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http://ir.nhri.org.tw/handle/3990099045/11818
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| Title: | Multicenter, phase II trial of biweekly S-1, leucovorin (LV), oxaliplatin and gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma (mPDAC): Final report of TCOG T1211 study |
| Authors: | Chiang, NJ;Tsai, KK;Chen, JS;Yang, SH;Hsiao, HH;Shan, YS;Chen, LT |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: Our previous studies showed a triplet GOFL regimen consisting of gemcitabine plus modified FOLFOX4 was well-tolerated and moderate active in advanced PDAC, and the feasibility of replacing infusion 5-FU/LV with oral S-1/LV, the SLOG regimen, in a dose-escalating, phase I study. Herein, we report the phase II results of the SLOG in mPDAC patients. Methods: Patients with chemo-naïve mPDAC, ECOG PS 0-1, and 20-75 y/o of age were eligible. Intravenous fixed-rate infusion of 800 mg/m2 gemcitabine followed by 2-hr infusion of 85mg/m2 oxaliplatin on D1 plus oral S-1/LV 35/20 mg/m2, twice daily, D1-D7 were given Q 14 days as a cycle. The primary endpoint was objective response rate (ORR). Simon’s optimal two-stage design was used with estimated p0=25% and p1=40%. Results: Between Jun. 2013 and Oct. 2015, a total of 54 patients were included, with median age of 59 y/o, ECOG PS = 1 in 82%, and the presence of liver metastases in 66.7%. At the cut-off Feb.01, 2017, nine patients remained alive and their median follow-up time was 21.3 months. The ORR was partial response in 22 patients (ORR=40.7%, 95% CI, 28-55%) and stable diseases in 19 patients (35.2%). Long-term disease control rate (stable disease >16 weeks) was 64.8% (95% CI, 51-77%). The median progression-free survival and overall survival was 7.6 (95% CI, 4.4-10.7) and 11.4 (95% CI, 8.1-16.3) months, respectively. One-year and two-year survival rates were 46% and 17%, respectively. The most common treatment-related grade 3-4 adverse events included neutropenia (40.7%), anorexia (14.8%), nausea (11.1%), thrombocytopenia (9.3%), and diarrhea (7.4%). Conclusions: Current study demonstrated SLOG is a highly active regimen with manageable and favorable safety profiles for mPDAC patients. A randomized phase II trial comparing SLOG vs. modified FOLFIRINOX in advanced PDAC patients is ongoing.Clinical trial identification: NCT01415713. |
| Date: | 2018-10 |
| Relation: | Annals of Oncology. 2018 Oct;29(Suppl. 8):Meeting Abstract 736P. |
| Link to: | https://doi.org/10.1093/annonc/mdy282.119 |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000459277301315 |
| Cited Times(Scopus): | https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081531798 |
| Appears in Collections: | [姜乃榕] 會議論文/會議摘要
[陳立宗] 會議論文/會議摘要
[蔡坤志] 會議論文/會議摘要
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| ISI000459277301315.pdf | | 77Kb | Adobe PDF | 274 | View/Open |
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