Phase II study with the combination of gemcitabine and DTIC in patients with advanced soft tissue sarcomas

Losa, R.; Fra, J.; López‐Pousa, Antonio; Sierra, Marta; Goitia, A.; Uña, Esther; Nadal, Rosa; Muro, Javier García del; Gion, Massimo; Maurel, Joan; Escudero, P.; Esteban, Emilio; Buesa, J. M.

doi:10.1007/s00280-006-0263-0

Cited by 26 publications

(14 citation statements)

References 32 publications

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“…Combined with vinorelbine in a 40-patient study, gemcitabine produced a clinical benefit response rate (CBR), defined as the sum of ORR and SD of 25% at 4 months [67]. Another small study of gemcitabine/dacarbazine yielded low ORR in 4%, but SD in 72.6% of patients [68]. Gemcitabine and dacarbazine were further explored in a randomized phase 2 trial enrolling 113 patients, assessing the progression-free rate (PFR) at 3 months [69•].…”

Section: Taxanes and Gemcitabinementioning

confidence: 96%

Systematic Therapy for Unresectable or Metastatic Soft-Tissue Sarcomas: Past, Present, and Future

Morgan

Cranmer

2011

Curr Oncol Rep

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Unresectable or metastatic disease occurs in 40% to 60% of soft-tissue sarcoma (STS) patients and portends a poor prognosis. For decades, doxorubicin has formed the backbone of systemic treatment, with response rates of approximately 26%. Patients progressing following first-line therapy were left with few proven options. No other cytotoxic chemotherapy agent or combination has demonstrated superiority to doxorubicin. Advances in targeted therapy of STS have been hindered by STS heterogeneity and poorly understood disease biology. Despite challenges, progress has been made in specific STS subtypes. Here, we highlight the challenges, progress, and lessons learned from STS trials published in the last 20 to 25 years.

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Section: Taxanes and Gemcitabinementioning

confidence: 96%

Systematic Therapy for Unresectable or Metastatic Soft-Tissue Sarcomas: Past, Present, and Future

Morgan

Cranmer

2011

Curr Oncol Rep

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“…Regarding combination therapy for second-line treatment in advanced STS, there are a few data on clinical trials comparing different schedules. e combination of gemcitabine and dacarbazine has activity in patients with previously treated STS [41][42][43], with a better tolerance profile than the one observed with the combination of gemcitabine and docetaxel in the SARC002 study [44]. To be specific, the rate of progression-free survival (PFS) after three months of treatment with the combination of gemcitabine and dacarbazine was 46% in the study by Losa et al [41] and 56% in the one conducted by García del Muro et al [42].…”

Section: Sarcomamentioning

confidence: 99%

Optimization of the Therapeutic Approach to Patients with Sarcoma: Delphi Consensus

Álvarez

Jurado

Soláns

et al. 2019

Sarcoma

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Soft tissue sarcomas (STS) constitute a heterogeneous group of rare solid tumors associated with significant morbidity and mortality. The evaluation and treatment of STS require a multidisciplinary team with extensive experience in the management of these types of tumors. National and international clinical practice guidelines for STS do not always provide answers to a great many situations that specialists have to contend with in their everyday practice. This consensus provides a series of specific recommendations based on available scientific evidence and the experience of a group of experts to assist in decision-making by all the specialists involved in the management of STS.

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“…57,58 Phase II studies of gemcitabine in combination with either vinorelbine or dacarbazine, showed only limited efficacy for STS. 59–61 Meanwhile, docetaxel is a taxane with microtubule-inhibiting activity, and also has single-agent activity as second-line therapy. 62,63 Given that GD have different mechanisms of action from either anthracyclines or alkylating agents, as well as preclinical evidence of their synergy, there was rationale for combining these agents for treating STS.…”

Section: Gemcitabine and Docetaxelmentioning

confidence: 99%

Treatment of advanced, metastatic soft tissue sarcoma: latest evidence and clinical considerations

Tseng

2017

Ther Adv Med Oncol

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Soft tissue sarcoma (STS) is a biologically heterogeneous malignancy with over 50 subtypes. Historically, there have been few systemic treatment options for this relatively rare disease. Traditional cytotoxic agents, such as anthracyclines, alkylating agents, and taxanes have limited clinical benefit beyond the first-line setting; across all high-grade STS subtypes, median overall survival remains approximately 12–18 months for advanced metastatic disease. The development of targeted therapies has led to recent US Food and Drug Administration approval of four new treatments for high-grade STS in the advanced metastatic setting. Among these, olaratumab is most notable for its improvement in overall survival for patients with anthracycline-naïve disease. Further progress in STS management will rely on novel trial design, subtype-specific therapies and validation of biomarkers to tailor therapy. Immunotherapy has shown promise as a new, but yet undiscovered frontier in the management of STS.

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Phase II study with the combination of gemcitabine and DTIC in patients with advanced soft tissue sarcomas

Cited by 26 publications

References 32 publications

Systematic Therapy for Unresectable or Metastatic Soft-Tissue Sarcomas: Past, Present, and Future

Systematic Therapy for Unresectable or Metastatic Soft-Tissue Sarcomas: Past, Present, and Future

Optimization of the Therapeutic Approach to Patients with Sarcoma: Delphi Consensus

Treatment of advanced, metastatic soft tissue sarcoma: latest evidence and clinical considerations

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