Pemetrexed in patients with refractory soft tissue sarcoma: a non-comparative multicenter phase II study of the German Sarcoma Group AIO-STS 005
Background This study evaluated efficacy and safety of pemetrexed in patients with refractory soft tissue sarcoma. Methods Patients received pemetrexed intravenously at a dose of 500 mg/m² every 21 days until progression or unacceptable toxicity. The primary endpoint was objective tumor response. Re...
Gespeichert in:
| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2013
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| In: |
Investigational new drugs
Year: 2013, Jahrgang: 31, Heft: 1, Pages: 167-174 |
| ISSN: | 1573-0646 |
| DOI: | 10.1007/s10637-012-9840-8 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1007/s10637-012-9840-8
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| Verfasserangaben: | J.T. Hartmann, S. Bauer, G. Egerer, M.S. Horger, H.-G. Kopp, V. Grünwald, F. Mayer |
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| 245 | 1 | 0 | |a Pemetrexed in patients with refractory soft tissue sarcoma |b a non-comparative multicenter phase II study of the German Sarcoma Group AIO-STS 005 |c J.T. Hartmann, S. Bauer, G. Egerer, M.S. Horger, H.-G. Kopp, V. Grünwald, F. Mayer |
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| 520 | |a Background This study evaluated efficacy and safety of pemetrexed in patients with refractory soft tissue sarcoma. Methods Patients received pemetrexed intravenously at a dose of 500 mg/m² every 21 days until progression or unacceptable toxicity. The primary endpoint was objective tumor response. Results Fourty-eight of 53 screened patients were included and received a total of 200 cycles (median 2; range 1-30). Median age was 53 years (range, 20-81). The observed toxicity profile was favorable. NCI-CTC hematologic grade 3/4 toxicity consisted of neutropenia in 13 %, anemia in 15 %, and febrile neutropenia in 4 % of patients of patients, respectively. Non-hematologic CTC grade 3/4 toxicity consisted of elevated ASAT/ALAT in 10 %, hyperglycemia in 6 %, infection with or without neutropenia in 6 %, nausea in 2 % and stomatitis in 2 % of patients. No other grade 3 toxicities and no treatment-related toxic deaths were observed. Overall response as defined by RECIST was 5 %, 16 patients experienced stable disease (40 %). The estimated 3- and 6-months progression-free rates were 33.3 % and 14.6 %, respectively. Conclusions In patients with refractory STS, pemetrexed is well tolerated and moderately effective. The confirmed objective response rate in STS is low, however, disease stabilizations are seen in a high proportion of patients (ClinicalTrials.gov NCT00427466). | ||
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