Can contemporary trials of chemotherapy for HER2-negative metastatic breast cancer detect overall survival benefit?

References

• MendesDAlvesCAfonsoNThe benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer – a systematic reviewBreast Cancer Res20151714026578067
   PubMed Web of Science ®Google Scholar
• Di LeoABleibergHBuyseMOverall survival is not a realistic end point for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancerJ Clin Oncol200321102045204712743164
   PubMed Web of Science ®Google Scholar
• SargentDJHayesDFAssessing the measure of a new drug: is survival the only thing that matters?J Clin Oncol200826121922192318421044
   PubMed Web of Science ®Google Scholar
• BroglioKRBerryDADetecting an overall survival benefit that is derived from progression-free survivalJ Natl Cancer Inst2009101231642164919903805
   PubMed Web of Science ®Google Scholar
• AmirESerugaBKwongRTannockIFOcañaAPoor correlation between progression-free and overall survival in modern clinical trials: are composite endpoints the answer?Eur J Cancer201248338538822115991
   PubMed Web of Science ®Google Scholar
• KornELFreidlinBAbramsJSOverall survival as the outcome for randomized clinical trials with effective subsequent therapiesJ Clin Oncol201129172439244221555691
   PubMed Web of Science ®Google Scholar
• AdunlinGCyrusJWDranitsarisGCorrelation between progression-free survival and overall survival in metastatic breast cancer patients receiving anthracyclines, taxanes, or targeted therapies: a trial-level meta-analysisBreast Cancer Res Treat2015154359160826596731
   PubMed Web of Science ®Google Scholar
• LiuLChenFZhaoJYuHCorrelation between overall survival and other endpoints in metastatic breast cancer with second- or third-line chemotherapy: literature-based analysis of 24 randomized trialsBull Cancer2016103433634426874974
   PubMed Web of Science ®Google Scholar
• ForsytheAChandiwanaDBarthJThabaneMBaeckJTremblayGProgression-free survival/time to progression as a potential surrogate for overall survival in HR+, HER2– metastatic breast cancerBreast Cancer201810697829765247
   PubMed Web of Science ®Google Scholar
• AcklandSPAntonABreitbachGPDose-intensive epirubicin-based chemotherapy is superior to an intensive intravenous cyclophosphamide, methotrexate, and fluorouracil regimen in metastatic breast cancer: a randomized multinational studyJ Clin Oncol200119494395311181656
   PubMed Web of Science ®Google Scholar
• EjlertsenBMouridsenHTLangkjerSTAndersenJSjöströmJKjaerMPhase III study of intravenous vinorelbine in combination with epirubicin versus epirubicin alone in patients with advanced breast cancer: a Scandinavian Breast Group Trial (SBG9403)J Clin Oncol200422122313232015197192
   PubMed Web of Science ®Google Scholar
• JassemJPieńkowskiTPłuzańskaADoxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trialJ Clin Oncol2001191707171511251000
   PubMed Web of Science ®Google Scholar
• von MinckwitzGChernozemskyISirakovaLBendamustine prolongs progression-free survival in metastatic breast cancer (MBC): a phase III prospective, randomized, multicenter trial of bendamustine hydrochloride, methotrexate and 5-fluorouracil (BMF) versus cyclophosphamide, methotrexate and 5-fluorouracil (CMF) as first-line treatment of MBCAnticancer Drugs200516887187716096436
   PubMed Web of Science ®Google Scholar
• BontenbalMCreemersGJBraunHJPhase II to III study comparing doxorubicin and docetaxel with fluorouracil, doxorubicin, and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: results of a Dutch Community Setting Trial for the Clinical Trial Group of the Comprehensive Cancer CentreJ Clin Oncol200523287081708816192591
   PubMed Web of Science ®Google Scholar
• AlbainKSNagSMCalderillo-RuizGGemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatmentJ Clin Oncol200826243950395718711184
   PubMed Web of Science ®Google Scholar
• GrayRBhattacharyaSBowdenCMillerKComisRLIndependent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancerJ Clin Oncol200927304966497219720913
   PubMed Web of Science ®Google Scholar
• CameronDBevacizumab in the first-line treatment of metastatic breast cancerEur J Cancer2008662128
   Google Scholar
• MillerKWangMGralowJPaclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancerN Engl J Med2007357262666267618160686
   PubMed Web of Science ®Google Scholar
• SparanoJAMakhsonANSemiglazovVFPegylated liposomal doxorubicin plus docetaxel significantly improves time to progression without additive cardiotoxicity compared with docetaxel monotherapy in patients with advanced breast cancer previously treated with neoadjuvant-adjuvant anthracycline therapy: results from a randomized phase III studyJ Clin Oncol200927274522452919687336
   PubMed Web of Science ®Google Scholar
• RobertNJDiérasVGlaspyJRIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancerJ Clin Oncol201129101252126021383283
   PubMed Web of Science ®Google Scholar
• Roche data on fileAVF3694g clinical study report addendum2009
   Google Scholar
• MilesDWChanADirixLYPhase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancerJ Clin Oncol201028203239324720498403
   PubMed Web of Science ®Google Scholar
• LamSWde GrootSMHonkoopAHPaclitaxel and bevacizumab with or without capecitabine as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a multicentre, open-label, randomised phase 2 trialEur J Cancer201450183077308825459393
   PubMed Web of Science ®Google Scholar
• GligorovJDovalDBinesJMaintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trialLancet Oncol201415121351136025273343
   PubMed Web of Science ®Google Scholar
• MilesDCameronDBondarenkoIBevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): a double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluationEur J Cancer20177014615527817944
   PubMed Web of Science ®Google Scholar
• MilesDCameronDHiltonMGarciaJO’ShaughnessyJOverall survival in MERiDiAN, a double-blind placebo-controlled randomised phase III trial evaluating first-line bevacizumab plus paclitaxel for HER2-negative metastatic breast cancerEur J Cancer20189015315529174181
   PubMed Web of Science ®Google Scholar
• TanAPorcherRCrequitPRavaudPDechartresADifferences in treatment effect size between overall survival and progression-free survival in immunotherapy trials: a meta-epidemiologic study of trials with results posted at ClinicalTrials.govJ Clin Oncol201735151686169428375786
   PubMed Web of Science ®Google Scholar
• SaadEDKatzAProgression-free survival and time to progression as primary end points in advanced breast cancer: often used, sometimes loosely definedAnn Oncol200920346046419095776
   PubMed Web of Science ®Google Scholar
• BurzykowskiTBuyseMPiccart-GebhartMJEvaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancerJ Clin Oncol200826121987199218421050
   PubMed Web of Science ®Google Scholar
• ForsytheAChandiwanaDBarthJIs progression-free survival a more relevant endpoint than overall survival in first-line HR+/HER2-metastatic breast cancer?Cancer Manag Res2018101015102529765249
   PubMed Web of Science ®Google Scholar
• ThillMLiedtkeCSolomayerEFMüllerVJanniWSchmidtMAGO recommendations for the diagnosis and treatment of patients with advanced and metastatic breast cancer: update 2017Breast Care201712318419128785187
   PubMed Web of Science ®Google Scholar
• HurvitzSALallaDCrosbyRDMathiasSDUse of the metastatic breast cancer progression (MBC-P) questionnaire to assess the value of progression-free survival for women with metastatic breast cancerBreast Cancer Res Treat2013142360360924218050
   PubMed Web of Science ®Google Scholar
• GrunfeldEAMaherEJBrowneSAdvanced breast cancer patients’ perceptions of decision making for palliative chemotherapyJ Clin Oncol20062471090109816505428
   PubMed Web of Science ®Google Scholar
• HerschbachPKellerMKnightLPsychological problems of cancer patients: a cancer distress screening with a cancer-specific questionnaireBr J Cancer200491350451115238979
   PubMed Web of Science ®Google Scholar
• IshakKJProskorovskyIKorytowskyBSandinRFaivreSValleJMethods for adjusting for bias due to crossover in oncology trialsPharmacoeconomics201432653354624595585
   PubMed Web of Science ®Google Scholar
• KorhonenPZuberEBransonMCorrecting overall survival for the impact of crossover via a rank-preserving structural failure time (RPSFT) model in the RECORD-1 trial of everolimus in metastatic renal-cell carcinomaJ Biopharm Stat20122261258127123075021
   PubMed Web of Science ®Google Scholar
• KaramALedermannJAKimJWFifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: first-line interventionsAnn Oncol20172871171728327917
   PubMed Web of Science ®Google Scholar
• Gourgou-BourgadeSCameronDPoortmansPGuidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)Ann Oncol2015261225052506
   PubMed Web of Science ®Google Scholar
• ChernyNIDafniUBogaertsJESMO-Magnitude of Clinical Benefit Scale version 1.1Ann Oncol201728102340236628945867
   PubMed Web of Science ®Google Scholar
• SchnipperLEDavidsonNEWollinsDSAmerican Society of Clinical Oncology Statement: a conceptual framework to assess the value of cancer treatment optionsJ Clin Oncol201533232563257726101248
   PubMed Web of Science ®Google Scholar
• Del PaggioJCAzariahBSullivanRDo contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit?Ann Oncol201728115716227742650
   PubMed Web of Science ®Google Scholar
• DelalogeSPérolDCourtinardCPaclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational studyAnn Oncol20162791725173227436849
   PubMed Web of Science ®Google Scholar
• BuyseMVansteelandtSThe potential and perils of observational studiesAnn Oncol201728118228177426
   PubMed Web of Science ®Google Scholar
• PiccartMPondéNCancer drugs, survival and ethics: a critical look from the insideESMO Open201716e00014928848670
   PubMedGoogle Scholar
• KümmelSJackischCMüllerVSchneeweissAKlawitterSLuxMPCan contemporary trials in HER2-negative metastatic breast cancer (mBC) detect overall survival (OS) benefit?Ann Oncol201728Suppl 5v86v87
   Google Scholar