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| Name | Class |
|---|---|
| Bundang CHA Hospital | OTHER |
| Ulsan University Hospital | OTHER |
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In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.
FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-P + GEM | Nab-paclitaxel plus gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab paclitaxel plus gemcitabine | Drug | Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from the start of 2nd-line nab-P+GEM to death from any cause | 1 year |
| Objective response rates | Tumor response graded by Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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Pathologically confirmed pancreatic ductal adenocarcinoma who received 2nd-line nab-paclitaxel plus gemcitabine after progression on 1st-line FOLFIRINOX
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| Name | Affiliation | Role |
|---|---|---|
| Changhoon Yoo, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26487945 | Background | da Rocha Lino A, Abrahao CM, Brandao RM, Gomes JR, Ferrian AM, Machado MC, Buzaid AC, Maluf FC, Peixoto RD. Role of gemcitabine as second-line therapy after progression on FOLFIRINOX in advanced pancreatic cancer: a retrospective analysis. J Gastrointest Oncol. 2015 Oct;6(5):511-5. doi: 10.3978/j.issn.2078-6891.2015.041. | |
| 30536151 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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|
| 1 year |
| Toxicity profile | Safety profile graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 | 1 year |
| Kang J, Yoo C, Hwang HS, Hong SM, Kim KP, Kim SY, Hong YS, Kim TW, Ryoo BY. Efficacy and safety of lanreotide in Korean patients with metastatic, well-differentiated gastroenteropancreatic-neuroendocrine tumors: a retrospective analysis. Invest New Drugs. 2019 Aug;37(4):763-770. doi: 10.1007/s10637-018-0710-x. Epub 2018 Dec 10. |
| 24559766 | Background | Portal A, Pernot S, Siauve N, Landi B, Lepere C, Colussi O, Rougier P, Zaanan A, Verriere B, Taieb J. Sustained response with gemcitabine plus Nab-paclitaxel after folfirinox failure in metastatic pancreatic cancer: report of an effective new strategy. Clin Res Hepatol Gastroenterol. 2014 Apr;38(2):e23-6. doi: 10.1016/j.clinre.2014.01.005. Epub 2014 Feb 18. |
| 28599496 | Background | Sarabi M, Mais L, Oussaid N, Desseigne F, Guibert P, De La Fouchardiere C. Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma. Oncol Lett. 2017 Jun;13(6):4917-4924. doi: 10.3892/ol.2017.6061. Epub 2017 Apr 20. |
| 32523632 | Derived | Chae H, Jeong H, Cheon J, Chon HJ, Ryu H, Kim IH, Kang MJ, Jeong JH, Ryoo BY, Kim KP, Yoo C. Efficacy and safety of second-line nab-paclitaxel plus gemcitabine after progression on FOLFIRINOX for unresectable or metastatic pancreatic ductal adenocarcinoma: multicenter retrospective analysis. Ther Adv Med Oncol. 2020 May 27;12:1758835920923424. doi: 10.1177/1758835920923424. eCollection 2020. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |