Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021
Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design.Cancer research and treatment · 2024Pooled it
- Docetaxel-oxaliplatin-capecitabine/5-fluorouracil (DOX/F) followed by docetaxel versus oxaliplatin-capecitabine/5-fluorouracil (CAPOX/FOLFOX) in HER2-negative advanced gastric cancers.JNCI cancer spectrum · 2024Trial
- Facilitating access to clinical data from a randomized controlled trial of complex adaptive design.BMC research notes · 2026Article
- Progression-Free Survival Effect Sizes in Randomized Controlled Trials of Targeted Cancer Therapies with Positive Outcomes.Acta haematologica · 2026Article
- Cost-effectiveness analysis of capecitabine versus active monitoring in stable or responding metastatic colorectal cancer after 16 weeks of first-line therapy.Annals of medicine · 2025Article
- Discontinuation of Immune Checkpoint Inhibition in Patients with Advanced Unresectable Melanoma Achieving CR, PR, or SD.Targeted oncology · 2025Article
- Treatment holidays in patients with Erdheim-Chester disease receiving vemurafenib: a prospective pilot study.Blood advances · 2025Article
- Taking a break: a therapeutic option for ECD?Blood advances · 2025Article
- Factors Influencing the Duration of Maintenance Therapy in Metastatic Colorectal Cancer.Cancers · 2024Article
- Optimising oncology drug expenditure in Ireland.Irish journal of medical science · 2024Review
- A two-stage maintenance trial of cetuximab-based treatment in RAS and BRAF wild-type unresectable metastatic colorectal cancer: a retrospective real-world study.Frontiers in oncology · 2024Article
- Thymosin α1 combined with XELOX improves immune function and reduces serum tumor markers in colorectal cancer patients after radical surgery.Open life sciences · 2024Article
- FOCUS4 biomarker laboratories: from the benefits to the practical and logistical issues faced during 6 years of centralised testing.Journal of clinical pathology · 2023Article
- Clinical Trial Design Innovations for Precision Medicine in Asthma.Advances in experimental medicine and biology · 2023Article
- The impact of clinical and translational research on the quality of life during the metastatic colorectal cancer patient journey.Frontiers in oncology · 2023Review
- Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer.Clinical trials (London, England) · 2022Article
- Current concepts of anti-EGFR targeting in metastatic colorectal cancer.Frontiers in oncology · 2022Review
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Authors and funding
22 authors at 12 institutions in 1 country.
Funding
Abstract
purposeDespite extensive randomized evidence supporting the use of treatment breaks in metastatic colorectal cancer (mCRC), they are not universally offered to patients despite improvements in quality of life without detriment to overall survival (OS). FOCUS4-N was set up to explore the impact of oral maintenance therapy in patients who are responding to first-line therapy.
methodsFOCUS4 was a molecularly stratified trial program that registered patients with newly diagnosed mCRC. The FOCUS4-N trial was offered to patients in whom a targeted subtrial was unavailable or biomarker tests failed. Patients were randomly assigned using a 1:1 ratio between maintenance capecitabine and active monitoring (AM). The primary outcome was progression-free survival (PFS) with secondary outcomes including OS toxicity and tolerability.
resultsBetween March 2014 and March 2020, 254 patients were randomly assigned (127 to capecitabine and 127 to AM) across 88 UK sites. Baseline characteristics were balanced. There was strong evidence of efficacy for PFS (hazard ratio = 0.40; 95% CI, 0.21 to 0.75;
conclusionDespite strong evidence of disease control with maintenance therapy, OS remains unaffected and FOCUS4-N provides additional evidence to support the use of treatment breaks as safe management alternatives for patients who are stable or responding to first-line treatment for mCRC. Capecitabine without bevacizumab may be used to extend PFS in the interval after 16 weeks of first-line therapy.
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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.