Evidence map›Paper›PMID 19997960›Full record

Trial reportInvestigational new drugs2011

A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer.

Chul Kim, Jae-Lyun Lee, Min-Hee Ryu, Heung Moon Chang, Tae Won Kim, Ho Young Lim, Hye Jin Kang, Young Suk Park, Baek-Yeol Ryoo, Yoon-Koo Kang

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
–field-weighted citation impact
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

38 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Improving trends in survival of patients who receive chemotherapy for metastatic or recurrent gastric cancer: 12 years of experience at a single institution.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2015
    Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Efficacy of Postoperative FOLFOXFrontiers in oncology · 2020
    Article
  12. Article
  13. Review
  14. Targeted therapies for advanced and metastatic adenocarcinoma of the gastroesophageal junction: is there something new?Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    Review
  15. New advances in targeted gastric cancer treatment.World journal of gastroenterology · 2016
    Review
  16. Targeted therapies in gastric cancer and future perspectives.World journal of gastroenterology · 2016
    Review
  17. Molecular targeted therapy for the treatment of gastric cancer.Journal of experimental & clinical cancer research : CR · 2016
    Review
  18. Article
  19. Review
  20. 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

10 authors.

Chul KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, South Korea.
Jae-Lyun Lee
Min-Hee Ryu
Heung Moon Chang
Tae Won Kim
Ho Young Lim
Hye Jin Kang
Young Suk Park
Baek-Yeol Ryoo
Yoon-Koo Kang

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the efficacy and safety of cetuximab in combination with XELOX [XELoda® (capecitabine) and OXaliplatin] in advanced gastric cancer (AGC) patients. The objectives were to evaluate overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety of cetuximab plus XELOX.

methodsPreviously untreated AGC patients received intravenous infusion of cetuximab 400 mg/m² on day 1 followed by weekly infusions of 250 mg/m². Oxaliplatin 130 mg/m² was administered intravenously on day 1 and capecitabine 1,000 mg/m² bid was administered orally for 14 days of a 3-week cycle. Chemotherapy was given until disease progression or intolerable toxicities. On completing maximum 8 cycles of chemotherapy, patients were allowed weekly cetuximab until progression. Response evaluations were done every two cycles and toxicities were assessed at each visit.

resultsForty-four patients (29 male) were enrolled; median age was 57.5 years (range 36-70). In total, 253 cycles of XELOX chemotherapy (range 1-8, median 6.5 cycles) and 917 cetuximab infusions (range 1-58, median 19.0) were delivered. Overall RR was 52.3%. Median PFS and OS were 6.5 months (95% CI, 4.9-8.4) and 11.8 months (95% CI, 6.7-16.8), respectively. The most common toxicities of all grades were anemia (81.8% of patients), asthenia (81.8%), anorexia (79.6%), hand-foot syndrome (79.6%), acneiform skin eruption (77.2%), and sensory neuropathy (75.0%), and they were mostly grade 1 or 2. Grade 3-4 hematologic toxicities were uncommon (anemia, 6.8%; thrombocytopenia, 2.3%).

conclusionsCetuximab in combination with XELOX chemotherapy was active and safe as first-line treatment of metastatic and/or recurrent AGC patients.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineCetuximabDeoxycytidineDisease-Free SurvivalErbB ReceptorsFemaleFluorouracilHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCapecitabineCetuximabDeoxycytidineErbB ReceptorsFluorouracilOxaloacetates

Identifiers

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Registered trials

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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.