A FNCLCC French Sarcoma Group—GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS)

Duffaud, Florence; Bui, Binh; Penel, Nicolas; Cioffi, A.; Isambert, Nicolás; Blay, Jean‐Yves; Cupissol, Didier; Jimenez, Marta; Rey, A; Pautier, Patricia

doi:10.1200/jco.2008.26.15_suppl.10511

Cited by 17 publications

(12 citation statements)

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“…The most frequently prescribed off-label drug in this study was gemcitabine. Indeed, gemcitabine with or without docetaxel is commonly used in some specific sarcoma subsets, particularly in leiomyosarcomas and angiosarcomas [18–21], although neither of these drugs is approved for this indication. Another not yet approved drug that is frequently used in the sarcoma field is paclitaxel, which shows activity particularly in angiosarcomas [22, 23].…”

Section: Discussionmentioning

confidence: 99%

Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study

Savina¹,

Cesne²,

Blay³

et al. 2017

BMC Med

163

125

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BackgroundWell-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.MethodsThe patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group were analyzed.ResultsThe median number of systemic treatments was 3 (range, 1–6); 27% of the patients did not receive any systemic treatment and 1054 (49%) patients underwent locoregional treatment of the metastasis. Half of the patients who underwent chemotherapy (n = 810) received an off-label drug. Leiomyosarcoma was associated with a significantly better outcome than the other histological subtypes. With the exception of leiomyosarcomas, the benefit of a greater than third-line regimen was very limited, with a median time to next treatment (TNT) and overall survival (OS) ranging between 2.3 and 3.7 months and 5.4 and 8.5 months, respectively. The TNT was highly correlated with OS. Female sex, leiomyosarcoma histology, locoregional treatment of metastases, inclusion in a clinical trial, and treatment with first-line polychemotherapy were significantly associated with improved OS in the multivariate analysis.ConclusionsThe combination of doxorubicin with a second drug, such as ifosfamide, represents a valid option, particularly when tumor shrinkage is expected to provide clinical benefits. After failure of the second-line therapy, best supportive care should be considered, particularly in patients with non-leiomyosarcoma histology who are not eligible to participate in a clinical trial. Locoregional treatment of metastasis should always be included in the therapeutic strategy when feasible. TNT may represent a useful surrogate endpoint for OS in clinical studies.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0831-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study

Savina¹,

Cesne²,

Blay³

et al. 2017

BMC Med

163

125

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“…Additionally, in the study by Bay and colleagues nearly 69% of patients were treated within the adjuvant setting [95]. A further RCT (TAXOGEM study) investigating gemcitabine vs. gemcitabine plus docetaxel [27,31], whilst identified in our review had not reported efficacy data at the cut-off date for the literature search and thus, while has done subsequently [96], the findings do not contribute to our conclusions.…”

Section: Discussionmentioning

confidence: 86%

Efficacy and safety of pharmacological interventions in second- or later-line treatment of patients with advanced soft tissue sarcoma: a systematic review

Sharma¹,

Takyar²,

Manson

et al. 2013

BMC Cancer

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BackgroundCurrent guidelines recommend anthracycline-based chemotherapy primarily with doxorubicin either as monotherapy or in combination with ifosfamide as the first-line treatment for most advanced STS subtypes. Therapeutic options after failure of doxorubicin and/or ifosfamide are limited. This study aimed to comprehensively review available data on the activity and safety of interventions in second- or later-line treatment of advanced STS.MethodsElectronic literature databases (Embase®, MEDLINE®, MEDLINE® In-Process, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews) were searched from 1980 to 01 March 2012 to identify randomised controlled trials (RCTs) and non-randomised studies (both prospective and retrospective) evaluating pharmacological interventions in patients with advanced STS pre-treated with anthracycline- and/or ifosfamide-based therapy.ResultsThe review identified six RCTs (one phase III and five phase II trials) and 94 non-randomised studies. Based on the primary trial endpoints, RCTs demonstrated favourable efficacy for pazopanib over placebo (PFS: 4.6 months vs. 1.6 months), gemcitabine plus dacarbazine over dacarbazine monotherapy (3-month PFS rate: 54.2% vs. 35.2%), and trabectedin 3-weekly schedule over weekly schedule (TTP: 3.7 months vs. 2.3 months. The non-randomised studies demonstrated heterogeneity in efficacy and safety results.ConclusionsAcross the RCTs, pazopanib over placebo, gemcitabine-dacarbazine over dacarbazine, and trabectedin 3-weekly over weekly regimen clearly demonstrated a PFS advantage in the second- and later-line treatment of advanced STS. With only one phase III trial in this setting, there is a clear need for additional comparative trials to better understand the risk: benefit ratios of available agents and combinations.

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“…However, others were not able to confirm the efficacy of this combination (30). Recently, trabectedin showed response rates up to 56% in LMSs (31), and it appeared to be especially useful in far-advanced and metastatic LMSs after failure of the combination of anthracyclines and ifosfamide (32), which is presently the best standard chemotherapy available in soft tissue sarcomas (33,34).…”

Section: Treatmentmentioning

confidence: 99%

Small bowel leiomyosarcoma: A case report and literature review

Arts

Bosscha²,

Ranschaert³

et al. 2012

Turk J Gastroenterol

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A FNCLCC French Sarcoma Group—GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS)

Cited by 17 publications

References 0 publications

Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study

Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study

Efficacy and safety of pharmacological interventions in second- or later-line treatment of patients with advanced soft tissue sarcoma: a systematic review

Small bowel leiomyosarcoma: A case report and literature review

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