Hyperthermic antiblastic perfusion with alpha tumor necrosis factor and doxorubicin for the treatment of soft tissue limb sarcoma in candidates for amputation: Results of a phase I study

Franco Di Filippo, Carlo R. Rossi, Maurizio Vaglini, Alberto Azzarelli, Michele Anzà, Mario Santinami, Mario Lise, Francesco Cavaliere, Diana Giannarelli, Vittorio Quagliuolo, Antonella Vecchiato, Marcello Deraco, Rosa Garinei, Maria Foletto, Claudio Botti, Renato Cavaliere

Research output: Contribution to journalArticlepeer-review

Abstract

To improve the therapeutic effectiveness of hyperthermic antiblastic perfusion (HAP), the association of recombinant tumor necrosis factor alpha (rTNFα), doxorubicin, and true hyperthermia (41°C) was employed for the treatment of soft tissue limb sarcoma. A dose-escalation study according to Fibonacci's modified scheme was conducted, starting with a rTNFα dose of 0.5-3.3 mg. The doxorubicin doses (0.7 and 1.4 mg for the upper and lower limbs, respectively) and temperature level (41°C) remained unchanged. Eighteen patients have been treated thus far: 9 males and 9 females of a mean age of 33 years (range: 24-71 years). The tumor was located in the upper limb in one patient and in the lower limbs in seventeen. Only 16 patients were evaluable, as 2 refused further treatment after the perfusion. In terms of local toxicity, a grade I limb reaction was observed in 3 patients, a grade II or III in 10 patients, and a grade IV in 5 patients, showing a strict correlation between the TNF dose and the grade of limb reaction. In fact, a grade III-IV limb reaction was observed in 66.6% of the patients treated with >1 mg of rTNFα. The maximum tolerable dose in association with doxorubicin and true hyperthermia (41°C) was 2.4 mg. Eleven patients showed a good pathological response (>75%) and five patients showed a partial response (>25%-

Original languageEnglish
Pages (from-to)407-414
Number of pages8
JournalJournal of Immunotherapy
Volume22
Issue number5
Publication statusPublished - 1999

Keywords

  • Doxorubicin
  • Perfusion
  • rTNFα
  • Soft tissue limb sarcoma

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Immunology

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