Intensified adjuvant IFADIC chemotherapy in combination with radiotherapy versus radiotherapy alone for soft tissue sarcoma: long-term follow-up of a prospective randomized feasibility trial.

Adjuvant chemotherapy for grade 2 and 3 soft tissue sarcoma (STS) patients still has to be considered experimental. Fifty-nine patients underwent primary surgery by wide or marginal excision and were subsequently randomized to receive radiotherapy alone or in combination with six courses of chemotherapy consisting of ifosfamide, DTIC, and doxorubicin administered in 14-day intervals supported by G-CSF on days 5-13. Twenty-eight patients received radiotherapy (control group) and 31 patients were treated with additional chemotherapy. After a median observation period of 97 months (range: 13-158 months), 58 patients were followed up to assess long-term relapse-free survival (RFS), time to local failure (TLF), time to distant failure (TDF), and overall survival (OS). Fifteen patients (56%) in the control group vs. 19 patients (61%) in the chemotherapy group were free of disease. Within the control group, tumor relapses occurred in 12 patients (44%) vs. 12 patients (39%) in the chemotherapy group. RFS (P = 0.87), TLF (P = 0.58), TDF (P = 0.60) as well as OS (P = 0.99) did not differ significantly between the two groups. Adjuvant chemotherapy was not translated into a significant benefit concerning RFS, TLF, TDF, and OS for STS patients.

RCT Entities:   Population Interventions Outcomes