Evidence map›Paper›PMID 33512054›Full record

Trial reportThe oncologist2021

Activity of Sorafenib Plus Capecitabine in Previously Treated Metastatic Colorectal Cancer.

Thomas J George, Alison M Ivey, Azka Ali, Ji-Hyun Lee, Yu Wang, Karen C Daily, Brian H Ramnaraign, Sanda A Tan, Krista P Terracina, Thomas E Read and 2 more

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 30% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Lidocaine enhances antitumor effects of sorafenib and GW5074 in colorectal cancer cells.Journal of enzyme inhibition and medicinal chemistry · 2026
    Article
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Thomas J GeorgeDivision of Hematology Oncology, Department of Medicine, University of Florida Cancer Center, Gainesville, Florida, USA.ORCID 0000-0002-6249-9180
Alison M IveyUniversity of Florida Health Cancer Center, Gainesville, Florida, USA.
Azka AliDivision of Hematology Oncology, Department of Medicine, University of Florida Cancer Center, Gainesville, Florida, USA.
Ji-Hyun LeeDepartment of Biostatistics, University of Florida, Gainesville, Florida, USA.
Yu WangDivision of Quantitative Sciences, UF Health Cancer Center, Gainesville, Florida, USA.
Karen C DailyDivision of Hematology Oncology, Department of Medicine, University of Florida Cancer Center, Gainesville, Florida, USA.
Brian H RamnaraignDivision of Hematology Oncology, Department of Medicine, University of Florida Cancer Center, Gainesville, Florida, USA.
Sanda A TanDepartment of Surgery, University of Florida, Gainesville, Florida, USA.
Krista P TerracinaDepartment of Surgery, University of Florida, Gainesville, Florida, USA.
Thomas E ReadDepartment of Surgery, University of Florida, Gainesville, Florida, USA.
Long H DangDepartment of Surgery, University of Florida, Gainesville, Florida, USA.
Atif IqbalDepartment of Oncology, Ochsner Health, Baton Rouge, Louisiana, Texas, USA.
University of Florida · USUF Health Cancer CenterUniversity of Florida Health · USOchsner Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedTreatment for patients with metastatic colorectal cancer (mCRC) typically involves multiple lines of therapy with eventual development of treatment resistance. In this single-arm, phase II study involving heavily pretreated patients, the combination of sorafenib and capecitabine yielded a clinically meaningful progression-free survival of 6.2 months with an acceptable toxicity profile. This oral doublet therapy is worthy of continued investigation for clinical use in patients with mCRC.

backgroundCapecitabine (Cape) is an oral prodrug of the antimetabolite 5-fluorouracil. Sorafenib (Sor) inhibits multiple signaling pathways involved in angiogenesis and tumor proliferation. SorCape has been previously studied in metastatic breast cancer.

methodsThis single-arm, phase II study was designed to evaluate the activity of SorCape in refractory metastatic colorectal cancer (mCRC). Patients received Sor (200 mg p.o. b.i.d. max daily) and Cape (1,000 mg/m

resultsForty-two patients were treated for a median number of 3.5 cycles (range 1-39). Median PFS was 6.2 (95% confidence interval [CI], 4.3-7.9) months, and overall survival (OS) was 8.8 (95% CI, 4.3-12.2) months. One patient (2.4%) had partial response (PR), and 22 patients (52.4%) had stable disease (SD) for a clinical benefit rate of 54.8% (95% CI, 38.7%-70.2%). Hand-foot syndrome was the most common adverse event seen in 36 patients (85.7%) and was grade ≥ 3 in 16 patients (38.1%). One patient (2.4%) had a grade 4 sepsis, and one patient (2.4%) died while on treatment.

conclusionSorCape in this heavily pretreated population yielded a reasonable PFS with manageable but notable toxicity. The combination should be investigated further.

Indexed as

Colorectal NeoplasmsDeoxycytidineAntineoplastic Combined Chemotherapy ProtocolsCapecitabineFluorouracilHumansSorafenibTreatment OutcomeCapecitabineDeoxycytidineFluorouracilSorafenibCapecitabineColorectal cancerMetastatic cancerOral therapySorafenib

Identifiers

PMID33512054
PMCPMC8100547
OpenAlexW3123405032

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.