PHASE-II STUDY WITH DOCETAXEL (TAXOTERE(R)) IN ADVANCED SOFT-TISSUE SARCOMAS OF THE ADULT

Background: Current regimens for treatment of distant metastases of so ft tissue sarcomas result in response rates of about 25%. Therefore th e search for active drugs remains a task for investigational groups. T axoids offer a new class of cytostatic drugs. Docetaxel has been studi ed as a second line chemotherapy in advanced soft tissue sarcomas of t he adult. Patients and methods: In a multi-center non-randomized phase II study docetaxel was administered at a dose of 100 Mg/M2 in a 1-hou r i.v. infusion q 3 weeks.Results: Twenty-nine patients (pts), median age 52 yr, performance status WHO 0: 16 pts, WHO 1: 11 pts, WHO 2: 2 p ts, were eligible. One patient had early death due to malignant diseas e, 1 patient died due to toxicity and progression, 1 pt refused after 1 course. Five partial responses (5/29 = 17%, C.I. 6%-36%) have been o bserved. Grade greater-than-or-equal-to 3 leucopenia occurred in 76% o f patients and grade greater-than-or-equal-to 3 thrombopenia did not o ccur. Median nadir of neutrophils was 0.23 x 10(9)/l. Episodes of feve r and documented infection have been observed in 10 and 5 pts respecti vely. Anaphylactoid type reactions occurred in 5 patients: ranging fro m flushing in 5 pts to cardiovascular symptoms in 1 pt. Sensory neurot oxicity was observed in 14 pts grade 1: 10 pts, grade 2: 3 pts, grade 3: 1 pt). Grade 1 motor neurotoxicity was experienced by 3 pts. Skin r eactions (pruritus, erythema, urticaria, exfoliation grade 1: 11 pts, grade 2: 7 pts, grade 3: 1 pt, grade 4: 1 pt) in 20 pts, among them 9 patients with nail changes. Peripheral edema and fluid retention has b een observed in 12 pts. Conclusion: Taxotere has activity in adult sof t tissue sarcoma in second line, warranting studies on first line effi cacy.