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High-dose Interferon (high-dose + interferon)
Selected AbstractsHigh-dose interferon, sentinel lymph node biopsy and the U.K. guidelines for cutaneous melanoma: reply from authorsBRITISH JOURNAL OF DERMATOLOGY, Issue 4 2002J.A. Newton Bishop No abstract is available for this article. [source] Impaired platelet aggregation in melanoma patients treated with interferon-,-2b adjuvant therapyCANCER, Issue 3 2002Haim Gutman M.D. Abstract BACKGROUND High-dose interferon (INF)- ,-2b is the only Food and Drug Administration-approved adjuvant treatment for patients with melanoma who are at high risk of recurrence. Although circumstantial evidence points to a potentially harmful effect of INF-,-2b on platelet function, to the authors' knowledge this has never been studied in humans. METHODS The study group was comprised of patients who had undergone surgery for melanoma and were free of disease but at a high risk of recurrence. All patients were candidates for adjuvant INF treatment (high-dose) and were undergoing routine evaluation to which platelet aggregation was added. Aggregation was triggered in standard fashion with adenosine diphosphate, epinephrine, collagen, thrombin, arachidonic acid, and ristocetin. Blood samples were drawn immediately before treatment, during the intravenous loading phase, during the subcutaneous maintenance phase, and 3,6 weeks after cessation of treatment. Patients receiving low-dose, long-standing INF-,-2b treatment also were tested. All results at each phase were compared with those of normal controls. RESULTS In those patients receiving high-dose INF-,-2b, ristocetin-induced aggregation did not appear to be affected. However, the response to , 1 of the other agonists was impaired in 5 of 6 samples during loading, 14 of 15 samples during the maintenance phase, and 8 of 13 samples after treatment, compared with only 1 of 8 samples before treatment (P = 0.025, P = 0.002, and P = 0.067, respectively). During treatment with low-dose INF, platelet function was affected to a lesser extent. CONCLUSIONS INF treatment in melanoma patients appears to be associated with severe impairment of platelet aggregation, which appears to be dose-dependent and cumulative,dose-dependent. This is not detectable by the standard coagulation profile. This effect has significant implications in the event of accidental injury or elective surgery. The antiaggregation activity may be the mechanism by which INF delays, reduces, or prevents the formation of melanoma metastases. Cancer 2002;94:780,5. © 2002 American Cancer Society. DOI 10.1002/cncr.10261 [source] Current therapeutic approaches in childhood chronic hepatitis B infection: A multicenter studyJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 2 2004BUNYAMIN DIKICI Abstract Background and Aim:, The aim of the present study was to compare the therapeutic efficacy of three different regimens in childhood chronic hepatitis B (CHB) infection. Methods:, A total of 182 children with CHB infection were prospectively allocated to three random groups. Sixty-two patients in the first group received high-dose interferon (IFN)-, 2b (10 MU/m2) thrice/weekly alone for 6 months. In the second (n = 60) and third groups (n = 60), IFN-, was used for 6 months (5 MU/m2) thrice/weekly in combination with lamivudine (LAM) (4 mg/kg, maximum 100 mg/day) for 12 months. Lamivudine was started simultaneously with IFN in the second group, while it was started 2 months prior to IFN injections in the third group. Results:, The initial mean alanine aminotransferase (ALT) values for the first, second and third groups were 109 ± 93 IU/L, 101 ± 64 IU/L and 92 ± 42 IU/L, respectively (P > 0.05). At the end of the therapy, ALT values decreased to 82 ± 111 IU/L, 38 ± 41 IU/L and 29 ± 16 IU/L in groups 1, 2 and 3, respectively. The mean ALT value of the first group was significantly different to the second and third groups (P = 0.046 and P = 0.002, respectively) at the end of the therapy and these differences were found to be sustained after 18 months. However, results in the second and third groups were similar (P > 0.05). There were no significant differences in HBeAg clearance and anti-HBe seroconversion at the initial stage, 12 months and 18 months between the three groups (P > 0.05). Hepatitis B virus (HBV) DNA clearance in the first group was different from the second and third groups, while the second and third groups had similar HBV DNA clearance ratios at 12 and 18 months. No significant difference was found in the complete response (normalization of ALT, clearance of HBV DNA and seroconversion of anti HBe) ratios of all groups (at 12 months: 28.8, 45.5, 35.8% and at 18 months 33.3, 49 and 34% in groups 1, 2 and 3, respectively, P > 0.05). Conclusions:, Although the ALT normalization and HBV DNA clearance ratios of IFN plus LAM combination groups were better than the high-dose IFN-, monotherapy group, no significant difference was found in the complete response ratios of all three groups. [source] Maximum Likelihood Methods for Nonignorable Missing Responses and Covariates in Random Effects ModelsBIOMETRICS, Issue 4 2003Amy L. Stubbendick Summary. This article analyzes quality of life (QOL) data from an Eastern Cooperative Oncology Group (ECOG) melanoma trial that compared treatment with ganglioside vaccination to treatment with high-dose interferon. The analysis of this data set is challenging due to several difficulties, namely, nonignorable missing longitudinal responses and baseline covariates. Hence, we propose a selection model for estimating parameters in the normal random effects model with nonignorable missing responses and covariates. Parameters are estimated via maximum likelihood using the Gibbs sampler and a Monte Carlo expectation maximization (EM) algorithm. Standard errors are calculated using the bootstrap. The method allows for nonmonotone patterns of missing data in both the response variable and the covariates. We model the missing data mechanism and the missing covariate distribution via a sequence of one-dimensional conditional distributions, allowing the missing covariates to be either categorical or continuous, as well as time-varying. We apply the proposed approach to the ECOG quality-of-life data and conduct a small simulation study evaluating the performance of the maximum likelihood estimates. Our results indicate that a patient treated with the vaccine has a higher QOL score on average at a given time point than a patient treated with high-dose interferon. [source] Is there a benefit to sentinel lymph node biopsy in patients with T4 melanoma?CANCER, Issue 24 2009Csaba Gajdos MD Abstract BACKGROUND: Controversy exists as to whether patients with thick (Breslow depth >4 mm), clinically lymph node-negative melanoma require sentinel lymph node (SLN) biopsy. The authors examined the impact of SLN biopsy on prognosis and outcome in this patient population. METHODS: A review of the authors' institutional review board-approved melanoma database identified 293 patients with T4 melanoma who underwent surgical excision between 1998 and 2007. Patient demographics, histologic features, and outcome were recorded and analyzed. RESULTS: Of 227 T4 patients who had an SLN biopsy, 107 (47%) were positive. The strongest predictors of a positive SLN included angiolymphatic invasion, satellitosis, or ulceration of the primary tumor. Patients with a T4 melanoma and a negative SLN had a significantly better 5-year distant disease-free survival (DDFS) (85.3% vs 47.8%; P < .0001) and overall survival (OS) (80% vs 47%; P < .0001) compared with those with metastases to the SLN. For SLN-positive patients, only angiolymphatic invasion was a significant predictor of DDFS, with a hazard ratio of 2.29 (P = .007). Ulceration was not significant when examining SLN-positive patients but the most significant factor among SLN-negative patients, with a hazard ratio of 5.78 (P = .02). Increasing Breslow thickness and mitotic rate were also significantly associated with poorer outcome. Patients without ulceration or SLN metastases had an extremely good prognosis, with a 5-year OS >90% and a 5-year DDFS of 95%. CONCLUSIONS: Clinically lymph node-negative T4 melanoma cases should be strongly considered for SLN biopsy, regardless of Breslow depth. SLN lymph node status is the most significant prognostic sign among these patients. T4 patients with a negative SLN have an excellent prognosis in the absence of ulceration and should not be considered candidates for adjuvant high-dose interferon. Cancer 2009. © 2009 American Cancer Society. [source] The feasibility of adjuvant interferon ,-2b in children with high-risk melanomaCANCER, Issue 4 2005Fariba Navid M.D. Abstract BACKGROUND It has been shown that induction high-dose interferon ,-2b (IFN-,-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes. METHODS Fifteen patients age , 18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU/m2 per day IFN-,-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-,-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence. RESULTS All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3,4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3,4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity. CONCLUSIONS High dose IFN-,-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity. Cancer 2005. © 2005 American Cancer Society. [source] | ||||||||||