Trial reportInternational journal of colorectal disease2012
Effect of neoadjuvant cetuximab, capecitabine, and radiotherapy for locally advanced rectal cancer: results of a phase II study.
Trial report in International journal of colorectal disease, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- The Addition of EGFR Inhibitors in Neoadjuvant Therapy for KRAS-Wild Type Locally Advanced Rectal Cancer Patients: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2020Pooled it
- The efficacy of adding targeted agents to neoadjuvant therapy for locally advanced rectal cancer patients: a meta-analysis.Cancer medicine · 2018Pooled it
- Germline and somatic genetic predictors of pathological response in neoadjuvant settings of rectal and esophageal cancers: systematic review and meta-analysis.The pharmacogenomics journal · 2016Pooled it
- Cetuximab Combined With Induction Oxaliplatin and Capecitabine, Followed by Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer: SWOG 0713.Clinical colorectal cancer · 2018Trial
- Prospective phase II trial of nimotuzumab in combination with radiotherapy and concurrent capecitabine in locally advanced rectal cancer.International journal of colorectal disease · 2015Trial
- Review
- Recent advances in (chemo-)radiation therapy for rectal cancer: a comprehensive review.Radiation oncology (London, England) · 2020Review
- MRI-Based Radiomics Predicts Tumor Response to Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer.Frontiers in oncology · 2019Article
- Prevalence of K-Ras mutations in hepatocellular carcinoma: A Turkish Oncology Group pilot study.Molecular and clinical oncology · 2015Article
- Does the Addition of Cetuximab to Radiochemotherapy Improve Outcome of Patients with Locally Advanced Rectal Cancer? Long-Term Results from Phase II Trials.Gastroenterology research and practice · 2015Article
- The status of targeted agents in the setting of neoadjuvant radiation therapy in locally advanced rectal cancers.Journal of gastrointestinal oncology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to investigate the efficacy and safety of neoadjuvant cetuximab, capecitabine, and radiotherapy for patients with locally advanced rectal cancer.
methodsSixty-three eligible patients were selectively enrolled in this study. Neoadjuvant treatment consisted of cetuximab and capecitabine for 6 weeks and radiotherapy for 5 weeks. Surgical resection was performed 6-8 weeks after the completion of neoadjuvant treatment. KRAS mutation statuses were analyzed retrospectively after the cetuximab treatment. All the patients underwent a standardized postoperative follow-up for at least 3 years.
resultsA pathological complete response (pCR) was achieved in eight patients (12.7 %). Overall down-staging was found in 49 patients (77.8 %). The 3-year disease-free survival (DFS) rate and overall survival (OS) rate was 76.2 % and 81.0 %, respectively. The most common adverse events during neoadjuvant treatment were acneiform skin rash (82.5 %), radiodermatitis (46.0 %), and diarrhea (36.5 %). KRAS mutations were detected in 19 of 63 (31.2 %) tumors. The down-staging rate in patients with KRAS wild-type (WT) was significantly higher than patients with KRAS mutation (P = 0.020). There was no significant difference in the pCR rate, 3-year DFS rate or 3-year OS rate between KRAS WT patients and KRAS-mutated patients.
conclusionNeoadjuvant treatment with cetuximab and capecitabine-based chemoradiotherapy is safe and well tolerated. The pCR rate, 3-year DFS rate and OS rate are not superior to the rate of neoadjuvant chemoradiotherapy using two or more cytotoxic agents. The KRAS WT is highly associated with tumor down-staging to cetuximab plus capecitabine-based CRT in patients with LARC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.