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Temozolamide Plus Capecitabine As Salvage Treatment for Patients with Advanced Neuroendocrine Tumors (nets) in the Community Setting.

Journal of clinical oncology(2013)

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摘要
e15169 Background: Streptozotocin and doxorubicin-based chemotherapy schemes have been widely used in the treatment of advanced NETs. Unfortunately, balance between efficacy and toxicity is clearly improvable. Novel combinations of cytotoxic agents like temozolamide and capecitabine have shown promising antitumoral activity in retrospective series.We aimed toevaluate the efficacy and safety of this combination in patients with advanced NETs derived from the daily clinical practice. Methods: We analyzed the clinical outcome of 34 patients (pts) treated with temozolamide (150 mg/m2 qo, days 10-14) plus capecitabine (1.000 mg/m2 bid, days 1-14) every 28 days, between June-2008 and December-2012 in five referenced centers in Spain. Results: 21 pts (61%), were pancreatic primary NETs (pNETs). 8 pts (24%) were treated as first-line. 26 pts (76,5%) had ECOG 0 or 1. One (2,9%), 18 (52,9%), and 11 (32,4%) pts had low (G1), intermediate (G2) or high-grade (G3) respectively. Grade was not available in 4 pts (11,8%). Median administered cycles were 8 (range 1-26). At the time of the data cut-off (Dec-2012) 5 pts (14,7%) were still on treatment after a median follow up of 6,4 months. 13 pts (38,2%) had partial response (PR) and 12 (32,4%) stable disease (SD) according to RECIST 1.1 criteria. Estimated median time to progression (TTP) was 9,4 months IC95% (4,2-14,6) in the intention to treat population. Thrombocytopenia was the most frequent toxicity found in grade 3 or more (9%). Other grade 3 toxicities according to CTCAE v4.0 were observed in less than 5% of pts. Conclusions: These encouraging results show a promising activity and a favorable safety profile of the combination of temozolamide and capecitabine in patients with advanced NETs and deserves for further clinical research in the future.
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