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1. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies

Author

Brown, Michael, Burge, Matthew, Cardaci, Giuseppe, Clarke, Stephen, Eliadis, Paul, Ferguson, Tom, Ganju, Vinod, Gibbs, Peter, van Hazel, Guy, James, Philip, Karapetis, Chris, Liauw, Winston, Marx, Gavin, Matos, Marco, Nott, Louise, Pavlakis, Nick, Powell, Alex, Price, Timothy, Ransom, David, Segelov, Eva, Shannon, Jenny, Singhal, Nimit, Strickland, Andrew, Walpole, Euan, Craninx, Michel, Delaunoit, Thierry, Deleporte, Amélie, Ferrante, Michel, Geboes, Karen, Hendlisz, Alain, Hendrickx, Koen, De Man, Marc, Monsaert, Els, Moons, Veerle, Peeters, Marc, Polus, Marc, Boucher, Eveline, Balosso, Jacques, Chevallier, Patrick, Louafi, Samy, Pracht, Marc, Rebischung, Christine, Smith, Denis, Taieb, Julien, Terrebonne, Eric, Bruch, Harald-Robert, Gehbauer, Gerald, Heinemann, Volker, Helmberger, Thomas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Nusch, Arnd, Pluntke, Stefan, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Riera, Jorge Ramon, Ricke, Jens, Sauerbruch, Tilmann, Scheidhauer, Klemens, Stötzer, Oliver, Tatsch, Klaus, Vehling-Kaiser, Ursula, Vogl, Thomas, Beny, Alex, Geva, Ravit, Shacham-Shmueli, Einat, Stemmer, Salomon, Tichler, Thomas, Wolf, Ido, Angelelli, Bruna, Martoni, Andrea, Findlay, Michael P.N., Isaacs, Richard, O’Donnell, Anne, Perez, David, Robinson, Bridget A., Rodríguez, Javier, Vera-Garcia, Ruth, Amin, Pradip, Bloomgarden, Daniel, Bui, James, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chuong, Michael, Coveler, Andrew, Facchini, Francis, Frenette, Gary, Frick, Jacob, Garofalo, Michael, George, Benjamin, Gordon, Michael, Gulec, Seza, Hannigan, James, Holtzman, Matthew, Kaubisch, Andreas, Kaiser, Adeel, Kooy, Todd, Limentani, Steven, Margolis, Jeffrey, Martin, Robert, Ozer, Howard, Padia, Siddarth, Rilling, William, Savin, Michael, Schneiderman, Elyse, Seeger, Grant, Sharma, Navesh, Shibata, Stephen, Smith, Randall, Wang, Eric, Whiting, Samuel, Aghmesheh, Morteza, Burge, Mathew, Cooray, Prasad, Feeney, Kynan, Lim, Lionel, Singh, Madhu, Underhill, Craig, Deleporte, Amelie, Durand, Aurelie, Faivre, Sandrine, Ferru, Aurelie, Hammel, Pascal, Bremer, Christoph, De Wit, Maike, Ayala, Hubert, Heching, Norman, Shani, Adi, Granetto, Cristina, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Trogu, Antonio, Kim, Yeul Hong, Sae-Won, Han, Jackson, Chris, O'Donnell, Anne, Fragoso, Maria, Tan, Iain, Casado, Ana Ruiz, Liang, Jin Tung, Liu, Jin Hwang, Ades, Steven, Auber, Miklos, Boland, Patrick, Bowers, Charles, Crain, Martin, Dowling, Kyran, Iyer, Renuka, Ratner, Lynn, Sanchez, Federico, Stoltzfus, Patricia, Westcott, Mark, Sharma, Navesh K., Findlay, Michael, Robinson, Bridget, Jackson, Christopher, Gebski, Val, Van Buskirk, Mark, and Zhao, Huaqing

Published
2018
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2. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Adams, Richard, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Mills, Jamie, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Weaver, Andrew, Wilson, Charles, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amélie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Findlay, Michael, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gibbs, Peter, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Heinemann, Volker, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, James, Philip, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Peeters, Marc, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ricke, Jens, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodríguez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stötzer, Oliver, Strickland, Andrew, Taieb, Julien, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, Wasan, Harpreet S, Sharma, Navesh K, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, and Gray, Alastair

Published
2017
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3. LBA-5 ANCHOR CRC: a single-arm, phase 2 study of encorafenib, binimetinib plus cetuximab in previously untreated BRAF V600E-mutant metastatic colorectal cancer

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Service d'hépato-gastro-entérologie, Grothey, A., Tabernero, J., Taieb, J., Yaeger, R., Yoshino, T., Maiello, E., Fernandez, E. Elez, Casado, A. Ruiz, Ross, P., André, T., Kato, T., Ruffinelli, J., Graham, J., Van den Eynde, Marc, Vera, R., Jean, B., Roussel, E. Carriere, Cahuzac, C., Issiakhem, Z., Vedovato, J., Cutsem, E. Van, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Service d'hépato-gastro-entérologie, Grothey, A., Tabernero, J., Taieb, J., Yaeger, R., Yoshino, T., Maiello, E., Fernandez, E. Elez, Casado, A. Ruiz, Ross, P., André, T., Kato, T., Ruffinelli, J., Graham, J., Van den Eynde, Marc, Vera, R., Jean, B., Roussel, E. Carriere, Cahuzac, C., Issiakhem, Z., Vedovato, J., and Cutsem, E. Van

Abstract

Background BRAFV600E mutations are identified in 8-15% of metastatic colorectal cancer (mCRC) patients and confer a poor prognosis. In patients with BRAFV600E-mutant mCRC, the combination of encorafenib (ENCO) + cetuximab (CETUX) ± binimetinib (BINI) in second- and third-line therapy has demonstrated improved outcomes compared to standard therapies (BEACON CRC study). The ANCHOR CRC study was designed to investigate the triplet combination (ENCO + BINI + CETUX) in the first line setting of this population. Methods ANCHOR CRC is an open-label, single arm, two-stage design, phase 2 study in patients with BRAFV600E-mutant mCRC who did not receive any prior systemic therapy for metastatic disease. Patients received ENCO 300 mg orally QD + BINI 45 mg orally BID and CETUX IV weekly (250mg/m2 after a first dose of 400mg/m2) for the first 28 weeks and then once every two weeks (500mg/m2). The primary endpoint was confirmed Objective Response Rate (cORR) based on local review; secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety. Analysis for Stage 1 was performed after the first 40 evaluable patients with a centrally confirmed BRAFV600E mutation had completed four post-baseline tumor assessments or discontinued. At least 12 responses in Stage 1 were needed to initiate Stage 2 and to enroll 50 additional patients to complete the recruitment with a total of 90 patients in the study. Stage 1 analysis results are presented here. Results Forty-one BRAFV600E-mutant mCRC patients with a median age of 67 years old (61% of the patients were ≥ 65 years old) were enrolled in Stage 1 and received the triplet combination as first line metastatic treatment. At study entry, 56% of patients presented with ECOG PS 1, 78% had metastases to at least 2 organs and 51% had peritoneal metastasis. Forty patients were evaluable for efficacy (BRAFV600E mutation was not centrally confirmed for one patient). The investigator assesse

Published
2020

4. Prevalence and Correlates of Cancer-related Fatigue in Breast Cancer Survivors

Author

Bustos, Alejandro Álvarez, primary, Pedro, Cristina G. de, additional, Elías, María Romero, additional, Ramos, Javier, additional, Osorio, Pablo, additional, Cantos, Blanca, additional, Maximiano, Constanza, additional, Méndez, Miriam, additional, Luces, Carmen Fiuza, additional, Otero, Marta Méndez, additional, Martín, Silvia, additional, Cebolla, Héctor, additional, and Casado, Ana Ruiz, additional

Published
2021
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5. LBA-5 ANCHOR CRC: a single-arm, phase 2 study of encorafenib, binimetinib plus cetuximab in previously untreated BRAF V600E-mutant metastatic colorectal cancer

Author

Grothey, A., primary, Tabernero, J., additional, Taieb, J., additional, Yaeger, R., additional, Yoshino, T., additional, Maiello, E., additional, Fernandez, E. Elez, additional, Casado, A. Ruiz, additional, Ross, P., additional, André, T., additional, Kato, T., additional, Ruffinelli, J., additional, Graham, J., additional, den Eynde, M. Van, additional, Vera, R., additional, Jean, B., additional, Roussel, E. Carriere, additional, Cahuzac, C., additional, Issiakhem, Z., additional, Vedovato, J., additional, and Cutsem, E. Van, additional

Published
2020
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6. Reversible dispersion and release of carbon nanotubes: Via cooperative clamping interactions with hydrogen-bonded nanorings

Author

Chamorro R., De Juan-Fernández L., Nieto-Ortega B., Mayoral M.J., Casado S., Ruiz-González L., Pérez E.M., González-Rodríguez D. and Funding from the European Union (ERC-Starting Grants: 279548 (DGR) and 307609 (EMP)), MINECO (Grants: CTQ2014-57729-P (DGR) and CTQ2014-60541-P (EMP), FPU13/03371 (LdJ), JdC-2015-23531 postdoctoral fellowship (BNO)) and the Comunidad de Madrid (Grant: MAD2D-CM program S2013/ MIT-3007 (EMP)) is gratefully acknowledged. IMDEA Nano-ciencia acknowledges support from the 'Severo Ochoa' Programme for Centres of Excellence in R&D (MINECO, Grant SEV-2016-0686). The computational work was supported by the Campus de Excelencia Internacional UAM + CSIC. Additionally, we express our gratitude to the Supercomputing and Bio-innovation Center (SCBI) of the University of Málaga (Spain) for their support and resources. We thank the National Centre for Electron Microscopy (ICTS-CNME, Universidad Complutense) for electron microscopy facilities.

Published
2018

7. Interfacing porphyrins and carbon nanotubes through mechanical links

Author

De Juan-Fernández L., Münich P.W., Puthiyedath A., Nieto-Ortega B., Casado S., Ruiz-González L., Pérez E.M., Guldi D.M. and Funding from the European Research Council (307609-StG), MINECO (CTQ2014-60541-P, FPU13/03371, JdC-2015-23531, CTQ2017-86060-P) and the Comunidad de Madrid (MAD2D- CM S2013/MIT-3007) is gratefully acknowledged. IMDEA Nanociencia acknowledges support from the 'Severo Ochoa' Programme for Centres of Excellence in R&D (MINECO, Grant SEV-2016-0686). The computational work was supported by the Campus de Excelencia Internacional UAM+CSIC. We thank the Supercomputing and Bioinnovation Center (SCBI) of the University of Málaga (Spain) for their support and resources. We thank the National Centre for Electron Microscopy (ICTS-CNME, Universidad Complutense) for electron microscopy facilities. P. W. M. acknowledges the Graduate School of Molecular Science for funding. This work was further supported by the Deutsche Forschungsgemeinscha? as part of the Excellence Cluster Engineering of Advanced Materials and SFB 953 Synthetic Carbon Allotropes as well as by the Bavarian State Government as part of the Solar Technologies go Hybrid initiative.

Published
2018

8. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Wasan, Harpreet S, Gibbs, Peter, Sharma, Navesh K, Taieb, Julien, Heinemann, Volker, Ricke, Jens, Peeters, Marc, Findlay, Michael, Weaver, Andrew, Mills, Jamie, Wilson, Charles, Adams, Richard, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, Gray, Alastair, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amã©lie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, MORRISON JR, PHILIP JAMES, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Yon-Dschun, Ko, Krã¶ning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodrã­guez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stã¶tzer, Oliver, Strickland, Andrew, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Deleporte, Amelie, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, FOXFIRE Trial Investigators, SIRFLOX Trial Investigators, and FOXFIRE-Global Trial Investigators

Subjects
Aged, 80 and over, Adult, Male, Radiotherapy, Brachytherapy, Liver Neoplasms, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Colorectal Neoplasms, Disease-Free Survival, Female, Humans, Middle Aged, Radiotherapy, Adjuvant, Treatment Outcome, Oncology, Articles, digestive system diseases, Editorial, Colonic Neoplasms, 80 and over, Human medicine, Adjuvant
Abstract

Background Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival. Methods FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1: 1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m(2) oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m(2) oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global). Findings Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43.3 months (IQR 31.6-58.4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1.04, 95% CI 0.90-1.19; p=0.61). The median survival time in the FOLFOX plus SIRT group was 22.6 months (95% CI 21.0-24.5) compared with 23.3 months (21.8-24.7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group. Interpretation Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed. Copyright (C) The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license.

Published
2017

9. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies

Author

Gibbs, Peter, primary, Heinemann, Volker, additional, Sharma, Navesh K., additional, Taieb, Julien, additional, Ricke, Jens, additional, Peeters, Marc, additional, Findlay, Michael, additional, Robinson, Bridget, additional, Jackson, Christopher, additional, Strickland, Andrew, additional, Gebski, Val, additional, Van Buskirk, Mark, additional, Zhao, Huaqing, additional, van Hazel, Guy, additional, Brown, Michael, additional, Burge, Matthew, additional, Cardaci, Giuseppe, additional, Clarke, Stephen, additional, Eliadis, Paul, additional, Ferguson, Tom, additional, Ganju, Vinod, additional, Gibbs, Peter, additional, James, Philip, additional, Karapetis, Chris, additional, Liauw, Winston, additional, Marx, Gavin, additional, Matos, Marco, additional, Nott, Louise, additional, Pavlakis, Nick, additional, Powell, Alex, additional, Price, Timothy, additional, Ransom, David, additional, Segelov, Eva, additional, Shannon, Jenny, additional, Singhal, Nimit, additional, Walpole, Euan, additional, Craninx, Michel, additional, Delaunoit, Thierry, additional, Deleporte, Amélie, additional, Ferrante, Michel, additional, Geboes, Karen, additional, Hendlisz, Alain, additional, Hendrickx, Koen, additional, De Man, Marc, additional, Monsaert, Els, additional, Moons, Veerle, additional, Polus, Marc, additional, Boucher, Eveline, additional, Balosso, Jacques, additional, Chevallier, Patrick, additional, Louafi, Samy, additional, Pracht, Marc, additional, Rebischung, Christine, additional, Smith, Denis, additional, Terrebonne, Eric, additional, Bruch, Harald-Robert, additional, Gehbauer, Gerald, additional, Helmberger, Thomas, additional, Ko, Yon-Dschun, additional, Kröning, Hendrik, additional, Lammert, Frank, additional, Nusch, Arnd, additional, Pluntke, Stefan, additional, Ridwelski, Karsten, additional, Riera-Knorrenschild, Jorge, additional, Riess, Hanno, additional, Riera, Jorge Ramon, additional, Sauerbruch, Tilmann, additional, Scheidhauer, Klemens, additional, Stötzer, Oliver, additional, Tatsch, Klaus, additional, Vehling-Kaiser, Ursula, additional, Vogl, Thomas, additional, Beny, Alex, additional, Geva, Ravit, additional, Shacham-Shmueli, Einat, additional, Stemmer, Salomon, additional, Tichler, Thomas, additional, Wolf, Ido, additional, Angelelli, Bruna, additional, Martoni, Andrea, additional, Findlay, Michael P.N., additional, Isaacs, Richard, additional, O’Donnell, Anne, additional, Perez, David, additional, Robinson, Bridget A., additional, Rodríguez, Javier, additional, Vera-Garcia, Ruth, additional, Amin, Pradip, additional, Bloomgarden, Daniel, additional, Bui, James, additional, Carlisle, James, additional, Chai, Seungjean, additional, Chen, Yi-Jen, additional, Chuong, Michael, additional, Coveler, Andrew, additional, Facchini, Francis, additional, Frenette, Gary, additional, Frick, Jacob, additional, Garofalo, Michael, additional, George, Benjamin, additional, Gordon, Michael, additional, Gulec, Seza, additional, Hannigan, James, additional, Holtzman, Matthew, additional, Kaubisch, Andreas, additional, Kaiser, Adeel, additional, Kooy, Todd, additional, Limentani, Steven, additional, Margolis, Jeffrey, additional, Martin, Robert, additional, Ozer, Howard, additional, Padia, Siddarth, additional, Rilling, William, additional, Savin, Michael, additional, Schneiderman, Elyse, additional, Seeger, Grant, additional, Sharma, Navesh, additional, Shibata, Stephen, additional, Smith, Randall, additional, Wang, Eric, additional, Whiting, Samuel, additional, Aghmesheh, Morteza, additional, Burge, Mathew, additional, Cooray, Prasad, additional, Feeney, Kynan, additional, Lim, Lionel, additional, Singh, Madhu, additional, Underhill, Craig, additional, Deleporte, Amelie, additional, Durand, Aurelie, additional, Faivre, Sandrine, additional, Ferru, Aurelie, additional, Hammel, Pascal, additional, Bremer, Christoph, additional, De Wit, Maike, additional, Ayala, Hubert, additional, Heching, Norman, additional, Shani, Adi, additional, Granetto, Cristina, additional, Masi, Gianluca, additional, Mosconi, Stefania, additional, Numico, Gianmauro, additional, Trogu, Antonio, additional, Kim, Yeul Hong, additional, Sae-Won, Han, additional, Jackson, Chris, additional, O'Donnell, Anne, additional, Fragoso, Maria, additional, Tan, Iain, additional, Casado, Ana Ruiz, additional, Liang, Jin Tung, additional, Liu, Jin Hwang, additional, Ades, Steven, additional, Auber, Miklos, additional, Boland, Patrick, additional, Bowers, Charles, additional, Crain, Martin, additional, Dowling, Kyran, additional, Iyer, Renuka, additional, Ratner, Lynn, additional, Sanchez, Federico, additional, Stoltzfus, Patricia, additional, and Westcott, Mark, additional

Published
2018
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