[Phase II study of docetaxel in patients with advanced stage soft tissue sarcoma].
OBJECTIVE
To evaluate the activity and toxicity of docetaxel (TXT) as second line therapy in advanced soft-tissue sarcoma.


METHODS
Adult patients (pts) with histologically proven locally advanced or metastatic soft tissue sarcoma, were treated with TXT at a dose of 100 mg/m2 in a 1-hour i.v. infusion every 21 days and steroid premedication with oral prednisone 50 mg twice a day for five days starting 24 hours prior to TXT.


RESULTS
From November 1995 to May 1997, 19 pretreated pts entered the trial. Characteristics of the pts: males/females 11/8, median age 58 years (30-74), median WHO performance status 1 (0-2); histotypes: leiomyosarcoma 6 pts, malignant fibrous histiocytoma 6 pts, fibrosarcoma 2 pts, others 5 pts. No objective responses were seen. The disease remained stable in 8 pts (42%). Median time to progression was 3.5 months (range, 2-8), median survival 6 months (range, 2-20). The treatment was well-tolerated: the main side effect was hematological toxicity with G3/4 leukopenia and neutropenia in 58% of the pts; G3 anemia and thrombocytopenia occurred only in 1 case. Other toxicities were alopecia that was universal, G3 emesis in 1 pt, G3 diarrhea in 2 pts, G3 stomatitis in 1 pt. Mild fluid retention was recorded only in 2 pts.


CONCLUSIONS
The results of this study do not suggest the use of TXT at this dosage and schedule in advanced soft tissue sarcoma.
Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italia.
A
A
Amodio
S
S
Carpano
G
G
Paoletti
T
T
Gionfra
M
M
Rinaldi
C
C
Manfredi
P
P
Foggi
M
M
Lopez
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D005260:Female; D005354:Fibrosarcoma / Q000188:drug therapy* / Q000473:pathology; D018219:Histiocytoma, Benign Fibrous / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000473:pathology; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage; D011292:Premedication; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids; D013921:Thrombocytopenia / Q000139:chemically induced
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D011241:Prednisone
Studio di fase II con docetaxel in pazienti con sarcoma dei tessuti molli in fase avanzata.