Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC soft tissue and bone sarcoma group

H. T. Mouridsen, L. Bastholt, R. Somers, A. Santoro, V. Bramwell, J. H. Mulder, A. T. Van Oosterom, J. Buesa, H. M. Pinedo, D. Thomas, R. Sylvester

Research output: Contribution to journalArticle

Abstract

The objective of this randomized phase II/phase III study was to investigate the efficacy and toxicity of equimolar doses of adriamycin (ADM) and 4-epiadriamycin (EPI) in patients with locally advanced and/or metastatic soft tissue sarcoma. Doses of ADM and EPI were 75 mg/m2 given as an i.v. bolus injection every 3 weeks. Two hundred and ten patients were entered into the study by 18 institutions. Twenty-eight patients were ineligible and 15 were non-evaluable, leaving 167 evaluable patients. The two treatment groups were well balanced for sex, performance status, age, prior radiotherapy, extent and site of disease. Rates of response were similar, 25% in the ADM group compared to 18% in the EPI group (P = 0.33), and there were no significant differences between the ADM and EPI groups with respect to median duration of response (45 weeks vs. 77 weeks, P = 0.08), time to progression (15 weeks vs. 12 weeks, P = 0.945), and median survival (41 weeks vs. 48 weeks, P = 0.363). Myelotoxicity as shown by leucopenia was significantly more pronounced in the ADM treated patients (P = 0.002). Other toxicities such as alopecia and nausea/vomiting were also more severe in the ADM group (P = 0.02 and 0.06, respectively). In conclusion, the use of equimolar doses of ADM and EPI in advanced soft tissue sarcoma produced response rates which did not differ significantly and were only slightly in favour of ADM. However, this was achieved at the expense of higher toxicity.

Original languageEnglish (US)
Pages (from-to)1477-1483
Number of pages7
JournalEuropean Journal of Cancer and Clinical Oncology
Volume23
Issue number10
DOIs
StatePublished - 1987
Externally publishedYes

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Epirubicin
Sarcoma
Doxorubicin
Alopecia
Leukopenia
Nausea
Vomiting
Radiotherapy
Injections
Survival

ASJC Scopus subject areas

  • Oncology

Cite this

Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC soft tissue and bone sarcoma group. / Mouridsen, H. T.; Bastholt, L.; Somers, R.; Santoro, A.; Bramwell, V.; Mulder, J. H.; Van Oosterom, A. T.; Buesa, J.; Pinedo, H. M.; Thomas, D.; Sylvester, R.

In: European Journal of Cancer and Clinical Oncology, Vol. 23, No. 10, 1987, p. 1477-1483.

Research output: Contribution to journalArticle

Mouridsen, HT, Bastholt, L, Somers, R, Santoro, A, Bramwell, V, Mulder, JH, Van Oosterom, AT, Buesa, J, Pinedo, HM, Thomas, D & Sylvester, R 1987, 'Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC soft tissue and bone sarcoma group', European Journal of Cancer and Clinical Oncology, vol. 23, no. 10, pp. 1477-1483. https://doi.org/10.1016/0277-5379(87)90089-7
Mouridsen, H. T. ; Bastholt, L. ; Somers, R. ; Santoro, A. ; Bramwell, V. ; Mulder, J. H. ; Van Oosterom, A. T. ; Buesa, J. ; Pinedo, H. M. ; Thomas, D. ; Sylvester, R. / Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC soft tissue and bone sarcoma group. In: European Journal of Cancer and Clinical Oncology. 1987 ; Vol. 23, No. 10. pp. 1477-1483.
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T1 - Adriamycin versus epirubicin in advanced soft tissue sarcomas. A randomized phase II/phase III study of the EORTC soft tissue and bone sarcoma group

AU - Mouridsen, H. T.

AU - Bastholt, L.

AU - Somers, R.

AU - Santoro, A.

AU - Bramwell, V.

AU - Mulder, J. H.

AU - Van Oosterom, A. T.

AU - Buesa, J.

AU - Pinedo, H. M.

AU - Thomas, D.

AU - Sylvester, R.

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N2 - The objective of this randomized phase II/phase III study was to investigate the efficacy and toxicity of equimolar doses of adriamycin (ADM) and 4-epiadriamycin (EPI) in patients with locally advanced and/or metastatic soft tissue sarcoma. Doses of ADM and EPI were 75 mg/m2 given as an i.v. bolus injection every 3 weeks. Two hundred and ten patients were entered into the study by 18 institutions. Twenty-eight patients were ineligible and 15 were non-evaluable, leaving 167 evaluable patients. The two treatment groups were well balanced for sex, performance status, age, prior radiotherapy, extent and site of disease. Rates of response were similar, 25% in the ADM group compared to 18% in the EPI group (P = 0.33), and there were no significant differences between the ADM and EPI groups with respect to median duration of response (45 weeks vs. 77 weeks, P = 0.08), time to progression (15 weeks vs. 12 weeks, P = 0.945), and median survival (41 weeks vs. 48 weeks, P = 0.363). Myelotoxicity as shown by leucopenia was significantly more pronounced in the ADM treated patients (P = 0.002). Other toxicities such as alopecia and nausea/vomiting were also more severe in the ADM group (P = 0.02 and 0.06, respectively). In conclusion, the use of equimolar doses of ADM and EPI in advanced soft tissue sarcoma produced response rates which did not differ significantly and were only slightly in favour of ADM. However, this was achieved at the expense of higher toxicity.

AB - The objective of this randomized phase II/phase III study was to investigate the efficacy and toxicity of equimolar doses of adriamycin (ADM) and 4-epiadriamycin (EPI) in patients with locally advanced and/or metastatic soft tissue sarcoma. Doses of ADM and EPI were 75 mg/m2 given as an i.v. bolus injection every 3 weeks. Two hundred and ten patients were entered into the study by 18 institutions. Twenty-eight patients were ineligible and 15 were non-evaluable, leaving 167 evaluable patients. The two treatment groups were well balanced for sex, performance status, age, prior radiotherapy, extent and site of disease. Rates of response were similar, 25% in the ADM group compared to 18% in the EPI group (P = 0.33), and there were no significant differences between the ADM and EPI groups with respect to median duration of response (45 weeks vs. 77 weeks, P = 0.08), time to progression (15 weeks vs. 12 weeks, P = 0.945), and median survival (41 weeks vs. 48 weeks, P = 0.363). Myelotoxicity as shown by leucopenia was significantly more pronounced in the ADM treated patients (P = 0.002). Other toxicities such as alopecia and nausea/vomiting were also more severe in the ADM group (P = 0.02 and 0.06, respectively). In conclusion, the use of equimolar doses of ADM and EPI in advanced soft tissue sarcoma produced response rates which did not differ significantly and were only slightly in favour of ADM. However, this was achieved at the expense of higher toxicity.

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