ECOG E1684
Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: Eastern Cooperative Oncology Group trial EST 1684
N = 287
- Population
- Patients after resection of deep primary (T4) or regionally metastatic (N1) cutaneous melanoma
- Design
- Randomised controlled study of interferon alfa-2b versus observation in 287 patients after resection of deep primary (T4) or regionally metastatic (N1) melanoma. Interferon: 20 MU/m2 per day intravenously for 1 month, then 10 MU/m2 three times per week subcutaneously for 48 weeks (maximum-tolerated doses).
- Arms
- Interferon alfa-2b (experimental): 20 MU/m2/day IV for 1 month, then 10 MU/m2 three times per week SC for 48 weeks
- Observation (control): Observation after surgery
- People
- Kirkwood JM, senior author Blum RH, Eastern Cooperative Oncology Group
Δ median RFS+0.7 yearsΔ median OS+1 years
Show the numbers
| Endpoint | Analysis | Interferon alfa-2b | Observation | Effect |
|---|---|---|---|---|
| RFSAll randomised patients (287) | finalmedian follow-up 6.9 yearsKirkwood 1996 | median 1.7 years | median 1 year | P=0.0023 (one-sided)The abstract's Results call the endpoint relapse-free survival; the Conclusion states the medians as median disease-free survival from 1 to 1.7 years. P value is one-sided. The proportion continuously disease-free after treatment was 37% with interferon vs 26% with observation (a 42% improvement, as stated by the authors); no time point is given. No hazard ratio in the abstract. |
| OSAll randomised patients (287) | finalmedian follow-up 6.9 yearsKirkwood 1996 | median 3.8 years | median 2.8 years | P=0.0237 (one-sided)P value is one-sided. No hazard ratio in the abstract. The authors' abstract describes interferon alfa-2b as the first agent to show a significant relapse-free and overall survival benefit in high-risk melanoma in a randomised controlled trial; this record reports it only as their statement. |
| Endpoint | Analysis | Interferon alfa-2b | Observation | Effect |
|---|---|---|---|---|
| RFSAll randomised patients (287) | finalmedian follow-up 6.9 yearsKirkwood 1996 | median 1.7 years | median 1 year | P=0.0023 (one-sided)The abstract's Results call the endpoint relapse-free survival; the Conclusion states the medians as median disease-free survival from 1 to 1.7 years. P value is one-sided. The proportion continuously disease-free after treatment was 37% with interferon vs 26% with observation (a 42% improvement, as stated by the authors); no time point is given. No hazard ratio in the abstract. |
| OSAll randomised patients (287) | finalmedian follow-up 6.9 yearsKirkwood 1996 | median 3.8 years | median 2.8 years | P=0.0237 (one-sided)P value is one-sided. No hazard ratio in the abstract. The authors' abstract describes interferon alfa-2b as the first agent to show a significant relapse-free and overall survival benefit in high-risk melanoma in a randomised controlled trial; this record reports it only as their statement. |
- Interferon alfa-2b (experimental)
- Observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Interferon alfa-2b | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 13 | 64.3% | 47.2% |
| 26 | 41.3% | 22.3% |
| 38 | 27.5% | 11.1% |
| 51 | 17.7% | 5.3% |
- Interferon alfa-2b (experimental)
- Observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Interferon alfa-2b | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 28 | 65.3% | 56.1% |
| 57 | 42.0% | 30.9% |
| 85 | 27.5% | 17.3% |
| 114 | 17.7% | 9.5% |