Quality-of-Life-Adjusted Survival Analysis of High-Dose Adjuvant Interferon Alfa-2b for High-Risk Melanoma Patients Using Intergroup Clinical Trial Data

2002 ◽  
Vol 20 (5) ◽  
pp. 1311-1318 ◽  
Author(s):  
K. L. Kilbridge
Keyword(s):  
Quality Of Life ◽  
Clinical Trial Data ◽  
Interferon Alfa ◽  
Trial Data ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Adjuvant Interferon

Quality-of-Life–Adjusted Survival Analysis of High-Dose Adjuvant Interferon Alfa-2b for High-Risk Melanoma Patients Using Intergroup Clinical Trial Data

2002 ◽  
Vol 20 (5) ◽  
pp. 1311-1318 ◽  
Author(s):  
Kerry L. Kilbridge ◽  
Bernard F. Cole ◽  
John M. Kirkwood ◽  
Frank G. Haluska ◽  
Michael A. Atkins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Interferon Alfa ◽  
Trial Data ◽  
Phase Iii ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Adjuvant Interferon

PURPOSE: High-dose adjuvant interferon alfa-2b (IFNα2b) for high-risk melanoma is a 1-year regimen that improves relapse-free and overall survival but has significant toxicity. A quality-of-life–adjusted survival (QAS) analysis analysis of two cooperative group phase III trials, E1684 and E1690/S9111/C9190, was performed, incorporating patient values (utilities) for the toxicity of IFNα2b treatment and melanoma recurrence. PATIENTS AND METHODS: Quality-Adjusted Time Without Symptoms or Toxicity methodology was used with melanoma patient utilities and trial data to estimate the effect of IFNα2b on QAS. The increase or decrease in QAS that patients could expect from treatment was estimated based on their utilities. Eleven utility predictor questions were tested to identify patients with utilities that result in decreased QAS. RESULTS: Using E1684 data, IFNα2b would result in an increase in QAS for all sets of patient utilities. This benefit was significant (P < .05) for 16% of patients. Using E1690/S9111/C9190 data, 77% of patients would experience a benefit in QAS from IFNα2b and 23% would experience a decrease in QAS; neither of these effects was statistically significant. Using utility predictors and the E1690/S9111/C9190 analysis, a decision rule was formulated that helps identify patients in whom IFNα2b may detract from QAS. CONCLUSION: Most patients experienced improvement in QAS in both trials, but this benefit was statistically significant in only 16% of patients in E1684. Change in QAS depends more on the utility for IFNα2b toxicity than on the utility for melanoma recurrence. Cancer patients probably have higher utilities for IFNα2b toxicity than members of the general population and will tend to favor IFNα2b treatment as a result.

Patient Preferences for Adjuvant Interferon Alfa-2b Treatment

2001 ◽  
Vol 19 (3) ◽  
pp. 812-823 ◽  
Author(s):  
Kerry L. Kilbridge ◽  
Jane C. Weeks ◽  
Arthur J. Sober ◽  
Frank G. Haluska ◽  
Craig L. Slingluff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Free Survival ◽  
Interferon Alfa ◽  
Health States ◽  
Free Survival ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Disease Free ◽  
Adjuvant Interferon

PURPOSE: Although trials of adjuvant interferon alfa-2b (IFNα-2b) in high-risk melanoma patients suggest improvement in disease-free survival, it is unclear whether treatment offers improvement in overall survival. Widespread use of adjuvant IFNα-2b has been tempered by its significant toxicity. To quantify the trade-offs between IFNα-2b toxicity and survival, we assessed patient utilities for health states associated with IFN therapy. Utilities are measures of preference for a particular health state on a scale of 0 (death) to 1 (perfect health).PATIENTS AND METHODS: We assessed utilities for health states associated with adjuvant IFN among 107 low-risk melanoma patients using the standard gamble technique. Health states described four IFNα-2b toxicity scenarios and the following three posttreatment outcomes: disease-free health and melanoma recurrence (with or without IFNα-2b) leading to cancer death. We also asked patients the improvement in 5-year disease-free survival they would require to tolerate IFN.RESULTS: Utilities for melanoma recurrence with or without IFNα-2b were significantly lower than utilities for all IFNα-2b toxicities but were not significantly different from each other. At least half of the patients were willing to tolerate mild-moderate and severe IFNα-2b toxicity for 4% and 10% improvements, respectively, in 5-year disease-free survival.CONCLUSION: On average, patients rate quality of life with melanoma recurrence much lower than even severe IFNα-2b toxicity. These results suggest that recurrence-free survival is highly valued by patients. The utilities measured in our study can be applied directly to quality-of-life determinations in clinical trials of adjuvant IFNα-2b to measure the net benefit of therapy.

Quality of Life in Patients Receiving High-Dose Interferon Alfa-2b After Resected High-Risk Melanoma

2009 ◽  
Vol 27 (24) ◽  
pp. e70-e70 ◽  
Author(s):  
Peter Mohr ◽  
Axel Hauschild ◽  
Uwe Trefzer ◽  
Michael Weichenthal
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon

Longitudinal course of depression, fatigue, and quality of life in patients with high risk melanoma receiving adjuvant interferon

2004 ◽  
Vol 13 (8) ◽  
pp. 526-536 ◽  
Author(s):  
Peter C. Trask ◽  
Amber G. Paterson ◽  
Peg Esper ◽  
Jason Pau ◽  
Bruce Redman
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Longitudinal Course ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Adjuvant Interferon ◽  
Course Of Depression

Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: an Eastern Cooperative Oncology Group study.

1996 ◽  
Vol 14 (10) ◽  
pp. 2666-2673 ◽  
Author(s):  
B F Cole ◽  
R D Gelber ◽  
J M Kirkwood ◽  
A Goldhirsch ◽  
E Barylak ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Eastern Cooperative Oncology Group ◽  
Tumor Burden ◽  
High Dose ◽  
Ifn Alpha ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Relative Value

PURPOSE To evaluate the quality-of-life effects of adjuvant high-dose interferon alfa-2b (IFN alpha 2b) treatment of high-risk melanoma. PATIENTS AND METHODS A quality-of-life-adjusted survival analysis (Quality-Adjusted Time Without Symptoms, and Toxicity [Q-TWiST]) was applied to the Eastern Cooperative Oncology Group Trial E1684, which compared high-dose IFN alpha 2b treatment for 1 year versus observation in 280 high-risk patients. IFN alpha 2b was administered at a dosage of 20 mU/m2 intravenously daily for 5 days per week for 4 weeks, and then three times weekly at 10 mU/m2 subcutaneously for 48 weeks. RESULTS After 84 months of median follow-up time, the IFN alpha 2b group gained a mean of 8.9 months without disease relapse (P = .03) and 7.0 months of overall survival (P = .07) as compared with the observation group, but had severe treatment-related toxicity for 5.8 months, on average. The IFN alpha 2b group had more quality-of-life-adjusted time than the observation group regardless of the relative valuations placed on time with toxicity (Tox) and time with relapse (Rel). This gain was significant (P < .05) for patients who consider Tox to have a high relative value and Rel to have a low relative value. In contrast, for patients who value Tox about the same as Rel, the quality-adjusted gain for IFN alpha 2b was not statistically significant. An analysis stratified according to tumor burden indicated that the benefit of IFN alpha 2b was greatest in the node-positive strata. CONCLUSION For patients with high-risk melanoma, the clinical benefits of high-dose IFN alpha 2b can offset the toxic effects. The optimal treatment for an individual patient depends on the patient's tumor burden and preferences regarding toxicity and disease relapse.

Dose-Dependent Treatment Benefit in High-Risk Melanoma Patients Receiving Adjuvant High-Dose Interferon Alfa-2b

2005 ◽  
Vol 20 (3) ◽  
pp. 280-289 ◽  
Author(s):  
Michael Fluck ◽  
Darab Kamanabrou ◽  
Andrea Lippold ◽  
Martina Reitz ◽  
Jens Atzpodien
Keyword(s):  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
Treatment Benefit ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Dose Dependent ◽  
High Dose Interferon

Economic analysis of adjuvant interferon alfa-2b in high-risk melanoma based on projections from Eastern Cooperative Oncology Group 1684.

1997 ◽  
Vol 15 (6) ◽  
pp. 2351-2358 ◽  
Author(s):  
B E Hillner ◽  
J M Kirkwood ◽  
M B Atkins ◽  
E R Johnson ◽  
T J Smith
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
High Risk ◽  
Incremental Cost ◽  
Interferon Alfa ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
The Cost

PURPOSE Interferon alfa-2b (IFN) in a randomized clinical trial (E1684) prolonged relapse-free and total survival in high-risk resected melanoma. However, the costs and toxicities of IFN are barriers to its widespread use. This study was undertaken to analyze the projected costs and long-term benefits of IFN by combining prospectively collected data on IFN actual dosage, time of recurrence, and survival with secondary data on long-term melanoma recurrence risks to project the cost-effectiveness of adjuvant IFN compared with observation. PATIENTS AND METHODS Two hypothetical cohorts of 50-year-old melanoma patients whose mean IFN dosage and clinical results were directly taken from E1684 were included in the study. Melanoma recurrence risks beyond 5 years were derived from international databases. Melanoma recurrence care costs and quality-of-life adjustments, when considered, were based on expert consensus. End points were incremental costs, life-years gained, and cost per life-year gained with and without quality-of-life adjustments. RESULTS The IFN cohort was projected to have an increased (undiscounted) survival of 0.52 years at 7 years and 1.90 years over a lifetime. The projected incremental cost (in 1996 United States dollars) per life-year gained in the IFN cohort ranged from $13,700 after 35 years to $32,600 at 7 years, the median follow-up of E1684. Using assigned quality-of-life values for IFN and recurrence, the lifetime cost per quality adjusted life-year increased to $15,200. Even if treatment costs for recurrence were excluded, the lifetime incremental cost per life-year gained was $21,600. CONCLUSION The cost and toxicity of IFN must be balanced against its projected benefits in high-risk melanoma. The derived cost-effectiveness and cost-utility ratios for IFN were comparable to other cancer interventions for which cost-effectiveness analysis has been performed.

Duration of High-Dose Interferon Alfa-2b Regimen for Resected High-Risk Melanoma

2009 ◽  
Vol 27 (25) ◽  
pp. e82-e83 ◽  
Author(s):  
Sanjiv S. Agarwala ◽  
Robert J. Gray ◽  
Michael K.K. Wong
Keyword(s):  
High Risk ◽  
Interferon Alfa ◽  
High Dose ◽  
High Risk Melanoma ◽  
Risk Melanoma ◽  
High Dose Interferon
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