| Title |
Phase II Study of Gemcitabine Plus Sirolimus in Previously Treated Patients with Advanced Soft-Tissue Sarcoma: a Spanish Group for Research on Sarcomas (GEIS) Study
|
|---|---|
| Published in |
Targeted Oncology, November 2017
|
| DOI | 10.1007/s11523-017-0539-9 |
| Pubmed ID | |
| Authors |
Juan Martin-Liberal, Antonio López-Pousa, Javier Martínez-Trufero, Javier Martín-Broto, Ricardo Cubedo, Javier Lavernia, Andrés Redondo, José Antonio López-Martín, Nùria Mulet-Margalef, Xavier Sanjuan, Òscar M. Tirado, Xavier Garcia-del-Muro |
| Abstract |
Gemcitabine plus sirolimus enhances apoptosis in vitro and increases anti-tumor efficacy in vivo in soft-tissue sarcoma (STS) models. The objective of this study was to evaluate the activity and toxicity of the combination of gemcitabine plus sirolimus in patients with STS after failure of standard chemotherapy. Advanced STS patients, previously treated with doxorubicin and/or ifosfamide, were included in this single-arm phase II study. Patients received gemcitabine 800 mg/m2 intravenously (iv) at 10 mg/m2/min on days 1 and 8 every 3 weeks plus sirolimus 5 mg daily orally (po). After enrolment of the first 12 patients, the study protocol was amended due to toxicity and the starting dose of sirolimus was reduced to 3 mg daily po. Archival tumor samples were analyzed for extracellular signal-regulated kinase 1 and 2 (ERK1/2) expression and correlated with outcome. The primary endpoint was progression-free rate (PFR) at 3 months. From May 2012 to May 2013, 28 patients were enrolled at eight centers. PFR at 3 and 6 months was 44% and 20%, respectively, with 12 patients being free of progression at 3 months. Median progression-free survival (PFS) was 1.85 months (95% confidence interval [CI] 0.73-2.97) and median overall survival (OS) was 9.2 months (95% CI 5.8-12.5). No responses were observed. The most common grade 3-4 hematologic toxicities were neutropenia (48%) and leukopenia (41%) and the most frequent grade 3 non-hematologic toxicities were infection (18.5%), transaminitis (15%), fatigue (11%), and pneumonitis (11%). ERK1/2 expression was significantly correlated with PFS (p = 0.026). The combination of gemcitabine and sirolimus is an active treatment in STS. Further investigation is warranted. ClinicalTrials.gov identifier: NCT01684449. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Canada | 1 | 50% |
| United States | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Science communicators (journalists, bloggers, editors) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 23 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 23 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 3 | 13% |
| Student > Ph. D. Student | 3 | 13% |
| Lecturer | 2 | 9% |
| Student > Master | 2 | 9% |
| Other | 1 | 4% |
| Other | 5 | 22% |
| Unknown | 7 | 30% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 9 | 39% |
| Biochemistry, Genetics and Molecular Biology | 4 | 17% |
| Nursing and Health Professions | 1 | 4% |
| Unknown | 9 | 39% |
Attention Score in Context
This research output has an Altmetric Attention Score of 34. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 18 January 2018.
All research outputs
#1,008,623
of 23,015,156 outputs
Outputs from Targeted Oncology
#5
of 555 outputs
Outputs of similar age
#25,057
of 438,315 outputs
Outputs of similar age from Targeted Oncology
#1
of 17 outputs
Altmetric has tracked 23,015,156 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 95th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 555 research outputs from this source. They receive a mean Attention Score of 2.8. This one has done particularly well, scoring higher than 99% of its peers.
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We're also able to compare this research output to 17 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 94% of its contemporaries.