Adjuvant treatment of high-risk adult soft tissue sarcomas: a survey by the Italian Sarcoma Group.
OBJECTIVE
After the first adjuvant study on adult soft tissue sarcomas was concluded, the participating institutions continued to select and treat patients according to that protocol. The aim of this study was to test the protocol reproducibility when applied as a standard practice.


METHODS
A call for retrospective data was launched in June 1999 (self-referral of consecutive unregistered patients); thereafter, a prospective follow-up was performed. The treatment regimen consisted of epirubicin (60 mg/m2 days 1 and 2), ifosfamide (3 g/m2/die for 3 days) and equimolar doses of 6-mercapto-ethansulfonate (MESNA), with 300 microg G-CSF administered subcutaneously from day +8 until recovery, every 3 weeks for a total of 5 cycles.


RESULTS
From November 1996 to June 1999, 55 high-risk, adult patients were treated. The average median dose intensity was 89% of the planned program. Grade 3-4 toxicities were leukopenia (49%), thrombocytopenia (14%), transfusion requiring anemia in 7 patients (16%), and alopecia in all patients (100%). After a median follow-up of 70 months, 23 patients (41.8%) relapsed and 19 died. Median disease-free, local disease-free and overall survival rates have not yet been reached. The disease-free survival rates at 2 and 4 years were 73% and 57%, respectively; the corresponding overall survival rates were 91% and 70%, respectively.


CONCLUSIONS
The feasibility and reproducibility of the original protocol were confirmed, since disease-specific overall survival and disease-free survival rates at the same period of observation and with the same prolonged follow-up did not differ.
Frustaci
Sergio
S
Department of Medical Oncology, National Cancer Institute, Aviano. sfrustaci@cro.it
Berretta
Massimiliano
M
Comandone
Alessandro
A
Bidoli
Ettore
E
De Paoli
Antonino
A
Gherlinzoni
Franco
F
De Pas
Tommaso
T
Barbieri
Enza
E
Pertici
Maurizio
M
Apice
Gaetano
G
Picci
Piero
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001803:Blood Transfusion; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006402:Hematologic Diseases / Q000139:chemically induced / Q000628:therapy; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007558:Italy; D008297:Male; D015080:Mesna / Q000627:therapeutic use; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D020011:Protective Agents / Q000627:therapeutic use; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome
D020011:Protective Agents; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D015080:Mesna; D007069:Ifosfamide