Gemcitabine/docetaxel for metastatic or locally advanced soft tissue sarcoma: A retrospective single-center experience.

10040 Background: Soft tissue sarcoma (STS) represent a group of rare malignant tumors. Survival for patients with disseminated disease is dismal. Gemcitabine/docetaxel (GD) is a commonly used systemic 2°-line regime in this setting. Methods: Here we report on our single center experience of GD (G 900 mg/m² or 675 mg/m² d1+8 and D 100 mg/m² d8) in STS. Patients were retrospectively analysed. Restaging according to RECIST criteria of primary tumor site and metastases was performed every 3 cycles or on clinical progression. Progression-free (PFS) and overall survival (OS) were estimated using the method of Kaplan and Meier. Results: Between 2005 and 2011, 34 STS patients (male=20, female=14, median age 59 years [range 32-75]) were treated with GD at our institution. Histological subtypes comprised leiomyo- (n=13), lipo- (n=7), pleomorphic- (n=6), rhabdomyo- (n=3), synovial sarcoma (n=2), and other subtypes (n=3) with tumor grades being G1 (n=1), G2 (n=9) and G3 (n=24). Primary tumor sites included extremities (n=19), abdomen/retroperitoneum (n=10), trunk (n=3), and others (n=2). Metastases were found in lung (n=26), soft tissue/solid organs (n=12), bone (n=8) and lymph nodes (n=5). Patients had received no (n=2), 1 (n=22), 2 (n=9) or 3 (n=1) previous lines of CTX. A total number of 158 cycles was administered with a median number of 6 cycles (range 1-6) per patient. Best response by RECIST criteria after 3 cycles of treatment was PR (n=2, 6%). Disease stabilisation (SD) was achieved in further 22 subjects, resulting in a clinical benefit rate (CBR) of 70%. Median PFS and OS for the whole population were 7.7 and 15.3 months, respectively. PFS at 6 months was 62%. Patients responding to therapy had a significantly longer median PFS with 8.6 months (p <0.0001; HR 33.1) and OS with 22.5 months (p<0.0001; HR 20.2). Major toxicities included hand-foot syndrome (n=10), febrile neutropenia (n=7), mucositis (n=7), oedema (n=5), hematological toxicity (n=4) and polyneuropathy (n=3), leading to dose reductions in 10 patients. Conclusions: GD is an active regimen in STS with tolerable side effects. CBR was 70% after 3 cycles. Patients achieving at least SD had a significantly prolonged PFS and OS.