Evidence map›Paper›PMID 24013904›Full record

Trial reportInvestigational new drugs2013

Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients.

Su Jin Lee, Jongtae Lee, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Kyoung-Mee Kim, In-Gu Do, Sin-Ho Jung and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
5.0field-weighted citation impact, top 4% 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

17 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. The NanoString-based multigene assay as a novel platform to screen EGFR, HER2, and MET in patients with advanced gastric cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2015
    Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Targeted therapies in gastric cancer and future perspectives.World journal of gastroenterology · 2016
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Gastric cancer: The times they are a-changin'.World journal of gastrointestinal oncology · 2015
    Review
  16. Article
  17. Integrated analysis of cancer-related pathways affected by genetic and epigenetic alterations in gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2015
    Article
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 3 institutions in 1 country.

Su Jin LeeDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong Gangnam-gu, Seoul, 135-710, South Korea.
Jongtae Lee
Jeeyun Lee
Se Hoon Park
Joon Oh Park
Young Suk Park
Ho Yeong Lim
Kyoung-Mee Kim
In-Gu Do
Sin-Ho Jung
Dong-Seok Yim
Won Ki Kang
Samsung Medical Center · KRSungkyunkwan University · KRSeoul St. Mary's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to assess the efficacy and safety of combination regimen of capecitabine plus everolimus in patients with refractory gastric cancer who have failed to at least two cytotoxic regimens.

methodsPatients received capecitabine 650 mg/m(2) twice daily (D1-14) and everolimus 5 mg twice daily (D1-21) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint of the study was overall response (partial or complete response) and the secondary endpoints were progression-free survival (time between registration and disease progression or death) and overall survival. Pharmacokinetic analysis was also performed. Patients who have failed to at least two cytotoxic regimens were enrolled.

resultsBetween March 2010 and June 2012, 47 patients were enrolled. 33 patients (70.2%) had received more than three previous regimens prior to enrolment. Among 43 evaluable patients for treatment response, 5 patients achieved confirmed partial response and 18 patients showed stable disease, resulting in an overall response rate (ORR) of 10.6% (95% C.I.: 1.8-19.4%) and disease control rate of 48.9% (95% C.I.:34.6-63.2%). At a median follow-up of 106 weeks (range, 21-141 weeks), the median progression-free survival and overall survival were 11.0 weeks (95% C.I.: 5.7-16.3 weeks) and 21.0 weeks (95% C.I.: 14.3-27.7 weeks), respectively. Grade 3 nausea, diarrhea and stomatitis occurred in two, three and three patients, respectively. Elevated liver enzyme was observed in 21 patients and no patient had pulmonary fibrosis.

conclusionsThe combination of capecitabine 650 mg/m(2) twice daily and everolimus 5 mg twice daily was found to be effective in a small subset of GC patients who were heavily pre-treated.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDeoxycytidineDrug Resistance, NeoplasmEverolimusFemaleFluorouracilHumansMaleMiddle AgedSirolimusStomach NeoplasmsYoung AdultCapecitabineDeoxycytidineEverolimusFluorouracilSirolimus

Identifiers

PMID24013904
OpenAlexW2060348895

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.