Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations

References

• JemalABrayFCenterMMFerlayJWardEFormanDGlobal cancer statisticsCA Cancer J Clin2011612699021296855
   PubMed Web of Science ®Google Scholar
• PerouCMSørlieTEisenMBMolecular portraits of human breast tumoursNature2000406679774775210963602
   PubMed Web of Science ®Google Scholar
• SlamonDJClarkGMWongSGLevinWJUllrichAMcGuireWLHuman breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogeneScience198723547851771823798106
   PubMed Web of Science ®Google Scholar
• SlamonDJGodolphinWJonesLAStudies of the HER-2/neu proto-oncogene in human breast and ovarian cancerScience198924449057077122470152
   PubMed Web of Science ®Google Scholar
• WolffACHammondMESchwartzJNAmerican Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancerArch Pathol Lab Med20071311184319548375
   PubMed Web of Science ®Google Scholar
• RossJSSlodkowskaEASymmansWFPusztaiLRavdinPMHortobagyiGNThe HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicineOncologist200914432036819346299
   PubMed Web of Science ®Google Scholar
• HudisCATrastuzumab – mechanism of action and use in clinical practiceN Engl J Med20073571395117611206
   PubMed Web of Science ®Google Scholar
• SlamonDJLeyland-JonesBShakSUse of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2N Engl J Med20013441178379211248153
   PubMed Web of Science ®Google Scholar
• MartyMCognettiFMaraninchiDRandomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study groupJ Clin Oncol200523194265427415911866
   PubMed Web of Science ®Google Scholar
• Piccart-GebhartMJProcterMLeyland-JonesBTrastuzumab after adjuvant chemotherapy in HER2-positive breast cancerN Engl J Med2005353161659167216236737
   PubMed Web of Science ®Google Scholar
• JoensuuHBonoPKatajaVFluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer TrialJ Clin Oncol200927345685569219884557
   PubMed Web of Science ®Google Scholar
• PerezEARomondEHSumanVJFour-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31J Clin Oncol201129253366337321768458
   PubMed Web of Science ®Google Scholar
• SlamonDEiermannWRobertNAdjuvant trastuzumab in HER2-positive breast cancerN Engl J Med2011365141273128321991949
   PubMed Web of Science ®Google Scholar
• FranklinMCCareyKDVajdosFFLeahyDJde VosAMSliwkowskiMXInsights into ErbB signaling from the structure of the ErbB2-pertuzumab complexCancer Cell20045431732815093539
   PubMed Web of Science ®Google Scholar
• YardenYSliwkowskiMXUntangling the ErbB signalling networkNat Rev Mol Cell Biol20012212713711252954
   PubMed Web of Science ®Google Scholar
• YardenYThe EGFR family and its ligands in human cancer. Signalling mechanisms and therapeutic opportunitiesEur J Cancer200137Suppl 4S3S811597398
   PubMed Web of Science ®Google Scholar
• SchechterALSternDFVaidyanathanLThe neu oncogene: an erb-B-related gene encoding a 185,000-Mr tumour antigenNature198431259945135166095109
   PubMed Web of Science ®Google Scholar
• TzaharEWatermanHChenXA hierarchical network of interreceptor interactions determines signal transduction by Neu differentiation factor/neuregulin and epidermal growth factorMol Cell Biol19961610527652878816440
   PubMed Web of Science ®Google Scholar
• Pinkas-KramarskiRSoussanLWatermanHDiversification of Neu differentiation factor and epidermal growth factor signaling by combinatorial receptor interactionsEMBO J19961510245224678665853
   PubMed Web of Science ®Google Scholar
• HolbroTBeerliRRMaurerFKoziczakMBarbasCF3rdHynesNEThe ErbB2/ErbB3 heterodimer functions as an oncogenic unit: ErbB2 requires ErbB3 to drive breast tumor cell proliferationProc Natl Acad Sci USA2003100158933893812853564
   PubMed Web of Science ®Google Scholar
• AdamsCWAllisonDEFlagellaKHumanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumabCancer Immunol Immunother200655671772716151804
   PubMed Web of Science ®Google Scholar
• BaselgaJA new anti-ErbB2 strategy in the treatment of cancer: prevention of ligand-dependent ErbB2 receptor heterodimerizationCancer Cell200222939512204526
   PubMed Web of Science ®Google Scholar
• AgusDBAkitaRWFoxWDTargeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growthCancer Cell20022212713712204533
   PubMed Web of Science ®Google Scholar
• NahtaRHungMCEstevaFJThe HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cellsCancer Res20046472343234615059883
   PubMed Web of Science ®Google Scholar
• Lee-HoeflichSTCrockerLYaoEA central role for HER3 in HER2-amplified breast cancer: implications for targeted therapyCancer Res200868145878588718632642
   PubMed Web of Science ®Google Scholar
• ScheuerWFriessTBurtscherHBossenmaierBEndlJHasmannMStrongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor modelsCancer Res200969249330933619934333
   PubMed Web of Science ®Google Scholar
• GianniLLladóABianchiGOpen-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancerJ Clin Oncol20102871131113720124183
   PubMed Web of Science ®Google Scholar
• AgusDBGordonMSTaylorCPhase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancerJ Clin Oncol200523112534254315699478
   PubMed Web of Science ®Google Scholar
• AttardGKitzenJBlagdenSPA phase Ib study of pertuzumab, a recombinant humanised antibody to HER2, and docetaxel in patients with advanced solid tumoursBr J Cancer200797101338134318000498
   PubMed Web of Science ®Google Scholar
• AlbanellJMontagutCJonesETA phase I study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumorsClin Cancer Res20081492726273118451238
   PubMed Web of Science ®Google Scholar
• YamamotoNYamadaYFujiwaraYPhase I and pharmacokinetic study of HER2-targeted rhuMAb 2C4 (pertuzumab, RO4368451) in Japanese patients with solid tumorsJpn J Clin Oncol200939426026619261664
   PubMed Web of Science ®Google Scholar
• MillerKGianniLAndreFA phase Ib/II trial of trastuzumab-DM1 (T-DM1) with pertuzumab (P) for women with HER2-positive, locally advanced or metastatic breast cancer (BC) who were previously treated with trastuzumab (T)J Clin Oncol201028Suppl 151012
   Web of Science ®Google Scholar
• NgCMLumBLGimenezVKelseySAllisonDRationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysisPharm Res20062361275128416715358
   PubMed Web of Science ®Google Scholar
• PorteraCCWalsheJMRosingDRCardiac toxicity and efficacy of trastuzumab combined with pertuzumab in patients with [corrected] human epidermal growth factor receptor 2-positive metastatic breast cancerClin Cancer Res20081492710271618451236
   PubMed Web of Science ®Google Scholar
• BaselgaJGelmonKAVermaSPhase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapyJ Clin Oncol20102871138114420124182
   PubMed Web of Science ®Google Scholar
• CortésJFumoleauPBianchiGVPertuzumab monotherapy after trastuzumab-based treatment and subsequent reintroduction of trastuzumab: activity and tolerability in patients with advanced human epidermal growth factor receptor 2-positive breast cancerJ Clin Oncol201230141594160022393084
   PubMed Web of Science ®Google Scholar
• BaselgaJCortésJKimSBPertuzumab plus trastuzumab plus docetaxel for metastatic breast cancerN Engl J Med2012366210911922149875
   PubMed Web of Science ®Google Scholar
• SwainSMKimSBCortésJPertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 studyLancet Oncol201314646147123602601
   PubMed Web of Science ®Google Scholar
• CortésJBaselgaJImYHHealth-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancerAnn Oncol201324102630263523868905
   PubMed Web of Science ®Google Scholar
• BradyMJCellaDFMoFReliability and validity of the Functional Assessment of Cancer Therapy – Breast quality-of-life instrumentJ Clin Oncol19971539749869060536
   PubMed Web of Science ®Google Scholar
• EtonDTCellaDYostKJA combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scaleJ Clin Epidemiol200457989891015504633
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyPerjeta (pertuzumab)2013 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002547/human_med_001628.jsp&mid=WC0b01ac058001d124Accessed October 7, 2013
   Google Scholar
• Health CanadaSummary basis of decision (SBD) for Perjeta2013 Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2013_perjeta_158419-eng.phpAccessed October 7, 2013
   Google Scholar
• TraynorKFDA approves pertuzumab for breast cancerAm J Health Syst Pharm201269141178
   Web of Science ®Google Scholar
• GianniLPienkowskiTImYHEfficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trialLancet Oncol2012131253222153890
   PubMed Web of Science ®Google Scholar
• SchneeweissAChiaSHickishTPertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA)Ann Oncol20132492278228423704196
   PubMed Web of Science ®Google Scholar
• US Food Drug AdministrationApproved drugs: pertuzumab injection2013 Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm370449.htmAccessed January 16, 2014
   Google Scholar
• SwainSMEwerMSCortésJCardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III studyOncologist201318325726423475636
   PubMed Web of Science ®Google Scholar
• LenihanDSuterTBrammerMNeateCRossGBaselgaJPooled analysis of cardiac safety in patients with cancer treated with pertuzumabAnn Oncol201223379180021665955
   PubMed Web of Science ®Google Scholar
• GenentechAn Observational Study of Pregnancy and Pregnancy Outcomes in Women with Breast Cancer Treated with Herceptin, Perjeta in Combination with Herceptin, or Kadcyla During Pregnancy or Within 6 Months Prior to Conception (MotHER) Available from: http://clinicaltrials.gov/show/NCT00833963. NLM identifier: NCT00833963Accessed September 24, 2013
   Google Scholar
• SOLTI Breast Cancer Research GroupStudy of Neoadjuvant Myocet^®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer (Opti-HER Heart) Available from: http://clinicaltrials.gov/show/NCT01669239. NLM identifier: NCT01669239Accessed October 5, 2013
   Google Scholar
• Dana-Farber Cancer InstitutePaclitaxel + Trastuzumab + Pertuzumab as Pre-Op for BrCa Available from: http://clinicaltrials.gov/show/NCT01796197. NLM identifier: NCT01796197Accessed October 5, 2013
   Google Scholar
• Hoffmann-La RocheA Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients with HER2-Positive Primary Breast Cancer Available from: http://clinicaltrials.gov/show/NCT01358877. NLM identifier: NCT01358877Accessed September 18, 2013
   Google Scholar
• Memorial Sloan-Kettering Cancer CenterPaclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer Available from: http://clinicaltrials.gov/show/NCT01276041. NLM identifier: NCT01276041Accessed October 5, 2013
   Google Scholar
• Hoffmann-La RocheA Study of Pertuzumab in Combination with Herceptin (Trastuzumab) and Vinorelbine in First Line in Patients with Metastatic or Locally Advanced HER2-Positive Breast Cancer Available from: http://clinicaltrials.gov/show/NCT01565083. NLM identifier: NCT01565083Accessed September 22, 2013
   Google Scholar
• Hoffmann-La RocheA Study of Pertuzumab in Combination with Trastuzumab Plus an Aromatase Inhibitor in Patients with Hormone Receptor-Positive, Metastatic HER2-Positive Breast Cancer Available from: http://clinicaltrials.gov/show/NCT01491737. NLM identifier: NCT01491737Accessed September 22, 2013
   Google Scholar
• Hoffmann-La RocheA Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients with Metastatic Breast Cancer (MARIANNE) Available from: http://clinicaltrials.gov/show/NCT01120184. NLM identifier: NCT01120184Accessed September 18, 2013
   Google Scholar
• City of Hope Medical CenterPertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients with HER2-Positive Metastatic Breast Cancer Available from: http://clinicaltrials.gov/show/NCT01730833. NLM identifier: NCT01730833Accessed October 5, 2013
   Google Scholar
• Hoffmann-La RocheA Study of Pertuzumab in Combination with Herceptin (Trastuzumab) and a Taxane in First-Line Treatment in Patients with HER2-Positive Advanced Breast Cancer (PERUSE) Available from: http://clinicaltrials.gov/show/NCT01572038. NLM identifier: NCT01572038Accessed October 5, 2013
   Google Scholar
• Hoffmann-La RocheHELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients with Her2-Positive Advanced Breast Cancer after Adjuvant Herceptin Therapy Available from: http://clinicaltrials.gov/show/NCT01777958. NLM identifier: NCT01777958Accessed October 5, 2013
   Google Scholar
• European Organisation for Research and Treatment of CancerElderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1 Available from: http://clinicaltrials.gov/show/NCT01597414. NLM identifier: NCT01597414Accessed October 5, 2013
   Google Scholar
• Hoffmann-La RocheA Study of a Combination of Trastuzumab and Capecitabine with or Without Pertuzumab in Patients with HER2-Positive Metastatic Breast Cancer (PHEREXA) Available from: http://clinicaltrials.gov/show/NCT01026142. NLM identifier: NCT01026142Accessed September 22, 2013
   Google Scholar
• BuzdarAUIbrahimNKFrancisDSignificantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancerJ Clin Oncol200523163676368515738535
   PubMed Web of Science ®Google Scholar
• ChambersJDLordJCohenJTNeumannPJBuxtonMJIllustrating potential efficiency gains from using cost-effectiveness evidence to reallocate Medicare expendituresValue Health201316462963823796298
   PubMed Web of Science ®Google Scholar
• SmithTJHillnerBEBending the cost curve in cancer careN Engl J Med2011364212060206521612477
   PubMed Web of Science ®Google Scholar
• Pan-Canadian Oncology Drug ReviewPerjeta-Herceptin combo pack for MBC – details2013 Available from: http://www.pcodr.ca/wcpc/portal/Home/FindaReview/PerjetaHerceptinMBC?afrLoop=2304129379749000&_afrWindowMode=0&_adf.ctrl-state=fgpie73cf_134Accessed September 20, 2013
   Google Scholar
• National Institute for Health and Care ExcellenceBreast cancer (HER2 positive, metastatic) – pertuzumab (with trastuzumab and docetaxel) [ID523] Available from: http://guidance.nice.org.uk/index.jsp?action=byId&o=13815Accessed September 20, 2013
   Google Scholar
• HirthRAChernewMEMillerEFendrickAMWeissertWGWillingness to pay for a quality-adjusted life year: in search of a standardMed Decis Making200020333234210929856
   PubMed Web of Science ®Google Scholar
• MasonHBakerRDonaldsonCWillingness to pay for a QALY: past, present and futureExpert Rev Pharmacoecon Outcomes Res20088657558220528368
   PubMedGoogle Scholar
• MurrayCJEvansDBAcharyaABaltussenRMDevelopment of WHO guidelines on generalized cost-effectiveness analysisHealth Econ20009323525110790702
   PubMed Web of Science ®Google Scholar
• Breast cancer (HER2 positive, metastatic) – pertuzumab (with trastuzumab and docetaxel): appraisal consultation documentNatl Inst Health Care Excell Available at: http://guidance.nice.org.uk/TAG/322/Consultation/DraftGuidanceAccessed September 24, 2013
   Google Scholar
• MakhijaSAmlerLCGlennDClinical activity of gemcitabine plus pertuzumab in platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancerJ Clin Oncol20102871215122319901115
   PubMed Web of Science ®Google Scholar
• ŞendurMANAksoySZenginNPertuzumab plus trastuzumab in metastatic breast cancerN Engl J Med2012366141348 author reply 1349–135022475602
   PubMedGoogle Scholar