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Gina Brown - One of the best experts on this subject based on the ideXlab platform.
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RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
Journal of Clinical Oncology, 2014Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, Andrew Wotherspoon, Clare Peckitt, David Gonzalez, Sanna Hullki Wilson, Gina BrownAbstract:RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
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Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
European Journal of Cancer, 2013Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Clare Peckitt, D. Gonzalez De Castro, Ian ChauAbstract:Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
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the impact of tp53 mutation on high risk rectal cancer patients treated within the expert c trial a randomized phase ii study of neoadjuvant oxaliplatin capecitabine CAPOX and chemoradiation crt with or without cetuximab
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, Jaume Capdevila, Bengt Glimelius, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De Castro, Ian Chau, Andres Cervantesruiperez, Sanna Hulkki WilsonAbstract:e14088 Background: The EXPERT-C trial randomised 165 patients into neoadjuvant CAPOX and CRT ± cetuximab and demonstrated a significant increase in radiological response (RR) and overall survival (...
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging-defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOX + C). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n = 44; CAPOX + C, n = 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P = 1.0; odds ratio, 1.22) or PFS (hazard ratio [ HR], 0.65; P = .363). Cetuximab significantly improved RR (CAPOX v CAPOX + C: after chemotherapy, 51% v 71%, respectively; P = .038; after chemoradiation, 75% v 93%, respectively; P = .028) and OS (HR, 0.27; P = .034). Skin toxicity and diarrhea were more frequent in the CAPOX + C arm. Conclusion Cetuximab led to a significant increase in RR and OS in patients with KRAS/BRAF wild-type rectal cancer, but the primary end point of improved CR was not met.
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging– defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOXC). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n 44; CAPOXC, n 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P 1.0; odds ratio, 1.22) or PFS (hazard ratio [HR], 0.65; P .363). Cetuximab significantly improved RR (CAPOX v CAPOXC: after chemotherapy, 51% v 71%, respectively; P .038; after chemoradiation, 75% v 93%, respectively; P .028) and OS (HR, 0.27; P .034). Skin toxicity and diarrhea were more frequent in the CAPOXC arm.
Goro Nakayama - One of the best experts on this subject based on the ideXlab platform.
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Randomized phase II trial of CAPOX with continuous versus intermittent use of oxaliplatin as an adjuvant chemotherapy after curative resection of stage II/III colon cancer (CCOG-1302 study).
Journal of Clinical Oncology, 2020Co-Authors: Masanori Nakamura, Goro Nakayama, Kiyoshi Ishigure, Hiroyuki Yokoyama, Norifumi Hattori, Keisuke Uehara, Suguru Yamada, Naoki Mashita, Masahiko Koike, Yasuhiro KoderaAbstract:95Background: The aim of this study was to evaluate the efficacy and safety of CAPOX with intermittent use of oxaliplatin compared to continuous use of oxaliplatin as an adjuvant setting for colon ...
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Phase II study of capecitabine plus oxaliplatin (CAPOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II).
International Journal of Clinical Oncology, 2019Co-Authors: Norifumi Hattori, Goro Nakayama, Kiyoshi Ishigure, Keisuke Uehara, Toshisada Aiba, Eiji Sakamoto, Yuichiro Tojima, Mitsuro Kanda, Daisuke Kobayashi, Chie TanakaAbstract:This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CAPOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer. Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CAPOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1–14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety. A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CAPOX therapy. The completion rate of all eight cycles of CAPOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57–86%) and 96% (95% CI 80–99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively. CAPOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.
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Randomized phase II trial of CAPOX with planned oxaliplatin stop-and-go strategy as adjuvant chemotherapy after curative resection of colon cancer (CCOG-1302 study)
Annals of Oncology, 2019Co-Authors: H. Yokoyama, Goro Nakayama, Kiyoshi Ishigure, Norifumi Hattori, Naomi Hayashi, K. Tanaka, Masayuki Tsutsuyama, Suguru Yamada, Yasuhiro KoderaAbstract:Abstract Background The aim of this study was to evaluate the efficacy and safety of CAPOX with planned oxaliplatin stop-and-go strategy compared to continuous use of oxaliplatin as an adjuvant setting for colon cancer. Methods Patients with curative resection of colon cancerwere randomly assigned to receive eitherCAPOX with continuous use of oxaliplatin (8 cycles of CAPOX; continuous arm) or CAPOX intermittentuse of oxaliplatin (2 cycles of CAPOX – 4 cycles of capecitabine – 2 cycles of CAPOX; intermittentarm).The primary endpoints were frequency of peripheral sensory neuropathy (PSN) at 1-year after surgery and disease-free survival rate at 3-year after surgery. The secondary end points included overall survival (OS), compliance and safety. Results A total of 200 patients were enrolled. The intent-to-treat and safety population comprised 100 and 99 patients in the continuous arm,and 100 and 98 patients in the intermittentarm. Compliance: The overall treatment completion rate and relative dose intensity of oxaliplatin were 64% and 71% in the continuous arm vs.92% and 95% in the intermittentarm(p = 0.21 and 0.12, respectively). Efficacy: The 3-year DFS was 81.6% in the continuous arm vs.82.4% in the intermittentarm(HR, 0.82; 95% CI, 0.48-1.18). Safety: The incidence of PSN (>grade 2) was 33%in the continuous arm vs.15% in the intermittentarm (p Conclusions CAPOX withplanned oxaliplatin stop-and-go strategy could be equally effectiveas an adjuvant setting for colon cancer, and substantially reduce long-term PSN and potential improve patient quality of life. Clinical trial identification 000012535 (09/December/2013). Legal entity responsible for the study Yasuhiro Kodera (Chubu Clinical Oncology Group, Japan). Funding Chubu Clinical Oncology Group. Disclosure All authors have declared no conflicts of interest.
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randomized phase ii trial of CAPOX plus bevacizumab and capiri plus bevacizumab as first line treatment for japanese patients with metastatic colorectal cancer ccog 1201 study
Oncologist, 2018Co-Authors: Goro Nakayama, Ayako Mitsuma, Yuki Sunagawa, Kiyoshi Ishigure, Hiroyuki Yokoyama, Takanori Matsui, Hiroshi Nakayama, Kazuhiko Nakata, Akiharu Ishiyama, Takahiro AsadaAbstract:PURPOSE The aim of this randomized, multicenter, noncomparative, phase II trial was to investigate the efficacy and safety of two potential first-line treatments, capecitabine and oxaliplatin (CAPOX) plus bevacizumab (BEV) and capecitabine and irinotecan (CapIRI) plus bevacizumab, in Japanese patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS Patients with untreated mCRC were randomly assigned to receive either CAPOX plus bevacizumab (CAPOX/BEV arm: bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 2,000 mg/m2 on days 1-14, every 3 weeks) or CapIRI plus bevacizumab (CapIRI/BEV arm: bevacizumab 7.5 mg/kg and irinotecan 200 mg/m2 on day 1 and capecitabine 1,600 mg/m2 on days 1-14, every 3 weeks). The primary endpoint was overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS A total of 107 patients were enrolled. The intent-to-treat population comprised 54 patients in the CAPOX/BEV arm and 53 patients in the CapIRI/BEV arm. The median follow-up period was 35.5 months. ORR was 56% in the CAPOX/BEV arm and 55% in the CapIRI/BEV arm. Median PFS and OS were 12.4 and 26.7 months in the CAPOX/BEV arm and 11.5 and 28.7 months in the CapIRI/BEV arm, respectively. The frequencies of hematological and nonhematological adverse events above grade 3 were 13% and 30% in the CAPOX/BEV arm and 25% and 23% in the CapIRI/BEV arm, respectively. CONCLUSION CAPOX plus bevacizumab and CapIRI plus bevacizumab are equally effective and feasible as the first-line treatments in Japanese patients with mCRC. IMPLICATIONS FOR PRACTICE The CCOG-1201 study was designed to evaluate the efficacy and safety of capecitabine and oxaliplatin plus bevacizumab and capecitabine and irinotecan plus bevacizumab as a first-line treatment in Japanese patients with metastatic colorectal cancer. This article reports on the trial and efforts to define the role of these regimens, including the effect of KRAS status and UGT1A1 polymorphisms in metastatic colorectal cancer.
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randomized phase ii trial of CAPOX plus bevacizumab versus capiri plus bevacizumab as first line treatment in japanese patients with metastatic colorectal cancer ccog 1201
Journal of Clinical Oncology, 2018Co-Authors: Masahiro Sasahara, Goro Nakayama, Kiyoshi Ishigure, Hiroyuki Yokoyama, Takanori Matsui, Hiroshi Nakayama, Akiharu Ishiyama, Keisuke Uehara, Daisuke Kobayashi, Shinichi UmedaAbstract:781Background: The aim of this randomized, multicenter, non-comparative phase II trial was to investigate the efficacy and safety of capecitabine/oxaliplatin (CAPOX) plus bevacizumab (BEV) and cape...
Kiyoshi Ishigure - One of the best experts on this subject based on the ideXlab platform.
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Randomized phase II trial of CAPOX with continuous versus intermittent use of oxaliplatin as an adjuvant chemotherapy after curative resection of stage II/III colon cancer (CCOG-1302 study).
Journal of Clinical Oncology, 2020Co-Authors: Masanori Nakamura, Goro Nakayama, Kiyoshi Ishigure, Hiroyuki Yokoyama, Norifumi Hattori, Keisuke Uehara, Suguru Yamada, Naoki Mashita, Masahiko Koike, Yasuhiro KoderaAbstract:95Background: The aim of this study was to evaluate the efficacy and safety of CAPOX with intermittent use of oxaliplatin compared to continuous use of oxaliplatin as an adjuvant setting for colon ...
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Phase II study of capecitabine plus oxaliplatin (CAPOX) as adjuvant chemotherapy for locally advanced rectal cancer (CORONA II).
International Journal of Clinical Oncology, 2019Co-Authors: Norifumi Hattori, Goro Nakayama, Kiyoshi Ishigure, Keisuke Uehara, Toshisada Aiba, Eiji Sakamoto, Yuichiro Tojima, Mitsuro Kanda, Daisuke Kobayashi, Chie TanakaAbstract:This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CAPOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer. Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CAPOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1–14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety. A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CAPOX therapy. The completion rate of all eight cycles of CAPOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57–86%) and 96% (95% CI 80–99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively. CAPOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.
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Randomized phase II trial of CAPOX with planned oxaliplatin stop-and-go strategy as adjuvant chemotherapy after curative resection of colon cancer (CCOG-1302 study)
Annals of Oncology, 2019Co-Authors: H. Yokoyama, Goro Nakayama, Kiyoshi Ishigure, Norifumi Hattori, Naomi Hayashi, K. Tanaka, Masayuki Tsutsuyama, Suguru Yamada, Yasuhiro KoderaAbstract:Abstract Background The aim of this study was to evaluate the efficacy and safety of CAPOX with planned oxaliplatin stop-and-go strategy compared to continuous use of oxaliplatin as an adjuvant setting for colon cancer. Methods Patients with curative resection of colon cancerwere randomly assigned to receive eitherCAPOX with continuous use of oxaliplatin (8 cycles of CAPOX; continuous arm) or CAPOX intermittentuse of oxaliplatin (2 cycles of CAPOX – 4 cycles of capecitabine – 2 cycles of CAPOX; intermittentarm).The primary endpoints were frequency of peripheral sensory neuropathy (PSN) at 1-year after surgery and disease-free survival rate at 3-year after surgery. The secondary end points included overall survival (OS), compliance and safety. Results A total of 200 patients were enrolled. The intent-to-treat and safety population comprised 100 and 99 patients in the continuous arm,and 100 and 98 patients in the intermittentarm. Compliance: The overall treatment completion rate and relative dose intensity of oxaliplatin were 64% and 71% in the continuous arm vs.92% and 95% in the intermittentarm(p = 0.21 and 0.12, respectively). Efficacy: The 3-year DFS was 81.6% in the continuous arm vs.82.4% in the intermittentarm(HR, 0.82; 95% CI, 0.48-1.18). Safety: The incidence of PSN (>grade 2) was 33%in the continuous arm vs.15% in the intermittentarm (p Conclusions CAPOX withplanned oxaliplatin stop-and-go strategy could be equally effectiveas an adjuvant setting for colon cancer, and substantially reduce long-term PSN and potential improve patient quality of life. Clinical trial identification 000012535 (09/December/2013). Legal entity responsible for the study Yasuhiro Kodera (Chubu Clinical Oncology Group, Japan). Funding Chubu Clinical Oncology Group. Disclosure All authors have declared no conflicts of interest.
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randomized phase ii trial of CAPOX plus bevacizumab and capiri plus bevacizumab as first line treatment for japanese patients with metastatic colorectal cancer ccog 1201 study
Oncologist, 2018Co-Authors: Goro Nakayama, Ayako Mitsuma, Yuki Sunagawa, Kiyoshi Ishigure, Hiroyuki Yokoyama, Takanori Matsui, Hiroshi Nakayama, Kazuhiko Nakata, Akiharu Ishiyama, Takahiro AsadaAbstract:PURPOSE The aim of this randomized, multicenter, noncomparative, phase II trial was to investigate the efficacy and safety of two potential first-line treatments, capecitabine and oxaliplatin (CAPOX) plus bevacizumab (BEV) and capecitabine and irinotecan (CapIRI) plus bevacizumab, in Japanese patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS Patients with untreated mCRC were randomly assigned to receive either CAPOX plus bevacizumab (CAPOX/BEV arm: bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 2,000 mg/m2 on days 1-14, every 3 weeks) or CapIRI plus bevacizumab (CapIRI/BEV arm: bevacizumab 7.5 mg/kg and irinotecan 200 mg/m2 on day 1 and capecitabine 1,600 mg/m2 on days 1-14, every 3 weeks). The primary endpoint was overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS A total of 107 patients were enrolled. The intent-to-treat population comprised 54 patients in the CAPOX/BEV arm and 53 patients in the CapIRI/BEV arm. The median follow-up period was 35.5 months. ORR was 56% in the CAPOX/BEV arm and 55% in the CapIRI/BEV arm. Median PFS and OS were 12.4 and 26.7 months in the CAPOX/BEV arm and 11.5 and 28.7 months in the CapIRI/BEV arm, respectively. The frequencies of hematological and nonhematological adverse events above grade 3 were 13% and 30% in the CAPOX/BEV arm and 25% and 23% in the CapIRI/BEV arm, respectively. CONCLUSION CAPOX plus bevacizumab and CapIRI plus bevacizumab are equally effective and feasible as the first-line treatments in Japanese patients with mCRC. IMPLICATIONS FOR PRACTICE The CCOG-1201 study was designed to evaluate the efficacy and safety of capecitabine and oxaliplatin plus bevacizumab and capecitabine and irinotecan plus bevacizumab as a first-line treatment in Japanese patients with metastatic colorectal cancer. This article reports on the trial and efforts to define the role of these regimens, including the effect of KRAS status and UGT1A1 polymorphisms in metastatic colorectal cancer.
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randomized phase ii trial of CAPOX plus bevacizumab versus capiri plus bevacizumab as first line treatment in japanese patients with metastatic colorectal cancer ccog 1201
Journal of Clinical Oncology, 2018Co-Authors: Masahiro Sasahara, Goro Nakayama, Kiyoshi Ishigure, Hiroyuki Yokoyama, Takanori Matsui, Hiroshi Nakayama, Akiharu Ishiyama, Keisuke Uehara, Daisuke Kobayashi, Shinichi UmedaAbstract:781Background: The aim of this randomized, multicenter, non-comparative phase II trial was to investigate the efficacy and safety of capecitabine/oxaliplatin (CAPOX) plus bevacizumab (BEV) and cape...
Bengt Glimelius - One of the best experts on this subject based on the ideXlab platform.
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RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
Journal of Clinical Oncology, 2014Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, Andrew Wotherspoon, Clare Peckitt, David Gonzalez, Sanna Hullki Wilson, Gina BrownAbstract:RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
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Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
European Journal of Cancer, 2013Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Clare Peckitt, D. Gonzalez De Castro, Ian ChauAbstract:Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
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the impact of tp53 mutation on high risk rectal cancer patients treated within the expert c trial a randomized phase ii study of neoadjuvant oxaliplatin capecitabine CAPOX and chemoradiation crt with or without cetuximab
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, Jaume Capdevila, Bengt Glimelius, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De Castro, Ian Chau, Andres Cervantesruiperez, Sanna Hulkki WilsonAbstract:e14088 Background: The EXPERT-C trial randomised 165 patients into neoadjuvant CAPOX and CRT ± cetuximab and demonstrated a significant increase in radiological response (RR) and overall survival (...
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging-defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOX + C). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n = 44; CAPOX + C, n = 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P = 1.0; odds ratio, 1.22) or PFS (hazard ratio [ HR], 0.65; P = .363). Cetuximab significantly improved RR (CAPOX v CAPOX + C: after chemotherapy, 51% v 71%, respectively; P = .038; after chemoradiation, 75% v 93%, respectively; P = .028) and OS (HR, 0.27; P = .034). Skin toxicity and diarrhea were more frequent in the CAPOX + C arm. Conclusion Cetuximab led to a significant increase in RR and OS in patients with KRAS/BRAF wild-type rectal cancer, but the primary end point of improved CR was not met.
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging– defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOXC). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n 44; CAPOXC, n 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P 1.0; odds ratio, 1.22) or PFS (hazard ratio [HR], 0.65; P .363). Cetuximab significantly improved RR (CAPOX v CAPOXC: after chemotherapy, 51% v 71%, respectively; P .038; after chemoradiation, 75% v 93%, respectively; P .028) and OS (HR, 0.27; P .034). Skin toxicity and diarrhea were more frequent in the CAPOXC arm.
David Cunningham - One of the best experts on this subject based on the ideXlab platform.
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RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
Journal of Clinical Oncology, 2014Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, Andrew Wotherspoon, Clare Peckitt, David Gonzalez, Sanna Hullki Wilson, Gina BrownAbstract:RAS mutations in EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab (C) in MRI-defined, high-risk rectal cancer (RC).
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Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
European Journal of Cancer, 2013Co-Authors: Francesco Sclafani, David Cunningham, Josep Tabernero, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Clare Peckitt, D. Gonzalez De Castro, Ian ChauAbstract:Updated survival analysis of EXPERT-C, a randomized phase II trial of neoadjuvant capecitabine and oxaliplatin (CAPOX) and chemoradiotherapy (CRT) with or without cetuximab in MRI-defined high risk rectal cancer patients
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging-defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOX + C). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n = 44; CAPOX + C, n = 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P = 1.0; odds ratio, 1.22) or PFS (hazard ratio [ HR], 0.65; P = .363). Cetuximab significantly improved RR (CAPOX v CAPOX + C: after chemotherapy, 51% v 71%, respectively; P = .038; after chemoradiation, 75% v 93%, respectively; P = .028) and OS (HR, 0.27; P = .034). Skin toxicity and diarrhea were more frequent in the CAPOX + C arm. Conclusion Cetuximab led to a significant increase in RR and OS in patients with KRAS/BRAF wild-type rectal cancer, but the primary end point of improved CR was not met.
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multicenter randomized phase ii clinical trial comparing neoadjuvant oxaliplatin capecitabine and preoperative radiotherapy with or without cetuximab followed by total mesorectal excision in patients with high risk rectal cancer expert c
Journal of Clinical Oncology, 2012Co-Authors: Alice Dewdney, David Cunningham, Josep Tabernero, Jaume Capdevila, Bengt Glimelius, Andres Cervantes, D Tait, Gina Brown, Andrew Wotherspoon, David Gonzalez De CastroAbstract:Purpose To evaluate the addition of cetuximab to neoadjuvant chemotherapy before chemoradiotherapy in high-risk rectal cancer. Patients and Methods Patients with operable magnetic resonance imaging– defined high-risk rectal cancer received four cycles of capecitabine/oxaliplatin (CAPOX) followed by capecitabine chemoradiotherapy, surgery, and adjuvant CAPOX (four cycles) or the same regimen plus weekly cetuximab (CAPOXC). The primary end point was complete response (CR; pathologic CR or, in patients not undergoing surgery, radiologic CR) in patients with KRAS/BRAF wild-type tumors. Secondary end points were radiologic response (RR), progression-free survival (PFS), overall survival (OS), and safety in the wild-type and overall populations and a molecular biomarker analysis. Results One hundred sixty-five eligible patients were randomly assigned. Ninety (60%) of 149 assessable tumors were KRAS or BRAF wild type (CAPOX, n 44; CAPOXC, n 46), and in these patients, the addition of cetuximab did not improve the primary end point of CR (9% v 11%, respectively; P 1.0; odds ratio, 1.22) or PFS (hazard ratio [HR], 0.65; P .363). Cetuximab significantly improved RR (CAPOX v CAPOXC: after chemotherapy, 51% v 71%, respectively; P .038; after chemoradiation, 75% v 93%, respectively; P .028) and OS (HR, 0.27; P .034). Skin toxicity and diarrhea were more frequent in the CAPOXC arm.
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a multicentre study of capecitabine oxaliplatin plus bevacizumab as perioperative treatment of patients with poor risk colorectal liver only metastases not selected for upfront resection
Annals of Oncology, 2011Co-Authors: Rachel Wong, David Cunningham, Gina Brown, Y Barbachano, Claire Saffery, Juan W Valle, Tamas Hickish, Satvinder Mudan, Adeel Khan, A WotherspoonAbstract:Background: Perioperative chemotherapy improves outcome in resectable colorectal liver-only metastasis (CLM). This study aimed to evaluate perioperative CAPOX (capecitabine-oxaliplatin) plus bevacizumab in patients with poor-risk CLM not selected for upfront resection. Patients and methods: Poor-risk CLM was defined as follows: more than four metastases, diameter >5 cm, R0 resection unlikely, inadequate viable liver function if undergoing upfront resection, inability to retain liver vascular supply, or synchronous colorectal primary presentation. Patients underwent baseline computed tomography, magnetic resonance imaging, and/or positron emission tomography (PET) for staging and received neoadjuvant CAPOX plus bevacizumab, with resectability assessed every four cycles. Primary end point was radiological objective response rate (ORR). Results: Forty-six patients were recruited, of which 91% underwent PET to ensure metastases confined to liver. Following neoadjuvant CAPOX plus bevacizumab, the ORR was 78% (95% confidence interval 63% to 89%). This allowed 12 of 30 (40%) patients with initial nonsynchronous unresectable CLM to be converted to resectability. In addition, 10 of 15 (67%) patients with synchronous resectable CLM underwent liver resection, with four additional patients being observed alone due to excellent response to neoadjuvant therapy. No grade 3-4 perioperative complications were seen. Conclusion: Neoadjuvant CAPOX plus bevacizumab resulted in a high response rate for patients with CLMs with poor-risk features not selected for upfront resection and converted 40% of patients to resectability.
