Liposomal doxorubicin with and without TNFα in the perfusional treatment of advanced soft tissue limb sarcoma: Preliminary results

Franco Di Filippo, Michele Anzà, Rosa Garinei, Francesco Cavaliere, Pasquale Perri, Claudio Botti, Piera Di Angelo, Simona Di Filippo, Carlo Ludovico Maini, Rossella Pasqualoni, Susanna Di Segni, Simona Colantonio, Pietro Bruno, Loredana Piarulli, Francesca Principi

Research output: Contribution to journalArticle

Abstract

Background: A combination of doxorubicin and tumor necrosis factor alpha (TNFα) has been proven to be very effective in the perfusional treatment of advanced soft tissue limb sarcoma both in terms of tumor necrosis and limb conservative surgery rate. Unfortunately, in some patients a grade IV limb reaction has been recorded. The key solution might be the use of liposomal doxorubicin (Caelyx®) because the carrier seems to release the drug preferentially in the tumor rather than in the healthy tissue. Patients and Methods: Twenty patients were treated with Caelyx: 14 with Caelyx alone and 6 in combination with a low TNFα dose (1 mg). In the first series of 14 patients a dose escalation study was carried out starting from a dose of 10 mg/L of limb volume. Six patients were treated with Caelyx (16 mg) and TNFα (1 mg). Results: The maximum tolerated dose (MTD) was 16 mg/L as in two patients treated with 18 mg/L a grade IV limb reaction was observed. Tumor response was satisfactory and conservative surgery was carried out in 13 patients. In 6 patients treated with Caelyx and TNFα, only a grade I limb reaction was recorded, thus, confirming that TNFα did not increase toxicity, at least at a dose of 1 mg. The Caelyx- TNFα combination did increase treatment efficacy. Tumor necrosis ≥ 70% was observed in 4 out of 6 patients, one with 100% necrosis (pathological complete response). All the patients underwent conservative surgery. Conclusion: The Caelyx-TNFα combination was proven to increase the efficacy of Caelyx alone, with a very low toxicity. These preliminary results have to be tested in a larger patient population.

Original languageEnglish
Pages (from-to)735-738
Number of pages4
JournalIn Vivo
Volume20
Issue number6 A
Publication statusPublished - Nov 2006

Keywords

  • Caelyx®
  • Perfusion
  • Soft tissue sarcoma

ASJC Scopus subject areas

  • Medicine(all)

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    Di Filippo, F., Anzà, M., Garinei, R., Cavaliere, F., Perri, P., Botti, C., Di Angelo, P., Di Filippo, S., Maini, C. L., Pasqualoni, R., Di Segni, S., Colantonio, S., Bruno, P., Piarulli, L., & Principi, F. (2006). Liposomal doxorubicin with and without TNFα in the perfusional treatment of advanced soft tissue limb sarcoma: Preliminary results. In Vivo, 20(6 A), 735-738.