Trial reportBMC cancer2015
Randomized phase III clinical trial comparing the combination of capecitabine and oxaliplatin (CAPOX) with the combination of 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) as adjuvant therapy in patients with operated high-risk stage II or stage III colorectal cancer.
Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Capecitabine Versus Continuous Infusion Fluorouracil for the Treatment of Advanced or Metastatic Colorectal Cancer: a Meta-analysis.Current treatment options in oncology · 2018Pooled it
- NCCN Guidelines Insights: Colon Cancer, Version 2.2018.Journal of the National Comprehensive Cancer Network : JNCCN · 2018Guideline
- Oral versus intravenous fluoropyrimidines for colorectal cancer.The Cochrane database of systematic reviews · 2017Pooled it
- Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial.JAMA oncology · 2019Trial
- Evaluation of CpG Island Methylator Phenotype as a Biomarker in Colorectal Cancer Treated With Adjuvant Oxaliplatin.Clinical colorectal cancer · 2016Trial
- Impact of Dose Reductions, Delays Between Chemotherapy Cycles, and/or Shorter Courses of Adjuvant Chemotherapy in Stage II and III Colorectal Cancer Patients: a Single-Center Retrospective Study.Journal of gastrointestinal cancer · 2015Trial
- Molecular biomarkers for predicting complete response to preoperative chemoradiation in people with locally advanced rectal cancer.The Cochrane database of systematic reviews · 2024Article
- Irregular delay of adjuvant chemotherapy correlated with poor outcome in stage II-III colorectal cancer.BMC cancer · 2022Article
- Nanocarriers as a Tool for the Treatment of Colorectal Cancer.Pharmaceutics · 2021Review
- The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.Surgery today · 2021Article
- The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study.International journal of colorectal disease · 2021Article
- Article
- Impact of the COVID-19 outbreak on adjuvant chemotherapy for patients with stage II or III colon cancer: experiences from a multicentre clinical trial in China.Current oncology (Toronto, Ont.) · 2020Article
- Outcomes of Adjuvant Oral versus Intravenous Fluoropyrimidines for High-Risk Stage II or Stage III Colon Adenocarcinoma: A Propensity Score-Matched, Nationwide, Population-Based Cohort Study.Journal of Cancer · 2020Article
- Essential advances in surgical and adjuvant therapies for colorectal cancer 2018-2019.Annals of gastroenterological surgery · 2020Review
- Adjuvant therapy for stages II and III colon cancer: risk stratification, treatment duration, and future directions.Current oncology (Toronto, Ont.) · 2019Review
- Influence of DPYD*9A, DPYD*6 and GSTP1 ile105val Genetic Polymorphisms on Capecitabine and Oxaliplatin (CAPOX) Associated Toxicities in Colorectal Cancer (CRC) Patients.Asian Pacific journal of cancer prevention : APJCP · 2019Article
- Prolonged Capecitabine Chemotherapy Following Capecitabine and Oxaliplatin (CAPOX) Regimen Chemotherapy Failed to Improve Survival of Stage III Colorectal Cancer After Radical Resection.Medical science monitor : international medical journal of experimental and clinical research · 2019Article
- Effects of oxaliplatin-containing adjuvant chemotherapy on short-term survival of patients with colon cancer in Dr. Sardjito Hospital, Yogyakarta, Indonesia.Journal of gastrointestinal oncology · 2019Article
- Prognostic implications of mismatch repair deficiency in patients with nonmetastatic colorectal and endometrial cancer.ESMO open · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of the trial was to compare two active adjuvant chemotherapy regimens in patients with early stage colorectal cancer (CRC).
methodsPatients were assigned to oxaliplatin, leucovorin and 5-FU for 12 cycles (group A, FOLFOX6) or oxaliplatin and capecitabine for eight cycles (group B, CAPOX). Primary endpoint was disease-free survival (DFS). Tumors were classified as mismatch repair proficient (pMMR) or deficient (dMMR) according to MLH1, PMS2, MSH2 and MSH6 protein expression. KRAS exon two and BRAF V600E mutational status were also assessed.
resultsBetween 2005 and 2008, 441 patients were enrolled, with 408 patients being eligible. After a median follow-up of 74.7 months, 3-year DFS was 79.8 % (95 % CI 76.5-83.4) in the FOLFOX group and 79.5 % (95 % CI 75.9-83.1) in the CAPOX group (p = 0.78). Three-year OS was 87.2 % (95 % CI 84.1-91.1) in the FOLFOX and 86.9 % (95 % CI 83.4-89.9) in the CAPOX group (p = 0.84). Among 306 available tumors, 11.0 % were dMMR, 34.0 % KRAS mutant and 4.9 % BRAF mutant. Multivariate analysis showed that primary site in the left colon, earlier TNM stage and the presence of anemia at diagnosis were associated with better DFS and overall survival (OS), while grade one-two tumors were associated with better OS. Finally, a statistically significant interaction was detected between the primary site and MMR status (p = 0.010), while KRAS mutated tumors were associated with shorter DFS. However, the sample was too small for safe conclusions.
conclusionsNo significant differences were observed in the efficacy of FOLFOX versus CAPOX as adjuvant treatment in high-risk stage II or stage III CRC patients, but definitive conclusions cannot be drawn because of the small sample size.
trial registrationANZCTR 12610000509066 . Date of Registration: June 21, 2010.
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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.