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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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13. Early results from implementation of a 'watch and wait' protocol for complete clinical response following chemoradiotherapy for rectal cancer.

Author

Balasuriya, Hasitha D., Timon, Charles, Entriken, Fiona, Neely, David, Herron, John, Tang, Colin, Van Hazel, Guy, and Warner, Michael W.

Subjects
RECTAL cancer, MEDICAL protocols, CHEMORADIOTHERAPY
Abstract

Background: Neoadjuvant long course chemoradiotherapy (NLCRT) for rectal cancer can result in complete pathological response (pCR). In 2017, we started offering patients who had a complete clinical response (cCR), a choice between total mesorectal excision (TME) and an intensive surveillance or 'watch and wait' (W&W) program. We report the early outcomes of this prospective study. Methods: All patients undergoing NLCRT from 2017 to 2019 were included. All patients were restaged at 8 weeks, and those who had a cCR were offered TME or W&W. Results: Of 59 patients who underwent NLCRT, 55 had restaging. Eleven of these patients had a cCR (20%). Three chose to have TME and all had a pCR. Eight were enrolled in W&W. Two patients were diagnosed with local regrowth and underwent TME at 7 and 17 months after NLCRT. A further nine patients, who were surgically unfit or refused TME, and had an excellent response to NLCRT, but one that did not reach criteria for a cCR, were also managed with W&W. Of these, two patients developed regrowth with distant metastases. From 2017 to 2019, of the 17 patients who were managed with a W&W approach, 13 patients have remained regrowth free after a median of 28 (13–58) months of W&W. Conclusion: Preliminary findings suggest management with W&W, following cCR, may be a safe alternative to TME. There have so far been no instances of distant failure, and those with cCR that had regrowth, were identified early and successfully managed with salvage TME. [ABSTRACT FROM AUTHOR]

Published
2022
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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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25. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE‐global randomised trials of selective internal radiotherapy for metastatic colorectal cancer.

Author

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

Subjects
COLORECTAL cancer, METASTASIS, CANCER chemotherapy, QUALITY of life, RADIOTHERAPY
Abstract

Selective internal radiotherapy (SIRT) is a liver‐directed treatment involving the injection of yttrium‐90 microspheres into the blood supply of liver tumours. There are very few studies assessing health‐related quality of life (HRQOL) in patients treated with SIRT. Patients with liver metastases from colorectal cancer (CRC) were randomised in the FOXFIRE (FFr; ISRCTN83867919), SIRFLOX (SF; NCT00724503) and FOXFIRE‐Global (FFrG; NCT01721954) trials of first‐line oxaliplatin–fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone. HRQOL was assessed using the three‐level EQ‐5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ‐C30) and EORTC Colorectal Liver Metastases cancer module (EORTC QLQ‐LMC21) at baseline, ≤3 months, 6 months, 12 months and annually thereafter from randomisation, and at disease progression. Analyses were conducted on an intention‐to‐treat basis. In total, 554 patients were randomised to SIRT + FOLFOX and 549 patients to FOLFOX alone. HRQOL was statistically significant lower in SIRT + FOLFOX patients ≤3 months after SIRT administration in all three instruments, particularly global health, physical and role functioning and symptoms of fatigue, nausea/vomiting and appetite loss. By accepted thresholds, these differences were deemed not clinically important. Differences between SIRT + FOLFOX and FOLFOX alone over the 2‐year follow up and at disease progression were also not clinically important. Although there is some decrease in HRQOL for up to 3 months following SIRT, the addition of SIRT to FOLFOX chemotherapy does not change HRQOL to a clinically important degree in metastatic CRC patients. What's new? Selective internal radiotherapy (SIRT) is a liver‐directed treatment involving injection of yttrium‐90 microspheres into the blood supply of liver tumours. Few studies have assessed health‐related quality of life (HRQOL) in patients treated with SIRT. This study compared HRQOL between liver metastases from colorectal cancer patients receiving SIRT plus FOLFOX chemotherapy and FOLFOX alone. With a total of 1,103 patients, this is the largest analysis of patient‐reported outcomes for SIRT and the largest prospective QOL study in interventional oncology. Following non‐clinically important deterioration up to 3 months post‐SIRT, SIRT could be added to FOLFOX chemotherapy without a detrimental impact on QOL. [ABSTRACT FROM AUTHOR]

Published
2020
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26. 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

27. 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

29. 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, Heinemann, Volker, Sharma, Navesh K., Taieb, Julien, Ricke, Jens, Peeters, Marc, Findlay, Michael, Robinson, Bridget, Jackson, Christopher, Strickland, Andrew, Gebski, Val, Van Buskirk, Mark, Huaqing Zhao, van Hazel, Guy, Zhao, Huaqing, and SIRFLOX and FOXFIRE Global Trial Investigators

Published
2018
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32. O-027 - 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, van Hazel, Guy, Heinemann, Volker, Sharma, Navesh, Taieb, Julien, Ricke, Jens, Peeters, Marc, Findlay, Michael, Virdee, Pradeep S., Love, Sharon, Moschandreas, Joanna, Dutton, Peter, Gebski, Val, Gray, Alastair, Price, Dave, Bower, Geoff, Montazeri, Amir, Swinson, Daniel, Brown, Ewan, Wilson, Greg, Lowndes, Sarah, Sharma, Ricky A., and Gibbs, Peter

Published
2017
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35. 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, Thavaneswaran, Subotheni, Waring, Paul M., Desai, Jayesh, Robledo, Kristy P., Gebski, Val J., Elez, Elena, Nott, Louise M., Karapetis, Christos S., Lunke, Sebastian, Chantrill, Lorraine A., Pavlakis, Nick, Khasraw, Mustafa, Underhill, Craig, Ciardiello, Fortunato, Jefford, Michael, Wasan, Harpreet, Haydon, Andrew, Price, Timothy J., and van Hazel, Guy

Published
2016
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36. 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, and Haydon, Andrew

Subjects
COLON cancer patients, CETUXIMAB, IRINOTECAN, OXALIPLATIN, CANCER chemotherapy, ANTINEOPLASTIC agents, CAMPTOTHECIN, COLON tumors, COMPARATIVE studies, EXPERIMENTAL design, HYDROLASES, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, MEMBRANE proteins, GENETIC mutation, PEPTIDES, PROGNOSIS, PROTEINS, RECTUM tumors, RESEARCH, TRANSFERASES, EVALUATION research, RANDOMIZED controlled trials
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, and the rare KRAS G13D mutated tumours, which are also postulated to be sensitive to the drug. The focus on establishing both positive and negative predictive factors for the response to targeted therapy is an attempt to improve outcomes, reduce toxicity and contain treatment costs. Tissue and blood will yield a resource for molecular studies. Recruitment, particularly of patients with the rare G13D mutation, will demonstrate the ability for international collaboration to run prospective trials in small colorectal cancer molecular subgroups.Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12612000901808 , registered 16 August 2012. [ABSTRACT FROM AUTHOR]

Published
2016
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37. 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., Heinemann, Volker, Sharma, Navesh K., Findlay, Michael P. N., Ricke, Jens, Peeters, Marc, Perez, David, Robinson, Bridget A., Strickland, Andrew H., Ferguson, Tom, Rodríguez, Javier, Kröning, Hendrik, Wolf, Ido, Ganju, Vinod, Walpole, Euan, Boucher, Eveline, Tichler, Thomas, Shacham-Shmueli, Einat, Powell, Alex, and Eliadis, Paul

Published
2016
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38. Phase II trial of selective internal radiation therapy and systemic chemotherapy for liver-predominant metastases from pancreatic adenocarcinoma.

Author

Gibbs, Peter, Cuong Do, Lipton, Lara, Cade, David N., Tapner, Michael J., Price, David, Bower, Geoff D., Dowling, Richard, Lichtenstein, Meir, van Hazel, Guy A., and Do, Cuong

Subjects
PANCREATIC cancer treatment, CANCER chemotherapy, PROGRESSION-free survival, CANCER radiotherapy, LIVER failure, CANCER patients, PANCREATIC cancer, ANTINEOPLASTIC agents, FLUOROURACIL, THERAPEUTIC use of antimetabolites, CLINICAL trials, COMBINED modality therapy, COMPARATIVE studies, LIVER tumors, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, PANCREATIC tumors, RADIOISOTOPES, RESEARCH, EVALUATION research, DIAGNOSIS
Abstract

Background: This prospective, open-label phase II study assessed the impact of liver-directed therapy with selective internal radiation therapy (SIRT) and systemic chemotherapy on progression-free survival (PFS) in liver-dominant metastatic pancreatic adenocarcinoma.Methods: Patients received yttrium-90-labelled ((90)Y) resin microspheres (SIR-Spheres; Sirtex Medical Limited, Sydney, Australia) as a single procedure on day 2 of the first weekly cycle of 5-fluorouracil (5FU; 600 mg/m(2)) with the option to switch to gemcitabine (1000 mg/m(2)) after 8 weeks of 5FU. Statistical analysis was conducted using Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA). The primary endpoint of the study was PFS in the liver, with a median of ≥ 16 weeks defined as the threshold for clinical significance. PFS and overall survival (OS) were summarised by the Kaplan-Meier method using non-parametric estimates of the survivor function.Results: Fourteen eligible patients were enrolled; ten had primary tumour in situ and eight had liver-only metastases. Patients received a median (90)Y activity of 1.1 GBq and 8 weekly doses of 5FU; seven patients received a median of two doses of gemcitabine. Disease control in the liver was 93% (two confirmed partial responses [PR], one unconfirmed PR, ten stable disease). Median reduction in cancer antigen 19-9 was 72%. Median PFS was 5.2 months in the liver, which met the primary endpoint of the study, and 4.4 months at any site. PFS was prolonged in those with a resected primary compared with patients with primary in situ (median 7.8 vs. 3.4 months; p = 0.017). Median OS was 5.5 months overall and 13.6 months in patients with a resected primary. Grade 3/4 adverse events occurred in eight (57%) patients during days 0-60. There was one sudden death and another patient who died from possible treatment-related liver failure 7.0 months after SIRT.Conclusions: SIRT and chemotherapy appears to be an effective treatment for liver metastases from pancreatic cancer, likely to be of most benefit in selected patients with a resected primary tumour and liver only disease. Significant toxicity was observed and the safety of this approach in patients with metastatic pancreatic cancer will need to be confirmed in subsequent studies. Further study is warranted with SIRT and modern chemotherapies.Trial Registration: ACTRN12606000015549. [ABSTRACT FROM AUTHOR]

Published
2015
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41. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen.

Author

Van Cutsem, Eric, Tabernero, Josep, Lakomy, Radek, Prenen, Hans, Prausová, Jana, Macarulla, Teresa, Ruff, Paul, van Hazel, Guy A., Moiseyenko, Vladimir, Ferry, David, McKendrick, Joe, Polikoff, Jonathan, Tellier, Alexia, Castan, Rémi, and Allegra, Carmen

Published
2012
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42. Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer.

Author

Stockler, Martin R., Harvey, Vernon J., Francis, Prudence A., Byrne, Michael J., Ackland, Stephen P., Fitzharris, Bernie, Van Hazel, Guy, Wilcken, Nicholas R. C., Grimison, Peter S., Nowak, Anna K., Gainford, M. Corona, Fong, Akiko, Paksec, Lisa, Sourjina, Tatiana, Zannino, Diana, Gebski, Val, Simes, R. John, Forbes, John F., and Coates, Alan S.

Published
2011
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43. Treatment of fluorouracil-refractory patients with liver metastases from colorectal cancer by using yttrium-90 resin microspheres plus concomitant systemic irinotecan chemotherapy.

Author

van Hazel GA, Pavlakis N, Goldstein D, Olver IN, Tapner MJ, Price D, Bower GD, Briggs GM, Rossleigh MA, Taylor DJ, George J, van Hazel, Guy A, Pavlakis, Nick, Goldstein, David, Olver, Ian N, Tapner, Michael J, Price, David, Bower, Geoffrey D, Briggs, Gregory M, and Rossleigh, Monica A

Published
2009
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44. Corrigendum to “Single-agent irinotecan or 5-fluorouracil and leucovorin (FOLFIRI) as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis” [Eur J Cancer 47 (12) (2011) 1826–1836]

Author

Clarke, Stephen J., Yip, Sonia, Brown, Chris, van Hazel, Guy A., Ransom, David T., Goldstein, David, Mark Jeffrey, G., Tebbutt, Niall C., Buck, Martin, Lowenthal, Raymond M., Boland, Amy, Gebski, Val, Zalcberg, John, and John Simes, R.

Published
2012
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49. 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

Subjects
610 Medicine & health, 3. Good health

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