Tumor size is a significant prognostic variable for attaining complete
regression (CR) with local hyperthermia (HT) and radiation therapy (R
T). The addition of weekly chemotherapy was evaluated to improve the e
fficacy of thermoradiotherapy in poor-prognosis lesions (i.e. greater
than or equal to 7 cm(2) or greater than or equal to 14 cm(3)) which h
ave an expected CR rate of similar to 30 +/- 8%. Patients were entered
into a two-arm phase-II study: arm 1 = breast cancer (10 patients), i
fosfamide (1.5 g/m(2)) + epirubicin (20 mg/m(2)) + HT + RT; arm 2 = sa
rcoma (7 patients) and head and neck cancer (9 patients), cisplatin (4
0 mg/m(2)) + HT + RT. Therapy encompassing 106 triple-modality session
s was generally well tolerated for both arms; 2 instances of grade-3 a
nd 1 of grade-4 (arm 2) local toxicity (WHO criteria) were observed. T
here were 4 instances of grade-3 myelosuppression (arm 1). The CR rate
s for arms 1 and 2 were 70 and 19%, respectively, suggesting that the
combination of ifosfamide/epirubicin/HT/RT deserves further investigat
ion in the context of localized breast cancer.