E. Spath-schwalbe et al., Phase II trial of gemcitabine in patients with pretreated advanced soft tissue sarcomas, ANTI-CANC D, 11(5), 2000, pp. 325-329
Because of the low number of active cytotoxic drugs and their limited activ
ity, the evaluation of new anti-cancer agents for their activity in soft ti
ssue sarcomas is a continuing need. The objectives of this prospective phas
e II trial of gemcitabine were to estimate the response rate and to define
the toxicities of prolonged infusions of low-dose gemcitabine in patients w
ith pretreated advanced soft tissue sarcomas, Patients were eligible if the
y had a histologic diagnosis of unresectable, recurrent or metastatic, prog
ressive soft tissue sarcoma, and if they had been treated with at least one
prior chemotherapy consisting of an anthracycline- and/or ifosfamide-conta
ining regimen. Gemcitabine was administered as a 360 min infusion on days 1
, 8 and 15 of a 28 day cycle. The initial dose of gemcitabine was 200 mg/m(
2) in all patients. Dose escalation to 250 mg/m(2) was allowed in the case
of stable disease and good tolerability of the drug. All 18 patients (media
n age 58 years) who enrolled were treated with gemcitabine, and all were as
sessable for toxicity, response and survival. Only two of these 18 patients
had an objective response to a previous palliative chemotherapy. A median
of 3 cycles (range 1-7) of gemcitabicin were administered. Two (11%) of the
patients had a partial response lasting 5 and 6 months, respectively. Both
of these patients had only lung metastases, Whereas one of these patients
had a transient partial response to the foregoing chemotherapy (consisting
of ifosfamide and doxorubicin), the other patient has been progressive on t
hese drugs. One additional patient, progressive on ifosfamide and doxorubic
in, had an objective response of greater than 50% confined to the lungs and
stable local recurrence for 6 months. Six patients had stable disease for
3-6 months and nine patients had disease progression. The median survival w
as 8 months. Treatment generally was well tolerated with six patients havin
g transient grade 3 non-hematologic toxicity, four having grade 3 neutropen
ia, and one having grade 4 neutropenia and thrombocytopenia. Gemcitabine, g
iven as a prolonged infusion at a low dose level, has a favorable toxicity
profile and displays antitumor activity in patients with intensively pretre
ated, advanced soft tissue sarcomas. [(C) 2000 Lippincott Williams & Wilkin
s.].