Trial reportBMC cancer2019
First-line single-agent regorafenib in frail patients with metastatic colorectal cancer: a pilot phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD).
Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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
12 citing papers in PubMed.
- Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study.Investigational new drugs · 2025Trial
- Regorafenib plus FOLFIRINOX as first-line treatment for patients with RAS-mutant metastatic colorectal cancer (FOLFIRINOX-R trial): a dose-escalation study.Cancer chemotherapy and pharmacology · 2024Trial
- Targeted Therapy and Immunotherapy in Elderly Patients with Metastatic Colorectal Cancer.Current treatment options in oncology · 2025Review
- Global research landscape of antiangiogenic therapy for colorectal cancer: a bibliometric analysis of mechanistic insights and clinical advancements.Frontiers in oncology · 2025Review
- Digital patient modeling identifies predictive biomarkers of regorafenib response in elderly metastatic colorectal cancer.Frontiers in systems biology · 2025Article
- Intestinal Perforation in a patient with peritoneal carcinomatosis from colon cancer treated with Regorafenib. Description of a case and review of the literature.Radiology case reports · 2024Article
- Navigating through novelties concerning mCRC treatment-the role of immunotherapy, chemotherapy, and targeted therapy in mCRC.Frontiers in surgery · 2024Review
- Efficacy of apatinib combined with FOLFIRI in the first-line treatment of patients with metastatic colorectal cancer.Investigational new drugs · 2022Article
- Management of Metastatic Colorectal Carcinoma in Older Adults: Balancing Risks and Benefits of Novel Therapies.Drugs & aging · 2021Review
- Article
- Chemotherapy and Targeted Agents in the Treatment of Elderly Patients with Metastatic Colorectal Cancer.Journal of clinical medicine · 2020Review
- Diarrhea Induced by Small Molecule Tyrosine Kinase Inhibitors Compared With Chemotherapy: Potential Role of the Microbiome.Integrative cancer therapiesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
backgroundTreatment of frail patients with advanced colorectal cancer (CRC) is controversial. This pilot phase II trial aimed to assess the efficacy and safety of regorafenib when administered in first-line to frail patients with advanced CRC.
methodsFrail patients without prior advanced colorectal cancer treatment were included in the study. Definition of frailty was defined per protocol based on dependency criteria, presence of chronic comorbid pathologies and/or geriatric features. MAIN
objectiveto assess progression-free survival (PFS) rate at 6 months. Treatment consisted of 28-day cycles of orally administered regorafenib 160 mg/day (3 weeks followed by 1 week rest).
resultsForty-seven patients were included in the study. Median age was 81 years (range 63-89). Frailty criteria: dependency was observed in 26 patients (55%), comorbidities in 27 (57%) and geriatric features in 18 (38%). PFS rate at 6 months was 45% (95% confidence interval [CI] 30-60]. Median PFS was 5.6 months (95%CI 2.7-8.4). Median overall survival (OS) was 16 months (95%CI 7.8-24). Complete response, partial response and stable disease were observed in one, two and 21 patients respectively (objective response rate 6.4%; disease control rate 51%). Thirty-nine patients (83%) experienced grade 3-4 adverse events (AEs). The most common grade 3-4 AEs were hypertension (15 patients; 32%), asthenia (14; 30%), hypophosphatemia (6; 13%); diarrhea (4; 8%), hand-foot-skin reaction (4; 8%). There were two toxic deaths (4.2%) (grade 5 rectal bleeding and death not further specified). Dose reduction was required in 26 patients (55%) and dose-delays in 13 patients (28%).
conclusionsThe study did not meet the pre-specified boundary of 55% PFS rate at 6 months. Toxicity observed (83% patients experienced grade 3 and 4 AEs) preclude its current use in clinical practice on this setting. Disease control rate and overall survival results are interesting and might warrant further investigation to identify those who benefit from this approach.
trial registrationThis trial was prospectively registered at EudraCT ( 2013-000236-94 ). Date of trial registration: April 9th, 2013.
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