Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer
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摘要
AIM To directly compare the efficacy and toxicity of standarddose FOLFIRINOX(sFOLFIRINOX) and modified-dose FOLFIRINOX(mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.METHODS One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX(n = 88) or mFOLFIRINOX(n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate(ORR),disease control rate(DCR), progression-free survival(PFS), and overall survival(OS) were evaluated and compared using Pearson's chi-square test, Kaplan-Meier plot and log-rank test. The adverse events(AEs) were evaluated, and severe(≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.RESULTS The mFOLFIRINOX group included more female patients(30.7% vs 57.1%; P = 0.004) and older patients [age(median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups(ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups(PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia(83.0% vs 66.7%; P = 0.044), anorexia(48.9% vs 28.6%; P = 0.029) and diarrhea(13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group.CONCLUSION m FOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.
AIM To directly compare the efficacy and toxicity of standarddose FOLFIRINOX(sFOLFIRINOX) and modified-dose FOLFIRINOX(mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.METHODS One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX(n = 88) or mFOLFIRINOX(n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate(ORR),disease control rate(DCR), progression-free survival(PFS), and overall survival(OS) were evaluated and compared using Pearson's chi-square test, Kaplan-Meier plot and log-rank test. The adverse events(AEs) were evaluated, and severe(≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.RESULTS The mFOLFIRINOX group included more female patients(30.7% vs 57.1%; P = 0.004) and older patients [age(median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups(ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups(PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia(83.0% vs 66.7%; P = 0.044), anorexia(48.9% vs 28.6%; P = 0.029) and diarrhea(13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group.CONCLUSION m FOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.
AIM To directly compare the efficacy and toxicity of standarddose FOLFIRINOX(sFOLFIRINOX) and modified-dose FOLFIRINOX(mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.METHODS One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX(n = 88) or mFOLFIRINOX(n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate(ORR),disease control rate(DCR), progression-free survival(PFS), and overall survival(OS) were evaluated and compared using Pearson's chi-square test, Kaplan-Meier plot and log-rank test. The adverse events(AEs) were evaluated, and severe(≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.RESULTS The mFOLFIRINOX group included more female patients(30.7% vs 57.1%; P = 0.004) and older patients [age(median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups(ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups(PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia(83.0% vs 66.7%; P = 0.044), anorexia(48.9% vs 28.6%; P = 0.029) and diarrhea(13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group.CONCLUSION m FOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.
引文
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19 National Cancer Institute.Common Terminology Criteria for Adverse Events(CTCAE).v4.03.ed:U.S.Department of Health and Human Services,National Institutes of Health,National Cancer Institute.2010;Available from:https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/
20 Le N,Vinci A,Schober M,Krug S,Javed MA,Kohlmann T,Sund M,Neesse A,Beyer G.Real-World Clinical Practice of Intensified Chemotherapies for Metastatic Pancreatic Cancer:Results from a Pan-European Questionnaire Study.Digestion 2016;94:222-229[PMID:28030863 DOI:10.1159/000453257]
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22 Okusaka T,Ikeda M,Fukutomi A,Ioka T,Furuse J,Ohkawa S,Isayama H,Boku N.Phase II study of FOLFIRINOX for chemotherapy-na?ve Japanese patients with metastatic pancreatic cancer.Cancer Sci 2014;105:1321-1326[PMID:25117729 DOI:10.1111/cas.12501]
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2 Jung KW,Won YJ,Oh CM,Kong HJ,Lee DH,Lee KH;Community of Population-Based Regional Cancer Registries.Cancer Statistics in Korea:Incidence,Mortality,Survival,and Prevalence in2014.Cancer Res Treat 2017;49:292-305[PMID:28279062 DOI:10.4143/crt.2017.118]
3 Burris HA 3rd,Moore MJ,Andersen J,Green MR,Rothenberg ML,Modiano MR,Cripps MC,Portenoy RK,Storniolo AM,Tarassoff P,Nelson R,Dorr FA,Stephens CD,Von Hoff DD.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;15:2403-2413[PMID:9196156 DOI:10.1200/jco.1997.15.6.2403]
4 Heinemann V,Quietzsch D,Gieseler F,Gonnermann M,Sch?nek?s 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;24:3946-3952[PMID:16921047 DOI:10.1200/jco.2005.05.1490]
5 Moore MJ,Goldstein D,Hamm J,Figer A,Hecht JR,Gallinger S,Au HJ,Murawa P,Walde D,Wolff RA,Campos D,Lim R,Ding K,Clark G,Voskoglou-Nomikos T,Ptasynski M,Parulekar W;National Cancer Institute of Canada Clinical Trials Group.Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer:a phase III trial of the National Cancer Institute of Canada Clinical Trials Group.J Clin Oncol 2007;25:1960-1966[PMID:17452677 DOI:10.1200/jco.2006.07.9525]
6 Von Hoff DD,Ervin T,Arena FP,Chiorean EG,Infante J,Moore M,Seay T,Tjulandin SA,Ma WW,Saleh MN,Harris M,Reni M,Dowden S,Laheru D,Bahary N,Ramanathan RK,Tabernero J,Hidalgo M,Goldstein D,Van Cutsem E,Wei X,Iglesias J,Renschler MF.Increased survival in pancreatic cancer with nabpaclitaxel plus gemcitabine.N Engl J Med 2013;369:1691-1703[PMID:24131140 DOI:10.1056/NEJMoa1304369]
7 Conroy T,Desseigne F,Ychou M,BouchéO,Guimbaud R,Bécouarn Y,Adenis A,Raoul JL,Gourgou-Bourgade S,de la Fouchardière C,Bennouna J,Bachet JB,Khemissa-Akouz F,Péré-VergéD,Delbaldo C,Assenat E,Chauffert B,Michel P,MontotoGrillot C,Ducreux M;Groupe Tumeurs Digestives of Unicancer;PRODIGE Intergroup.FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.N Engl J Med 2011;364:1817-1825[PMID:21561347 DOI:10.1056/NEJMoa1011923]
8 Petrelli F,Coinu A,Borgonovo K,Cabiddu M,Ghilardi M,Lonati V,Aitini E,Barni S;Gruppo Italiano per lo Studio dei Carcinomi dell’Apparato Digerente(GISCAD).FOLFIRINOX-based neoadjuvant therapy in borderline resectable or unresectable pancreatic cancer:a meta-analytical review of published studies.Pancreas 2015;44:515-521[PMID:25872127 DOI:10.1097/MPA.0000000000000314]
9 Suker M,Beumer BR,Sadot E,Marthey L,Faris JE,Mellon EA,El-Rayes BF,Wang-Gillam A,Lacy J,Hosein PJ,Moorcraft SY,Conroy T,Hohla F,Allen P,Taieb J,Hong TS,Shridhar R,Chau I,van Eijck CH,Koerkamp BG.FOLFIRINOX for locally advanced pancreatic cancer:a systematic review and patient-level metaanalysis.Lancet Oncol 2016;17:801-810[PMID:27160474 DOI:10.1016/S1470-2045(16)00172-8]
10 Ducreux M,Cuhna AS,Caramella C,Hollebecque A,Burtin P,GoéréD,Seufferlein T,Haustermans K,Van Laethem JL,Conroy T,Arnold D;ESMO Guidelines Committee.Cancer of the pancreas:ESMO Clinical Practice Guidelines for diagnosis,treatment and follow-up.Ann Oncol 2015;26 Suppl 5:v56-v68[PMID:26314780DOI:10.1093/annonc/mdv295]
11 Sohal DP,Mangu PB,Khorana AA,Shah MA,Philip PA,O'Reilly EM,Uronis HE,Ramanathan RK,Crane CH,Engebretson A,Ruggiero JT,Copur MS,Lau M,Urba S,Laheru D.Metastatic Pancreatic Cancer:American Society of Clinical Oncology Clinical Practice Guideline.J Clin Oncol 2016;34:2784-2796[PMID:27247222 DOI:10.1200/JCO.2016.67.1412]
12 Tempero MA,Malafa MP,Al-Hawary M,Asbun H,Bain A,Behrman SW,Benson AB 3rd,Binder E,Cardin DB,Cha C,Chiorean EG,Chung V,Czito B,Dillhoff M,Dotan E,Ferrone CR,Hardacre J,Hawkins WG,Herman J,Ko AH,Komanduri S,Koong A,LoConte N,Lowy AM,Moravek C,Nakakura EK,O'Reilly EM,Obando J,Reddy S,Scaife C,Thayer S,Weekes CD,Wolff RA,Wolpin BM,Burns J,Darlow S.Pancreatic Adenocarcinoma,Version 2.2017,NCCN Clinical Practice Guidelines in Oncology.J Natl Compr Canc Netw 2017;15:1028-1061[PMID:28784865DOI:10.6004/jnccn.2017.0131]
13 Mahaseth H,Brutcher E,Kauh J,Hawk N,Kim S,Chen Z,Kooby DA,Maithel SK,Landry J,El-Rayes BF.Modified FOLFIRINOXregimen with improved safety and maintained efficacy in pancreatic adenocarcinoma.Pancreas 2013;42:1311-1315[PMID:24152956DOI:10.1097/MPA.0b013e31829e2006]
14 Blazer M,Wu C,Goldberg RM,Phillips G,Schmidt C,Muscarella P,Wuthrick E,Williams TM,Reardon J,Ellison EC,Bloomston M,Bekaii-Saab T.Neoadjuvant modified(m)FOLFIRINOX for locally advanced unresectable(LAPC)and borderline resectable(BRPC)adenocarcinoma of the pancreas.Ann Surg Oncol 2015;22:1153-1159[PMID:25358667 DOI:10.1245/s10434-014-4225-1]
15 Ghorani E,Wong HH,Hewitt C,Calder J,Corrie P,Basu B.Safety and Efficacy of Modified FOLFIRINOX for Advanced Pancreatic Adenocarcinoma:A UK Single-Centre Experience.Oncology 2015;89:281-287[PMID:26372905 DOI:10.1159/000439171]
16 Nanda RH,El-Rayes B,Maithel SK,Landry J.Neoadjuvant modified FOLFIRINOX and chemoradiation therapy for locally advanced pancreatic cancer improves resectability.J Surg Oncol2015;111:1028-1034[PMID:26073887 DOI:10.1002/jso.23921]
17 Stein SM,James ES,Deng Y,Cong X,Kortmansky JS,Li J,Staugaard C,Indukala D,Boustani AM,Patel V,Cha CH,Salem RR,Chang B,Hochster HS,Lacy J.Final analysis of a phase IIstudy of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.Br J Cancer 2016;114:737-743[PMID:27022826 DOI:10.1038/bjc.2016.45]
18 Eisenhauer EA,Therasse P,Bogaerts J,Schwartz LH,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 RECISTguideline(version 1.1).Eur J Cancer 2009;45:228-247[PMID:19097774 DOI:10.1016/j.ejca.2008.10.026]
19 National Cancer Institute.Common Terminology Criteria for Adverse Events(CTCAE).v4.03.ed:U.S.Department of Health and Human Services,National Institutes of Health,National Cancer Institute.2010;Available from:https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/
20 Le N,Vinci A,Schober M,Krug S,Javed MA,Kohlmann T,Sund M,Neesse A,Beyer G.Real-World Clinical Practice of Intensified Chemotherapies for Metastatic Pancreatic Cancer:Results from a Pan-European Questionnaire Study.Digestion 2016;94:222-229[PMID:28030863 DOI:10.1159/000453257]
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