Dose-intensive first-line chemotherapy with epirubicin and continuous infusion ifosfamide in adult patients with advanced soft tissue sarcomas: A phase II study

R. Palumbo, C. Neumaier, M. Cosso, G. Bertero, P. Raffo, N. Spadini, S. Valente, G. Villani, M. Pastorino, S. Toma

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

This phase II study was designed to verify the activity and safety of an intensive epirubicin/ifosfamide schedule in untreated soft tissue sarcoma (STS) patients by using both the agents at the identified maximal tolerated doses. 39 adult patients were treated with epirubicin at 55 mg/m2, on days 1 and 2 (total dose per cycle 110 mg/m2) combined with ifosfamide at 2.5 g/m2 days 1-4 (total dose per cycle 10 g/m2), with equidose mesna uroprotection and G-CSF support. Treatment was given on an ambulatory basis, at 3-week intervals. The overall objective response (OR) rate was 59% (95% confidence interval, CI, 43-72%), with 5 complete responses (13%) and 18 partial responses (46%); 12 partial responders were rendered disease-free following surgery. The median survival time was 19 months, being 23 and 13 months, respectively, for responding and non-responding patients. The median time to response was 40 days (range 21-60). Treatment-related toxicity was overall acceptable. The OR of 59% was the highest ever reported in our consecutive studies in advanced STS, confirming that improved therapeutic efficacy can be obtained with intensified regimens in such a disease; both the response duration and survival were also longer. The observed activity proved to be interesting with regard to the high response rate in the lung (86%), as well as the proportion of patients rendered disease-free by early surgery after the achievement of a partial response (55%). Both these findings may be important in the multimodality approach to patients with lesions potentially resectable for cure.

Original languageEnglish
Pages (from-to)66-72
Number of pages7
JournalEuropean Journal of Cancer
Volume35
Issue number1
DOIs
Publication statusPublished - Apr 1999

Fingerprint

Epirubicin
Ifosfamide
Sarcoma
Drug Therapy
Mesna
Survival
Maximum Tolerated Dose
Granulocyte Colony-Stimulating Factor
Appointments and Schedules
Therapeutics
Confidence Intervals
Safety
Lung

Keywords

  • Epirubicin
  • Ifosfamide
  • Intensified regimens
  • Soft tissue sarcomas

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

Cite this

Dose-intensive first-line chemotherapy with epirubicin and continuous infusion ifosfamide in adult patients with advanced soft tissue sarcomas : A phase II study. / Palumbo, R.; Neumaier, C.; Cosso, M.; Bertero, G.; Raffo, P.; Spadini, N.; Valente, S.; Villani, G.; Pastorino, M.; Toma, S.

In: European Journal of Cancer, Vol. 35, No. 1, 04.1999, p. 66-72.

Research output: Contribution to journalArticle

Palumbo, R. ; Neumaier, C. ; Cosso, M. ; Bertero, G. ; Raffo, P. ; Spadini, N. ; Valente, S. ; Villani, G. ; Pastorino, M. ; Toma, S. / Dose-intensive first-line chemotherapy with epirubicin and continuous infusion ifosfamide in adult patients with advanced soft tissue sarcomas : A phase II study. In: European Journal of Cancer. 1999 ; Vol. 35, No. 1. pp. 66-72.
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