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Annals of Oncology 5:539-542, 1994
© 1994 European Society for Medical Oncology

other

Phase II study with Docetaxel (Taxotere®) in advanced soft tissue sarcomas of the adult

Q. G. C. M.van Hoesel1,, J. Verweij2, G. Catimel3, M. Clavel3, P. Kerbrat4, A. T.van Oosterom5, J. Kerger6, T. Tursz7, M.van Glabbeke8, C.van Pottelsberghe8, N.le Bail9, H. Mouridsen10 and For the EORTC Soft Tissue and Bone Sarcoma Group

1St. Radboud University Hospital Nijmegen
2 Daniël den Hoed Kliniek, Rotterdam, The Netherlands
3Centre Léon Bérard Lyon
4Centre Eugène Marquis Rennes, France
5Universitair Ziekenhuis Edegem
6Institut Jules Bordet Brussels, Belgium
7lnstitut Gustave Roussy Villejuif, France
8EORTC Data Centre Brussels, Belgium
9 Rhône-Poulenc Rorer, Antony, France
10University Hospital Copenhagen, Denmark

Correspondence to: Q. G. C. M van Hoesel M.D., Ph.D. Dept. of Internal Medicine Division of Medical Oncology, St. Radboud University Hospital P.O. Box 9101 6500 HB Nijmegen, The Netherlands

BACKGROUND: Current regimens for treatment of distant metastases of soft tissue sarcomas result in response rates of about 25%. Therefore the search for active drugs remains a task for investigationaJ groups. Taxoids offer a new class of cytostatic drugs. Docetaxel has been studied as a second line chemotherapy in advanced soft tissue sarcomas of the 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-hour 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 pts, were eligible. One patient had early death due to malignant disease, 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 observed. Grade ≥3 leucopenia occurred in 76% of patients and grade ≥3 thrombopenia did not occur. Median nadir of neutrophils was 0.23 x 109/1. Episodes of fever and documented infection have been observed in 10 and 5 pts respectively. Anaphylactoid type reactions occurred in 5 patients: ranging from flushing in 5 pts to cardiovascular symptoms in 1 pt. Sensory neurotoxicity 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 reactions (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 been observed in 12 pts.

CONCLUSION: Taxotere has activity in adult soft tissue sarcoma in second line, warranting studies on first line efficacy.

docetaxel, soft tissue sarcoma


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