Abstract
Purpose: To compare the response rate, survival, and toxicity of treatment with high-dose intravenous (IV) bolus interleukin-2 (IL-2) plus interferon alfa-2a (IFN-α) with high-dose IL-2 alone in patients with advanced melanoma in a randomized phase III trial design. Patients and Methods: Eighty-five patients with advanced melanoma were randomly assigned to receive IL-2 6 × 106 U/m2 per dose every 8 hours as tolerated for a maximum of 14 doses on days 1 through 5 and 15 through 19, or IL-2 4.5 × 106 U/m2 per dose, plus IFN-α 3 × 106 U/m2 using an identical schedule. A planned interim analysis was performed after 85 patients were entered, which forms the basis for this report. Results: Partial response (PR) occurred in two of 44 patients (5%; 95% confidence interval, 1% to 15%) receiving IL-2 alone, compared with four of 41 patients (10%; 95% confidence interval, 3% to 23%) receiving IL-2/IFN-α (P = .30). There were no complete responses (CRs). The median duration of response was 11.5 months (range, 2.0 to 15.7+). There was no significant difference in the median survival duration for patients receiving IL-2 alone (10.2 months) compared with patients receiving IL-2/IFN-α (9.7 months). The median and mean number of doses of IL-2 were equivalent in both groups, as was toxicity. There were three treatment-related deaths, two in the IL-2-alone arm and one in the IL-2/IFN-α arm. The trial was terminated after the first interim analysis based on predefined early-stopping rules, which included termination if the response rate in the IL-2/IFN-α arm was less than 25%. Conclusion: Using the preparation, dose, and schedule of IL-2 in our trial, IFN-α failed to enhance significantly the response rate to high-dose IL-2 in the treatment of patients with advanced melanoma.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1969-1977 |
| Number of pages | 9 |
| Journal | Journal of Clinical Oncology |
| Volume | 11 |
| Issue number | 10 |
| State | Published - 1993 |
Fingerprint
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Randomized phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alfa-2a in patients with advanced melanoma. / Sparano, Joseph A.; Fisher, Richard I.; Sunderland, Margaret; Margolin, Kim; Ernest, Mary Lou; Sznol, Mario; Atkins, Michael B.; Dutcher, Janice P.; Micetich, Kenneth C.; Weiss, Geoffrey R.; Doroshow, James H.; Aronson, Frederick R.; Rubinstein, Lawrence V.; Mier, James W.
In: Journal of Clinical Oncology, Vol. 11, No. 10, 1993, p. 1969-1977.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alfa-2a in patients with advanced melanoma
AU - Sparano, Joseph A.
AU - Fisher, Richard I.
AU - Sunderland, Margaret
AU - Margolin, Kim
AU - Ernest, Mary Lou
AU - Sznol, Mario
AU - Atkins, Michael B.
AU - Dutcher, Janice P.
AU - Micetich, Kenneth C.
AU - Weiss, Geoffrey R.
AU - Doroshow, James H.
AU - Aronson, Frederick R.
AU - Rubinstein, Lawrence V.
AU - Mier, James W.
PY - 1993
Y1 - 1993
N2 - Purpose: To compare the response rate, survival, and toxicity of treatment with high-dose intravenous (IV) bolus interleukin-2 (IL-2) plus interferon alfa-2a (IFN-α) with high-dose IL-2 alone in patients with advanced melanoma in a randomized phase III trial design. Patients and Methods: Eighty-five patients with advanced melanoma were randomly assigned to receive IL-2 6 × 106 U/m2 per dose every 8 hours as tolerated for a maximum of 14 doses on days 1 through 5 and 15 through 19, or IL-2 4.5 × 106 U/m2 per dose, plus IFN-α 3 × 106 U/m2 using an identical schedule. A planned interim analysis was performed after 85 patients were entered, which forms the basis for this report. Results: Partial response (PR) occurred in two of 44 patients (5%; 95% confidence interval, 1% to 15%) receiving IL-2 alone, compared with four of 41 patients (10%; 95% confidence interval, 3% to 23%) receiving IL-2/IFN-α (P = .30). There were no complete responses (CRs). The median duration of response was 11.5 months (range, 2.0 to 15.7+). There was no significant difference in the median survival duration for patients receiving IL-2 alone (10.2 months) compared with patients receiving IL-2/IFN-α (9.7 months). The median and mean number of doses of IL-2 were equivalent in both groups, as was toxicity. There were three treatment-related deaths, two in the IL-2-alone arm and one in the IL-2/IFN-α arm. The trial was terminated after the first interim analysis based on predefined early-stopping rules, which included termination if the response rate in the IL-2/IFN-α arm was less than 25%. Conclusion: Using the preparation, dose, and schedule of IL-2 in our trial, IFN-α failed to enhance significantly the response rate to high-dose IL-2 in the treatment of patients with advanced melanoma.
AB - Purpose: To compare the response rate, survival, and toxicity of treatment with high-dose intravenous (IV) bolus interleukin-2 (IL-2) plus interferon alfa-2a (IFN-α) with high-dose IL-2 alone in patients with advanced melanoma in a randomized phase III trial design. Patients and Methods: Eighty-five patients with advanced melanoma were randomly assigned to receive IL-2 6 × 106 U/m2 per dose every 8 hours as tolerated for a maximum of 14 doses on days 1 through 5 and 15 through 19, or IL-2 4.5 × 106 U/m2 per dose, plus IFN-α 3 × 106 U/m2 using an identical schedule. A planned interim analysis was performed after 85 patients were entered, which forms the basis for this report. Results: Partial response (PR) occurred in two of 44 patients (5%; 95% confidence interval, 1% to 15%) receiving IL-2 alone, compared with four of 41 patients (10%; 95% confidence interval, 3% to 23%) receiving IL-2/IFN-α (P = .30). There were no complete responses (CRs). The median duration of response was 11.5 months (range, 2.0 to 15.7+). There was no significant difference in the median survival duration for patients receiving IL-2 alone (10.2 months) compared with patients receiving IL-2/IFN-α (9.7 months). The median and mean number of doses of IL-2 were equivalent in both groups, as was toxicity. There were three treatment-related deaths, two in the IL-2-alone arm and one in the IL-2/IFN-α arm. The trial was terminated after the first interim analysis based on predefined early-stopping rules, which included termination if the response rate in the IL-2/IFN-α arm was less than 25%. Conclusion: Using the preparation, dose, and schedule of IL-2 in our trial, IFN-α failed to enhance significantly the response rate to high-dose IL-2 in the treatment of patients with advanced melanoma.
UR - http://www.scopus.com/inward/record.url?scp=0027524697&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027524697&partnerID=8YFLogxK
M3 - Article
C2 - 8410122
AN - SCOPUS:0027524697
VL - 11
SP - 1969
EP - 1977
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 10
ER -