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http://ir.nhri.org.tw/handle/3990099045/13587
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| Title: | A phase I study of biweekly abraxane in combination with oxaliplatin and oral S-1/leucovorin as first line treatment for advanced gastric, pancreatic and biliary tract cancers |
| Authors: | Tsai, H;Yang, S;Hsiao, C;Kao, H;Shan, Y;Lin, Y;Yen, C;Du, J;Hsu, C;Wu, I;Chen, L |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: Advanced gastric, pancreatic and biliary tract cancer patients have poor prognosis. Platinum, fluoropyrimidine, taxane, irinotecan, and gemcitabine used alone or in combination are commonly used for these patients. However, the overall survival (OS) of these patients is still less than 1 year. Further development of other combinational regimens is needed. Oxaliplatin, nab-paclitaxel and S-1 have been shown to be effective for advanced gastric, pancreatic and biliary tract cancers according to previous studies. However, the toxicity of combination of these three drugs is concerned. Therefore, we conducted a phase I dose-escalating study using biweekly nab-paclitaxel in combination with oxaliplatin and oral S-1/leucovorin as first-line treatment for advanced gastric, pancreatic and biliary tract cancers to evaluate the toxicity of this regimen. Methods: The dose of nab-paclitaxel was 150 mg/m 2 in D1. The dose of S-1/leucovorin was 35 mg/m 2 and 30 mg twice daily from D1 to D7. The dose of oxaliplatin was 60, 75 or 85 mg/m 2 in D1. A 3+3 design was used to escalate the dose of oxaliplatin. Dose-limiting toxicity (DLT) was observed in the first 2 cycles (4 weeks). The primary endpoint was to determine maximal tolerated dose (MTD) of oxaliplatin in this regimen. An expansion cohort was included at the MTD level. The secondary endpoints were overall response rate (ORR), progression free survival (PFS), OS and toxicities of this regimen. Results: A total of 19 patients were enrolled from June 2018 to November 2020. The median follow-up time was 12 (1.9-27.1) months. No DLT developed at dose levels 1 and 2. One patient at dose level 3 (oxaliplatin 85 mg/m 2) was given with 60 mg/m 2. Therefore, 4 patients received oxaliplatin of dose level 1 (60 mg/m 2). One patient developed DLT (grade 3 diarrhea) among 6 patients at dose level 3. The MTD of oxaliplatin was 85 mg/m 2. Another 6 patients were enrolled in the expansion cohort of MTD. The mean age of all patients was 53.8 (29-68) years old. Thirteen patients had pancreatic cancer, 4 patients had biliary tract cancer and 2 patients had gastric cancer. The mean number of cycles of treatment of all patients was 11.4 (3-51). Thirteen patients discontinued treatment and five of them were due to progressive disease. The other patients discontinued treatment due to adverse events (AE), or concern for the AE or further treatment plan by patient or investigator’s decision. The most common treatment-related grade 3/4 AEs were neutropenia (57.9%), diarrhea (21.1%), and febrile neutropenia (10.5%). The ORR of all patients was 57.9% with 50%, 61.5%, and 50% for gastric, pancreatic, and biliary tract cancer, respectively. The median PFS of all patients was 13.4 months (95% confidence interval: 12.5-not reached). The median OS was not reached yet. Conclusions: This phase I study demonstrated that the MTD of oxaliplatin is 85 mg/m 2 in combination with nab-paclitaxel and oral S-1/leucovorin as first-line treatment for advanced gastric, pancreatic, and biliary tract cancers. The toxicities are acceptable with a durable response. Further phase II study is warranted to evaluate the efficacy of this regimen. |
| Date: | 2021-07 |
| Relation: | Annals of Oncology. 2021 Jul;32(Suppl. 3):S146-S147. |
| Link to: | http://dx.doi.org/10.1016/j.annonc.2021.05.195 |
| 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:000670004200139 |
| Appears in Collections: | [其他] 會議論文/會議摘要
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| ISI000670004200139.pdf | | 125Kb | Adobe PDF | 175 | View/Open |
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