Evidence map›Paper›PMID 21811258›Full record

Trial reportBritish journal of cancer2011

Phase II trial of modified FOLFOX6 and erlotinib in patients with metastatic or advanced adenocarcinoma of the oesophagus and gastro-oesophageal junction.

Z A Wainberg, L-S Lin, B DiCarlo, K M Dao, R Patel, D J Park, H-J Wang, R Elashoff, N Ryba, J R Hecht

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
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  10. Cell cycle arrest and apoptosis induction byFood science & nutrition · 2021
    Article
  11. Targeting EGFR in Esophagogastric Cancer.Frontiers in oncology · 2020
    Review
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  16. Article
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  20. Update on Gastroesophageal Adenocarcinoma Targeted Therapies.Hematology/oncology clinics of North America · 2017
    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

10 authors at 2 institutions in 1 country.

Z A WainbergDivision of Hematology/Oncology, Department of Medicine, Geffen School of Medicine at UCLA, Los Angeles, CA, USA. zwainberg@mednet.ucla.edu
L-S Lin
B DiCarlo
K M Dao
R Patel
D J Park
H-J Wang
R Elashoff
N Ryba
J R Hecht
Research International (United States) · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is increased recognition that cancers of the upper GI tract comprise distinct epidemiological and molecular entities. Erlotinib has shown activity in patients with adenocarcinoma of the oesophagus/gastro-oesophageal junction (GEJ), but not in distal gastric cancer. mFOLFOX6 is one of several active regimens used to treat adenocarcinoma of the Eso/GEJ. This study evaluates the efficacy and safety of mFOLFOX6 and erlotinib in patients with metastatic or advanced Eso/GEJ cancers.

methodsPatients with previously untreated advanced or metastatic Eso/GEJ adenocarcinoma are treated with oxaliplatin 85 mg m(-2), 5-FU 400 mg m(-2), LV 400 mg m(-2) on day 1, 5-FU 2400 mg m(-2) over 48 h and erlotinib 150 mg PO daily. Treatment was repeated every 14 days. The primary objective was response rate (RR), secondary objectives include toxicity, progression-free survival (PFS), overall survival (OS) and to correlate clinical outcome with expression patterns and molecular alterations in the epidermal growth factor receptor-dependent pathways.

resultsA total of 33 patients were treated and evaluable: there were two complete responses, 15 partial responses for an objective RR of 51.5% (95% CI, 34.5-68.6%). Median PFS was 5.5 months (95% CI, 3.1-7.5 months) and median OS was 11.0 months (95% CI, 8.0-17.4 months). The most common grade 3-4 toxicities were: diarrhoea (24%), nausea/vomiting (11%), skin rash (8%) and peripheral neuropathy (8%). The frequency of alterations was KRAS mutations (8%), EGFR mutations (0%) and HER2 amplification (19%).

conclusionIn patients with Eso/GEJ adenocarcinoma, mFOLFOX6 and erlotinib is active, has an acceptable toxicity profile and FOLFOX ± erlotinib could be considered for further development.

Indexed as

Esophagogastric JunctionAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDisease-Free SurvivalErlotinib HydrochlorideEsophageal NeoplasmsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisBiomarkers, TumorErlotinib HydrochlorideFluorouracilLeucovorinOrganoplatinum CompoundsProtein Kinase InhibitorsQuinazolines

Identifiers

PMID21811258
PMCPMC3171005
OpenAlexW2087488835

What OpenQuestion holds

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LicenceCC BY
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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.