Intensified Adjuvant IFADIC Chemotherapy for Adult Soft TissueSarcoma: A Prospective Randomized Feasibility Trial

[摘要] Purpose.The present prospective randomized adjuvant trial wascarried out to compare the toxicity, feasibility and efficacy of augmented chemotherapyadded to hyperfractionated accelerated radiotherapy after wide or marginal resection of grade2 and grade 3 soft tissue sarcoma (STS).Patients and methods.Fifty-nine patients underwent primary surgeryby wide or marginal excision and were subsequently randomized to receive radiotherapyalone or under the addition of six courses of ifosfamide (1500 mg/m2, days 1–4), dacarbazine(DTIC) (200 mg/m2, days 1–4) and doxorubicin (25 mg/m2, days 1–2) administered in14-day-intervals supported by granulocyte-colony stimulating factor (30 ×106IU/day, s.c.)on days 5–13. According to the randomization protocol, 28 patients received radiotherapyonly, whereas 31 patients were treated with additional chemotherapy.Results.The relative ifosfamide–doxorubicin–DTIC (IFADIC) doseintensity achieved was 93%. After a mean observation period of 41±19.7 months(range, 8.1–84 months), 16 patients (57%) in the control group versus 24 patients (77%) in the chemotherapy group were free of disease (p>0.05).Within the control group, tumor relapses occurred in 12 patients (43%;six patients with distant metastases, two with local relapse, four with both) versus seven patients (23%; five patients with distant metastases, one with local recurrence, one with both) from the chemotherapy group. Relapse-free survival (RFS)(p=0.1), time to local failure (TLF) (p=0.09), time to distant failure (TDF) (p=0.17) as well asoverall survival (OS) (p=0.4) did not differ significantly between the two treatment groups.Treatment-related toxicity was generally mild in both treatment arms.Conclusion.We conclude that the safety profile of intensified IFADICadded to radiotherapy was manageable and tolerable in the current setting. Inclusionof intensified IFADIC was not translated into a significant benefit concerning OS, RFS,TLF andTDF as compared with radiotherapy only, although a potential benefit ofchemotherapy for grade 3 STS patients needs to be validated in prospective randomizedtrials including larger patient numbers.

[学科分类] 肿瘤学