A Phase II Study of Gemcitabine, Vincristine, and Cisplatin As Second-Line Treatment for Patients with Advanced Soft Tissue Sarcoma

Zhiguo Luo, Xiaowei Zhang, Wei Peng, Xianghua Wu, Huijie Wang, Hui Yu, Jialei Wang, Jianhua Chang, Xiaonan Hong, Zhiguo Luo, Xiaowei Zhang, Wei Peng, Xianghua Wu, Huijie Wang, Hui Yu, Jialei Wang, Jianhua Chang, Xiaonan Hong

Abstract

Patients with advanced soft tissue sarcoma (aSTS) typically have a poor prognosis. Patients progressing to doxorubicin-based regimen have limited therapeutic options. Monotherapy with cytotoxic drugs appears to have only modest activity in the second-line setting. The purpose of this phase II study was to prospectively evaluate the safety and efficacy of combination regimen with gemcitabine, vincristine, and cisplatin (GVP) as a salvage treatment for patients with aSTS.Eligible patients were female with 18∼75 years old, and had aSTS that had progressed after 1 prior anthracyclines-based chemotherapy regimen. Patients were treated with 1,000 mg/m gemcitabine intravenously (IV) on days 1 and 8, 1.4 mg/m (max 2 mg) vincristine IV on day 1 and 25 mg/m cisplatin IV on days 1 through 3 every 21 days until disease progression, unacceptable toxicity or up to 6 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), over response rate (ORR) and safety. This trial was registered with http://www.clinicaltrials.gov (no. NCT01192633).A total of 26 patients with a median age 47 years (21-72) were recruited. ORR was 23.1% [1 complete response and 5 partial responses]. The median PFS and OS were 4.8 (95% CI, 0.1-9.5) months and 15.0 (95% CI, 6.1-23.9) months, respectively. Grade 3/4 hematologic toxicities included neutropenia (34.6%), leukopenia (23.1%), thrombocytopenia (11.5%) and anemia (3.8%). No febrile neutropenia and grade 3/4 non-hematologic toxicities occurred. The most frequent non-hematologic toxicities were nausea/vomiting (50.0%), fatigue (30.8%), and fever (11.5%).We conclude that GVP regimen is effective with a favorable safety profile as the second-line chemotherapy in aSTS patients, which warrants further investigation in a phase III study.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Kaplan-Meier estimates of progression-free survival (PFS) (A) and overall survival (OS).

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