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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. Cetuximab Alone or With Irinotecan for Resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type Metastatic Colorectal Cancer: The AGITG Randomized Phase II ICECREAM Study

Author

Shapiro, Jeremy D., Thavaneswaran, Subotheni, Underhill, Craig R., Robledo, Kristy P., Karapetis, Christos S., Day, Fiona L., Nott, Louise M., Jefford, Michael, Chantrill, Lorraine A., Pavlakis, Nick, Tebbutt, Niall C., Price, Timothy. J., Khasraw, Mustafa, Van Hazel, Guy A., Waring, Paul M., Tejpar, Sabine, Simes, John, Gebski, Val J., Desai, Jayesh, and Segelov, Eva

Published
2018
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4. 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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6. Time course of safety and efficacy of aflibercept in combination with FOLFIRI in patients with metastatic colorectal cancer who progressed on previous oxaliplatin-based therapy

Author

Ruff, Paul, Ferry, David R., Lakomỳ, Radek, Prausová, Jana, Van Hazel, Guy A., Hoff, Paulo M., Cunningham, David, Arnold, Dirk, Schmoll, Hans J., Moiseyenko, Vladimir M., McKendrick, Joseph J., ten Tije, Albert J., Vishwanath, Raghu L., Bhargava, Pankaj, Chevalier, Soazig, Macarulla, Teresa, and Van Cutsem, Eric

Published
2015
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8. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy

Author

Van Cutsem, Eric, Joulain, Florence, Hoff, Paulo M., Mitchell, Edith, Ruff, Paul, Lakomý, Radek, Prausová, Jana, Moiseyenko, Vladimir M., van Hazel, Guy, Cunningham, David, Arnold, Dirk, Schmoll, Hans-Joachim, ten Tije, Albert J., McKendrick, Joseph, Kröning, Hendrik, Humblet, Yves, Grávalos, Cristina, Le-Guennec, Solenn, Andria, Michael, Dochy, Emmanuelle, Vishwanath, Raghu L., Macarulla, Teresa, and Tabernero, Josep

Published
2016
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16. Cetuximab for the treatment of colorectal cancer

Author

Jonker, Derek J., O'Callaghan, Chris J., Karapetis, Christos S., Zalcberg, John R., Tu, Dongsheng, Au, Heather-Jane, Berry, Scott R., Krahn, Marianne, Price, Timothy, Simes, R. John, Tebbutt, Niall C., van Hazel, Guy, Wierzbicki, Rafal, Langer, Christiane, and Moore, Malcolm J.

Subjects
Colorectal cancer -- Drug therapy, Monoclonal antibodies -- Dosage and administration, Monoclonal antibodies -- Complications and side effects
Abstract

The trial results for the treatment of colorectal cancer with cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR) is reported. The overall survival and progression-free survival were found to be better among patients receiving cetuximab in whom other treatments failed.

Published
2007

19. Adjuvant Chemotherapy With Sequential or Concurrent Anthracycline and Docetaxel: Breast International Group 02–98 Randomized Trial

Author

Francis, Prudence, Crown, John, Di Leo, Angelo, Buyse, Marc, Balil, Ana, Andersson, Michael, Nordenskjöld, Bo, Lang, Istvan, Jakesz, Raimund, Vorobiof, Daniel, Gutiérrez, Jorge, van Hazel, Guy, Dolci, Stella, Jamin, Sophie, Bendahmane, Belguendouz, Gelber, Richard D., Goldhirsch, Aron, Castiglione-Gertsch, Monica, and Piccart-Gebhart, Martine

Published
2008

21. Capecitabine as Adjuvant Treatment for Stage III Colon Cancer

Author

Twelves, Chris, Wong, Alfred, Nowacki, Marek P., Abt, Markus, Burris, Howard, Carrato, Alfredo, Cassidy, Jim, Cervantes, Andres, Fagerberg, Jan, Georgoulias, Vassilis, Husseini, Fares, Jodrell, Duncan, Koralewski, Piotr, Kroning, Hendrik, Maroun, Jean, Marschner, Norbert, McKendrick, Joseph, Pawlicki, Marek, Rosso, Riccardo, Schuller, Johannes, Seitz, Jean-Francois, Stabuc, Borut, Tujakowski, Jerzy, Van Hazel, Guy, Zaluski, Jerzy, and Scheithauer, Werner.

Published
2005
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24. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE‐global randomised trials of selective internal radiotherapy for metastatic colorectal cancer

Author

Wolstenholme, Jane, primary, Fusco, Francesco, additional, Gray, Alastair M., additional, Moschandreas, Joanna, additional, Virdee, Pradeep S., additional, Love, Sharon, additional, Van Hazel, Guy, additional, Gibbs, Peter, additional, Wasan, Harpreet S., additional, and Sharma, Ricky A., additional

Published
2020
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25. Secondary technical resectability of colorectal cancer liver metastases after chemotherapy with or without selective internal radiotherapy in the randomized SIRFLOX trial

Author

Garlipp, Benjamin, Gibbs, Peter, Van Hazel, Guy Arthur, Jeyarajah, Rohan, Martin, Robert R.C.G., Bruns, Christiane Josephine, Lang, Hauke, Manas, Derek, Ettorre, Giuseppe Maria, Pardo, Fernando, Donckier De Donceel, Vincent, Benckert, Christoph, van Gulik, Thomas Matthijs, Goere, Diane, Schoen, Michael, Pratschke, Johann, Bechstein, Wolf Otto, de la Cuesta, Antonio Martínez, Adeyemi, S., Ricke, Jens, Seidensticker, Max, Garlipp, Benjamin, Gibbs, Peter, Van Hazel, Guy Arthur, Jeyarajah, Rohan, Martin, Robert R.C.G., Bruns, Christiane Josephine, Lang, Hauke, Manas, Derek, Ettorre, Giuseppe Maria, Pardo, Fernando, Donckier De Donceel, Vincent, Benckert, Christoph, van Gulik, Thomas Matthijs, Goere, Diane, Schoen, Michael, Pratschke, Johann, Bechstein, Wolf Otto, de la Cuesta, Antonio Martínez, Adeyemi, S., Ricke, Jens, and Seidensticker, Max

Abstract

Background: Secondary resection of initially unresectable colorectal cancer liver metastases (CRLM) can prolong survival. The added value of selective internal radiotherapy (SIRT) to downsize lesions for resection is not known. This study evaluated the change in technical resectability of CRLM with the addition of SIRT to FOLFOX-based chemotherapy. Methods: Baseline and follow-up hepatic imaging of patients who received modified FOLFOX (mFOLFOX6: fluorouracil, leucovorin, oxaliplatin) chemotherapy with or without bevacizumab (control arm) versus mFOLFOX6 (with or without bevacizumab) plus SIRT using yttrium-90 resin microspheres (SIRT arm) in the phase III SIRFLOX trial were reviewed by three or five (of 14) expert hepatopancreatobiliary surgeons for resectability. Reviewers were blinded to one another, treatment assignment, extrahepatic disease status, and information on clinical and scanning time points. Technical resectability was defined as at least 60 per cent of reviewers (3 of 5, or 2 of 3) assessing a patient's liver metastases as surgically removable. Results: Some 472 patients were evaluable (SIRT, 244; control, 228). There was no significant baseline difference in the proportion of technically resectable liver metastases between SIRT (29, 11·9 per cent) and control (25, 11·0 per cent) arms (P = 0·775). At follow-up, significantly more patients in both arms were deemed technically resectable compared with baseline: 159 of 472 (33·7 per cent) versus 54 of 472 (11·4 per cent) respectively (P = 0·001). More patients were resectable in the SIRT than in the control arm: 93 of 244 (38·1 per cent) versus 66 of 228 (28·9 per cent) respectively (P < 0·001). Conclusion: Adding SIRT to chemotherapy may improve the resectability of unresectable CRLM., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2019

27. 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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28. 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, van Hazel, Guy, Sharma, Ricky A, SIRFLOX Trial Investigators, the, and Geboes, Karen

Subjects
RADIOEMBOLIZATION, III TRIAL, MICROSPHERES, RADIATION-THERAPY SIRT, Medicine and Health Sciences, EQ-5D, OXALIPLATIN, digestive system diseases, SYSTEMIC THERAPY, FLUOROURACIL, CETUXIMAB, LEUCOVORIN
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.

Published
2017

29. Quality of life in patients with liver metastases from colorectal cancer treated with first-line selective internal radiotherapy (SIRT): EQ-5D, EORTC QLQ-C30 and LMC21 results from the FOXFIRE study

Author

Wolstenholme, Jane, primary, Fusco, Francesco, additional, Gray, Alastair, additional, Chau, Ian, additional, Dunham, Luise, additional, Roberts, Anne, additional, Love, Sharon, additional, Moschandreas, Joanna, additional, Virdee, Pradeep, additional, Van Hazel, Guy, additional, Gibbs, Peter, additional, Gebski, Val, additional, Lewington, Val, additional, Wilson, Gregory, additional, Tait, Paul, additional, Khan, Nasir, additional, Berry, David, additional, Wotherspoon, Andrew, additional, Morgan, Bruno, additional, Pearson, Sarah, additional, Francis, Anne, additional, Al-Nahhas, Adil, additional, Wasan, Harpreet, additional, and Sharma, Ricky, additional

Published
2018
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30. Quality of life in patients with liver metastases from colorectal cancer treated with first-line selective internal radiotherapy (SIRT): EQ-5D, EORTC QLQ-C30 and LMC21 results from the FOXFIRE study

Author

Wolstenholme, Jane, primary, Fusco, Francesco, additional, Gray, Alastair, additional, Chau, Ian, additional, Dunham, Luise, additional, Roberts, Anne, additional, Love, Sharon, additional, Moschandreas, Joanna, additional, Virdee, Pradeep, additional, Van Hazel, Guy, additional, Gibbs, Peter, additional, Gebski, Val, additional, Lewington, Val, additional, Wilson, Gregory, additional, Tait, Paul, additional, Khan, Nasir, additional, Berry, David, additional, Wotherspoon, Andrew, additional, Morgan, Bruno, additional, Pearson, Sarah, additional, Francis, Anne, additional, Al-Nahhas, Adil, additional, Wasan, Harpreet, additional, and Sharma, Ricky, additional

Published
2017
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32. Clinical News

Author

Moore, Mackenzie, primary, Fricker, Janet, additional, Leigh, Roland, additional, Brahmania, Mayur, additional, and van Hazel, Guy, additional

Published
2017
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33. Overall survival analysis of the FOXFIRE-SIRFLOX-FOXFIRE global prospective randomized studies of first-line selective internal radiotherapy (SIRT) in patients with liver metastases from colorectal cancer

Author

Wasan, Harpreet, primary, van Hazel, Guy, additional, Heinemann, Volker, additional, Sharma, Navesh, additional, Taieb, Julien, additional, Ricke, Jens, additional, Peeters, Marc, additional, Findlay, Michael, additional, Virdee, Pradeep S., additional, Love, Sharon, additional, Moschandreas, Joanna, additional, Dutton, Peter, additional, Gebski, Val, additional, Gray, Alastair, additional, Price, Dave, additional, Bower, Geoff, additional, Montazeri, Amir, additional, Swinson, Daniel, additional, Brown, Ewan, additional, Wilson, Greg, additional, Lowndes, Sarah, additional, Sharma, Ricky A., additional, and Gibbs, Peter, additional

Published
2017
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35. REsect: Blinded assessment of amenability to potentially curative treatment of previously unresectable colorectal cancer liver metastases (CRC LM) after chemotherapy ± RadioEmbolization (SIRT) in the randomized SIRFLOX trial.

Author

Garlipp, Benjamin, primary, Gibbs, Peter, additional, Van Hazel, Guy A., additional, Jeyarajah, Rohan, additional, Martin, Robert C. G., additional, Bruns, Christiane J., additional, Lang, Hauke, additional, Manas, Derek M., additional, Ettorre, Giuseppe Maria, additional, Pardo, Fernando, additional, Donckier, Vincent, additional, Benckert, Christoph, additional, van Gulik, Thomas M, additional, Goere, Diane, additional, Schoen, Michael, additional, Pratschke, Johann, additional, Bechstein, Wolf O., additional, Martínez de la Cuesta, Antonio, additional, Adeyemi, Shola, additional, and Seidensticker, Max, additional

Published
2017
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36. Overall survival analysis of the FOXFIRE prospective randomized studies of first-line selective internal radiotherapy (SIRT) in patients with liver metastases from colorectal cancer.

Author

Sharma, Ricky A., primary, Wasan, Harpreet Singh, additional, Van Hazel, Guy A., additional, Heinemann, Volker, additional, Sharma, Navesh K., additional, Taieb, Julien, additional, Ricke, Jens, additional, Mills, Jamie, additional, Tait, Nicholas Paul, additional, Boardman, Philip, additional, Peeters, Marc, additional, Findlay, Michael P. N., additional, Virdee, Pradeep Singh, additional, Moschandreas, Joanna, additional, Gebski, Val, additional, Love, Sharon, additional, Gray, Alastair, additional, and Gibbs, Peter, additional

Published
2017
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37. Results of the Quad wild type arm of the AGITG ICECREAM study: A randomised phase II study of cetuximab alone or in combination with irinotecan in patients with refractory metastatic colorectal cancer with no mutations in KRAS, NRAS, BRAF or PIK3CA.

Author

Shapiro, Jeremy David, primary, Thavaneswaran, Subotheni, additional, Underhill, Craig, additional, Robledo, Kristy Pamela, additional, Karapetis, Christos Stelios, additional, Day, Fiona Lee, additional, Nott, Louise M., additional, Jefford, Michael, additional, Chantrill, Lorraine A., additional, Pavlakis, Nick, additional, Tebbutt, Niall C., additional, Price, Timothy Jay, additional, Khasraw, Mustafa, additional, Van Hazel, Guy A., additional, Waring, Paul Michael, additional, Tejpar, Sabine, additional, Simes, John, additional, Gebski, Val, additional, Desai, Jayesh, additional, and Segelov, Eva, additional

Published
2017
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38. Adjuvant Chemotherapy With Sequential or Concurrent Anthracycline and Docetaxel: Breast International Group 02-98 Randomized Trial

Author

Francis, Prudence, Crown, John, Di Leo, Angelo, Buyse, Marc, Balil, Ana, Andersson, Michael, Nordenskjöld, Bo, Lang, Istvan, Jakesz, Raimund, Vorobiof, Daniel, Gutiérrez, Jorge, van Hazel, Guy, Dolci, Stella, Jamin, Sophie, Bendahmane, Belguendouz, Gelber, Richard D., Goldhirsch, Aron, Castiglione-Gertsch, Monica, Piccart-Gebhart, Martine, Francis, Prudence, Crown, John, Di Leo, Angelo, Buyse, Marc, Balil, Ana, Andersson, Michael, Nordenskjöld, Bo, Lang, Istvan, Jakesz, Raimund, Vorobiof, Daniel, Gutiérrez, Jorge, van Hazel, Guy, Dolci, Stella, Jamin, Sophie, Bendahmane, Belguendouz, Gelber, Richard D., Goldhirsch, Aron, Castiglione-Gertsch, Monica, and Piccart-Gebhart, Martine

Abstract

Background Docetaxel is more effective than doxorubicin for patients with advanced breast cancer. The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration of doxorubicin and docetaxel. Methods Patients with lymph node-positive breast cancer (n = 2887) were randomly assigned to one of four treatments: 1) sequential control (four cycles of doxorubicin at 75 mg/m2, followed by three cycles of cyclophosphamide, methotrexate, and 5-fluorouracil [CMF]); 2) concurrent control (four cycles of doxorubicin at 60 mg/m2 plus cyclophosphamide at 600 mg/m2, followed by three cycles of CMF); 3) sequential docetaxel (three cycles of doxorubicin at 75 mg/m2, followed by three cycles of docetaxel at 100 mg/m2, followed by three cycles of CMF); 4) concurrent docetaxel (four cycles of doxorubicin at 50 mg/m2 plus docetaxel at 75 mg/m2, followed by three cycles of CMF). The primary comparison evaluated the efficacy of including docetaxel regardless of schedule and was planned after 1215 disease-free survival (DFS) events (ie, relapse, second primary cancer, or death from any cause). Docetaxel and control treatment groups were compared by log-rank tests, and hazard ratios (HR) of DFS events were calculated by Cox modeling. All statistical tests were two-sided. Results Due to a lower-than-anticipated rate of relapse, this analysis was performed after 5 years with 732 events. Patients in control arms had a 5-year DFS of 73% (95% confidence interval [CI] = 70% to 75%). Docetaxel treatment resulted in an improvement in DFS of borderline statistical significance compared with control treatment (HR = 0.86, 95% CI = 0.74 to 1.00; P = .05). However, DFS in the sequential docetaxel arm was better than that in the concurrent docetaxel arm (HR = 0.83, 95% CI = 0.69 to 1.00) and in the sequential control arm (HR = 0.79, 95% CI = 0.64 to 0.98). Conclusions Inco

Published
2017

39. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Author

Virdee, Pradeep S, primary, Moschandreas, Joanna, additional, Gebski, Val, additional, Love, Sharon B, additional, Francis, E Anne, additional, Wasan, Harpreet S, additional, van Hazel, Guy, additional, Gibbs, Peter, additional, and Sharma, Ricky A, additional

Published
2017
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40. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Van Cutsem, Eric, Joulain, Florence, Hoff, Paulo M, Mitchell, Edith, Ruff, Paul, Lakomý, Radek, Prausová, Jana, Moiseyenko, Vladimir M, van Hazel, Guy, Cunningham, David, Arnold, Dirk, Schmoll, Hans-Joachim, Ten Tije, Albert J, McKendrick, Joseph, Kröning, Hendrik, Humblet, Yves, Grávalos, Cristina, Le-Guennec, Solenn, Andria, Michael, Dochy, Emmanuelle, Vishwanath, Raghu L, Macarulla, Teresa, Tabernero, Josep, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, Van Cutsem, Eric, Joulain, Florence, Hoff, Paulo M, Mitchell, Edith, Ruff, Paul, Lakomý, Radek, Prausová, Jana, Moiseyenko, Vladimir M, van Hazel, Guy, Cunningham, David, Arnold, Dirk, Schmoll, Hans-Joachim, Ten Tije, Albert J, McKendrick, Joseph, Kröning, Hendrik, Humblet, Yves, Grávalos, Cristina, Le-Guennec, Solenn, Andria, Michael, Dochy, Emmanuelle, Vishwanath, Raghu L, Macarulla, Teresa, and Tabernero, Josep

Abstract

The aim of this post hoc analysis of the VELOUR study (ClinicalTrials.gov NCT00561470) was to investigate the treatment effect of adding aflibercept to second-line infusional 5-fluorouracil (5-FU), leucovorin and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) who had failed any prior oxaliplatin-containing regimen. Adjuvant rapid relapsers (ARR), who were enrolled directly following relapse during or within 6 months of completion of oxaliplatin-containing adjuvant chemotherapy (N = 124, including 17 patients who also received bevacizumab as part of their adjuvant therapy), were excluded from the original VELOUR intention-to-treat (ITT) population (N = 1226). After exclusion of the ARR, overall survival (OS) in the ITT minus ARR (ITT-ARR) population (N = 1102) was longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm [hazard ratio (HR) 0.78, 95 % confidence interval (CI) 0.68-0.90; median survival difference 1.87 months]. In the subgroup of patients assigned to the prior bevacizumab stratum at randomization, OS was numerically longer in the aflibercept plus FOLFIRI arm than in the placebo plus FOLFIRI arm (HR 0.81; 95 % CI 0.63-1.04; median survival difference 2.14 months). Comparison of the post hoc analysis results with the primary analysis from VELOUR suggests that the inclusion of the directly enrolled ARR may have understated the aflibercept treatment benefit for both bevacizumab-pretreated and bevacizumab-naïve patients in the strictly second-line setting although no definitive conclusion may be inferred. The benefit associated with the addition of aflibercept to second-line FOLFIRI in patients with mCRC was observed whatever the timing of first-line disease progression. There were no unexpected safety concerns.

Published
2016

41. ICECREAM: randomised phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer with either KRAS, NRAS, BRAF and PI3KCA wild type, or G13D mutated tumours

Author

Segelov, Eva, Waring, Paul, Desai, Jayesh, Wilson, Kate, Gebski, Val, Thavaneswaran, Subotheni, Elez, Elena, Underhill, Craig, Pavlakis, Nick, Chantrill, Lorraine, Nott, Louise, Jefford, Michael, Khasraw, Mustafa, Day, Fiona, Wasan, Harpreet, Ciardiello, Fortunato, Karapetis, Chris, Joubert, Warren, van Hazel, Guy, Haydon, Andrew, Price, Tim, Tejpar, Sabine, Tebbutt, Niall, Shapiro, Jeremy, Segelov, Eva, Waring, Paul, Desai, Jayesh, Wilson, Kate, Gebski, Val, Thavaneswaran, Subotheni, Elez, Elena, Underhill, Craig, Pavlakis, Nick, Chantrill, Lorraine, Nott, Louise, Jefford, Michael, Khasraw, Mustafa, Day, Fiona, Wasan, Harpreet, Ciardiello, Fortunato, Karapetis, Chris, Joubert, Warren, van Hazel, Guy, Haydon, Andrew, Price, Tim, Tejpar, Sabine, Tebbutt, Niall, and Shapiro, Jeremy

Abstract

BACKGROUND: Patients with metastatic colorectal cancer whose disease has progressed on oxaliplatin- and irinotecan-containing regimens may benefit from EGFR-inhibiting monoclonal antibodies if they do not contain mutations in the KRAS gene (are "wild type"). It is unknown whether these antibodies, such as cetuximab, are more efficacious in refractory metastatic colorectal cancer as monotherapy, or in combination with irinotecan. Lack of mutation in KRAS, BRAF and PIK3CA predicts response to EFGR-inhibitors. The ICECREAM trial examines the question of monotherapy versus combination with chemotherapy in two groups of patients: those with a "quadruple wild type" tumour genotype (no mutations in KRAS, NRAS, PI3KCA or BRAF genes) and those with the specific KRAS mutation in codon G13D, for whom possibly EGFR-inhibitor efficacy may be equivalent. METHODS AND DESIGN: ICECREAM is a randomised, phase II, open-label, controlled trial comparing the efficacy of cetuximab alone or with irinotecan in patients with "quadruple wild type" or G13D-mutated metastatic colorectal cancer, whose disease has progressed on, or who are intolerant of oxaliplatin- and fluoropyrimidine-based chemotherapy. The primary endpoint is the 6-month progression-free survival benefit of the treatment regimen. Secondary endpoints are response rate, overall survival, and quality of life. The tertiary endpoint is prediction of outcome with further biological markers. International collaboration has facilitated recruitment in this prospective trial of treatment in these infrequently found molecular subsets of colorectal cancer. DISCUSSION: This unique trial will yield prospective information on the efficacy of cetuximab and whether this is further enhanced with chemotherapy in two distinct populations of patients with metastatic colorectal cancer: the "quadruple wild type", which may 'superselect' for tumours sensitive to EGFR-inhibition, a

Published
2016

44. Response to Cetuximab With or Without Irinotecan in Patients With Refractory Metastatic Colorectal Cancer Harboring the KRAS G13D Mutation: Australasian Gastro-Intestinal Trials Group ICECREAM Study

Author

Segelov, Eva, primary, Thavaneswaran, Subotheni, additional, Waring, Paul M., additional, Desai, Jayesh, additional, Robledo, Kristy P., additional, Gebski, Val J., additional, Elez, Elena, additional, Nott, Louise M., additional, Karapetis, Christos S., additional, Lunke, Sebastian, additional, Chantrill, Lorraine A., additional, Pavlakis, Nick, additional, Khasraw, Mustafa, additional, Underhill, Craig, additional, Ciardiello, Fortunato, additional, Jefford, Michael, additional, Wasan, Harpreet, additional, Haydon, Andrew, additional, Price, Timothy J., additional, van Hazel, Guy, additional, Wilson, Kate, additional, Simes, John, additional, and Shapiro, Jeremy D., additional

Published
2016
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45. ICECREAM: randomised phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer with either KRAS, NRAS, BRAF and PI3KCA wild type, or G13D mutated tumours

Author

Segelov, Eva, primary, Waring, Paul, additional, Desai, Jayesh, additional, Wilson, Kate, additional, Gebski, Val, additional, Thavaneswaran, Subotheni, additional, Elez, Elena, additional, Underhill, Craig, additional, Pavlakis, Nick, additional, Chantrill, Lorraine, additional, Nott, Louise, additional, Jefford, Michael, additional, Khasraw, Mustafa, additional, Day, Fiona, additional, Wasan, Harpreet, additional, Ciardiello, Fortunato, additional, Karapetis, Chris, additional, Joubert, Warren, additional, van Hazel, Guy, additional, Haydon, Andrew, additional, Price, Tim, additional, Tejpar, Sabine, additional, Tebbutt, Niall, additional, and Shapiro, Jeremy, additional

Published
2016
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46. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer

Author

van Hazel, Guy A., primary, Heinemann, Volker, additional, Sharma, Navesh K., additional, Findlay, Michael P.N., additional, Ricke, Jens, additional, Peeters, Marc, additional, Perez, David, additional, Robinson, Bridget A., additional, Strickland, Andrew H., additional, Ferguson, Tom, additional, Rodríguez, Javier, additional, Kröning, Hendrik, additional, Wolf, Ido, additional, Ganju, Vinod, additional, Walpole, Euan, additional, Boucher, Eveline, additional, Tichler, Thomas, additional, Shacham-Shmueli, Einat, additional, Powell, Alex, additional, Eliadis, Paul, additional, Isaacs, Richard, additional, Price, David, additional, Moeslein, Fred, additional, Taieb, Julien, additional, Bower, Geoff, additional, Gebski, Val, additional, Van Buskirk, Mark, additional, Cade, David N., additional, Thurston, Kenneth, additional, and Gibbs, Peter, additional

Published
2016
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47. Hypertension and beta-blocker use as prognostic and predictive factors in metastatic colorectal cancer: A retrospective analysis of NCIC CTG CO.17.

Author

Sud, Shelly, primary, O'Callaghan, Christopher J., additional, Karapetis, Christos Stelios, additional, Jonker, Caleb, additional, Price, Timothy Jay, additional, Tebbutt, Niall C., additional, Shapiro, Jeremy David, additional, Van Hazel, Guy A., additional, Pavlakis, Nick, additional, Gibbs, Peter, additional, Jeffery, Mark, additional, Siu, Lillian L., additional, Gill, Sharlene, additional, Wong, Ralph, additional, Jonker, Derek J., additional, Tu, Dongsheng, additional, and Goodwin, Rachel Anne, additional

Published
2016
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48. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer : the SIRFLOX study

Author

Gibbs, Peter, Gebski, Val, Van Buskirk, Mark, Thurston, Kenneth, Cade, David N, Van Hazel, Guy A, SIRFLOX Study group, the, Geboes, Karen, Peeters, Marc, Peeters, Marc, and SIRFLOX Study Group

Subjects
Oncology, Cancer Research, Organoplatinum Compounds, BIOLOGIC THERAPIES, Colorectal cancer, Leucovorin, SIR-Spheres (R) microspheres, Study Protocol, Liver metastases, FOLFOX, SIR-Spheres® microspheres, Antineoplastic Combined Chemotherapy Protocols, Medicine and Health Sciences, Yttrium Radioisotopes, OXALIPLATIN, Metastatic colorectal cancer, Selective internal radiation therapy, Liver Neoplasms, PHASE-III TRIAL, Chemoradiotherapy, Microspheres, Fluorouracil, Colorectal Neoplasms, medicine.drug, Adult, medicine.medical_specialty, CONTINUOUS-INFUSION, Bevacizumab, LEUCOVORIN, Internal medicine, medicine, Genetics, Humans, Systemic chemotherapy, EXPERT CONSENSUS STATEMENT, RECTAL-CANCER, RESCUE SURGERY, Performance status, business.industry, LONG-TERM SURVIVAL, medicine.disease, FLUOROURACIL, Oxaliplatin, Surgery, Regimen, Selective Internal Radiation Therapy (SIRT), Human medicine, business
Abstract

Background In colorectal cancer (CRC), unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres®; Sirtex Medical Limited, North Sydney, Australia). Methods/Design SIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy ± SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-naïve patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of ≥3 months and a WHO performance status of 0–1. Patients will be randomised to receive either mFOLFOX6 or SIRT + mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1–3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting ≥450 patients will be sufficient for 80% power and 95% confidence. Discussion The SIRFLOX trial will establish the potential role of SIRT + standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases. Trial registration SIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008. Electronic supplementary material The online version of this article (doi:10.1186/1471-2407-14-897) contains supplementary material, which is available to authorized users.

Published
2014

50. Hypertension as a predictor of outcome and treatment response to cetuximab: A retrospective analysis of NCIC CTG CO.17.

Author

Sud, Shelly, primary, O'Callaghan, Christopher J., additional, Jonker, Caleb, additional, Karapetis, Christos Stelios, additional, Price, Timothy Jay, additional, Tebbutt, Niall C., additional, Shapiro, Jeremy David, additional, Van Hazel, Guy A., additional, Pavlakis, Nick, additional, Gibbs, Peter, additional, Jeffery, Mark, additional, Siu, Lillian L., additional, Gill, Sharlene, additional, Wong, Ralph, additional, Jonker, Derek J., additional, Tu, Dongsheng, additional, and Goodwin, Rachel Anne, additional

Published
2016
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