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136 results on '"Simes R.J."'

1. Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.

Author

Zeverijn, L.J., Looze, E.J., Thavaneswaran, S., Berge Henegouwen, J.M. van, Simes, R.J., Hoes, L.R., Sjoquist, K.M., Wijngaart, H. van der, Sebastian, L., Geurts, B.S., Lee, C.K., Wit, G.F. de, Espinoza, D., Roepman, P., Lin, F.P., Jansen, A.M.L, Leng, W.W.J. de, Noort, V. van der, Leek, L.V.M., Vos, F.Y.F.L. de, Herpen, C.M.L. van, Gelderblom, H., Verheul, H.M.W., Thomas, D.M., Voest, E.E., Zeverijn, L.J., Looze, E.J., Thavaneswaran, S., Berge Henegouwen, J.M. van, Simes, R.J., Hoes, L.R., Sjoquist, K.M., Wijngaart, H. van der, Sebastian, L., Geurts, B.S., Lee, C.K., Wit, G.F. de, Espinoza, D., Roepman, P., Lin, F.P., Jansen, A.M.L, Leng, W.W.J. de, Noort, V. van der, Leek, L.V.M., Vos, F.Y.F.L. de, Herpen, C.M.L. van, Gelderblom, H., Verheul, H.M.W., Thomas, D.M., and Voest, E.E.

Abstract

Contains fulltext : 295941.pdf (Publisher’s version ) (Closed access), The Dutch Drug Rediscovery Protocol (DRUP) and the Australian Cancer Molecular Screening and Therapeutic (MoST) Program are similar nonrandomized, multidrug, pan-cancer trial platforms that aim to identify signals of clinical activity of molecularly matched targeted therapies or immunotherapies outside their approved indications. Here, we report results for advanced or metastatic cancer patients with tumors harboring cyclin D-CDK4/6 pathway alterations treated with CDK4/6 inhibitors palbociclib or ribociclib. We included adult patients that had therapy-refractory solid malignancies with the following alterations: amplifications of CDK4, CDK6, CCND1, CCND2 or CCND3, or complete loss of CDKN2A or SMARCA4. Within MoST, all patients were treated with palbociclib, whereas in DRUP, palbociclib and ribociclib were assigned to different cohorts (defined by tumor type and alteration). The primary endpoint for this combined analysis was clinical benefit, defined as confirmed objective response or stable disease ≥16 weeks. We treated 139 patients with a broad variety of tumor types; 116 with palbociclib and 23 with ribociclib. In 112 evaluable patients, the objective response rate was 0% and clinical benefit rate at 16 weeks was 15%. Median progression-free survival was 4 months (95% CI: 3-5 months), and median overall survival 5 months (95% CI: 4-6 months). In conclusion, only limited clinical activity of palbociclib and ribociclib monotherapy in patients with pretreated cancers harboring cyclin D-CDK4/6 pathway alterations was observed. Our findings indicate that monotherapy use of palbociclib or ribociclib is not recommended and that merging data of two similar precision oncology trials is feasible.

Published
2023

2. Estimated GFR and the Effect of Intensive Blood Pressure Lowering After Acute Intracerebral Hemorrhage

Author

Anderson, C.S., Chalmers, J., Arima, H., Davis, S., Heeley, E., Huang, Y., Lavados, P., Neal, B., Parsons, M.W., Lindley, R., Morgenstern, L., Robinson, T., Stapf, C., Tzourio, C., Wang, J.G., Chen, S., Chen, X.Y., Cui, L., Liu, Z., Lu, C., Wang, J., Wu, S., Xu, E., Yang, Q., Zhang, C., Zhang, J., Beer, R., Schmutzhard, E., Redondo, P., Kaste, M., Soinne, L., Tatlisumak, T., Wartenberg, K., Ricci, S., Klijn, K., Azevedo, E., Chamorro, A., Arnold, M., Fischer, U., Kaul, S., Pandian, J., Boyini, H., Singh, S., Rabinstein, A.A., Estol, C., Silva, G., Olavarria, V.V., Robinson, T.G., Simes, R.J., Bousser, M.-G., Hankey, G., Jamrozik, K., Johnston, S.C., Li, S., Bailey, K., Cheung, T., Delcourt, C., Chintapatla, S., Ducasse, E., Erho, T., Hata, J., Holder, B., Knight, E., Leroux, M., Sassé, T., Odgers, E., Walsh, R., Wolfowicz, Z., Chen, G., Fuentes, S., Peng, B., Schneble, H.-M., Wang, M.-X., Billot, L., Heritier, S., Li, Q., Woodward, M., Abimbola, S., Anderson, S., Chan, E., Cheng, G., Chmielnik, P., Leighton, S., Liu, J.-Y., Rasmussen, B., Saxena, A., Tripathy, S., Armenis, M., Baig, M.A., Naidu, B., Starzec, G., Steley, S., Moles, A., Ruiz, A., Zimmermann, M., Marinho, J., Alves, S., Angelim, R., Araujo, J., Kawakami, L., Bustos, C., Gonzalez, F., Munoz Venturelli, P., Chen, X., Jia, R., Li, N., Qu, S., Shu, Y., Song, A., Sun, J., Xiao, J., Zhao, Y., Huang, Q., Vicaut, E., Chamam, A., Viaud, M.-C., Dert, C., Fiedler, U., Jovis, V., Kabla, S., Marchand, S., Pena, A., Rochaud, V., Mallikarjuna, K., Hasan, N., Berge, E., Sandset, E.C., Forårsveen, A.S., Richardson, D., Kumar, T., Lewin, S., Poulter, N., Field, J., Anjum, A., Wilson, A., Perelmuter, H., Agarie, A.M., Barboza, A.G., Recchia, L.A., Miranda, I.F., Rauek, S.G., Duplessis, R.J., Dewey, H., Walker, L., Petrolo, S., Bladin, C., Sturm, J., Crimmins, D., Griffiths, D., Schutz, A., Zenteno, V., Miteff, F., Spratt, N., Kerr, E., Levi, C.R., Phan, T.G., Ma, H., Sanders, L., Moran, C., Wong, K., Read, S., Henderson, R., Wong, A., Hull, R., Skinner, G., Hand, P., Yan, B., Tu, H., Campbell, B., Blacker, D.J., Wijeratne, T., Pathirage, M., Jasinararchchi, M., Matkovic, Z., Celestino, S., Gruber, F., Vosko, M.R., Diabl, E., Rathmaier, S., Pfausler, B., Helbok, R., Fazekas, F., Fischer, R., Poltrum, B., Zechner, B., Trummer, U., Rutgers, M.P., Peeters, A., Dusart, A., Duray, M.-C., Parmentier, C., Ferrao-Santos, S., Brouns, R., De Raedt, S., De Smedt, A., VanHooff, R.-J., De Keyser, J., Martins, S.C.O., de Almeida, A.G., Broudani, R., Titton, N.F., de Freitas, G.R., Cardoso, F.M., Giesel, L.M., Lima, N.A., Jr, Ferraz de Almeida, A.C., Gomes, R.B., Borges dos Santos, T.S., Veloso Soares, E.M., Neto, O.L.A., Silva, G.S., Gomes, D.L., de Carvalho, F.A., Miranda, M., Marques, A., Zétola, V.F., de Matia, G., Lange, M.C., Montes, J., Reccius, A., Soto, A., Rivas, R., Klapp, C., Illanes, S., Aguilera, C., Castro, A., Figueroa, C., Benavides, J., Salamanca, P., Concha, M.C., Pajarito, J., Araya, P., Guerra, F., Li, Y., Liu, G., Wang, B., Chong, Y., He, M., Wang, L., Liu, J., Zhang, X., Lai, C., Jiang, H., Cui, S., Tao, Q., Zhang, Y., Yao, S., Xu, M., Xiao, H., Hu, J., Tang, J., Ji, H., Jiang, M., Yu, F., Yang, X., Guo, X., Wang, Y., Wu, L., Gao, Y., Sun, D., Huang, X., Liu, L., Li, P., Jiang, Y., Li, H., Lu, H., Zhou, J., Yuan, C., Qi, X., Qiu, F., Qian, H., Wang, W., Sun, W., Li, F., Liu, R., Peng, Q., Ren, Z., Fan, C., Wang, H., Wang, T., Shi, F., Duan, C., Chen, Z., Tan, X., Zhao, Z., Chen, J., Han, T., Zhang, L., Hu, Q., Hou, Q., Zhao, X., Zeng, G., Ma, L., Wang, F., Zeng, L., Guo, Z., Fu, Y., Song, Y., Tai, L., Liu, X., Su, X., Yang, Y., Dong, R., Xu, Y., Tian, S., Cheng, S., Su, L., Xie, X., Xu, T., Geng, D., Yan, X., Fan, H., Zhao, N., Wang, S., Yang, J., Yan, M., Li, L., Li, Z., Xu, X., Lian, Y., Sun, H., Liu, D., Wang, N., Tang, Q., Han, Z., Feng, L., Cui, Y., Tian, J., Chang, H., Sun, X., Liu, C., Wen, Z., Lin, Q., Sun, L., Hu, B., Zou, M., Bao, Q., Lin, X., Zhao, L., Tian, X., Wang, X., Li, X., Hao, L., Duan, Y., Wang, R., Wei, Z., Ren, S., Ren, H., Dong, Y., Cheng, Y., Liu, W., Han, J., Zhang, Z., Zhu, J., Qian, J., Sun, Y., Liu, K., Long, F., Peng, X., Zhang, Q., Yuan, Z., Wang, C., Huang, M., He, P., You, Y., Xia, J., Zhou, L., Hou, Y., Qi, Y., Mei, L., Lu, R., Ping, L., Zhou, S., Zhang, S., Zou, R., Guo, J., Li, M., Wei, W., Curtze, S., Saarela, M., Strbian, D., Scheperjans, F., De Broucker, T., Henry, C., Cumurciuc, R., Ibos-Augé, N., Zéghoudi, A.-C., Pico, F., Dereeper, O., Simian, M.-C., Boisselier, C., Mahfoud, A., Timsit, S., Merrien, F.M., Guillon, B., Sevin, M., Herisson, F., Magne, C., Ameri, A., Cret, C., Stefanizzi, S., Klapzcynski, F., Denier, C., Sarov-Riviere, M., Reiner, P., Mawet, J., Hervé, D., Buffon, F., Touzé, E., Domigo, V., Lamy, C., Calvet, D., Pasquini, M., Alamowitch, S., Favrole, P., Muresan, I.-P., Crozier, S., Rosso, C., Pires, C., Leger, A., Deltour, S., Cordonnier, C., Henon, H., Rossi, C., Zuber, M., Bruandet, M., Tamazyan, R., Join-Lambert, C., Juettler, E., Krause, T., Maul, S., Endres, M., Jungehulsing, G.J., Hennerici, M., Griebe, M., Sauer, T., Knoll, K., Huber, R., Knauer, K., Knauer, C., Raubold, S., Schneider, H., Hentschel, H., Lautenschläger, C., Schimmel, E., Dzialowski, I., Foerch, C., Lorenz, M., Singer, O., Meyer dos Santos, I.M.R., Hartmann, A., Hamann, A., Schacht, A., Schrader, B., Teíchmann, A., Wartenberg, K.E., Mueller, T.J., Jander, S., Gliem, M., Boettcher, C., Rosenkranz, M., Beck, C., Otto, D., Thomalla, G., Cheng, B., Wong, K.S., Leung, T.W., Soo, Y.O.Y., Prabhakar, S., Kesavarapu, S.R., Gajjela, P.K., Chenna, R.R., Ummer, K., Basheer, M., Andipet, A., Jagarlapudi, M.K.M., Mohammed, A.U.R., Pawar, V.G., Eranki, S.S.K., Singh, Y., Akhtar, N., Borah, N.C., Ghose, M., Choudhury, N., Ichaporia, N.R., Shendge, J., Khese, S., Pamidimukkala, V., Inbamuthaiah, P., Nuthakki, S.R., Tagallamudi, N.M.R., Gutti, A.K., Khurana, D., Kesavarapu, P., Jogi, V., Garg, A., Samanta, D., Sarma, G.R.K., Nadig, R., Mathew, T., Anandan, M.A., Caterbi, E., Zini, A., Cavazzuti, M., Casoni, F., Pentore, R., Falzone, F., Mazzoli, T., Greco, L.M., Menichetti, C., Coppola, F., Cenciarelli, S., Gallinella, E., Mattioni, A., Condurso, R., Sicilia, I., Zampolini, M., Corea, F., Barbi, M., Proietti, C., Toni, D., Pieroni, A., Anzini, A., Falcou, A., Demichele, M., Klijn, C.J.M., Tveiten, A., Thortveit, E.T., Pettersen, S., Holand, N., Hitland, B., Johnsen, S.H., Eltoft, A., Wasay, M., Kamal, A., Iqrar, A., Ali, L., Begum, D., Gama, G., Fonseca, L., Moreira, G., Veloso, L.M., Pinheiro, D., Paredes, L., Rozeira, C., Gregorio, T., Segura Martin, T., Ayo, O., Garcia-Garcia, J., Feria Vilar, I., Gómez Fernández, I., Amaro, S., Urra, X., Obach, V., Cervera, A., Silva, Y., Serena, J., Castellanos, M., Terceno, M., Van Eendenburg, C., Weck, A., Findling, O., Lüdi, R., Warburton, E.A., Day, D., Butler, N., Bumanlag, E., Caine, S., Steele, A., Osborn, M., Dodd, E., Murphy, P., Esisi, B., Brown, E., Hayman, R., Baliga, V.K.V., Minphone, M., Kennedy, J., Reckless, I., Pope, G., Teal, R., Michael, K., Manawadu, D., Kalra, L., Lewis, R., Mistry, B., Cattermole, E., Hassan, A., Mandizvidza, L., Bamford, J., Brooks, H., Bedford, C., Whiting, R., Baines, P., Hussain, M., Harvey, M., Fotherby, K., McBride, S., Bourke, P., Morgan, D., Jennings-Preece, K., Price, C., Huntley, S., Riddell, V.E., Storey, G., Lakey, R.L., Subramanian, G., Jenkinson, D., Kwan, J., David, O., Tiwari, D., James, M., Keenan, S., Eastwood, H., Shaw, L., Kaye, P., Button, D., Madigan, B., Williamson, D., Dixit, A., Davis, J., Hossain, M.O., Ford, G.A., Parry-Jones, A., O'Loughlin, V., Jarapa, R., Naing, Z., Lovelock, C., O'Reilly, J., Khan, U., Bhalla, A., Rudd, A., Birns, J., Werring, D.J., Law, R., Perry, R., Jones, I., Erande, R., Roffe, C., Natarajan, I., Ahmad, N., Finney, K., Lucas, J., Mistri, A., Eveson, D., Marsh, R., Haunton, V., Fugate, J.E., Lepore, S.W., Zheng, Danni, Sato, Shoichiro, Arima, Hisatomi, Heeley, Emma, Delcourt, Candice, Cao, Yongjun, Chalmers, John, and Anderson, Craig S.

Published
2016
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3. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-Analysis Collaboration

Author

Askie, L.M., Darlow, B.A., Finer, N., Schmidt, B., Stenson, B., Tarnow-Mordi, W., Davis, P.G., Carlo, W.A., Brocklehurst, P., Davies, L.C., Das, A., Rich, W., Gantz, M.G., Roberts, R.S., Whyte, R.K., Costantini, L., Poets, C., Asztalos, E., Battin, M., Halliday, H.L., Marlow, N., Tin, W., King, A., Juszczak, E., Morley, C.J., Doyle, L.W., Gebski, V., Hunter, K.E., and Simes, R.J.

Published
2019
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8. Observation by electroabsorption of strain-enhanced interface roughening in Ga(x)In(1-x)As/Ga0.22In0.78As0.48P0.52 quantum wells prepared by gas-source molecular beam epitaxy

Author

Simes, R.J., Starck, C., Weihofen, R., and Weiser, G.

Subjects
Semiconductor lasers -- Research, Quantum wells -- Evaluation, Photoluminescence -- Usage, Electron optics -- Observations, Physics
Abstract

Gas source molecular beam epitaxy (GSMBE) aids the development of Ga(x)In(1-x)As/Ga(0.22)In(0.78)As(0.48)P(0.52) single quantum wells (QW),which exhibit an interface roughening increased by strain, as is revealed by electroabsorption (EA). As the strain is enhanced, the photoluminescence (PL) emission lines of the strained QW samples spread, in contrast to the samples with unstrained QWs, which show narrow PL emission lines. The meandering of many narrow emission lines causes the broadening of lines, as is revealed by EA measurements.

Published
1993

9. Induced electrostatic confinement of the electron gas in tensile strained InGaAs/InGaAsP quantum well lasers

Author

Barrau, J., Amand, T., Brosseau, M., Simes, R.J., and Goldstein, L.

Subjects
Lasers -- Research, Electrostatics -- Research, Electrons -- Research, Quantum wells -- Research, Physics
Abstract

Injection induced electrostatic confinement of electron gas was used to investigate the laser effect in tensile strained GaInAs/GaInAsP quantum well lasers. The results showed that the confinement principal in tensile strained quantum well lasers functioned at high densities in an electron-hole system when the holes were structurally confined. In addition, when free electron states were occupied, the confinement principal played a significant role.

Published
1992

12. Estimated GFR and the Effect of Intensive Blood Pressure Lowering after Acute Intracerebral Hemorrhage.

Author

Fischer R., Gama G., Fonseca L., Moreira G., Veloso L.M., Pinheiro D., Paredes L., Rozeira C., Gregorio T., Segura Martin T., Ayo O., Garcia-Garcia J., Feria Vilar I., Gomez Fernandez I., Amaro S., Urra X., Obach V., Cervera A., Silva Y., Serena J., Castellanos M., Terceno M., Van Eendenburg C., Weck A., Findling O., Ludi R., Warburton E.A., Day D., Butler N., Bumanlag E., Caine S., Steele A., Osborn M., Dodd E., Murphy P., Esisi B., Brown E., Hayman R., Baliga V.K.V., Minphone M., Kennedy J., Reckless I., Pope G., Teal R., Michael K., Manawadu D., Kalra L., Lewis R., Mistry B., Cattermole E., Hassan A., Mandizvidza L., Bamford J., Brooks H., Bedford C., Whiting R., Baines P., Hussain M., Harvey M., Fotherby K., McBride S., Bourke P., Morgan D., Jennings-Preece K., Price C., Huntley S., Riddell V.E., Storey G., Lakey R.L., Subramanian G., Jenkinson D., Kwan J., David O., Tiwari D., James M., Keenan S., Eastwood H., Shaw L., Kaye P., Button D., Madigan B., Williamson D., Dixit A., Davis J., Hossain M.O., Ford G.A., Parry-Jones A., O'Loughlin V., Jarapa R., Naing Z., Lovelock C., O'Reilly J., Khan U., Bhalla A., Rudd A., Birns J., Werring D.J., Law R., Perry R., Jones I., Erande R., Roffe C., Natarajan I., Ahmad N., Finney K., Lucas J., Mistri A., Eveson D., Marsh R., Haunton V., Fugate J.E., Lepore S.W., Zheng D., Sato S., Arima H., Heeley E., Delcourt C., Cao Y., Chalmers J., Anderson C.S., Davis S., Huang Y., Lavados P., Neal B., Parsons M.W., Lindley R., Morgenstern L., Robinson T., Stapf C., Tzourio C., Wang J.G., Chen S., Chen X.Y., Cui L., Liu Z., Lu C., Wang J., Wu S., Xu E., Yang Q., Zhang C., Zhang J., Beer R., Schmutzhard E., Redondo P., Kaste M., Soinne L., Tatlisumak T., Wartenberg K., Ricci S., Klijn K., Azevedo E., Chamorro A., Arnold M., Fischer U., Kaul S., Pandian J., Boyini H., Singh S., Rabinstein A.A., Estol C., Silva G., Olavarria V.V., Robinson T.G., Simes R.J., Bousser M.-G., Hankey G., Jamrozik K., Johnston S.C., Li S., Bailey K., Cheung T., Chintapatla S., Ducasse E., Erho T., Hata J., Holder B., Knight E., Leroux M., Sasse T., Odgers E., Walsh R., Wolfowicz Z., Chen G., Fuentes S., Peng B., Schneble H.-M., Wang M.-X., Billot L., Heritier S., Li Q., Woodward M., Abimbola S., Anderson S., Chan E., Cheng G., Chmielnik P., Leighton S., Liu J.-Y., Rasmussen B., Saxena A., Tripathy S., Armenis M., Baig M.A., Naidu B., Starzec G., Steley S., Moles A., Ruiz A., Zimmermann M., Marinho J., Alves S., Angelim R., Araujo J., Kawakami L., Bustos C., Gonzalez F., Munoz Venturelli P., Chen X., Jia R., Li N., Qu S., Shu Y., Song A., Sun J., Xiao J., Zhao Y., Huang Q., Vicaut E., Chamam A., Viaud M.-C., Dert C., Fiedler U., Jovis V., Kabla S., Marchand S., Pena A., Mallikarjuna K., Hasan N., Berge E., Sandset E.C., Forarsveen A.S., Richardson D., Kumar T., Lewin S., Poulter N., Field J., Anjum A., Wilson A., Perelmuter H., Agarie A.M., Barboza A.G., Recchia L.A., Miranda I.F., Rauek S.G., Duplessis R.J., Dewey H., Walker L., Petrolo S., Bladin C., Sturm J., Crimmins D., Griffiths D., Schutz A., Zenteno V., Miteff F., Spratt N., Kerr E., Levi C.R., Phan T.G., Ma H., Sanders L., Moran C., Wong K., Read S., Henderson R., Wong A., Hull R., Skinner G., Hand P., Yan B., Tu H., Campbell B., Blacker D.J., Wijeratne T., Pathirage M., Jasinararchchi M., Matkovic Z., Celestino S., Gruber F., Vosko M.R., Diabl E., Rathmaier S., Pfausler B., Helbok R., Fazekas F., Poltrum B., Zechner B., Trummer U., Rutgers M.P., Peeters A., Dusart A., Duray M.-C., Parmentier C., Ferrao-Santos S., Brouns R., De Raedt S., De Smedt A., Vanhooff R.-J., De Keyser J., Martins S.C.O., De Almeida A.G., Broudani R., Titton N.F., De Freitas G.R., Cardoso F.M., Giesel L.M., Lima N.A., Ferraz De Almeida A.C., Gomes R.B., Borges Dos Santos T.S., Veloso Soares E.M., Neto O.L.A., Silva G.S., Gomes D.L., De Carvalho F.A., Miranda M., Marques A., Zetola V.F., De Matia G., Lange M.C., Montes J., Reccius A., Soto A., Rivas R., Klapp C., Illanes S., Aguilera C., Castro A., Figueroa C., Benavides J., Salamanca P., Concha M.C., Pajarito J., Araya P., Guerra F., Li Y., Liu G., Wang B., Chong Y., He M., Wang L., Liu J., Zhang X., Lai C., Jiang H., Cui S., Tao Q., Zhang Y., Yao S., Xu M., Xiao H., Hu J., Tang J., Ji H., Jiang M., Yu F., Yang X., Guo X., Wang Y., Wu L., Gao Y., Sun D., Huang X., Liu L., Li P., Jiang Y., Li H., Lu H., Zhou J., Yuan C., Qi X., Qiu F., Qian H., Wang W., Sun W., Li F., Liu R., Peng Q., Ren Z., Fan C., Wang H., Wang T., Shi F., Duan C., Chen Z., Tan X., Zhao Z., Chen J., Han T., Zhang L., Hu Q., Hou Q., Zhao X., Zeng G., Ma L., Wang F., Guo Z., Fu Y., Song Y., Tai L., Liu X., Su X., Yang Y., Dong R., Xu Y., Tian S., Cheng S., Su L., Xie X., Xu T., Geng D., Yan X., Fan H., Zhao N., Wang S., Yang J., Yan M., Li L., Li Z., Xu X., Lian Y., Sun H., Liu D., Wang N., Tang Q., Han Z., Feng L., Cui Y., Tian J., Chang H., Sun X., Liu C., Wen Z., Lin Q., Sun L., Hu B., Zou M., Bao Q., Lin X., Zhao L., Tian X., Wang X., Li X., Hao L., Duan Y., Wang R., Wei Z., Ren S., Ren H., Dong Y., Cheng Y., Liu W., Han J., Zhang Z., Zhu J., Qian J., Sun Y., Liu K., Long F., Peng X., Zhang Q., Yuan Z., Wang C., Huang M., He P., You Y., Xia J., Zhou L., Hou Y., Qi Y., Mei L., Lu R., Ping L., Zhou S., Zhang S., Zou R., Guo J., Li M., Wei W., Curtze S., Saarela M., Strbian D., Scheperjans F., De Broucker T., Henry C., Cumurciuc R., Ibos-Auge N., Zeghoudi A.-C., Pico F., Dereeper O., Simian M.-C., Boisselier C., Mahfoud A., Timsit S., Merrien F.M., Guillon B., Sevin M., Herisson F., Magne C., Ameri A., Cret C., Stefanizzi S., Klapzcynski F., Denier C., Sarov-Riviere M., Reiner P., Mawet J., Herve D., Buffon F., Touze E., Domigo V., Lamy C., Calvet D., Pasquini M., Alamowitch S., Favrole P., Muresan I.-P., Crozier S., Rosso C., Pires C., Leger A., Deltour S., Cordonnier C., Henon H., Rossi C., Zuber M., Bruandet M., Tamazyan R., Join-Lambert C., Juettler E., Krause T., Maul S., Endres M., Jungehulsing G.J., Hennerici M., Griebe M., Sauer T., Knoll K., Huber R., Knauer K., Knauer C., Raubold S., Schneider H., Hentschel H., Lautenschlager C., Schimmel E., Dzialowski I., Foerch C., Lorenz M., Singer O., Meyer Dos Santos I.M.R., Hartmann A., Hamann A., Schacht A., Schrader B., Teichmann A., Wartenberg K.E., Mueller T.J., Jander S., Gliem M., Boettcher C., Rosenkranz M., Beck C., Otto D., Thomalla G., Cheng B., Wong K.S., Leung T.W., Soo Y.O.Y., Prabhakar S., Kesavarapu S.R., Gajjela P.K., Chenna R.R., Ummer K., Basheer M., Andipet A., Jagarlapudi M.K.M., Mohammed A.U.R., Pawar V.G., Eranki S.S.K., Singh Y., Akhtar N., Borah N.C., Ghose M., Choudhury N., Ichaporia N.R., Shendge J., Khese S., Pamidimukkala V., Inbamuthaiah P., Nuthakki S.R., Tagallamudi N.M.R., Gutti A.K., Khurana D., Kesavarapu P., Jogi V., Garg A., Samanta D., Sarma G.R.K., Nadig R., Mathew T., Anandan M.A., Caterbi E., Zini A., Cavazzuti M., Casoni F., Pentore R., Falzone F., Mazzoli T., Greco L.M., Menichetti C., Coppola F., Cenciarelli S., 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Abstract

Background: The kidney-brain interaction has been a topic of growing interest. Past studies of the effect of kidney function on intracerebral hemorrhage (ICH) outcomes have yielded inconsistent findings. Although the second, main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2) suggests the effectiveness of early intensive blood pressure (BP) lowering in improving functional recovery after ICH, the balance of potential benefits and harms of this treatment in those with decreased kidney function remains uncertain. Study Design: Secondary analysis of INTERACT2, which randomly assigned patients with ICH with elevated systolic BP (SBP) to intensive (target SBP < 140 mm Hg) or contemporaneous guideline-based (target SBP < 180 mm Hg) BP management. Setting & Participants: 2,823 patients from 144 clinical hospitals in 21 countries. Predictors Admission estimated glomerular filtration rates (eGFRs) of patients were categorized into 3 groups based on the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation: normal or high, mildly decreased, and moderately to severely decreased (>90, 60-90, and <60 mL/min/1.73 m2, respectively). Outcome(s): The effect of admission eGFR on the primary outcome of death or major disability at 90 days (defined as modified Rankin Scale scores of 3-6) was analyzed using a multivariable logistic regression model. Potential effect modification of intensive BP lowering treatment by admission eGFR was assessed by interaction terms. Result(s): Of 2,623 included participants, 912 (35%) and 280 (11%) had mildly and moderately/severely decreased eGFRs, respectively. Patients with moderately/severely decreased eGFRs had the greatest risk for death or major disability at 90 days (adjusted OR, 1.82; 95% CI, 1.28-2.61). Effects of early intensive BP lowering were consistent across different eGFRs (P = 0.5 for homogeneity). Limitation(s): Generalizability issues arising from a clinical tri

Published
2016

13. Estimated GFR and the Effect of Intensive Blood Pressure Lowering After Acute Intracerebral Hemorrhage

Author

Zheng, Danni, primary, Sato, Shoichiro, additional, Arima, Hisatomi, additional, Heeley, Emma, additional, Delcourt, Candice, additional, Cao, Yongjun, additional, Chalmers, John, additional, Anderson, Craig S., additional, Anderson, C.S., additional, Chalmers, J., additional, Arima, H., additional, Davis, S., additional, Heeley, E., additional, Huang, Y., additional, Lavados, P., additional, Neal, B., additional, Parsons, M.W., additional, Lindley, R., additional, Morgenstern, L., additional, Robinson, T., additional, Stapf, C., additional, Tzourio, C., additional, Wang, J.G., additional, Chen, S., additional, Chen, X.Y., additional, Cui, L., additional, Liu, Z., additional, Lu, C., additional, Wang, J., additional, Wu, S., additional, Xu, E., additional, Yang, Q., additional, Zhang, C., additional, Zhang, J., additional, Beer, R., additional, Schmutzhard, E., additional, Redondo, P., additional, Kaste, M., additional, Soinne, L., additional, Tatlisumak, T., additional, Wartenberg, K., additional, Ricci, S., additional, Klijn, K., additional, Azevedo, E., additional, Chamorro, A., additional, Arnold, M., additional, Fischer, U., additional, Kaul, S., additional, Pandian, J., additional, Boyini, H., additional, Singh, S., additional, Rabinstein, A.A., additional, Estol, C., additional, Silva, G., additional, Olavarria, V.V., additional, Robinson, T.G., additional, Simes, R.J., additional, Bousser, M.-G., additional, Hankey, G., additional, Jamrozik, K., additional, Johnston, S.C., additional, Li, S., additional, Bailey, K., additional, Cheung, T., additional, Delcourt, C., additional, Chintapatla, S., additional, Ducasse, E., additional, Erho, T., additional, Hata, J., additional, Holder, B., additional, Knight, E., additional, Leroux, M., additional, Sassé, T., additional, Odgers, E., additional, Walsh, R., additional, Wolfowicz, Z., additional, Chen, G., additional, Fuentes, S., additional, Peng, B., additional, Schneble, H.-M., additional, Wang, M.-X., additional, Billot, L., additional, Heritier, S., additional, Li, Q., additional, Woodward, M., additional, Abimbola, S., additional, Anderson, S., additional, Chan, E., additional, Cheng, G., additional, Chmielnik, P., additional, Leighton, S., additional, Liu, J.-Y., additional, Rasmussen, B., additional, Saxena, A., additional, Tripathy, S., additional, Armenis, M., additional, Baig, M.A., additional, Naidu, B., additional, Starzec, G., additional, Steley, S., additional, Moles, A., additional, Ruiz, A., additional, Zimmermann, M., additional, Marinho, J., additional, Alves, S., additional, Angelim, R., additional, Araujo, J., additional, Kawakami, L., additional, Bustos, C., additional, Gonzalez, F., additional, Munoz Venturelli, P., additional, Chen, X., additional, Jia, R., additional, Li, N., additional, Qu, S., additional, Shu, Y., additional, Song, A., additional, Sun, J., additional, Xiao, J., additional, Zhao, Y., additional, Huang, Q., additional, Vicaut, E., additional, Chamam, A., additional, Viaud, M.-C., additional, Dert, C., additional, Fiedler, U., additional, Jovis, V., additional, Kabla, S., additional, Marchand, S., additional, Pena, A., additional, Rochaud, V., additional, Mallikarjuna, K., additional, Hasan, N., additional, Berge, E., additional, Sandset, E.C., additional, Forårsveen, A.S., additional, Richardson, D., additional, Kumar, T., additional, Lewin, S., additional, Poulter, N., additional, Field, J., additional, Anjum, A., additional, Wilson, A., additional, Perelmuter, H., additional, Agarie, A.M., additional, Barboza, A.G., additional, Recchia, L.A., additional, Miranda, I.F., additional, Rauek, S.G., additional, Duplessis, R.J., additional, Dewey, H., additional, Walker, L., additional, Petrolo, S., additional, Bladin, C., additional, Sturm, J., additional, Crimmins, D., additional, Griffiths, D., additional, Schutz, A., additional, Zenteno, V., additional, Miteff, F., additional, Spratt, N., additional, Kerr, E., additional, Levi, C.R., additional, Phan, T.G., additional, Ma, H., additional, Sanders, L., additional, Moran, C., additional, Wong, K., additional, Read, S., additional, Henderson, R., additional, Wong, A., additional, Hull, R., additional, Skinner, G., additional, Hand, P., additional, Yan, B., additional, Tu, H., additional, Campbell, B., additional, Blacker, D.J., additional, Wijeratne, T., additional, Pathirage, M., additional, Jasinararchchi, M., additional, Matkovic, Z., additional, Celestino, S., additional, Gruber, F., additional, Vosko, M.R., additional, Diabl, E., additional, Rathmaier, S., additional, Pfausler, B., additional, Helbok, R., additional, Fazekas, F., additional, Fischer, R., additional, Poltrum, B., additional, Zechner, B., additional, Trummer, U., additional, Rutgers, M.P., additional, Peeters, A., additional, Dusart, A., additional, Duray, M.-C., additional, Parmentier, C., additional, Ferrao-Santos, S., additional, Brouns, R., additional, De Raedt, S., additional, De 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Pasquini, M., additional, Alamowitch, S., additional, Favrole, P., additional, Muresan, I.-P., additional, Crozier, S., additional, Rosso, C., additional, Pires, C., additional, Leger, A., additional, Deltour, S., additional, Cordonnier, C., additional, Henon, H., additional, Rossi, C., additional, Zuber, M., additional, Bruandet, M., additional, Tamazyan, R., additional, Join-Lambert, C., additional, Juettler, E., additional, Krause, T., additional, Maul, S., additional, Endres, M., additional, Jungehulsing, G.J., additional, Hennerici, M., additional, Griebe, M., additional, Sauer, T., additional, Knoll, K., additional, Huber, R., additional, Knauer, K., additional, Knauer, C., additional, Raubold, S., additional, Schneider, H., additional, Hentschel, H., additional, Lautenschläger, C., additional, Schimmel, E., additional, Dzialowski, I., additional, Foerch, C., additional, Lorenz, M., additional, Singer, O., additional, Meyer dos Santos, I.M.R., additional, Hartmann, A., additional, Hamann, A., additional, Schacht, A., additional, Schrader, B., additional, Teíchmann, A., additional, Wartenberg, K.E., additional, Mueller, T.J., additional, Jander, S., additional, Gliem, M., additional, Boettcher, C., additional, Rosenkranz, M., additional, Beck, C., additional, Otto, D., additional, Thomalla, G., additional, Cheng, B., additional, Wong, K.S., additional, Leung, T.W., additional, Soo, Y.O.Y., additional, Prabhakar, S., additional, Kesavarapu, S.R., additional, Gajjela, P.K., additional, Chenna, R.R., additional, Ummer, K., additional, Basheer, M., additional, Andipet, A., additional, Jagarlapudi, M.K.M., additional, Mohammed, A.U.R., additional, Pawar, V.G., additional, Eranki, S.S.K., additional, Singh, Y., additional, Akhtar, N., additional, Borah, N.C., additional, Ghose, M., additional, Choudhury, N., additional, Ichaporia, N.R., additional, Shendge, J., additional, Khese, S., additional, Pamidimukkala, V., additional, Inbamuthaiah, P., additional, Nuthakki, S.R., additional, Tagallamudi, N.M.R., additional, Gutti, A.K., additional, Khurana, D., additional, Kesavarapu, P., additional, Jogi, V., additional, Garg, A., additional, Samanta, D., additional, Sarma, G.R.K., additional, Nadig, R., additional, Mathew, T., additional, Anandan, M.A., additional, Caterbi, E., additional, Zini, A., additional, Cavazzuti, M., additional, Casoni, F., additional, Pentore, R., additional, Falzone, F., additional, Mazzoli, T., additional, Greco, L.M., additional, Menichetti, C., additional, Coppola, F., additional, Cenciarelli, S., additional, Gallinella, E., additional, Mattioni, A., additional, Condurso, R., additional, Sicilia, I., additional, Zampolini, M., additional, Corea, F., additional, Barbi, M., additional, Proietti, C., additional, Toni, D., additional, Pieroni, A., additional, Anzini, A., additional, Falcou, A., additional, Demichele, M., additional, Klijn, C.J.M., additional, Tveiten, A., additional, Thortveit, E.T., additional, Pettersen, S., additional, Holand, N., additional, Hitland, B., additional, Johnsen, S.H., additional, Eltoft, A., additional, Wasay, M., additional, Kamal, A., additional, Iqrar, A., additional, Ali, L., additional, Begum, D., additional, Gama, G., additional, Fonseca, L., additional, Moreira, G., additional, Veloso, L.M., additional, Pinheiro, D., additional, Paredes, L., additional, Rozeira, C., additional, Gregorio, T., additional, Segura Martin, T., additional, Ayo, O., additional, Garcia-Garcia, J., additional, Feria Vilar, I., additional, Gómez Fernández, I., additional, Amaro, S., additional, Urra, X., additional, Obach, V., additional, Cervera, A., additional, Silva, Y., additional, Serena, J., additional, Castellanos, M., additional, Terceno, M., additional, Van Eendenburg, C., additional, Weck, A., additional, Findling, O., additional, Lüdi, R., additional, Warburton, E.A., additional, Day, D., additional, Butler, N., additional, Bumanlag, E., additional, Caine, S., additional, Steele, A., additional, Osborn, M., additional, Dodd, E., additional, Murphy, P., additional, Esisi, B., additional, Brown, E., additional, Hayman, R., additional, Baliga, V.K.V., additional, Minphone, M., additional, Kennedy, J., additional, Reckless, I., additional, Pope, G., additional, Teal, R., additional, Michael, K., additional, Manawadu, D., additional, Kalra, L., additional, Lewis, R., additional, Mistry, B., additional, Cattermole, E., additional, Hassan, A., additional, Mandizvidza, L., additional, Bamford, J., additional, Brooks, H., additional, Bedford, C., additional, Whiting, R., additional, Baines, P., additional, Hussain, M., additional, Harvey, M., additional, Fotherby, K., additional, McBride, S., additional, Bourke, P., additional, Morgan, D., additional, Jennings-Preece, K., additional, Price, C., additional, Huntley, S., additional, Riddell, V.E., additional, Storey, G., additional, Lakey, R.L., additional, Subramanian, G., additional, Jenkinson, D., additional, Kwan, J., additional, David, O., additional, Tiwari, D., additional, James, M., additional, Keenan, S., additional, Eastwood, H., additional, Shaw, L., additional, Kaye, P., additional, Button, D., additional, Madigan, B., additional, Williamson, D., additional, Dixit, A., additional, Davis, J., additional, Hossain, M.O., additional, Ford, G.A., additional, Parry-Jones, A., additional, O'Loughlin, V., additional, Jarapa, R., additional, Naing, Z., additional, Lovelock, C., additional, O'Reilly, J., additional, Khan, U., additional, Bhalla, A., additional, Rudd, A., additional, Birns, J., additional, Werring, D.J., additional, Law, R., additional, Perry, R., additional, Jones, I., additional, Erande, R., additional, Roffe, C., additional, Natarajan, I., additional, Ahmad, N., additional, Finney, K., additional, Lucas, J., additional, Mistri, A., additional, Eveson, D., additional, Marsh, R., additional, Haunton, V., additional, Fugate, J.E., additional, and Lepore, S.W., additional

Published
2016
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14. The FIELD study

Author

Foger, Bernhard, Sirtori, Cesare R., Keech, A., Simes, R.J., Barter, P., Best, J., Scott, R., and Taskinen, M.-R.

Published
2006

15. Precision Medicine for Advanced Pancreas Cancer: Early Lessons Learned from Negotiating the Pitfalls of a Molecular Therapeutics Trial in a Poor Prognosis Cancer

Author

Chantrill, L., primary, Johns, A., additional, Watson, C., additional, Mead, S., additional, Gill, A., additional, Pavlakis, N., additional, Grimison, P., additional, Asghari, G.R., additional, Li, B., additional, Chou, A., additional, Simpson, S., additional, Martyn-Smith, M., additional, Nagrial, A., additional, Chin, V., additional, Sebastian, L., additional, Yip, S., additional, Sjoquist, K., additional, Grimmond, S., additional, Simes, R.J., additional, and Biankin, A., additional

Published
2014
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17. Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomized trial

Author

White, H.D., Simes, R.J., Aylward, P.E.G., Armstrong, P.W., Califf, R.M., French, J.K., Granger, C.B., Marschner, I.C., Topol, E.J., Van de Werf, F.J., and Wilcox, R.G.

Subjects
acute myocardial infarction, treatment, bivalirudin
Abstract

The combination of fibrinolytic therapy and heparin for acute myocardial infarction fails to achieve reperfusion in 40-70% of patients, and early reocclusion occurs in a substantial number. We did a randomised, open-label trial to compare the thrombin-specific anticoagulant, bivalirudin, with heparin in patients undergoing fibrinolysis with streptokinase for acute myocardial infarction. Bivalirudin did not reduce mortality compared with unfractionated heparin, but did reduce the rate of adjudicated reinfarction within 96 h by 30%. Small absolute increases were seen in mild and moderate bleeding in patients given bivalirudin. Bivalirudin is a new anticoagulant treatment option in patients with acute myocardial infarction treated with streptokinase.

Published
2001

18. Risk of arterial thromboembolic events in patients with advanced colorectal cancer receiving bevacizumab.

Author

Price T.J., Lowenthal R.M., Marx G., Karapetis C., Shannon J., Goldstein D., Nayagam S.S., Blum R., Chantrill L., Simes R.J., Tebbutt N.C., Murphy F., Zannino D., Wilson K., Cummins M.M., Abdi E., Strickland A.H., Price T.J., Lowenthal R.M., Marx G., Karapetis C., Shannon J., Goldstein D., Nayagam S.S., Blum R., Chantrill L., Simes R.J., Tebbutt N.C., Murphy F., Zannino D., Wilson K., Cummins M.M., Abdi E., and Strickland A.H.

Abstract

Background: Bevacizumab is an antiangiogenic mAb with efficacy against several cancers, but it is associated with risk of arterial thromboembolism (ATE). Further data are needed to determine the safety of bevacizumab. Patients and Methods: We recorded grade 3, 4, or 5 ATE events and other data (including age, baseline cardiovascular risk factors, history of ATE, and aspirin use) from 471 patients with metastatic colorectal cancer in the MAX (Mitomycin, Avastin, Xeloda) trial of capecitabine monotherapy versus capecitabine with bevacizumab with or without mitomycin C. Result(s): Bevacizumab-treated patients had 12 grade 3, 4, or 5 ATEs (3.8% incidence). ATEs occurred in 2.1% of patients >65 years, 5% of those with a history of ATE, and 5% of those with cardiac risk factors. Age, history of ATE, or vascular risk factors did not increase risk. Aspirin users had a higher incidence than nonusers (8.9% versus 2.7%) but had higher rates of vascular risk factors. Conclusion(s): Bevacizumab was associated with a modestly higher risk of ATE, but safety was not significantly worse in older patients or patients with a history of ATE or vascular risk factors. The effect of aspirin in preventing ATE in patients receiving bevacizumab could not be determined from this study. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Published
2012

19. Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomised trial

Author

Topol, E., Califf, R.M., Simes, R.J., Werf, F. van de, Diaz, R., Paoloasso, E., Aylward, P., Keech, A., Klein, W., Piegas, L., Tomov, I., Armstrong, P.W., Widimsky, P., Grande, P., Halinen, M., Vahanian, A., Neuhaus, K., Dimas, A.P., White, H., Preda, I., Kristinsson, A., Ardissino, D., Tzivoni, D., Madsen, S., Sugrue, D., Sadowski, Z., Seabra-Gomes, R., Apetrei, E., Dalby, A., Betriu, A., Pfisterer, M., Verheugt, F.W.A., Fox, K., Bates, E.R., Gibler, W.B., Granger, C., Harrington, R.A., Hochman, J.S., Holmes, D.R., Kleiman, N.S., Lee, K.L., Molietrno, D.J., Newby, L.K., and Ohman, E.M.

Subjects
Reperfusion therapy in acute coronary syndromes, Reperfusietherapie bij acute coronaire syndromen
Abstract

Item does not contain fulltext 15 p.

Published
2000

20. Prognostic nomogram to predict progression-free survival in patients with platinum-sensitive recurrent ovarian cancer

Author

Lee, C.K., Simes, R.J., Brown, C., Lord, S., Wagner, U., Plante, M., Vergote, I., Pisano, C., Parma, G., Burges, A., Bourgeois, H., Hogberg, T., Bentley, J., Angleitner-Boubenizek, L., Ferrero, A., Richter, B., Hirte, H., Gebski, V., Pfisterer, J., Pujade-Lauraine, E., Friedlander, M., Lee, C.K., Simes, R.J., Brown, C., Lord, S., Wagner, U., Plante, M., Vergote, I., Pisano, C., Parma, G., Burges, A., Bourgeois, H., Hogberg, T., Bentley, J., Angleitner-Boubenizek, L., Ferrero, A., Richter, B., Hirte, H., Gebski, V., Pfisterer, J., Pujade-Lauraine, E., and Friedlander, M.

Abstract

BACKGROUND: Patients with platinum-sensitive recurrent ovarian cancer are a heterogeneous group, and it is not possible to accurately predict the progression-free survival (PFS) in these patients. We developed and validated a nomogram to help improve prediction of PFS in patients treated with platinum-based chemotherapy. METHODS: The nomogram was developed in a training cohort (n = 955) from the CALYPSO trial and validated in the AGO-OVAR 2.5 Study (n = 340). The proportional-hazards model (nomogram) was based on pre-treatment characteristics. RESULTS: The nomogram had a concordance index (C-index) of 0.645. Significant predictors were tumour size platinum-chemotherapy-free interval, CA-125, number of organ metastatic sites and white blood count. When the nomogram was applied without CA-125 (CA-125 was not available in validation cohort), the C-indices were 0.624 (training) and 0.594 (validation). When classification was based only on the platinum-chemotherapy-free interval, the indices were 0.571 (training) and 0.560 (validation). The calibration plot in the validation cohort based on four predictors (without CA-125) suggested good agreement between actual and nomogram-predicted 12-month PFS probabilities. CONCLUSION: This nomogram, using five pre-treatment characteristics, improves prediction of PFS in patients with platinum-sensitive ovarian cancer having platinum-based chemotherapy. It will be useful for the design and stratification of patients in clinical trials and also for counselling patients.

Published
2011
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21. High-risk patients with ST-elevation myocardial infarction derive greatest absolute benefit from primary percutaneous coronary intervention: results from the Primary Coronary Angioplasty Trialist versus thrombolysis (PCAT)-2 collaboration

Author

Boer, S.P. de, Barnes, E.H., Westerhout, C.M., Simes, R.J., Granger, C.B., Kastrati, A., Widimsky, P., Boer, M.J. de, Zijlstra, F., Boersma, E., Boer, S.P. de, Barnes, E.H., Westerhout, C.M., Simes, R.J., Granger, C.B., Kastrati, A., Widimsky, P., Boer, M.J. de, Zijlstra, F., and Boersma, E.

Abstract

Item does not contain fulltext, BACKGROUND: Meta-analyses of randomized trials show that primary percutaneous coronary intervention (PPCI) results in lower mortality than fibrinolytic therapy in patients with myocardial infarction. We investigated which categories of patients with myocardial infarction would benefit most from the strategy of PPCI and, thus, have lowest numbers needed to treat to prevent a death. METHODS: Individual patient data were obtained from 22 (n = 6,763) randomized trials evaluating efficacy and safety of PPCI versus fibrinolysis. A risk score was developed and validated to estimate the probability of 30-day death in individuals. Patients were then divided in quartiles according to risk. Subsequent analyses were performed to evaluate if the treatment effect was modified by estimated risk. RESULTS: Overall, 446 patients (6.6%) died within 30 days after randomization. The mortality risk score contained clinical characteristics, including the time from symptom onset to randomization. The c-index was 0.76, and the Hosmer-Lemeshow test was nonsignificant, reflecting adequate discrimination and calibration. Patients randomized to PPCI had lower mortality than did patients randomized to fibrinolysis (5.3% vs 7.9%, adjusted odds ratio 0.63, 95% CI 0.42-0.84, P < .001). The interaction between risk score and allocated treatment interaction term had no significant contribution (P = .52) to the model, indicating that the relative mortality reduction by PPCI was similar at all levels of estimated risk. In contrast, the absolute risk reduction was strongly related to estimated risk at baseline: the numbers needed to treat to prevent a death by PPCI versus fibrinolysis was 516 in the lowest quartile of estimated risk compared with only 17 in the highest quartile. CONCLUSION: Primary percutaneous coronary intervention is consistently associated with a strong relative reduction in 30-day mortality, irrespective of patient baseline risk, and should therefore be considered as the first choic

Published
2011

22. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group randomized phase III MAX study.

Author

Howard J., Parker S., Welby S., Page F., Corker M., Wykes R., Goss C., Whitney S., Oates J., Soulis E., Hoque M., Gebbie C., Tebbutt N.C., Wilson K., Gebski V.J., Cummins M.M., Zannino D., Van Hazel G.A., Robinson B., Broad A., Ganju V., Ackland S.P., Forgeson G., Cunningham D., Saunders M.P., Stockler M.R., Chua Y., Zalcberg J.R., Simes R.J., Price T.J., Price T., Coates A., O'Connell D., Brown C., Hague W., France A., Hicks S., James R., Masson R., O'Connell R., Pike R., Shoulder J., Stevens L., Tunney V., Vachan B., Wong N., Ackland S., Moylan E., Strickland A., Abdi E., Ransom D., Lowenthal R., Marx G., Nayagam S.S., Shannon J., Goldstein D., Karapetis C., Blum R., Eek R., Ward R., Pavlakis N., Wilcken N., Burns I., Wyld D., Underhill C., Claringbold P., Liauw W., Clingan P., Jefford M., Horvath L., McKendrick J., Chong G., Boyce A., Cassidy J., Kirsten F., Clarke S., Guo Y., Innes-Rowe J., Smith A., Williams J., Tournier E., Maliepaard S., Vitullo E., Humm G., Nguyen V., Midolo P., Chorlton C., McDonald L., Oliver L., Sjursen A.-M., Inglis C., Marafioti T., McCourt J., Richards A., Provis A., Rundle A., Whatman A., Emmett L., Raymond B., Byrne S., Withers E., Campbell J., Hodgkins C., Szwajcer M., Howard J., Parker S., Welby S., Page F., Corker M., Wykes R., Goss C., Whitney S., Oates J., Soulis E., Hoque M., Gebbie C., Tebbutt N.C., Wilson K., Gebski V.J., Cummins M.M., Zannino D., Van Hazel G.A., Robinson B., Broad A., Ganju V., Ackland S.P., Forgeson G., Cunningham D., Saunders M.P., Stockler M.R., Chua Y., Zalcberg J.R., Simes R.J., Price T.J., Price T., Coates A., O'Connell D., Brown C., Hague W., France A., Hicks S., James R., Masson R., O'Connell R., Pike R., Shoulder J., Stevens L., Tunney V., Vachan B., Wong N., Ackland S., Moylan E., Strickland A., Abdi E., Ransom D., Lowenthal R., Marx G., Nayagam S.S., Shannon J., Goldstein D., Karapetis C., Blum R., Eek R., Ward R., Pavlakis N., Wilcken N., Burns I., Wyld D., Underhill C., Claringbold P., Liauw W., Clingan P., Jefford M., Horvath L., McKendrick J., Chong G., Boyce A., Cassidy J., Kirsten F., Clarke S., Guo Y., Innes-Rowe J., Smith A., Williams J., Tournier E., Maliepaard S., Vitullo E., Humm G., Nguyen V., Midolo P., Chorlton C., McDonald L., Oliver L., Sjursen A.-M., Inglis C., Marafioti T., McCourt J., Richards A., Provis A., Rundle A., Whatman A., Emmett L., Raymond B., Byrne S., Withers E., Campbell J., Hodgkins C., and Szwajcer M.

Abstract

Purpose: To determine whether adding bevacizumab, with or without mitomycin, to capecitabine monotherapy improves progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) in an open-label, three-arm randomized trial. Patients and Methods: Overall, 471 patients in Australia, New Zealand, and the United Kingdom with previously untreated, unresectable mCRC were randomly assigned to the following: capecitabine; capecitabine plus bevacizumab (CB); or capecitabine, bevacizumab, and mitomycin (CBM). We compared CB with capecitabine and CBM with capecitabine for progression-free survival (PFS). Secondary end points included overall survival (OS), toxicity, response rate (RR), and quality of life (QOL). Result(s): Median PFS was 5.7 months for capecitabine, 8.5 months for CB, and 8.4 months for CBM (capecitabine v CB: hazard ratio [HR], 0.63; 95% CI, 0.50 to 0.79; P < .001; C v CBM: HR, 0.59; 95% CI, 0.47 to 0.75; P < .001). After a median follow-up of 31 months, median OS was 18.9 months for capecitabine and was 16.4 months for CBM; these data were not significantly different. Toxicity rates were acceptable, and all treatment regimens well tolerated. Bevacizumab toxicities were similar to those in previous studies. Measures of overall QOL were similar in all groups. Conclusion(s): Adding bevacizumab to capecitabine, with or without mitomycin, significantly improves PFS without major additional toxicity or impairment of QOL. Copyright © 2010 by American Society of Clinical Oncology.

Published
2011

23. A prognostic nomogram to predict overall survival in patients with platinum-sensitive recurrent ovarian cancer

Author

Lee, C.K., primary, Simes, R.J., additional, Brown, C., additional, Gebski, V., additional, Pfisterer, J., additional, Swart, A.-M., additional, Berton-Rigaud, D., additional, Plante, M., additional, Skeie-Jensen, T., additional, Vergote, I., additional, Schauer, C., additional, Pisano, C., additional, Parma, G., additional, Baumann, K., additional, Ledermann, J.A., additional, Pujade-Lauraine, E., additional, Bentley, J., additional, Kristensen, G., additional, Belau, A., additional, Nankivell, M., additional, Canzler, U., additional, Lord, S.J., additional, Kurzeder, C., additional, and Friedlander, M., additional

Published
2013
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27. Bevacizumab is equally effective and no more toxic in elderly patients with advanced colorectal cancer: a subgroup analysis from the AGITG MAX trial: an international randomised controlled trial of Capecitabine, Bevacizumab and Mitomycin C

Author

Price, T.J., primary, Zannino, D., additional, Wilson, K., additional, Simes, R.J., additional, Cassidy, J., additional, Van Hazel, G.A., additional, Robinson, B.A., additional, Broad, A., additional, Ganju, V., additional, Ackland, S.P., additional, and Tebbutt, N.C., additional

Published
2012
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29. Sustained ventricular arrhythmias among patients with acute coronary syndromes with no ST-segment elevation: incidence, predictors, and outcomes

Author

White, H.D. (Harvey), Harrington, R.A. (Robert Alex), Simes, R.J. (John), Topol, E.J. (Eric), Moliterno, D.J. (David), Granger, C.B. (Christopher), Huang, Y. (Yao), Lee, K.L. (Kerry), Califf, R.M. (Robert), Simoons, M.L. (Maarten), Armstrong, P.W. (Paul), Werf, F.J.J. (Frans) van de, Al-Khatib, S.M. (Sana), White, H.D. (Harvey), Harrington, R.A. (Robert Alex), Simes, R.J. (John), Topol, E.J. (Eric), Moliterno, D.J. (David), Granger, C.B. (Christopher), Huang, Y. (Yao), Lee, K.L. (Kerry), Califf, R.M. (Robert), Simoons, M.L. (Maarten), Armstrong, P.W. (Paul), Werf, F.J.J. (Frans) van de, and Al-Khatib, S.M. (Sana)

Abstract

BACKGROUND: The prognosis of ventricular arrhythmias among patients with non-ST-elevation acute coronary syndromes is unknown. We studied the incidence, predictors, and outcomes of sustained ventricular arrhythmias in 4 large randomized trials of such patients. METHODS AND RESULTS: We pooled the datasets of the Global Use of Streptokinase and tPA for Occluded Arteries (GUSTO)-IIb, Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT), Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network (PARAGON)-A, and PARAGON-B trials (n=26 416). We identified independent predictors of ventricular fibrillation (VF) and ventricular tachycardia (VT) and compared the 30-day and 6-month mortality rates of patients who did (n=552) and did not (n=25 864) develop these arrhythmias during the index hospitalization. Independent predictors of in-hospital VF included prior hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, and ST-segment changes at presentation. Except for hypertension, these variables also independently predicted in-hospital VT. In Cox proportional-hazards modeling, in-hospital VF and VT were independently associated with 30-day mortality (hazard ratio [HR], 23.2 [95% CI, 18.1 to 29.8] for VF and HR, 7.6 [95% CI, 5.5 to 10.4] for VT) and 6-month mortality (HR, 14.8 [95% CI, 12.1 to 18.3] for VF and HR, 5.0 [95% CI, 3.8 to 6.5] for VT). These differences remained significant after excluding patients with heart failure or cardiogenic shock and those who died <24 hours after enrollment. CONCLUSIONS: Despite the use of effective therapies for non-ST-elevation acute coronary syndromes, ventricular arrhythmias in this setting are associated with increased 30-day and 6-month mortality. More effective therapies are needed to improve the survival of patients with these arrhythmias.

Published
2002

32. Selection of thrombolytic therapy for individual patients: development of a clinical model

Author

Califf, R.M. (Robert), Woodlief, L.H. (Lynn), Harrell, F.E. (Frank), Lee, K.L. (Kerry), White, H.D. (Harvey), Guerci, A.D. (Alan), Barbash, G.I., Simes, R.J. (John), Weaver, W.D., Simoons, M.L. (Maarten), Topol, E.J. (Eric), Califf, R.M. (Robert), Woodlief, L.H. (Lynn), Harrell, F.E. (Frank), Lee, K.L. (Kerry), White, H.D. (Harvey), Guerci, A.D. (Alan), Barbash, G.I., Simes, R.J. (John), Weaver, W.D., Simoons, M.L. (Maarten), and Topol, E.J. (Eric)

Abstract

We developed a logistic regression model with data from the GUSTO-I trial to predict mortality rate differences in individual patients who received accelerated tissue plasminogen activator (TPA) versus streptokinase treatment for acute myocardial infarction. A nomogram was developed from a reduced version of this model that approximated the underlying risk of patients treated with streptokinase, and thus the benefit of TPA. The 30-day mortality rate with accelerated TPA was 0.063 versus 0.073 with streptokinase and subcutaneously administered heparin and 0.074 with streptokinase and intravenously administered heparin. No baseline patient characteristics were significantly associated with a different relative effect of TPA. Older patients and those with anterior infarction, higher Killip classification (except Killip class IV), lower blood pressure, and increased heart rate had the greatest absolute benefit with accelerated TPA. Patients with acute myocardial infarction who had more high-risk characteristics derived a greater absolute benefit from treatment with accelerated TPA versus streptokinase.

Published
1997

33. Perspectives on Large-Scale Cardiovascular Clinical Trials for the New Millenium

Author

Topol, E.J. (Eric), Califf, R.M. (Robert), Simoons, M.L. (Maarten), Hampton, J.R. (John), Lee, K.L. (Kerry), White, H.D. (Harvey), Simes, R.J. (John), Armstrong, P.W. (Paul), Werf, F.J.J. (Frans) van de, Topol, E.J. (Eric), Califf, R.M. (Robert), Simoons, M.L. (Maarten), Hampton, J.R. (John), Lee, K.L. (Kerry), White, H.D. (Harvey), Simes, R.J. (John), Armstrong, P.W. (Paul), and Werf, F.J.J. (Frans) van de

Published
1997

38. Link Between the Angiographic Substudy and Mortality Outcomes in Large Randomized Trial of Myocardial Reperfusion

Author

Simes, R.J. (John), Topol, E.J. (Eric), Holmes Jr, D.R. (David), White, H.D. (Harvey), Rutsch, W.R. (Wolfgang), Vahanian, A.S. (Alec), Simoons, M.L. (Maarten), Morris, D. (Douglas), Bnetriu, A., Califf, R.M. (Robert), Ross, A.M. (Allan), Simes, R.J. (John), Topol, E.J. (Eric), Holmes Jr, D.R. (David), White, H.D. (Harvey), Rutsch, W.R. (Wolfgang), Vahanian, A.S. (Alec), Simoons, M.L. (Maarten), Morris, D. (Douglas), Bnetriu, A., Califf, R.M. (Robert), and Ross, A.M. (Allan)

Abstract

BACKGROUND: The Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries (GUSTO-I) trial was designed to test whether thrombolytic strategies achieving more complete, early, sustained coronary artery patency would lead to further reductions in mortality in patients with acute myocardial infarction. An angiographic substudy within GUSTO-I provided a unique opportunity to examine the relation between mortality and degrees of patency among the regimens. METHODS AND RESULTS: Four thrombolytic strategies were compared in 41,021 patients in GUSTO-I: streptokinase with subcutaneous or intravenous heparin, accelerated tissue plasminogen activator (TPA) with intravenous heparin, and combination streptokinase plus TPA with intravenous heparin. Accelerated TPA was associated with lower 30-day mortality (6.3%) than the other strategies (7.2%, 7.4%, and 7.0%, respectively). Among the 1210 patients in the angiographic substudy randomized to angiography 90 minutes after starting treatment, there was improved patency, particularly Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow, with accelerated TPA over the other regimens (P < .0001). Coronary artery perfusion (TIMI grade 3) at 90 minutes was also a significant predictor of 30-day survival (P < .01). To determine whether differences in mortality among the four strategies matched differences in 90-minute patency, a model was developed for predicting mortality differences in the main trial from the angiographic substudy. The model assumed that any differences in treatment effects on 30-day mortality were mediated through differences in 90-minute patency for the four treatments. The predicted rates were then compared with observed mortality rates of the remaining patients in the main trial for each treatment group. The predicted and observed 30-day mortality rates of the four treatments were streptokinase with subcutane

Published
1995

39. Cost effectiveness of thrombolytic therapy with tissue plasminogen activator as compared with streptokinase for acute myocardial infarction

Author

Mark, D.B. (Daniel), Hlatky, M.A. (Mark), Califf, R.M. (Robert), Naylor, C.D., Lee, K.L. (Kerry), White, H.D. (Harvey), Simoons, M.L. (Maarten), Nelson, C.L., Clapp-Channing, N., Knight, J.D. (David), Harrell, F.E. (Frank), Simes, R.J. (John), Topol, E.J. (Eric), Armstrong, P.W. (Paul), Barbash, G.I., Mark, D.B. (Daniel), Hlatky, M.A. (Mark), Califf, R.M. (Robert), Naylor, C.D., Lee, K.L. (Kerry), White, H.D. (Harvey), Simoons, M.L. (Maarten), Nelson, C.L., Clapp-Channing, N., Knight, J.D. (David), Harrell, F.E. (Frank), Simes, R.J. (John), Topol, E.J. (Eric), Armstrong, P.W. (Paul), and Barbash, G.I.

Abstract

BACKGROUND. Patients with acute myocardial infarction who were treated with accelerated tissue plasminogen activator (t-PA) (given over a period of 1 1/2 hours rather than the conventional 3 hours, and with two thirds of the dose given in the first 30 minutes) had a 30-day mortality that was 15 percent lower than that of patie

Published
1995

40. Relation of time to treatment on relative effects of primary coronary angioplasty vs thrombolytic therapy

Author

Patel, A., primary, Zijlstra, F., additional, Jones, M., additional, Grines, C., additional, Garcia, E., additional, Grinfeld, L., additional, Gibbons, R., additional, Ribeiro, E., additional, Ribichini, F., additional, Ellis, S., additional, Granger, C., additional, Akhras, F., additional, Weaver, W.D., additional, and Simes, R.J., additional

Published
2000
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46. Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: A randomised placebo-controlled trial

Author

Beller, E., primary, Tattersall, M., additional, Lumley, T., additional, Levi, J., additional, Dalley, D., additional, Olver, I., additional, Page, J., additional, Abdi, E., additional, Wynne, C., additional, Friedlander, M., additional, Boadle, D., additional, Wheeler, H., additional, Margrie, S., additional, and Simes, R.J., additional

Published
1997
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