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Journal of Clinical Oncology, Vol 19, Issue 5 (March), 2001: 1238-1247
© 2001 American Society for Clinical Oncology

Adjuvant Chemotherapy for Adult Soft Tissue Sarcomas of the Extremities and Girdles: Results of the Italian Randomized Cooperative Trial

By Sergio Frustaci, Franco Gherlinzoni, Antonino De Paoli, Marco Bonetti, Alberto Azzarelli, Alessandro Comandone, Patrizia Olmi, Angela Buonadonna, Giovanni Pignatti, Enza Barbieri, Gaetano Apice, Hassan Zmerly, Diego Serraino, Piero Picci

From the Unità Operativa di Oncologia Medica and di Oncologia Radioterapica and the Servizio di Epidemiologia, Centro di Riferimento Oncologico, Aviano; and Unità Operativa di Ortopedia, Ospedale Civile, Gorizia; and Unità Operativa di Chirurgia Muscolo-Scheletrica, Istituto Nazionale Tumori, Milano; and Unità Operativa di Oncologia Medica, Ospedale di Gradenigo, Torino; and Divisione di Radioterapia, Università di Firenze; and V Divisione and Laboratorio di Ricerca Oncologica, Istituti Ortopedici Rizzoli, and Istituto di Radioterapia, Università di Bologna, Bologna; and Unità Operativa di Oncologia Medica B, Istituto Pascale, Napoli, Italy; and Department of Biostatistics, Harvard School of Public Health and Dana-Farber Cancer Institute, Boston, MA.

Address reprint requests to Sergio Frustaci, MD, Division of Medical Oncology, Centro di Riferimento Oncologico di Aviano, Via Pedemontana Occ. 12, 33170 Aviano (PN), Italy; email: sfrustaci{at}cro.it

PURPOSE: Adjuvant chemotherapy for soft tissue sarcoma is controversial because previous trials reported conflicting results. The present study was designed with restricted selection criteria and high dose-intensities of the two most active chemotherapeutic agents.

PATIENTS AND METHODS: Patients between 18 and 65 years of age with grade 3 to 4 spindle-cell sarcomas (primary diameter >= 5 cm or any size recurrent tumor) in extremities or girdles were eligible. Stratification was by primary versus recurrent tumors and by tumor diameter greater than or equal to 10 cm versus less than 10 cm. One hundred four patients were randomized, 51 to the control group and 53 to the treatment group (five cycles of 4'-epidoxorubicin 60 mg/m2 days 1 and 2 and ifosfamide 1.8 g/m2 days 1 through 5, with hydration, mesna, and granulocyte colony-stimulating factor).

RESULTS: After a median follow-up of 59 months, 60 patients had relapsed and 48 died (28 and 20 in the treatment arm and 32 and 28 in the control arm, respectively). The median disease-free survival (DFS) was 48 months in the treatment group and 16 months in the control group (P = .04); and the median overall survival (OS) was 75 months for treated and 46 months for untreated patients (P = .03). For OS, the absolute benefit deriving from chemotherapy was 13% at 2 years and increased to 19% at 4 years (P = .04).

CONCLUSION: Intensified adjuvant chemotherapy had a positive impact on the DFS and OS of patients with high-risk extremity soft tissue sarcomas at a median follow-up of 59 months. Therefore, our data favor an intensified treatment in similar cases. Although cure is still difficult to achieve, a significant delay in death is worthwhile, also considering the short duration of treatment and the absence of toxic deaths.


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