27
274 頭頸癌抗癌藥物治療指引 Squamous Cell Cancers Lip, Oral Cavity, Oropharynx, Hypopharynx, Glottic Larynx, Supraglottic Larynx, Ethmoid Sinus, Maxillary Sinus, Occult Primary Primary systemic therapy + concurrent radiotherapy High-dose cisplatin (preferred) (category 1) 藥品名 劑量 /m 2 給藥日 頻率 參考文獻 Cisplatin 75~100 1 Q3W 1,2 Cetuximab (category 1) 藥品名 劑量 /m 2 給藥日 頻率 參考文獻 Cetuximab 400 1 QW 3 Followed by Cetuximab 250 1 QW Carboplatin/infusional 5-FU (category 1) 藥品名 劑量 /m 2 給藥日 頻率 參考文獻 Carboplatin 70 1~4 Q3W 4 Fluorouracil 600 1~4 Q3W 藥品名 劑量 /m 2 給藥日 頻率 參考文獻 Carboplatin 70 1~5 Q4W 5 Fluorouracil 600 1~5 Q4W

頭頸癌抗癌藥物治療指引 - tmuh.org.tw 頸癌... · Lip, Oral Cavity, Oropharynx, Hypopharynx, Glottic Larynx, Supraglottic Larynx, Ethmoid Sinus, Maxillary Sinus, ... high-risk

  • Upload
    tranthu

  • View
    241

  • Download
    0

Embed Size (px)

Citation preview

癌症診療指引

274

︽頭頸癌抗癌藥物治療指引︾

《 頭頸癌抗癌藥物治療指引 》

Squamous Cell CancersLip, Oral Cavity, Oropharynx, Hypopharynx, Glottic Larynx, Supraglottic Larynx, Ethmoid Sinus, Maxillary Sinus, Occult PrimaryPrimarysystemictherapy+concurrentradiotherapyHigh-dose cisplatin (preferred) (category 1)

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 75~100 1 Q3W 1,2

Cetuximab (category 1)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cetuximab 400 1 QW 3Followedby

Cetuximab 250 1 QW

Carboplatin/infusional 5-FU (category 1)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 70 1~4 Q3W 4Fluorouracil 600 1~4 Q3W

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 70 1~5 Q4W 5Fluorouracil 600 1~5 Q4W

癌症診療指引

275

︽頭頸癌抗癌藥物治療指引︾

5-FU/Hydroxyurea藥品名 劑量 /m2 給藥日 頻率 參考文獻

Hydroxyurea 1g PO BID 11 doses Q2W 6Fluorouracil 800 1~5 Q2W

Cisplatin/Paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Paclitaxel 30 1 QW 6Cisplatin 20 2 QW

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Paclitaxel 175 1 Q3W 8Cisplatin 75 1 Q3W

Cisplatin/infusional 5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3W 7Fluorouracil 800-1000 1~5 Q3W

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60 1 Q2W 7Fluorouracil 800 1~5 Q2W

癌症診療指引

276

︽頭頸癌抗癌藥物治療指引︾

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20 1~4 Q4W 19Fluorouracil 1000 1~4 Q4W

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3W 18Fluorouracil 600-1000 1~4 Q3W

Carboplatin/paclitaxel (category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 100 1 QW 8Paclitaxel 40-45 1 QW

Weekly cisplatin (category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20-40 1 QW 9

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 40 1 QW 10

癌症診療指引

277

︽頭頸癌抗癌藥物治療指引︾

Carboplatin daily藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 25 1~5 QW 16

Definitive CCRT + Cetuximab藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1, 22, 43 Q3W 17Cetuximab 400 1 QW

FollowedbyCetuximab 250 1 QW

Cisplatin/Tegafur/Leucovorin藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 50 1 Q2W 31UFUR 800 mg PO 1-14 Q2WLeucovorin 60 mg PO 1-14 Q2W

PostoperativeChemoradiationCisplatin(category 1 for high risk)

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 75-100 1, 22, 43 Q3W 11,12, 13,15

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 400 1 QW 20

癌症診療指引

278

︽頭頸癌抗癌藥物治療指引︾

(RTOG0234 compare to Intergroup 9501)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cetuximab 400 for once at 5-9 days QW 20Followedby

Cetuximab 250 1 QWCisplatin 30 1 QW

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cetuximab 400 for once at 5-9 days QW 20Followedby

Cetuximab 250 1 QWDocetaxel 15 1 QW

Cisplatin/infusional 5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20 1~5, 29~33 Q4W 21Fluorouracil 600 1~5, 29~33 Q4W

癌症診療指引

279

︽頭頸癌抗癌藥物治療指引︾

Lip, Oral Cavity, Oropharynx, Hypopharynx, Glottic Larynx, Supraglottic Larynx, Ethmoid Sinus, Maxillary Sinus, Occult PrimaryInduction/Sequential chemotherapyDocetaxel/cisplatin/5-FU (category 1 if induction is chosen)

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 60-75 1 Q3W 22,24Cisplatin 60-75 1 Q3WFluorouracil 600-750 1~5 Q3W

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 60-75 1 Q3W 23Cisplatin 60-100 1 Q3WFluorouracil 750-1000 1~4 Q3W

Paclitaxel/cisplatin/infusional 5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Paclitaxel 175 1 Q3W 25Cisplatin 100 2 Q3WFluorouracil 500 2~6 Q3W

Cisplatin + 5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 80-100 1 Q3W 26Fluorouracil 800-1000 /day 3~5 Q3W

癌症診療指引

280

︽頭頸癌抗癌藥物治療指引︾

Following induction, agents to be used with concurrent chemoradiation typically include weekly carboplatin or cetuximab藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 100 1, 8, 15, 22, 29, 36 QW 27

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 1.5AUC 1 QW 28

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cetuximab 400 1 QW 29Followedby

Cetuximab 250 1 QW

Cisplatin/Tegafur/Leucovorin藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 50 1 Q2W 30UFUR 800 mg PO 1-14 Q2WLeucovorin 60 mg PO 1-14 Q2W

參考文獻

1.ForastiereAA,ZhangQ,WeberRS,etal.Long-termresultsofradiotherapyOG91-11:acomparisonofthreenonsurgicaltreatmentstrategiestopreservethelarynxinpatientswithlocallyadvancedlarynxcancer.JClinOncol2013;31:845-852.

2.AdelsteinDJ,LiY,AdamsGL,etal.AnintergroupphaseIIIcomparisonofstandardradiationtherapyandtwoschedules

癌症診療指引

281

︽頭頸癌抗癌藥物治療指引︾

ofconcurrentchemoradiotherapy inpatientswithunresectablesquamouscellheadandneckcancer. JClinOncol2003;21(1):92-98.

3.BonnerJA,HarariPM,GiraltJ,etal.Radiotherapypluscetuximabforlocoregionallyadvancedheadandneckcancer:5-yearsurvivaldatafromaphase3randomisedtrial,andrelationbetweencetuximab-inducedrashandsurvival.LancetOncol 2010;11:21-28.

4.DenisF,GaraudP,BardetE,etal.Finalresultsofthe94-01FrenchHeadandNeckOncologyandRadiotherapyGrouprandomized trialcomparing radiotherapyalonewithconcomitant radiochemotherapy inadvanced-stageoropharynxcarcinoma. J Clin Oncol 2004;22:69-76.

5.BourhisJ,SireC,GraffP,etal.Concomitantchemoradiotherapyversusaccelerationofradiotherapywithorwithoutconcomitantchemotherapy in locallyadvancedheadandneckcarcinoma(GORTEC99-02):anopen-labelphase3randomised trial. Lancet Oncol 2012;13:145-153.

6.GardenAS,HarrisJ,VokesEE,etal.PreliminaryresultsofRadiationTherapyOncologyGroup97-03:ArandomizedphaseIItrialofconcurrentradiationandchemotherapyforadvancedsquamouscellcarcinomasoftheheadandneck.JClin Oncol 2004;22:2856-2864.

7.TaylorS,MurthyA,VannetzelJ,etal.Randomizedcomparisonofneoadjuvantcisplatinandfluorouracil infusionfollowedbyradiationversusconcomitanttreatmentinadvancedheadandneckcancer.JClinOncol1994;12:385-395.

8.SuntharalingamM,HaasML,ConleyBA,etal.Theuseofcarboplatinandpaclitaxelwithdailyradiotherapyinpatientswithlocallyadvancedsquamouscellcarcinomasoftheheadandneck.IntJRadiatOncolBiolPhys2000;47:49-56.

9.BeckmannGK,HoppeF,PfreundnerL,etal.Hyperfractionatedacceleratedradiotherapyincombinationwithweeklycisplatinforlocallyadvancedheadandneckcancer.HeadNeck2005;27:36-43.

10.MedinaJA,RuedaA,dePasosAS,etal.AphaseIIstudyofconcomitantboostradiationplusconcurrentweeklycisplatinforlocallyadvancedunresectableheadandneckcarcinomas.RadiotherOncol2006;79:34-38

11.CooperJS,PajakTF,ForastiereAA,etal.Postoperativeconcurrent radiotherapyandchemotherapyforhigh-risksquamous-cellcarcinomaoftheheadandneck.NEnglJMed2004;350:1937-1944

12.BernierJ,DomengeC,OzsahinM,etal.Postoperativeirradiationwithorwithoutconcomitantchemotherapyforlocallyadvancedheadandneckcancer.NEnglJMed2004;350:1945-1952

癌症診療指引

282

︽頭頸癌抗癌藥物治療指引︾

13.BernierJ,CooperJS,PajakTF,etal.Definingrisklevels inlocallyadvancedheadandneckcancers:AcomparativeanalysisofconcurrentpostoperativeradiationpluschemotherapytrialsoftheEORTC(#22931)andradiotherapyOG(#9501). Head Neck 2005;27:843-850.

14.BachaudJM,Cohen-JonathanE,AlzieuC,etal.Combinedpostoperativeradiotherapyandweeklycisplatininfusionforlocallyadvancedheadandneckcarcinoma:finalreportofarandomizedtrial.IntJRadiatOncolBiolPhys1996Dec1;36:999-1004.

15.CooperJS,ZhangQ,PajakTF,etal.Long-termfollow-upof the radiotherapyOG9501/intergroupphase III trial:postoperativeconcurrentradiationtherapyandchemotherapyinhigh-risksquamouscellcarcinomaoftheheadandneck.IntJRadiatOncolBiolPhys2012;84:1198-1205.

16.JeremicB,MilicicB,DagovicA,etal.RadiationTherapyWithorWithoutConcurrentLow-DoseDailyChemotherapyinLocallyAdvanced,NonmetastaticSquamousCellCarcinomaoftheHeadandNeck.JClinOncol,2004,22:3540-3548

17.RTOG0522:arandomizedphaseIIItrialofconcurrentacceleratedradiationandcisplatinversusconcurrentacceleratedradiation,cisplatin,andcetuximab[followedbysurgeryforselectedpatients] forStageIIIandIVheadandneckcarcinomas. Clin Adv Hematol Oncol 2007;5: 79-81

18.GibsonMK,LiY,MurphyB,etal.RandomizedphaseIIIevaluationofcisplatinplusfluorouracilversuscisplatinpluspaclitaxelinadvancedheadandneckcancer(E1395):anintergrouptrialoftheEasternCooperativeOncologyGroup.JClin Oncol 2005;23:3562-3567

19.SooKC,TanEH,WeeJ,etal.Surgeryandadjuvant radiotherapyvsconcurrentchemoradiotherapy instageIII/IVnonmetastaticsquamouscellheadandneckcancer:arandomisedcomparison.BrJCancer.2005;93:279-286

20.HarariPM,HarrisJ,KiesMS,etal.Postoperativechemoradiotherapyandcetuximabforhigh-risksquamouscellcarcinomaoftheheadandneck:RadiationTherapyOncologyGroupradiotherapyOG-0234.JClinOncol.2014;32:2486-2495

21.FietkauR,LautenschlägerC,SauerR ,etal.Postoperativeconcurrent radio-chemotherapyversusradiotherapy in

癌症診療指引

283

︽頭頸癌抗癌藥物治療指引︾

high-riskSCCAof theheadandneck:Resultsof theGermanphaseIII trialARO96–32006ASCOAnnualMeetingProceedings(Post-MeetingEdition)24,(18S)2006:5507

22.VermorkenJB,RemenarE,vanHerpenC,etal;EORTC24971/TAX323StudyGroup.Cisplatin,fluorouracil,anddocetaxelinunresectableheadandneckcancer.NEnglJMed2007;357(17):1695-1704.

23.PosnerMR,HershockDM,BlajmanCR,etal.Cisplatinandfluorouracilaloneorwithdocetaxel inheadandneckcancer.NEnglJMed2007;357(17):1705-1715

24.PointreauY,GaraudP,ChapetS,etal.Randomizedtrialofinductionchemotherapywithcisplatinand5-fluorouracilwithorwithoutdocetaxelforlarynxpreservation.JNatlCancerInst2009;101:498-506

25.HittR,López-PousaA,Martínez-TruferoJ,etal.PhaseIIIstudycomparingcisplatinplusfluorouracil topaclitaxel,cisplatin,andfluorouracilinductionchemotherapyfollowedbychemoradiotherapyinlocallyadvancedheadandneckcancer. J Clin Oncol 2005;23:8636-8645.

26.PaccagnellaA,OrlandoA,MarchioriC,etal.PhaseIIItrialofinitialchemotherapyinstageIIIorIVheadandneckcancers:astudybytheGruppodiStudiosuiTumoridellaTestaedelCollo.JNatlCancerInst.1994;86:265-272

27.ChitapanaruxI,LorvidhayaV,KamnerdsupaphonP,etal.Chemoradiationcomparingcisplatinversuscarboplatininlocallyadvancednasopharyngealcancer:Randomised,non-inferiority,opentrial.EurJCancer2007;43:1399-1406

28.HaddadR,O'NeillA,RabinowitsG,etal.Inductionchemotherapyfollowedbyconcurrentchemoradiotherapy(sequentialchemoradiotherapy)versusconcurrentchemoradiotherapyaloneinlocallyadvancedheadandneckcancer(PARADIGM):arandomisedphase3trial.LancetOncol.2013;14:257-4264

29.Lefebvre JL,PointreauY,RollandF, et al. Inductionchemotherapy followedbyeither chemoradiotherapyorbioradiotherapyforlarynxpreservation:theTREMPLINrandomizedphaseIIstudy.JClinOncol2013;31:853-859.

30.Hung-MingWang,Cheng-SuWang,Jen-ShiChen,etal.Cisplatin,tegafur,andleucovorin:Amoderatelyeffectiveandminimallytoxicoutpatientneoadjuvantchemotherapyforlocallyadvancedsquamouscellcarcinomaoftheheadandneck. Cancer 2002; 94 (11): 2982-2995

癌症診療指引

284

︽頭頸癌抗癌藥物治療指引︾

Recurrent, Unresectable, or Metastatic (incurable)Combination therapy

Cisplatin/5-FU/cetuximab (category 1)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3Wmax6cycles 1Fluorouracil 600-1000 1-4 Q3WCetuximab 400 1 QW

FollowedbyCetuximab 250 1 QW

Carboplatin/5-FU/cetuximab (category 1)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 5AUC 1 Q3Wmax6cycles 1Fluorouracil 600-1000 1-4 Q3WCetuximab 400 1 QW

FollowedbyCetuximab 250 1 QW

Carboplatin/Docetaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 65 1 Q3W 2Carboplatin 6AUC 1 Q3W

癌症診療指引

285

︽頭頸癌抗癌藥物治療指引︾

Cisplatin/paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 75 1 Q3W 3Paclitaxel 175 1 Q3W

Carboplatin/Paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 6AUC 1 Q3W 3Paclitaxel 175 1 Q3W

Cisplatin/Cetuximab藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 100 1 Q4W 4Cetuximab 200 1 QW

FollowedbyCetuximab 125 1 QW

Cisplatin/5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3W 3,5Fluorouracil 600-1000 1-4 Q3W

癌症診療指引

286

︽頭頸癌抗癌藥物治療指引︾

Cisplatin/Docetaxel/Cetuximab藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 75 1 Q3W4cycles 6Cisplatin 75 1 Q3WCetuximab 400 1 QW

FollowedbyCetuximab 250 1 QW

FollowedbyCetuximab 500 1 Q2W

Single agents藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cispaltin 100 1 Q3~4W 7, 8

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Paclitaxel 80 1 QW 9

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 100 1 Q3W 10

藥品名 劑量 /m2 給藥日 頻率 參考文獻

5-FU 1000 1 Q3W 8

癌症診療指引

287

︽頭頸癌抗癌藥物治療指引︾

藥品名 劑量 /m2 給藥日 頻率 參考文獻

MTX 40 1 QW 11, 12

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cetuximab 400 QW 13

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Capecitabine 1250 PO BID 1~14 Q3W2cycle+ 14

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Vinorelbine 30 QW 15, 16

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Afatinib 40 mg PO QDAC 17

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Pembrolizumab 2~10 mg/kg Q2W24month 18

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Pembrolizumab 200 mg Q3W24month 19

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Nivolumab 3 mg/kg Q2W 20

癌症診療指引

288

︽頭頸癌抗癌藥物治療指引︾

參考文獻

1.VermorkenJB,MesiaR,RiveraF,etal.Platinum-basedchemotherapypluscetuximabinheadandneckcancer.NEnglJMed 2008;359:1116-1127.

2.SamlowskiWE,MoonJ,KueblerJP,etal.Evaluationof thecombinationofdocetaxel/carboplatin inpatientswithmetastaticorrecurrentsquamouscellcarcinomaoftheheadandneck(SCCHN):aSouthwestOncologyGroupPhaseIIstudy. Cancer Invest 2007;25:182-188.

3.GibsonMK,LiY,MurphyB,etal.RandomizedphaseIIIevaluationofcisplatinplusfluorouracilversuscisplatinpluspaclitaxelinadvancedheadandneckcancer(E1395):AnIntergroupTrialoftheEasternCooperativeOncologyGroup.JClin Oncol 2005;23:3562-3567.

4.BurtnessB,GoldwasserMA,FloodW,etal.PhaseIIIrandomizedtrialofcisplatinplusplaceboversuscisplatinpluscetuximabinmetastatic/recurrentheadandneckcancer:AnEasternCooperativeOncologyGroupStudy.JClinOncol2005;23:8646-8654.

5.ForastiereAA,MetchB,SchullerDE,etal.Randomizedcomparisonofcisplatinplusflurouracilandcarboplatinplusfluorouracilversusmethotrexate inadvancedsquamouscellcarcinomaof theheadandneck:ASouthwestOncologyGroup Study. J Clin Oncol 1992;10:1245-1251.

6.GuigayJ,FayetteJ,DilliesA-F,etal.Cetuximab,docetaxel,andcisplatin(TPEx)asfirst-linetreatmentinpatientswithrecurrentormetastatic(R/M)squamouscellcarcinomaoftheheadandneck(SCCHN):FinalresultsofphaseII trialGORTEC2008-03[abstract].JClinOncol2012;30(Suppl15):Abstract5505.

7.BurtheseB,GoldwasserMA,FloodW,etal.PhaseIIIRandomizedTrialofCisplatinPlusPlaceboComparedWithCisplatinPlusCetuximab inMetastatic/RecurrentHeadandNeckCancer:AnEasternCooperativeOncologyGroupStudy. J Clin Oncol 2005;23:8646-8654.

8.JacobsC,LymanG,Velez-GarciaE,etal.AphaseIIIrandomizedstudycomparingcisplatinandfluorouracilassingleagentsandincombinationforadvancedsquamouscellcarcinomaoftheheadandneck.JClinOncol1992;10:257-263.

9.GrauJJ,CaballeroM,VergerE,etal.Weeklypaclitaxelforplatin-resistantstageIVheadandneckcancerpatients.Acta

癌症診療指引

289

︽頭頸癌抗癌藥物治療指引︾

OtoLaryngol 2009;129:1294-1299. 10.Catimel1G,VerweijJ, MattijssenV,etal.Docetaxel(Taxotere):Anactivedrugfor the treatmentofpatientswith

advancedsquamouscellcarcinomaoftheheadandneck.AnnOncol1994;5:533-537.11.StewartJS,CohenEE,LicitraL,etal.PhaseIIIstudyofgefitinibcomparedwithintravenousmethotrexateforrecurrent

squamouscellcarcinomaoftheheadandneck[corrected].JClinOncol2009;27:1864-187112.ForastiereAA,MetchB,SchullerDE,etal.Randomizedcomparisonofcisplatinplusfluorouracilandcarboplatinplus

fluorouracilversusmethotrexateinadvancedsquamous-cellcarcinomaof theheadandneck:aSouthwestOncologyGroup study. J Clin Oncol. 1992 Aug;10(8):1245-51.

13.VermorkenJB,TrigoJ,HittR,etal.Open-label,uncontrolled,multicenterphaseIIstudytoevaluatetheefficacyandtoxicityofcetuximabasasingleagentinpatientswithrecurrentand/ormetastaticsquamouscellcarcinomaoftheheadandneckwhofailedtorespondtoplatinum-basedtherapy.JClinOncol.2007Jun1;25(16):2171-7.

14.Martinez-TruferoJ, IslaD,AdansaJC,etal.PhaseIIstudyofcapecitabineaspalliativetreatmentforpatientswithrecurrent andmetastatic squamousheadandneckcancer afterpreviousplatinum-based treatment.Br JCancer2010;102:1687-1691.

15.DegardinM,OliveiraJ,GeoffroisL,AnEORTC-ECSGphaseIIstudyofvinorelbineinpatientswithrecurrentand/ormetastaticsquamouscellcarcinomaoftheheadandneck.AnnOncol1998;9:1103-1107.

16.SaxmanS,MannB,CanfieldV,etal.APhaseIITrialofVinorelbineinPatientsWithRecurrentorMetastaticSquamousCellCarcinomaoftheHeadandNeck.AmJClinOncol1998;21:398-400.

17.MachielsJP,HaddadRI,FayetteJ,etal.Afatinibversusmethotrexateassecond-linetreatmentinpatientswithrecurrentormetastaticsquamous-cellcarcinomaoftheheadandneckprogressingonorafterplatinum-basedtherapy(LUX-Head&Neck1):anopen-label,randomisedphase3trial.LancetOncol2015;16:583-594.

18.SeiwentTY,BurtnessB,MehraR,etal.Safetyandclinicalactivityofpembrolizumabfor treatmentofrecurrentormetastaticsquamouscellcarcinomaoftheheadandneck(KEYNOTE-012):anopen-label,multicentre,phase1btrial.Lancet 2016;17:956-965.

19.ChowLQ,HaddadR,GuptaS,etal.AntitumorActivityofPembrolizumabinBiomarker-UnselectedPatientsWithRecurrentand/orMetastaticHeadandNeckSquamousCellCarcinoma:ResultsFromthePhaseIbKEYNOTE-012

癌症診療指引

290

︽頭頸癌抗癌藥物治療指引︾

ExpansionCohort.JClinOncol2016.20.FerrisR,BlumenscheinG,FayetteJ,etal.furtherevaluationsofnivolumabversusinvestigator'schoicechemotherapy

forrecurrentormetastatic(R/M)squamouscellcarcinomaoftheheadandneck:CheckMate-141.OralpresentationatTheAmericanSocietyofClinicalOncology(ASCO)2016AnnualMeeting;June3-7,2016;Chicago,Illinois.

癌症診療指引

291

︽頭頸癌抗癌藥物治療指引︾

NasopharynxChemoradiation followed by adjuvant chemotherapy

Cisplatin + RT followed by cisplatin/5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1, 22, 43 1Followedby

Cisplatin 60-100 1 Q4W5-FU 600-1000 1-4 Q4W

Carboplatin/5-FU (Category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 6AUC 1 Q3W 2Followedby

Carboplatin 5AUC 1 Q3W5-FU 1000 1-4 Q3W

Cisplatin + RT without chemotherapy (Category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20-40 1 QW 3

癌症診療指引

292

︽頭頸癌抗癌藥物治療指引︾

Cisplatin/Tegafur/Leucovorin + RT藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 50 1 Q2W 13UFUR 800 mg PO 1-14 Q2WLeucovorin 60 mg PO 1-14 Q2W

Induction (Category 3)/Sequential chemotherapyDocetaxel/Cisplatin/5-FU

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 60-70 1 Q3W 4Cisplatin 60-75 1 Q3W5-FU 750-1000 1-4 Q3W

FollowedbyCisplatin 100 1 Q3W

Docetaxel/cisplatin (category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 60-75 1 Q3W 5Cisplatin 60-75 1 Q3W

FollowedbyCisplatin 40 1 QW

癌症診療指引

293

︽頭頸癌抗癌藥物治療指引︾

Cisplatin/5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3W 65-FU 600-1000 1-4 Q3W

Cisplatin/Epirubicin/Paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Epirubicin 75 1 Q3W 7Paclitaxel 175 1 Q3WCisplatin 60-75 2 Q3W

FollowedbyPaclitaxel 60 1 QW

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 40 1 QW 8

Cisplatin/Epirubicin/Mitomycin藥品名 劑量 /m2 給藥日 頻率 參考文獻

Epirubicin 60-75 1 Q4W 9Mitomycin 10 1 Q4WCisplatin 60-100 1 Q4W

FollowedbyPaclitaxel 60 1 QW

癌症診療指引

294

︽頭頸癌抗癌藥物治療指引︾

Adjuvant CT (post RT or CCRT completion on day 29) (category 2B)藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 80 1 Q4W 105-FU 800 1-4 Q4W± Leucovorin 1-4 Q4W

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20 1-45-FU 800 1-4± Leucovorin 1-4

Following induction, agents to be used with concurrent chemoradiation typically include weekly cisplatin or carboplatin藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 40 1 QW 11

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 100 1, 8, 15, 22, 29, 36 12

參考文獻

1.Al-SarrafM,LeBlancM,GiriPG,FuKK,etal.Chemoradiotherapyversusradiotherapy inpatientswithadvancednasopharyngealcancer:phaseIIIrandomizedIntergroupstudy0099.JClinOncol.1998;16:1310-1317.

2.DechaphunkulT,PruegsanusakK,SangthawanD,etal.Concurrentchemoradiotherapywithcarboplatinfollowedby

癌症診療指引

295

︽頭頸癌抗癌藥物治療指引︾

carboplatinand5-fluorouracilinlocallyadvancednasopharyngealcarcinoma.HeadNeckOncol.2011;3:30.3.ChenL,HuCS,ChenXZ, et al.Concurrent chemoradiotherapyplus adjuvant chemotherapyversusconcurrentchemoradiotherapyalone inpatientswith locoregionallyadvancednasopharyngealcarcinoma:aphase3multicentrerandomised controlled trial. Lancet Oncol. 2012;13:163-171

4.BaeWK,HwangJE,ShimHJ,etal.PhaseIIstudyofdocetaxel,cisplatin,and5-FUinductionchemotherapyfollowedbychemoradiotherapyinlocoregionallyadvancednasopharyngealcancer.CancerChemotherPharmacol.2010;65:589-595.

5.HuiEP,MaBB,LeungSF,etal,Randomizedphase II trialofconcurrentcisplatin-radiotherapywithorwithoutneoadjuvantdocetaxelandcisplatininadvancednasopharyngealcarcinoma.JClinOncol.2009;27:242-249

6.PosnerMR,HershockDM,BlajmanCR,etal.Cisplatinandfluorouracilaloneorwithdocetaxelinheadandneckcancer.NEnglJMed2007;357(17):1705-1715.

7.FountzilasG,TolisC,Kalogera-FountzilaA,etal.Inductionchemotherapywithcisplatin,epirubicin,andpaclitaxel(CEP),followedbyconcomitantradiotherapyandweeklypaclitaxelfor themanagementof locallyadvancednasopharyngealcarcinoma

8.AHellenicCooperativeOncologyGroupphaseIIstudy.StrahlentherOnkol.2005;181:223-2309.HongRL,TingLL,KoJY,etal. Inductionchemotherapywithmitomycin,epirubicin,cisplatin, fluorouracil, andleucovorinfollowedbyradiotherapyinthetreatmentoflocoregionallyadvancednasopharyngealcarcinoma.JClinOncol.2001;19:4305-4313.

10.ChenL,HuCS,ChenXZ,et al.Concurrentchemoradiotherapyplusadjuvantchemotherapyversusconcurrentchemoradiotherapyaloneinpatientswith locoregionallyadvancednasopharyngealcarcinoma:aphase3multicentrerandomisedcontrolledtrial.LancetOncol2012;13:163–171

11.ChanAT,LeungSF,NganRK,etal.Overallsurvivalafterconcurrentcisplatin-radiotherapycomparedwithradiotherapyaloneinlocoregionallyadvancednasopharyngealcarcinoma.JNatlCancerInst.2005Apr6;97(7):536-539

12.ChitapanaruxI,LorvidhayaV,KamnerdsupaphonP,Chemoradiationcomparingcisplatinversuscarboplatininlocallyadvancednasopharyngealcancer:randomised,non-inferiority,opentrial.EurJCancer.2007;43:1399-1406

13.Concurrentchemoradiotherapyusingbiweeklycisplatin/tegafurplusuracil/leucovorin instage IIInasopharyngealcarcinoma. J Clin Oncol. 2005 23(16): 5510

癌症診療指引

296

︽頭頸癌抗癌藥物治療指引︾

Recurrent, Unresectable, or Metastatic (incurable)Combination therapy

Carboplatin/Docetaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 65 1 Q3W 1Carboplatin 6AUC 1 Q3W

Cisplatin/Paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 75 1 Q3W 2Paclitaxel 175 1 Q3W

Carboplatin/Paclitaxel藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 6AUC 1 Q3W 2Paclitaxel 175 1 Q3W

Cisplatin/5-FU藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 60-100 1 Q3W 2,3Fluorouracil 600-1000 1-4 Q3W

癌症診療指引

297

︽頭頸癌抗癌藥物治療指引︾

Carboplatin/Cetuximab藥品名 劑量 /m2 給藥日 頻率 參考文獻

Carboplatin 5AUC 1 Q3W 4Cetuximab 400 1 QW

FollowedbyCetuximab 250 1 QW

Cisplatin/Gemcitabine藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cisplatin 20-30 1-3 Q3W 5Gemcitabine 1000 1,8 Q3W

Single agents藥品名 劑量 /m2 給藥日 頻率 參考文獻

Cispaltin 100 Q3~4W 6,7

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Paclitaxel 80 QW 8

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Docetaxel 100 Q3W 9

藥品名 劑量 /m2 給藥日 頻率 參考文獻

5-FU 1000 Q3W 7

癌症診療指引

298

︽頭頸癌抗癌藥物治療指引︾

藥品名 劑量 /m2 給藥日 頻率 參考文獻

MTX 40 QW 10, 11

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Gemcitabine 1000 1, 8, 15 Q4W 12

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Capecitabine 1250 PO 1~14 Q3W 13

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Pembrolizumab 2~10 mg/kg Q2W 14

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Pembrolizumab 200 mg Q3W 15

藥品名 劑量 /m2 給藥日 頻率 參考文獻

Nivolumab 3 mg/kg 1 Q2W 16

參考文獻

1.SamlowskiWE,MoonJ,KueblerJP,etal.Evaluationof thecombinationofdocetaxel/carboplatin inpatientswithmetastaticorrecurrentsquamouscellcarcinomaoftheheadandneck(SCCHN):aSouthwestOncologyGroupPhaseIIstudy. Cancer Invest 2007;25:182-188.

癌症診療指引

299

︽頭頸癌抗癌藥物治療指引︾

2.GibsonMK,LiY,MurphyB,etal.RandomizedphaseIIIevaluationofcisplatinplusfluorouracilversuscisplatinpluspaclitaxelinadvancedheadandneckcancer(E1395):AnIntergroupTrialoftheEasternCooperativeOncologyGroup.JClin Oncol 2005;23:3562-3567.

3.ForastiereAA,MetchB,SchullerDE,etal.Randomizedcomparisonofcisplatinplusflurouracilandcarboplatinplusfluorouracilversusmethotrexate inadvancedsquamouscellcarcinomaof theheadandneck:ASouthwestOncologyGroup Study. J Clin Oncol 1992;10:1245-1251.

4.ChanAT,HsuMM,GohBC,etal.Multicenter,phaseIIstudyofcetuximabincombinationwithcarboplatininpatientswithrecurrentormetastaticnasopharyngealcarcinoma.JClinOncol2005;23:3568-3576.

5.JinY,CaiXY,ShiYX,etal.Comparisonoffivecisplatin-basedregimensfrequentlyusedasthefirst-lineprotocolsinmetastaticnasopharyngealcarcinoma.JCancerResClinOncol2012Oct;138(10):1717-25.

6.BurtheseB,GoldwasserMA,FloodW,etal.PhaseIIIRandomizedTrialofCisplatinPlusPlaceboComparedWithCisplatinPlusCetuximab inMetastatic/RecurrentHeadandNeckCancer:AnEasternCooperativeOncologyGroupStudy. J Clin Oncol 2005;23:8646-8654.

7.JacobsC,LymanG,Velez-GarciaE,etal.AphaseIIIrandomizedstudycomparingcisplatinandfluorouracilassingleagentsandincombinationforadvancedsquamouscellcarcinomaoftheheadandneck.JClinOncol1992;10:257-263.

8.GrauJJ,CaballeroM,VergerE,etal.Weeklypaclitaxelforplatin-resistantstageIVheadandneckcancerpatients.ActaOtoLaryngol 2009;129:1294-1299.

9.Catimel1G,VerweijJ, MattijssenV,etal.Docetaxel (Taxotere):Anactivedrugfor the treatmentofpatientswithadvancedsquamouscellcarcinomaoftheheadandneck.AnnOncol1994;5:533-537.

10.StewartJS,CohenEE,LicitraL,etal.PhaseIIIstudyofgefitinibcomparedwithintravenousmethotrexateforrecurrentsquamouscellcarcinomaoftheheadandneck[corrected].JClinOncol2009;27:1864-1871

11.ForastiereAA,MetchB,SchullerDE,etal.Randomizedcomparisonofcisplatinplusfluorouracilandcarboplatinplusfluorouracilversusmethotrexateinadvancedsquamous-cellcarcinomaof theheadandneck:aSouthwestOncologyGroup study. J Clin Oncol. 1992 Aug;10(8):1245-51.

12.ZhangL,ZhangY,HuangPY,etal.PhaseIIclinicalstudyofgemcitabineinthetreatmentofpatientswithadvancednasopharyngealcarcinomaafterthefailureofplatinum-basedchemotherapy.CancerChemotherPharmacol.2008;61:33-

癌症診療指引

300

︽頭頸癌抗癌藥物治療指引︾

8.Epub2007Mar20.13.Martinez-TruferoJ, IslaD,AdansaJC,etal.PhaseIIstudyofcapecitabineaspalliativetreatmentforpatientswith

recurrent andmetastatic squamousheadandneckcancer afterpreviousplatinum-based treatment.Br JCancer2010;102:1687-1691.

14.SeiwentTY,BurtnessB,MehraR,etal.Safetyandclinicalactivityofpembrolizumabfor treatmentofrecurrentormetastaticsquamouscellcarcinomaoftheheadandneck(KEYNOTE-012):anopen-label,multicentre,phase1btrial.Lancet 2016;17:956-965.

15.ChowLQ,HaddadR,GuptaS,etal.AntitumorActivityofPembrolizumabinBiomarker-UnselectedPatientsWithRecurrentand/orMetastaticHeadandNeckSquamousCellCarcinoma:ResultsFromthePhaseIbKEYNOTE-012ExpansionCohort.JClinOncol2016.

16.FerrisR,BlumenscheinG,FayetteJ,etal.furtherevaluationsofnivolumabversusinvestigator'schoicechemotherapyforrecurrentormetastatic(R/M)squamouscellcarcinomaoftheheadandneck:CheckMate-141.OralpresentationatTheAmericanSocietyofClinicalOncology(ASCO)2016AnnualMeeting;June3-7,2016;Chicago,Illinois.