Purpose Gemcitabine as a single agent and the combination of gemcitabine and docetaxel have activity in patients with metastatic soft tissue sarcoma. To determine if the addition of docetaxel to gemcitabine improved clinical outcome of patients with metastatic soft tissue sarcomas, we compared a fixed dose rate infusion of gemcitabine versus a lower dose of gemcitabine with docetaxel. Patients and Methods In this open-label phase II clinical trial, the primary end point was tumor response, defined as complete or partial response or stable disease lasting at least 24 weeks. A Bayesian adaptive randomization procedure was used to produce an imbalance in the randomization in favor of the superior treatment, accounting for treatment-subgroup interactions. Results One hundred nineteen of 122 randomly assigned patients had assessable outcomes. The adaptive randomization assigned 73 patients (60%) to gemcitabine-docetaxel and 49 patients (40%) to gemcitabine alone, indicating gemcitabine-docetaxel was superior. ...

https://ascopubs.org/doi/pdf/10.1200/JCO.2006.10.4117

Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas

Soft tissue sarcoma is a term used to describe a heterogeneous group of many rare tumors. Since the initial description of activity of doxorubicin, several additional agents have been brought to bear in the treatment of these diseases. Despite 2 recent drug approvals, doxorubicin and ifosfamide remain the most effective chemotherapy drugs available for the treatment of majority of these tumors. Optimal dosing and administration influence outcomes because of the steep dose-response curves associated with these agents. The debate endures regarding whether patients who have advanced disease should routinely receive single agents sequentially or in combination. Adjuvant therapy remains similarly controversial, although meta-analyses do support its use. Contemporary treatment of soft tissue sarcoma routinely incorporates additional lines of treatment that have become available over the last 15 years. Fixed-dose-rate gemcitabine with or without docetaxel is a standard second-line treatment. In keeping with the paradigm shift favoring subset-specific therapy, several recent approvals are linked with specific sarcoma subtypes. Eribulin has recently been approved on the basis of improved overall survival for patients with adipocytic sarcomas, and trabectedin is now approved in the United States for patients with leiomyosarcoma and liposarcoma. Within the spectrum of targeted therapies, pazopanib is approved for all nonadipocytic sarcomas, and imatinib is approved for dermatofibrosarcoma protuberans. Each of these drugs represents incremental rather than radical progress, although they constitute important and much needed treatment options for patients with these diseases. Cancer 2016;122:2952-2960. © 2016 American Cancer Society.

Chemotherapy for soft tissue sarcoma

Gemcitabine in advanced adult soft-tissue sarcomas : a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group

Background. Gemcitabine and docetaxel have a broad spectrum of clinical activity in patients with carcinoma. The Sarcoma Alliance for Research Through Collaboration conducted aphaseIItrialofgemcitabineincombinationwithdocetaxelin children and adults with recurrent Ewing sarcoma (EWS), osteosarcoma (OS), or unresectable or recurrent chondrosarcoma. The primaryobjectivewastodeterminetheobjectiveresponserateusing Response Evaluation Criteria in Solid Tumors (RECIST). Methods. Gemcitabine (675 mg/m 2 i.v. over 90 minutes on days 1 and 8) was administered in combination with docetaxel (75mg/m 2 i.v.over1houronday8)every21days.Allpatients received filgrastim or pegfilgrastim. A Bayesian formulation was used to determine the probability of achieving the target response rate for each subtype—0.35 for EWS and OS or 0.20 for chondrosarcoma. If the probability of achieving the target response rate was 0.05, the combination was considered inactive. Toxicity was graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Results. Fifty-three eligible patients were enrolled in the three subtype groups—OS (n 14), EWS (n 14), and chondrosarcoma (n 25). Toxicities included neutropenia, thrombocytopenia, fatigue, dyspnea, bronchospasm, edema, neuropathy, and liver function abnormalities. Dose modification for toxicity was required for eight patients during cycle 1 and 16 patients in subsequent cycles. Seven patients withdrew from therapy as a result of toxicity. No complete responses were observed. Partial responses were observed in OS (n1), EWS (n 2), and chondrosarcoma (n 2) patients. Conclusion. Gemcitabine in combination with docetaxel was associated with a probability of reaching the target 35% response rate of 5% in OS patients and 5.6% in EWS patients; the probability of reaching a 20% response rate in chondrosarcoma patients was 14%.

Phase II Study of Sequential Gemcitabine Followed by Docetaxel for Recurrent Ewing Sarcoma, Osteosarcoma, or Unresectable or Locally Recurrent Chondrosarcoma: Results of Sarcoma Alliance for Research Through Collaboration Study 003

The treatment of advanced soft-tissue sarcomas is often palliative, although a subset of patients may be cured or have a long disease-free interval. This paper reviews the historical data over 30 years of treatment that has led to the use of ifosfamide and doxorubicin as the mainstay in the treatment of metastatic disease. These treatments have a high toxicity, relative to other chemotherapeutic regimens, with median response durations on the order of months. Agents developed in the last few years, whose role in the treatment of sarcomas is still evolving, are discussed as well. Finally, we discuss the role of chemotherapy in combination with surgery and radiation in the adjuvant and neoadjuvant settings. The Oncologist 2002;7:348-359

https://theoncologist.onlinelibrary.wiley.com/doi/pdf/10.1634/theoncologist.7-4-348

The Use of Chemotherapy in Soft-Tissue Sarcomas

Purpose: To assess the efficacy of gemcitabine in patients with a variety of sarcomas that have failed to respond or escaped Adriamycin- and ifosfamide-based chemotherapy. Patients and methods: A group of 18 symptomatic heavily pretreated patients with sarcomas of bone or soft tissue received one induction course of gemcitabine at a dose of 1000 mg/m2 per week for 7 consecutive weeks, followed by 1 week rest. Response to the induction course was assessed by interview and by repeated ancillary tests. If no progression was observed, maintenance by gemcitabine 1000 mg/m2 per week for 3 weeks every 28 days was given until failure was clinically or radiologically evident. Results: A total of 51 cycles of gemcitabine were given including 18 cycles of induction. A mean of 3.6 postinduction cycles were given to nine patients. The treatment was well tolerated by the patients. One partial response (leiomyosarcoma) and one minimal response (angiosarcoma) were observed, yielding a true objective response rate of 5.5%. An additional six patients achieved stabilization of disease (chondrosarcoma and osteosarcoma), yielding an overall progression-free rate of 44%. The median time to progression was more than 27 weeks. Clinical benefit response was observed only in those who also achieved a progression-free state. Conclusion: Gemcitabine was found to be effective in achieving stabilization and even a minimal response of soft tissue or bone sarcoma refractory to standard chemotherapy.

Gemcitabine in soft tissue or bone sarcoma resistant to standard chemotherapy: a phase II study

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Gemcitabine in soft tissue or bone sarcoma resistant to standard chemotherapy: a phase II study