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Hyperthermic isolated limb perfusion in locally advanced soft tissue sarcoma and progressive desmoid-type fibromatosis with TNF 1 mg and melphalan (T1-M HILP) is safe and efficient.

AbstractBACKGROUND:
In a prior randomized phase II trial comparing hyperthermic isolated limb perfusion (HILP) with four different doses of tumor necrosis factor alpha (TNF-alpha), no dose effect was detected for response, but systemic toxicity was far lower with low-dose TNF-alpha. The objective of the present study was to confirm these data on a larger sample size of locally advanced or recurrent extremity soft tissue sarcomas with low-dose TNF-alpha.
METHODS:
We assessed a prospective database comprising 100 HILP (38-40 degrees C) with melphalan (10 mg/L) and TNF-alpha (1 mg). The remnant tumor was resected 2 months later.
RESULTS:
Among 52 recurrences, 18 were in a previously irradiated field. Stages according to the American Joint Committee on Cancer classification were II (19 patients), III (78 patients), and IV (3 patients). The site/size were: 30 patients/57 mm and 70 patients/86 mm for the upper and lower limbs, respectively. Tumor grades (FNCLCC) were 1 (23 patients), 2 (34 patients), and 3 (43 patients). Fifty-one patients had received systemic chemotherapy before HILP. Responses on magnetic resonance imaging were 30% complete, 49% partial, 9% no change, and 12% progression. No mortality or systemic toxicity occurred. Local toxicity (Wieberdink) attained grade 2 (16 patients), 3 (5 patients), and 4 (1 patient). Limbs were able to be saved in 87% patients. Three-year overall survival and the local recurrence rate were 89% and 18%, respectively. Age, sex, tumor size, recurrence, uni- or multifocality, grade, preoperative chemotherapy, and a previously irradiated field were not predictive of response or local toxicity.
CONCLUSIONS:
We confirm that 1 mg of TNF-alpha is as effective as the standard dose and results in no systemic toxicity.
AuthorsSylvie Bonvalot, Françoise Rimareix, Sylvain Causeret, Cécile Le Péchoux, Bérénice Boulet, Philippe Terrier, Axel Le Cesne, Jane Muret
JournalAnnals of surgical oncology (Ann Surg Oncol) Vol. 16 Issue 12 Pg. 3350-7 (Dec 2009) ISSN: 1534-4681 [Electronic] United States
PMID19830495 (Publication Type: Journal Article)
Chemical References
  • Antineoplastic Agents, Alkylating
  • Tumor Necrosis Factor-alpha
  • Melphalan
Topics
  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Agents, Alkylating (administration & dosage)
  • Chemotherapy, Cancer, Regional Perfusion
  • Drug Therapy, Combination
  • Extremities (pathology)
  • Female
  • Fibromatosis, Aggressive (pathology, therapy)
  • Follow-Up Studies
  • Humans
  • Hyperthermia, Induced
  • Male
  • Melphalan (administration & dosage)
  • Middle Aged
  • Neoplasm Staging
  • Prognosis
  • Prospective Studies
  • Sarcoma (pathology, therapy)
  • Survival Rate
  • Tumor Necrosis Factor-alpha (administration & dosage)
  • Young Adult

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