Generic placeholder image

当代肿瘤药物靶点

Editor-in-Chief

ISSN (Print): 1568-0096
ISSN (Online): 1873-5576

Clinical Trial

NAPA-紫杉醇联合吉西他滨治疗转移性胰腺癌的临床疗效和安全性:NAPA研究

卷 20, 期 11, 2020

页: [887 - 895] 页: 9

弟呕挨: 10.2174/1568009620999200918122426

价格: $65

摘要

背景:III期MPACT试验证明了吉西他滨(Gem)联合Nab-紫杉醇(Nab-P)相对于单独使用吉西他滨在先前未经治疗的转移性胰腺导管腺癌(PDAC)患者中的优势。这项研究的目的是评估Gem / Nab-P在常规临床实践中的作用。 方法:从2015年1月至2018年12月,接受吉西他滨和Nab-紫杉醇联合一线治疗的转移性PDAC患者纳入多中心回顾性观察研究。对功效,预后和预测指标进行了探索性分析。 结果:该队列包括115名患者(中位年龄65 [50-84]岁),表现良好(ECOG PS 0-1)。中位总体生存期(OS)为11个月(95%CI; 9-13),中位无进展生存期(PFS)为6个月(95%CI 5-7)。分别有44例和30例患者实现了部分缓解和疾病稳定,总体疾病控制率(DCR)为64.3%。中性粒细胞减少症的3-4级血液学毒性频率为22.61%,贫血为5.22%,血小板减少症为3.48%。 2.61%的患者记录为3级虚弱。没有4级非血液学事件的报道。 51.3%的患者必须减少剂量。 结论:我们的结果证实了吉西他滨和纳布紫杉醇一线方案在实际人群中转移性PDAC中的有效性和安全性。

关键词: 转移性胰腺腺癌,联合化疗,纳布紫杉醇,吉西他滨,预后因素,癌症。

图形摘要
[1]
Maisonneuve, P. Epidemiology and burden of pancreatic cancer. Presse Med., 2019, 48(3 Pt 2), e113-e123.
[http://dx.doi.org/10.1016/j.lpm.2019.02.030] [PMID: 30878335]
[2]
Ferlay, J.; Colombet, M.; Soerjomataram, I.; Dyba, T.; Randi, G.; Bettio, M.; Gavin, A.; Visser, O.; Bray, F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur. J. Cancer, 2018, 103, 356-387.
[http://dx.doi.org/10.1016/j.ejca.2018.07.005] [PMID: 30100160]
[3]
Bilimoria, K.Y.; Bentrem, D.J.; Ko, C.Y.; Ritchey, J.; Stewart, A.K.; Winchester, D.P.; Talamonti, M.S. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer, 2007, 110(4), 738-744.
[http://dx.doi.org/10.1002/cncr.22852] [PMID: 17580363]
[4]
Vincent, A.; Herman, J.; Schulick, R.; Hruban, R.H.; Goggins, M. Pancreatic cancer. Lancet, 2011, 378(9791), 607-620.
[http://dx.doi.org/10.1016/S0140-6736(10)62307-0] [PMID: 21620466]
[5]
Burris, H.A., III; Moore, M.J.; Andersen, J.; Green, M.R.; Rothenberg, M.L.; Modiano, M.R.; Cripps, M.C.; Portenoy, R.K.; Storniolo, A.M.; Tarassoff, P.; Nelson, R.; Dorr, F.A.; Stephens, C.D.; Von Hoff, D.D. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J. Clin. Oncol., 1997, 15(6), 2403-2413.
[http://dx.doi.org/10.1200/JCO.1997.15.6.2403] [PMID: 9196156]
[6]
Rocha Lima, C.M.; Green, M.R.; Rotche, R.; Miller, W.H., Jr; Jeffrey, G.M.; Cisar, L.A.; Morganti, A.; Orlando, N.; Gruia, G.; Miller, L.L. Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. J. Clin. Oncol., 2004, 22(18), 3776-3783.
[http://dx.doi.org/10.1200/JCO.2004.12.082] [PMID: 15365074]
[7]
Sultana, A.; Smith, C.T.; Cunningham, D.; Starling, N.; Neoptolemos, J.P.; Ghaneh, P. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J. Clin. Oncol., 2007, 25(18), 2607-2615.
[http://dx.doi.org/10.1200/JCO.2006.09.2551] [PMID: 17577041]
[8]
Heinemann, V.; Quietzsch, D.; Gieseler, F.; Gonnermann, M.; Schönekäs, H.; Rost, A.; Neuhaus, H.; Haag, C.; Clemens, M.; Heinrich, B.; Vehling-Kaiser, U.; Fuchs, M.; Fleckenstein, D.; Gesierich, W.; Uthgenannt, D.; Einsele, H.; Holstege, A.; Hinke, A.; Schalhorn, A.; Wilkowski, R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J. Clin. Oncol., 2006, 24(24), 3946-3952.
[http://dx.doi.org/10.1200/JCO.2005.05.1490] [PMID: 16921047]
[9]
Kindler, H.L.; Niedzwiecki, D.; Hollis, D.; Sutherland, S.; Schrag, D.; Hurwitz, H.; Innocenti, F.; Mulcahy, M.F.; O’Reilly, E.; Wozniak, T.F.; Picus, J.; Bhargava, P.; Mayer, R.J.; Schilsky, R.L.; Goldberg, R.M. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303). J. Clin. Oncol., 2010, 28(22), 3617-3622.
[http://dx.doi.org/10.1200/JCO.2010.28.1386] [PMID: 20606091]
[10]
Conroy, T.; Desseigne, F.; Ychou, M.; Bouché, O.; Guimbaud, R.; Bécouarn, Y.; Adenis, A.; Raoul, J.L.; Gourgou-Bourgade, S.; de la Fouchardière, C.; Bennouna, J.; Bachet, J.B.; Khemissa-Akouz, F.; Péré-Vergé, D.; Delbaldo, C.; Assenat, E.; Chauffert, B.; Michel, P.; Montoto-Grillot, C.; Ducreux, M. Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N. Engl. J. Med., 2011, 364(19), 1817-1825.
[http://dx.doi.org/10.1056/NEJMoa1011923] [PMID: 21561347]
[11]
Von Hoff, D.D.; Ervin, T.; Arena, F.P.; Chiorean, E.G.; Infante, J.; Moore, M.; Seay, T.; Tjulandin, S.A.; Ma, W.W.; Saleh, M.N.; Harris, M.; Reni, M.; Dowden, S.; Laheru, D.; Bahary, N.; Ramanathan, R.K.; Tabernero, J.; Hidalgo, M.; Goldstein, D.; Van Cutsem, E.; Wei, X.; Iglesias, J.; Renschler, M.F. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N. Engl. J. Med., 2013, 369(18), 1691-1703.
[http://dx.doi.org/10.1056/NEJMoa1304369] [PMID: 24131140]
[12]
Sohal, D.P.S.; Mangu, P.B.; Khorana, A.A.; Shah, M.A.; Philip, P.A.; O’Reilly, E.M.; Uronis, H.E.; Ramanathan, R.K.; Crane, C.H.; Engebretson, A.; Ruggiero, J.T.; Copur, M.S.; Lau, M.; Urba, S.; Laheru, D. Metastatic pancreatic cancer: American Society of Clinical Oncology clinical practice guideline. J. Clin. Oncol., 2016, 34(23), 2784-2796.
[http://dx.doi.org/10.1200/JCO.2016.67.1412] [PMID: 27247222]
[13]
Panel NP adenocarcinoma. NCCN Guidelines Pancreatic Adenocarcinoma Gastrointest Oncol, 2019.www.nccn.org
[14]
Eisenhauer, E.A.; Therasse, P.; Bogaerts, J.; Schwartz, L.H.; Sargent, D.; Ford, R.; Dancey, J.; Arbuck, S.; Gwyther, S.; Mooney, M.; Rubinstein, L.; Shankar, L.; Dodd, L.; Kaplan, R.; Lacombe, D.; Verweij, J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer, 2009, 45(2), 228-247.
[http://dx.doi.org/10.1016/j.ejca.2008.10.026] [PMID: 19097774]
[15]
National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. NIH Publ 2009.ctep.cancer.gov
[16]
Frese, K.K.; Neesse, A.; Cook, N.; Bapiro, T.E.; Lolkema, M.P.; Jodrell, D.I.; Tuveson, D.A. nab-Paclitaxel potentiates gemcitabine activity by reducing cytidine deaminase levels in a mouse model of pancreatic cancer. Cancer Discov., 2012, 2(3), 260-269.
[http://dx.doi.org/10.1158/2159-8290.CD-11-0242] [PMID: 22585996]
[17]
De Vita, F.; Ventriglia, J.; Febbraro, A.; Laterza, M.M.; Fabozzi, A.; Savastano, B.; Petrillo, A.; Diana, A.; Giordano, G.; Troiani, T.; Conzo, G.; Galizia, G.; Ciardiello, F.; Orditura, M. NAB-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC): from clinical trials to clinical practice. BMC Cancer, 2016, 16(1), 709.
[http://dx.doi.org/10.1186/s12885-016-2671-9] [PMID: 27590845]
[18]
Lo Re, G.; Santeufemia, D.A.; Foltran, L.; Bidoli, E.; Basso, S.M.M.; Lumachi, F. Prognostic factors of survival in patients treated with nab-paclitaxel plus gemcitabine regimen for advanced or metastatic pancreatic cancer: a single institutional experience. Oncotarget, 2015, 6(10), 8255-8260.
[http://dx.doi.org/10.18632/oncotarget.3143] [PMID: 25779664]
[19]
Montes, AF; Villarroel, PG; Ayerbes, M; De La Cámara Gómez, J; Aldana, GQ; Tuñas, LV Prognostic and predictive markers of response to treatment in patients with locally advanced unresectable and metastatic pancreatic adenocarcinoma treated with gemcitabine/nab-paclitaxel: Results of a retrospective analysis J Cancer Res Ther, 2017, 13(2), 240-245.
[20]
Papneja, N; Zaidi, A; Chalchal, H; Moser, M; Tan, K; Olson, C Comparisons of Outcomes of Real-World Patients With Advanced Pancreatic Cancer Treated With FOLFIRINOX Versus Gemcitabine and Nab-Paclitaxel: A Population-Based Cohort Study Pancreas, 2019, 48(7), 920-926.
[http://dx.doi.org/10.1097/MPA.0000000000001340]
[21]
Wang, Y.; Camateros, P.; Cheung, W.Y. A Real-World Comparison of FOLFIRINOX, Gemcitabine Plus nab-Paclitaxel, and Gemcitabine in Advanced Pancreatic Cancers. J. Gastrointest. Cancer, 2019, 50(1), 62-68.
[http://dx.doi.org/10.1007/s12029-017-0028-5] [PMID: 29143916]
[22]
Blomstrand, H.; Scheibling, U.; Bratthäll, C.; Green, H.; Elander, N.O. Real world evidence on gemcitabine and nab-paclitaxel combination chemotherapy in advanced pancreatic cancer. BMC Cancer, 2019, 19(1), 40.
[http://dx.doi.org/10.1186/s12885-018-5244-2] [PMID: 30621618]
[23]
Kobayashi, S.; Ueno, M.; Ikeda, M.; Ozaka, M.; Sano, Y.; Hirotani, A.; Tozuka, Y.; Fukushima, T.; Tezuka, S.; Moriya, S.; Umemoto, K.; Watanabe, K.; Sasaki, M.; Hashimoto, Y.; Imaoka, H.; Ohno, I.; Mitsunaga, S.; Yamada, I.; Sasaki, T.; Sasahira, N.; Morimoto, M. A Multicenter Retrospective Study of Gemcitabine Plus Nab-Paclitaxel for Elderly Patients With Advanced Pancreatic Cancer. Pancreas, 2020, 49(2), 187-192.
[http://dx.doi.org/10.1097/MPA.0000000000001484] [PMID: 32011536]
[24]
Walker, E.J.; Ko, A.H. Beyond first-line chemotherapy for advanced pancreatic cancer: an expanding array of therapeutic options? World J. Gastroenterol., 2014, 20(9), 2224-2236.
[http://dx.doi.org/10.3748/wjg.v20.i9.2224] [PMID: 24605022]
[25]
Oettle, H; Riess, H; Stieler, JM; Heil, G; Schwaner, I; Seraphin, J Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: Outcomes from the CONKO-003 Trial J Clin Oncol, 2014, 32(23), 2423-9.
[26]
Kaddis, N.; Saif, M.W. Second-line treatment for pancreatic cancer. JOP, 2014, 15(4), 344-347.
[PMID: 25076339]
[27]
Taieb, J.; Pointet, A.L.; Van Laethem, J.L.; Laquente, B.; Pernot, S.; Lordick, F.; Reni, M. What treatment in 2017 for inoperable pancreatic cancers? Ann. Oncol., 2017, 28(7), 1473-1483.
[http://dx.doi.org/10.1093/annonc/mdx174] [PMID: 28459988]
[28]
Braiteh, F.; Patel, M.B.; Parisi, M.; Ni, Q.; Park, S.; Faria, C. Comparative effectiveness and resource utilization of nab-paclitaxel plus gemcitabine vs FOLFIRINOX or gemcitabine for the first-line treatment of metastatic pancreatic adenocarcinoma in a US community setting. Cancer Manag. Res., 2017, 9, 141-148.
[http://dx.doi.org/10.2147/CMAR.S126073] [PMID: 28461766]
[29]
Scheithauer, W.; Ramanathan, R.K.; Moore, M.; Macarulla, T.; Goldstein, D.; Hammel, P.; Kunzmann, V.; Liu, H.; McGovern, D.; Romano, A.; Von Hoff, D.D. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J. Gastrointest. Oncol., 2016, 7(3), 469-478.
[http://dx.doi.org/10.21037/jgo.2016.01.03] [PMID: 27284481]
[30]
Dell’Aquila, E.; Fulgenzi, C.A.M.; Minelli, A.; Citarella, F.; Stellato, M.; Pantano, F.; Russano, M.; Cursano, M.C.; Napolitano, A.; Zeppola, T.; Vincenzi, B.; Tonini, G.; Santini, D. Prognostic and predictive factors in pancreatic cancer. Oncotarget, 2020, 11(10), 924-941.
[http://dx.doi.org/10.18632/oncotarget.27518] [PMID: 32206189]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy