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ATIR101 administered after T-cell-depleted haploidentical HSCT reduces NRM and improves overall survival in acute leukemia.

Roy DC, Walker I, Maertens J, Lewalle P, Olavarria E, Selleslag D, Lachance S, Buyse M, Wang K, Rovers J, Santi I, Bonig H, Sandler A, Velthuis J, Mielke S.

Leukemia. 2020 Feb 11. doi: 10.1038/s41375-020-0733-0. [Epub ahead of print]


A randomized phase III trial in patients with recurrent platinum sensitive ovarian cancer comparing efficacy and safety of paclitaxel micellar and Cremophor EL-paclitaxel.

Vergote I, Bergfeldt K, Franquet A, Lisyanskaya AS, Bjermo H, Heldring N, Buyse M, Brize A.

Gynecol Oncol. 2020 Feb;156(2):293-300. doi: 10.1016/j.ygyno.2019.11.034. Epub 2019 Dec 9.


Evaluation of Continuous Tumor-Size-Based End Points as Surrogates for Overall Survival in Randomized Clinical Trials in Metastatic Colorectal Cancer.

Burzykowski T, Coart E, Saad ED, Shi Q, Sommeijer DW, Bokemeyer C, Díaz-Rubio E, Douillard JY, Falcone A, Fuchs CS, Goldberg RM, Hecht JR, Hoff PM, Hurwitz H, Kabbinavar FF, Koopman M, Maughan TS, Punt CJA, Saltz L, Schmoll HJ, Seymour MT, Tebbutt NC, Tournigand C, Van Cutsem E, de Gramont A, Zalcberg JR, Buyse M; Aide et Recherche en Cancerologie Digestive Group.

JAMA Netw Open. 2019 Sep 4;2(9):e1911750. doi: 10.1001/jamanetworkopen.2019.11750.


A Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas.

Philip PA, Buyse ME, Alistar AT, Rocha Lima CM, Luther S, Pardee TS, Van Cutsem E.

Future Oncol. 2019 Oct;15(28):3189-3196. doi: 10.2217/fon-2019-0209. Epub 2019 Sep 12.


A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses.

Xie W, Halabi S, Tierney JF, Sydes MR, Collette L, Dignam JJ, Buyse M, Sweeney CJ, Regan MM.

JNCI Cancer Spectr. 2019 Feb 6;3(1):pkz002. doi: 10.1093/jncics/pkz002. eCollection 2019 Mar. Review.


Open science: The open clinical trials data journey.

Rockhold F, Bromley C, Wagner EK, Buyse M.

Clin Trials. 2019 Oct;16(5):539-546. doi: 10.1177/1740774519865512. Epub 2019 Jul 26.


Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring.

Trotta L, Kabeya Y, Buyse M, Doffagne E, Venet D, Desmet L, Burzykowski T, Tsuburaya A, Yoshida K, Miyashita Y, Morita S, Sakamoto J, Praveen P, Oba K.

Clin Trials. 2019 Oct;16(5):512-522. doi: 10.1177/1740774519862564. Epub 2019 Jul 23.


Adherence with metreleptin therapy and health self-perception in patients with lipodystrophic syndromes.

Vatier C, Kalbasi D, Vantyghem MC, Lascols O, Jéru I, Daguenel A, Gautier JF, Buyse M, Vigouroux C.

Orphanet J Rare Dis. 2019 Jul 12;14(1):177. doi: 10.1186/s13023-019-1141-2.


Chronological Trends in Progression-Free, Overall, and Post-Progression Survival in First-Line Therapy for Advanced NSCLC.

Rutkowski J, Saad ED, Burzykowski T, Buyse M, Jassem J.

J Thorac Oncol. 2019 Sep;14(9):1619-1627. doi: 10.1016/j.jtho.2019.05.030. Epub 2019 Jun 1.


What Does Metastasis-Free Survival Actually Mean?

Sweeney CJ, De Abreu Lourenco R, Hamid AA, Buyse M.

J Clin Oncol. 2019 Jul 1;37(19):1679-1680. doi: 10.1200/JCO.18.02372. Epub 2019 May 3. No abstract available.


PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial.

Chia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A.

Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2.


Assessing Long-Term Survival Benefits of Immune Checkpoint Inhibitors Using the Net Survival Benefit.

Péron J, Lambert A, Munier S, Ozenne B, Giai J, Roy P, Dalle S, Machingura A, Maucort-Boulch D, Buyse M.

J Natl Cancer Inst. 2019 Nov 1;111(11):1186-1191. doi: 10.1093/jnci/djz030.


Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis.

Saad ED, Squifflet P, Burzykowski T, Quinaux E, Delaloge S, Mavroudis D, Perez E, Piccart-Gebhart M, Schneider BP, Slamon D, Wolmark N, Buyse M.

Lancet Oncol. 2019 Mar;20(3):361-370. doi: 10.1016/S1470-2045(18)30750-2. Epub 2019 Jan 29. Erratum in: Lancet Oncol. 2019 Mar;20(3):e132.


Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial.

Delaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipović S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M.

Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016.


The Benefit-Risk Balance of Nab-Paclitaxel in Metastatic Pancreatic Adenocarcinoma.

Péron J, Giai J, Maucort-Boulch D, Buyse M.

Pancreas. 2019 Feb;48(2):275-280. doi: 10.1097/MPA.0000000000001234.


Adipocyte Glucocorticoid Receptor Deficiency Promotes Adipose Tissue Expandability and Improves the Metabolic Profile Under Corticosterone Exposure.

Dalle H, Garcia M, Antoine B, Boehm V, Do TTH, Buyse M, Ledent T, Lamazière A, Magnan C, Postic C, Denis RG, Luquet S, Fève B, Moldes M.

Diabetes. 2019 Feb;68(2):305-317. doi: 10.2337/db17-1577. Epub 2018 Nov 19.


Adaptive β-Cell Neogenesis in the Adult Mouse in Response to Glucocorticoid-Induced Insulin Resistance.

Courty E, Besseiche A, Do TTH, Liboz A, Aguid FM, Quilichini E, Buscato M, Gourdy P, Gautier JF, Riveline JP, Haumaitre C, Buyse M, Fève B, Guillemain G, Blondeau B.

Diabetes. 2019 Jan;68(1):95-108. doi: 10.2337/db17-1314. Epub 2018 Oct 16.


The search for surrogate endpoints for immunotherapy trials.

Buyse M, Burzykowski T, Saad ED.

Ann Transl Med. 2018 Jun;6(11):231. doi: 10.21037/atm.2018.05.16. No abstract available.


Understanding and Communicating Measures of Treatment Effect on Survival: Can We Do Better?

Saad ED, Zalcberg JR, Péron J, Coart E, Burzykowski T, Buyse M.

J Natl Cancer Inst. 2018 Mar 1;110(3):232-240. doi: 10.1093/jnci/djx179. Review.


Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial.

Malorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, Arpino G, Bernardo A, Martignetti A, Criscitiello C, Puglisi F, Pestrin M, Sanna G, Moretti E, Risi E, Biagioni C, McCartney A, Boni L, Buyse M, Migliaccio I, Biganzoli L, Di Leo A.

Ann Oncol. 2018 Aug 1;29(8):1748-1754. doi: 10.1093/annonc/mdy214.


Sleeve Gastrectomy in Morbidly Obese HIV Patients: Focus on Anti-retroviral Treatment Absorption After Surgery.

Amouyal C, Buyse M, Lucas-Martini L, Hirt D, Genser L, Torcivia A, Bouillot JL, Oppert JM, Aron-Wisnewsky J.

Obes Surg. 2018 Sep;28(9):2886-2893. doi: 10.1007/s11695-018-3308-7.


The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer?

Sobrero A, Grothey A, Iveson T, Labianca R, Yoshino T, Taieb J, Maughan T, Buyse M, André T, Meyerhardt J, Shields AF, Souglakos I, Douillard JY, Cervantes A.

Ann Oncol. 2018 May 1;29(5):1099-1107. doi: 10.1093/annonc/mdy064.


Meta-analysis of randomized clinical trials in the era of individual patient data sharing.

Kawahara T, Fukuda M, Oba K, Sakamoto J, Buyse M.

Int J Clin Oncol. 2018 Jun;23(3):403-409. doi: 10.1007/s10147-018-1237-z. Epub 2018 Jan 12.


Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.

Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group.

Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.


Monitoring of Potentially Inappropriate Prescriptions in Older Inpatients: A French Multicenter Study.

Pandraud-Riguet I, Bonnet-Zamponi D, Bourcier E, Buyse M, Laribe-Caget S, Frémont P, Pautas E, Verny C, Hindlet P, Fernandez C.

J Am Geriatr Soc. 2017 Dec;65(12):2713-2719. doi: 10.1111/jgs.15081. Epub 2017 Oct 9.


Relapse-Free Survival as a Surrogate for Overall Survival in the Evaluation of Stage II-III Melanoma Adjuvant Therapy.

Suciu S, Eggermont AMM, Lorigan P, Kirkwood JM, Markovic SN, Garbe C, Cameron D, Kotapati S, Chen TT, Wheatley K, Ives N, de Schaetzen G, Efendi A, Buyse M.

J Natl Cancer Inst. 2018 Jan 1;110(1). doi: 10.1093/jnci/djx133. Review.


Quality of prescribing in community-dwelling elderly patients in France: an observational study in community pharmacies.

Bourcier E, Mille F, Brunie V, Korb-Savoldelli V, Lafortune C, Buyse M, Fernandez C, Hindlet P.

Int J Clin Pharm. 2017 Dec;39(6):1220-1227. doi: 10.1007/s11096-017-0531-6. Epub 2017 Sep 14.


Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.

Xie W, Regan MM, Buyse M, Halabi S, Kantoff PW, Sartor O, Soule H, Clarke NW, Collette L, Dignam JJ, Fizazi K, Paruleker WR, Sandler HM, Sydes MR, Tombal B, Williams SG, Sweeney CJ; ICECaP Working Group.

J Clin Oncol. 2017 Sep 20;35(27):3097-3104. doi: 10.1200/JCO.2017.73.9987. Epub 2017 Aug 10.


Antenatal antipsychotic exposure induces multigenerational and gender-specific programming of adiposity and glucose tolerance in adult mouse offspring.

Courty E, Gobalakichenane P, Garcia M, Muscat A, Kazakian C, Ledent T, Moldes M, Blondeau B, Mitanchez D, Buyse M, Fève B.

Diabetes Metab. 2018 Jun;44(3):281-291. doi: 10.1016/j.diabet.2017.06.005. Epub 2017 Jul 17.


A Poisson approach to the validation of failure time surrogate endpoints in individual patient data meta-analyses.

Rotolo F, Paoletti X, Burzykowski T, Buyse M, Michiels S.

Stat Methods Med Res. 2019 Jan;28(1):170-183. doi: 10.1177/0962280217718582. Epub 2017 Jul 6.


The impact of data errors on the outcome of randomized clinical trials.

Buyse M, Squifflet P, Coart E, Quinaux E, Punt CJ, Saad ED.

Clin Trials. 2017 Oct;14(5):499-506. doi: 10.1177/1740774517716158. Epub 2017 Jun 22.


Authors' Reply to Schoenfeld: "Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors".

Michiels S, Saad ED, Buyse M.

Drugs. 2017 Jul;77(10):1139-1140. doi: 10.1007/s40265-017-0761-x. No abstract available.


Stronger diversity effects with increased environmental stress: A study of multitrophic interactions between oak, powdery mildew and ladybirds.

Dillen M, Smit C, Buyse M, Höfte M, De Clercq P, Verheyen K.

PLoS One. 2017 Apr 18;12(4):e0176104. doi: 10.1371/journal.pone.0176104. eCollection 2017.


Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors.

Michiels S, Saad ED, Buyse M.

Drugs. 2017 May;77(7):713-719. doi: 10.1007/s40265-017-0728-y.


Improving public health by improving clinical trial guidelines and their application.

Landray MJ, Bax JJ, Alliot L, Buyse M, Cohen A, Collins R, Hindricks G, James SK, Lane S, Maggioni AP, Meeker-O'Connell A, Olsson G, Pocock SJ, Rawlins M, Sellors J, Shinagawa K, Sipido KR, Smeeth L, Stephens R, Stewart MW, Stough WG, Sweeney F, Van de Werf F, Woods K, Casadei B.

Eur Heart J. 2017 Jun 1;38(21):1632-1637. doi: 10.1093/eurheartj/ehx086.


Time to Review the Role of Surrogate End Points in Health Policy: State of the Art and the Way Forward.

Ciani O, Buyse M, Drummond M, Rasi G, Saad ED, Taylor RS.

Value Health. 2017 Mar;20(3):487-495. doi: 10.1016/j.jval.2016.10.011. Epub 2016 Dec 22. Review.


The potential and perils of observational studies.

Buyse M, Vansteelandt S.

Ann Oncol. 2017 Jan 1;28(1):182. doi: 10.1093/annonc/mdw539. No abstract available.


Precision medicine needs randomized clinical trials.

Saad ED, Paoletti X, Burzykowski T, Buyse M.

Nat Rev Clin Oncol. 2017 May;14(5):317-323. doi: 10.1038/nrclinonc.2017.8. Epub 2017 Feb 7. Review.


Study protocol of the Asian XELIRI ProjecT (AXEPT): a multinational, randomized, non-inferiority, phase III trial of second-line chemotherapy for metastatic colorectal cancer, comparing the efficacy and safety of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab.

Kotaka M, Xu R, Muro K, Park YS, Morita S, Iwasa S, Uetake H, Nishina T, Nozawa H, Matsumoto H, Yamazaki K, Han SW, Wang W, Ahn JB, Deng Y, Cho SH, Ba Y, Lee KW, Zhang T, Satoh T, Buyse ME, Ryoo BY, Shen L, Sakamoto J, Kim TW.

Chin J Cancer. 2016 Dec 22;35(1):102. doi: 10.1186/s40880-016-0166-3.


Adoption of Pathologic Complete Response as a Surrogate End Point in Neoadjuvant Trials in HER2-Positive Breast Cancer Still an Open Question.

Burzykowski T, Saad ED, Buyse M.

JAMA Oncol. 2017 Mar 1;3(3):416. doi: 10.1001/jamaoncol.2016.3941. No abstract available.


HER2 Status in Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma for Entry to the TRIO-013/LOGiC Trial of Lapatinib.

Press MF, Ellis CE, Gagnon RC, Grob TJ, Buyse M, Villalobos I, Liang Z, Wu S, Bang YJ, Qin SK, Chung HC, Xu J, Park JO, Jeziorski K, Afenjar K, Ma Y, Estrada MC, Robinson DM, Scherer SJ, Sauter G, Hecht JR, Slamon DJ.

Mol Cancer Ther. 2017 Jan;16(1):228-238. doi: 10.1158/1535-7163.MCT-15-0887. Epub 2016 Nov 3.


Adaptive Randomization of Neratinib in Early Breast Cancer.

Buyse M, Saad ED, Burzykowski T.

N Engl J Med. 2016 Oct 20;375(16):1591-2. doi: 10.1056/NEJMc1609993. No abstract available.


Data Sharing - Is the Juice Worth the Squeeze?

Strom BL, Buyse ME, Hughes J, Knoppers BM.

N Engl J Med. 2016 Oct 27;375(17):1608-1609. No abstract available.


An assessment of the benefit-risk balance of FOLFIRINOX in metastatic pancreatic adenocarcinoma.

Péron J, Roy P, Conroy T, Desseigne F, Ychou M, Gourgou-Bourgade S, Stanbury T, Roche L, Ozenne B, Buyse M.

Oncotarget. 2016 Dec 13;7(50):82953-82960. doi: 10.18632/oncotarget.12761.


Epirubicin With Cyclophosphamide Followed by Docetaxel With Trastuzumab and Bevacizumab as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group, FB-5.

Smith JW 2nd, Buyse ME, Rastogi P, Geyer CE Jr, Jacobs SA, Patocskai EJ, Robidoux A, Conlin AK, Ansari B, Keogh GP, Stella PJ, Gross HM, Lord RS, Polikoff JA, Mauquoi C, Mamounas EP, Swain SM, Wolmark N.

Clin Breast Cancer. 2017 Feb;17(1):48-54.e3. doi: 10.1016/j.clbc.2016.07.008. Epub 2016 Jul 28.


HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials.

Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ.

J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.


An extension of generalized pairwise comparisons for prioritized outcomes in the presence of censoring.

Péron J, Buyse M, Ozenne B, Roche L, Roy P.

Stat Methods Med Res. 2018 Apr;27(4):1230-1239. doi: 10.1177/0962280216658320. Epub 2016 Aug 2.


Neratinib after trastuzumab in patients with HER2-positive breast cancer - Author's reply.

Chan A, Buyse M, Yao B.

Lancet Oncol. 2016 May;17(5):e176-7. doi: 10.1016/S1470-2045(16)30018-3. Epub 2016 Apr 27. No abstract available.


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