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- Dewdney, Alice, et al.
(författare)
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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)
- 2012
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Ingår i: Journal of Clinical Oncology. - 0732-183X .- 1527-7755. ; 30:14, s. 1620-1627
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Tidskriftsartikel (refereegranskat)abstract
- 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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| 2. |
- Salazar, Ramon, et al.
(författare)
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Comparison of ColoPrint risk classification with clinical risk in the prospective PARSC trial
- 2014
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Ingår i: Journal of Clinical Oncology. - Inst Catala Oncol, Early Clin Res Unit, Lhospitalet Barcelona, Spain. Vall dHebron Univ Hosp, Barcelona, Spain. Kantonsspital Baden, Dept Surg, Baden, Switzerland. Akad Univ Hosp, Uppsala, Sweden. Westfries Gasthuis, Hoorn, Netherlands. Inst Canc Montpelier, Dept Pathol, Montpellier, France. Med Spectrum Twente, Enschede, Netherlands. Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA. Med Ctr Alkmaar, Alkmaar, Netherlands. Med Univ Vienna, Vienna, Austria. Univ Oxford, Dept Oncol, Oxford, England. Wake Forest Univ, Bowman Gray Sch Med, Winston Salem, NC USA. Matsuda Hosp, Hamamatsu, Shizuoka, Japan. Acad Teaching Hosp, Linz, Austria. South Orange Cty Surg Med Grp, Laguna Hills, CA USA. Norfolk & Norwich Univ Hosp NHS FT, Norwich, Norfolk, England. Univ Hong Kong, Queen Mary Hosp, Hong Kong, Hong Kong, Peoples R China. Long Beach Mem Med Ctr, Long Beach, CA USA. Agendia, Amsterdam, Netherlands. Georgetown Univ, Lombardi Comprehens Canc Ctr, Washington, DC USA.. - 0732-183X .- 1527-7755. ; 32:15
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Tidskriftsartikel (refereegranskat)
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| 3. |
- Sclafani, Francesco, et al.
(författare)
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FC gamma RIIa and FC gamma RIIa polymorphisms (SNPs) and cetuximab (C) benefit in the EXPERT-C trial
- 2014
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Ingår i: Journal of Clinical Oncology. - Royal Marsden NHS Fdn Trust, London, England. Royal Marsden NHS Fdn Trust, Surrey, England. Vall Hebren Univ Hosp, Barcelona, Spain. Akad Univ Hosp, Uppsala, Sweden. Univ Valencia, INCLIVA, Dept Hematol & Med Oncol, Valencia, Spain.. - 0732-183X .- 1527-7755. ; 32:15
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Tidskriftsartikel (refereegranskat)
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| 4. |
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| 5. |
- Yao, James C., et al.
(författare)
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Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors : Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study
- 2016
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Ingår i: Journal of Clinical Oncology. - : AMER SOC CLINICAL ONCOLOGY. - 0732-183X .- 1527-7755. ; 34:32, s. 3906-3913
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors (NET) compared with placebo in the RADIANT-3 study. Here, we present the final overall survival (OS) data and data on the impact of biomarkers on OS from the RADIANT-3 study. Methods Patients with advanced, progressive, low-or intermediate-grade pancreatic NET were randomly assigned to everolimus 10 mg/day (n = 207) or placebo (n = 203). Crossover from placebo to openlabel everolimus was allowed on disease progression. Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator's discretion (extension phase). OS analysis was performed using a stratified log-rank test in the intent-to-treat population. The baseline levels of chromogranin A, neuron-specific enolase, and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored. Results Of 410 patients who were enrolled between July 2007 and March 2014, 225 received open-label everolimus, including 172 patients (85%) randomly assigned initially to the placebo arm. Median OS was 44.0 months (95% CI, 35.6 to 51.8 months) for those randomly assigned to everolimus and 37.7 months (95% CI, 29.1 to 45.8 months) for those randomly assigned to placebo (hazard ratio, 0.94; 95% CI, 0.73 to 1.20; P = .30). Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were poor prognostic factors for OS. The most common adverse events included stomatitis, rash, and diarrhea. Conclusion Everolimus was associated with a median OS of 44 months in patients with advanced, progressive pancreatic NET, the longest OS reported in a phase III study for this population. Everolimus was associated with a survival benefit of 6.3 months, although this finding was not statistically significant. Crossover of patients likely confounded the OS results.
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