Effect of Recombinant or Lymphoblastoid Interferon-α on Alanine Aminotransferase in Patients with Chronic Hepatitis C or Chronic Non-A Non-B Hepatitis

Bardelli, F.; Messori, Andrea; Rampazzo, Roberta; Alberti, Alfredo; Martini, Nello

doi:10.2165/00044011-199509050-00001

Cited by 24 publications

(15 citation statements)

References 45 publications

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“…In particular, the data of individual survivals were derived either from the original raw data provided by the trial's authors or from the information contained in the original survival graphs. A number of survival meta-analyses have already been published, [10][11][12][13][14][15][16][17] in which approximated methods have been used to reconstruct individual survival times from published information (such as the Kaplan-Meier graphs, the text of the article, the tables showing patients at risk at various follow-up times and so on). Formal methods have also been reported wherein a computer program is used to analyse KaplanMeier graphs to estimate the time distribution of the events and of the terminations of the follow-up.…”

Section: Literature Searchmentioning

confidence: 99%

Event-free survival and cost-effectiveness in adult acute lymphoblastic leukaemia in first remission treated with allogeneic transplantation

Orsi

Bartolozzi

Messori

et al. 2007

Bone Marrow Transplant

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Allogeneic transplantation in patients with acute lymphoblastic leukaemia in first remission (ALL-CR1) has been studied in several clinical trials. However, no pooled survival analysis has yet been done. We conducted a survival meta-analysis to compare allogeneic transplantation vs chemotherapy or autologous transplantation using an intention-to-treat approach. Our study included the controlled clinical trials, wherein allocation to allogeneic transplant was based on donor availability. The event-free individual survival data were reconstructed on the basis of published information and Kaplan-Meier graphs. We then generated the meta-analytic event-free survival curves for the two treatments. The mean survival gain per patient was estimated and a simplified cost-effectiveness assessment was carried out. In the allogeneic transplantation group, 293 patients were examined and 479 as controls (four trials). The event-free survival difference was statistically significant (P ¼ 0.011). The relative risk for event occurrence was 0.79 for the experimental group vs the controls (95% CI: 0.66-0.96; P ¼ 0.017). The mean survival gain was 1 year per patient. The cost per life-year gained was less than the conventional threshold of h50 000. Allogeneic transplantation in ALL-CR1 improves event-free survival as compared to chemotherapy or autologous transplantation. Its cost-effectiveness profile is acceptable.

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Section: Literature Searchmentioning

confidence: 99%

Event-free survival and cost-effectiveness in adult acute lymphoblastic leukaemia in first remission treated with allogeneic transplantation

Orsi

Bartolozzi

Messori

et al. 2007

Bone Marrow Transplant

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“…1,6,7 Numerous randomized trials have demonstrated that from 30% to 65% of hepatitis C patients undergo normalization of alanine aminotransferase (ALT) by the end of a 24-week course of interferon (IFN) treatment. [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] IFN treatment improves liver histology 9,12,[16][17][18]21,22 and hepatic function, 6,23 and is associated with loss of HCV RNA from blood and liver in most responders. 14,16,18,[24][25][26][27][28][29][30] As a result of these findings, IFN has become an accepted treatment for hepatitis C. Unfortunately, the initial response is often not sustained.…”

mentioning

confidence: 99%

Lymphoblastoid interferon alfa-n1 improves the long-term response to a 6-month course of treatment in chronic hepatitis C compared with recombinant interferon alfa-2b: Results of an international randomized controlled trial

1998

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The aim of this study was to compare the short-term and long-term efficacy and safety of lymphoblastoid interferon with a recombinant interferon alfa (IFN-␣) in a 24-week treatment course for chronic hepatitis C. One thousand seventy-one patients with chronic hepatitis C were randomized to receive lymphoblastoid IFN-␣n1 or recombinant IFN-␣2b at the same dosing regimen, 3 million units administered subcutaneously three times a week for 24 weeks. Hepatitis C viral (HCV) genotype (by line probe assay) was determined at baseline, and serum HCV RNA level (by quantitative reverse-transcriptase polymerase chain reaction) was measured at baseline and weeks 24, 48, and 72. Primary end points were normalization of serum alanine aminotransferase (ALT) levels at end of therapy (week 24) and sustained ALT normalization at weeks 48 and 72. Secondary end points were nondetectability of serum HCV RNA at 24, 48, and 72 weeks, and histological improvement at weeks 24 and 72. The two treatment groups were similar with respect to demographic, clinical, and histological variables (10% had cirrhosis at entry), baseline serum HCV RNA levels, and distribution of HCV genotypes. Intent-totreat analysis showed that ALT response at end of treatment was 35.3% for IFN-␣n1 and 37.9% for IFN-␣2b (P ‫؍‬ .38). Histological improvement and nondetectability of HCV RNA were also similar between the two treatment groups at the end of treatment, as were the type and frequency of reported adverse experiences. Among treatment responders, post-treatment relapse was significantly less frequent Abbreviations: HCV, hepatitis C virus; ALT, alanine aminotransferase; IFN, interferon; SR, sustained response; HAI, Knodell' s Histological Activity Index; ETR, end-of-treatment response in ALT levels.From the

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“…The approximations that we used for handling the survival data of the studies of Frassoni et al 7 and Mortimer et al 8 (ie the conversion of aggregated survival data into individual survival values) are known to imply an acceptable level of imprecision; there are several examples [34][35][36][37][38] showing that these indirect estimations have an excellent performance in meta-analysis studies. In contrast, the approximation that we used for managing the data of Kishi et al 2 and Radich et al 3 (ie conversion of disease-free survival data into data of overall survival using information of post-relapse survival from the study of Bosi et al) was 493 Table 2 Values of lifetime post-relapse survival in the two patient groups Another controversial point of our study design lies in the by-treatment approach that the clinical studies on 2BMT had adopted for analyzing the survival data.…”

Section: Discussionmentioning

confidence: 99%

“…The approximation based on the Fine method has often been used in previous retrospective overviews and meta-analysis of survival data. [34][35][36][37][38] The level of imprecision in the estimation of individual survival times is excellent: in fact, deviations between true survival times and estimated survival times are always confined to differences of a few weeks only. because both articles reported the actuarial curves of eventfree survival, but the corresponding curves of overall survival were unavailable.…”

Section: Appendix 1: Approximations Introduced In Our Survival Analysismentioning

confidence: 99%

Retrospective survival analysis and cost-effectiveness evaluation of second allogeneic bone marrow transplantation in patients with acute leukemia

Messori

Bosi

Bacci

et al. 1999

Bone Marrow Transplant

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Summary:The therapeutic options for patients with acute leukemia who relapse after the initial transplant include second bone marrow transplantation (2BMT) and conventional chemotherapy (CC). In this work, we conducted an analysis of published survival data and we evaluated the cost-effectiveness of 2BMT in comparison with CC. We retrieved survival information on 167 patients treated with 2BMT and 299 patients treated with CC. Survival figures were derived from individual patient data and were compared between 2BMT and CC. The mean lifetime survival (MLS) was estimated for each of the two patient cohorts using standard techniques of survival-curve extrapolation. The cost data of patients given 2BMT or CC were estimated from published data. Our analysis of individual survival data showed that 2BMT improved survival at levels of statistical significance (survival gain = 19.6 months per patient). Using an incremental cost of $90 000 per patient, the costeffectiveness ratio of 2BMT in comparison with CC was calculated as $52 215 discounted dollars per discounted life year gained. Our results indicate that, in patients with acute leukemia who relapse after their first transplant, 2BMT significantly prolongs survival in comparison with CC and seems to have an acceptable cost-effectiveness profile. Keywords: acute leukemia; second bone marrow transplantation; cost-effectiveness analysisIn patients with acute leukemia who have received an allogeneic bone marrow transplant, relapse implies a grim prognosis. To improve survival in these patients, a second allogeneic bone marrow transplant (2BMT) has been proposed as a more effective salvage intervention than conventional chemotherapy. [1][2][3][4][5][6][7][8] Six open uncontrolled studies [1][2][3][4][5][6] have thus far assessed the impact of 2BMT on survival, whereas at least two large-scale uncontrolled studies reported survival information for patients treated with a first allogeneic transplant and with conventional chemotherapy after relapse. In our work, seven of these studies [1][2][3][4][5]7,8 were utilized to conduct a retrospective survival analysis and to evaluate the cost-effectiveness ratio of 2BMT in comparison with conventional chemotherapy. Methods Study designOur study was aimed at evaluating survival and cost of the two following therapeutic options for patients with acute leukemia who relapse after the first allogeneic transplant: (1) 2BMT; (2) standard salvage chemotherapy.Our analysis consisted of three sequential phases: (1) literature search (from January 1985 to June 1998) of the clinical trials that evaluated survival for these two therapeutic options; (2) survival analysis with meta-analytic pooling of the results from the trials and with statistical testing; (3) cost-effectiveness analysis.Our survival meta-analysis was conducted through the following procedure (Model 1): firstly, the individual survival data were retrieved from the patient cohorts enrolled in the various studies; then, the survival difference between 2BMT vs conventional chemot...

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Effect of Recombinant or Lymphoblastoid Interferon-α on Alanine Aminotransferase in Patients with Chronic Hepatitis C or Chronic Non-A Non-B Hepatitis

Cited by 24 publications

References 45 publications

Event-free survival and cost-effectiveness in adult acute lymphoblastic leukaemia in first remission treated with allogeneic transplantation

Event-free survival and cost-effectiveness in adult acute lymphoblastic leukaemia in first remission treated with allogeneic transplantation

Lymphoblastoid interferon alfa-n1 improves the long-term response to a 6-month course of treatment in chronic hepatitis C compared with recombinant interferon alfa-2b: Results of an international randomized controlled trial

Retrospective survival analysis and cost-effectiveness evaluation of second allogeneic bone marrow transplantation in patients with acute leukemia

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