequency by intravenous gammaglobulins during intensive induction therapy for small cell carcinoma of the lung
Schmidt RE, Hartlapp JH, Niese D, Illiger HJ, Stroehmann I
Infection. 1984;12((3):):167-70.
Abstract
Thirty-two patients with small cell carcinoma of the lung received intensive induction chemoradiotherapy. In a randomized prospective study, we compared the outcome of patients who received 30 g immunoglobulin i.v. divided into three doses per therapy course for infection prophylaxis (Group A) with patients undergoing the same anti-tumor therapy (Group B). All patients were prospectively randomized to one of two groups in order to evaluate the role of intravenous immunoglobulin therapy for infection prophylaxis. Group A received 30 g intravenous immunoglobulin during each course of chemotherapy. Group B was a control group that received identical chemoradiotherapy but did not receive any immunoglobulin therapy. All patients had a severely impaired cellular immune response. IgG serum concentrations were significantly higher in group A. Patients who received intravenous immunoglobulin had significantly fewer infections during the entire treatment period than patients who did not receive prophylactic treatment.