Evidence map›Paper›PMID 20530271›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study.

Sam J Lubner, Michelle R Mahoney, Jill L Kolesar, Noelle K Loconte, George P Kim, Henry C Pitot, Philip A Philip, Joel Picus, Wei-Peng Yong, Lisa Horvath and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02254681 (A Phase 2 Study of Low-Dose Fractionated Radiation Therapy to the Whole Liver in Combination With Gemcitabine and Cisplatin in Locally Advanced Mass-Forming Intrahepatic Cholangiocarcinoma), which is not on this map. Cited by 120 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 4 pooled it
17.8field-weighted citation impact, top 1% 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.

NCT02254681 phase2terminatednot on this mapstarted 2014, after this paper: background citation

A Phase 2 Study of Low-Dose Fractionated Radiation Therapy to the Whole Liver in Combination With Gemcitabine and Cisplatin in Locally Advanced Mass-Forming Intrahepatic Cholangiocarcinoma

TypeinterventionalSponsorAllina Health SystemRan2014 to 2016Enrolled6ConditionsIntrahepatic CholangiocarcinomaArmsGemcitabine, Cisplatin, low dose radiotherapy
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 4 syntheses or guidelines pooled it, 267 citations in OpenAlex.

  1. Pooled it
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  16. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
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  19. Review
  20. Article

60 more citing papers are in PubMed but not listed here.

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

13 authors at 7 institutions in 3 countries.

Sam J LubnerUniversity of Wisconsin, Madison, WI 53792, USA. sjlubner@medicine.wisc.edu
Michelle R Mahoney
Jill L Kolesar
Noelle K Loconte
George P Kim
Henry C Pitot
Philip A Philip
Joel Picus
Wei-Peng Yong
Lisa Horvath
Guy Van Hazel
Charles E Erlichman
Kyle D Holen
National University Hospital · SGJacksonville College · USMayo Clinic in Florida · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Wisconsin–Madison · USMayo Clinic in Arizona · USRoyal Prince Alfred Hospital · AU

Funding

TAS:: 75 0850 ::TAS RECOVERY ACT - ACTNOW CLINICAL TRIAL 8288N01CM62205 · NCI · MAYO CLINIC ROCHESTER · PI ERLICHMAN, CHARLES · 2007 to 2011
$8.0M
NCI NIH HHS N01 CM062205NCI NIH HHS N01 CM62205
6 · The paper itself

Abstract

purposeBiliary cancers overexpress epidermal growth factor receptor (EGFR), and angiogenesis has been correlated with poor outcome. Erlotinib, an EGFR tyrosine kinase inhibitor, and bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor have each been shown to have activity in biliary cancer. The primary objective of this study was to evaluate the response rate by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary end points included overall survival (OS), time to progression (TTP), VEGF levels, and molecular studies of EGFR and k-ras. PATIENTS AND

methodsEligible patients had advanced cholangiocarcinoma or gallbladder cancer. Patients were treated with bevacizumab 5 mg/kg intravenously on days 1 and 15 and erlotinib 150 mg by mouth daily on days 1 through 28. Responses were evaluated by RECIST. VEGF levels were collected, and samples were analyzed for EGFR mutation by polymerase chain reaction.

resultsFifty-three eligible patients were enrolled at eight sites. Of 49 evaluable patients, six (12%; 95% CI, 6% to 27%) had a confirmed partial response. Stable disease was documented in another 25 patients (51%). Rash was the most common grade 3 toxicity. Four patients had grade 4 toxicities. Median OS was 9.9 months, and TTP was 4.4 months. Low repeats (< 16) in EGFR intron 1 polymorphism and G>G k-ras Q38 genotype (wild type) were associated with improved outcomes.

conclusionCombination chemotherapy with bevacizumab and erlotinib showed clinical activity with infrequent grade 3 and 4 adverse effects in patients with advanced biliary cancers. On the basis of preliminary molecular analysis, presence of a k-ras mutation may alter erlotinib efficacy. The combination of bevacizumab and erlotinib may be a therapeutic alternative in patients with advanced biliary cancer.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiliary Tract NeoplasmsCholangiocarcinomaDrug Administration ScheduleErbB ReceptorsErlotinib HydrochlorideFemaleHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabErbB ReceptorsErlotinib HydrochlorideQuinazolinesVascular Endothelial Growth Factor A

Identifiers

PMID20530271
PMCPMC2917213
OpenAlexW2171559250

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.