Evidence map›Paper›PMID 20570559›Full record

Trial reportThe Lancet. Oncology2010

Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial.

Roy S Herbst, Yan Sun, Wilfried E E Eberhardt, Paul Germonpré, Nagahiro Saijo, Caicun Zhou, Jie Wang, Longyun Li, Fairooz Kabbinavar, Yukito Ichinose and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in The Lancet. 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 NCT00312377 (A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel), which is not on this map. Cited by 170 papers, 28 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
170citing papers in PubMed, 28 pooled it
47.6field-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.

NCT00312377 phase3completednot on this map

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

TypeinterventionalSponsorGenzyme, a Sanofi CompanyRan2006 to 2014Enrolled1,690ConditionsNon-small Cell Lung Cancer, Lung CancerArmsDocetaxel, Vandetanib
3 · Its place in the literature

Who cites it

170 citing papers in PubMed, 28 syntheses or guidelines pooled it, 417 citations in OpenAlex.

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  13. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Guideline
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110 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 16 institutions in 7 countries.

Roy S HerbstDepartment of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 432, Houston, TX 77030-4009, USA. rherbst@mdanderson.org
Yan Sun
Wilfried E E Eberhardt
Paul Germonpré
Nagahiro Saijo
Caicun Zhou
Jie Wang
Longyun Li
Fairooz Kabbinavar
Yukito Ichinose
Shukui Qin
Li Zhang
Bonne Biesma
John V Heymach
Peter Langmuir
Sarah J Kennedy
Hiroomi Tada
Bruce E Johnson
AstraZeneca (United States) · USThe University of Texas MD Anderson Cancer Center · US81th Hospital of PLA · CNAntwerp University Hospital · BEAstraZeneca (United Kingdom) · GBDana-Farber Cancer Institute · USJeroen Bosch Ziekenhuis · NLKindai University · JPNational Hospital Organization Kyushu Cancer Center · JPPeking Union Medical College Hospital · CNPeking University · CNPeking University Cancer Hospital · CNShanghai Pulmonary Hospital · CNSun Yat-sen University Cancer Center · CNUCLA Jonsson Comprehensive Cancer CenterUniversity of Duisburg-Essen · DE

Funding

EGFR Mutations in Non-Small Cell Lung CancerR01CA114465 · NCI · DANA-FARBER CANCER INSTITUTE · PI JANNE, PASI A, JOHNSON, BRUCE E. · 2005 to 2016
$3.9M
NCI NIH HHS R01 CA114465
6 · The paper itself

Abstract

backgroundVandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) tyrosine kinases. In a randomised phase 2 study in patients with previously treated non-small-cell lung cancer (NSCLC), adding vandetanib 100 mg to docetaxel significantly improved progression-free survival (PFS) compared with docetaxel alone, including a longer PFS in women. These results supported investigation of the combination in this larger, definitive phase 3 trial (ZODIAC).

methodsBetween May, 2006, and April, 2008, patients with locally advanced or metastatic (stage IIIB-IV) NSCLC after progression following first-line chemotherapy were randomly assigned 1:1 through a third-party interactive voice system to receive vandetanib (100 mg/day) plus docetaxel (75 mg/m(2) intravenously every 21 days; maximum six cycles) or placebo plus docetaxel. The primary objective was comparison of PFS between the two groups in the intention-to-treat population. Women were a coprimary analysis population. This study has been completed and is registered with ClinicalTrials.gov, number NCT00312377.

findings1391 patients received vandetanib plus docetaxel (n=694 [197 women]) or placebo plus docetaxel (n=697 [224 women]). Vandetanib plus docetaxel led to a significant improvement in PFS versus placebo plus docetaxel (hazard ratio [HR] 0.79, 97.58% CI 0.70-0.90; p<0.0001); median PFS was 4.0 months in the vandetanib group versus 3.2 months in placebo group. A similar improvement in PFS with vandetanib plus docetaxel versus placebo plus docetaxel was seen in women (HR 0.79, 0.62-1.00, p=0.024); median PFS was 4.6 months in the vandetanib group versus 4.2 months in the placebo group. Among grade 3 or higher adverse events, rash (63/689 [9%] vs 7/690 [1%]), neutropenia (199/689 [29%] vs 164/690 [24%]), leukopenia (99/689 [14%] vs 77/690 [11%]), and febrile neutropenia (61/689 [9%] vs 48/690 [7%]) were more common with vandetanib plus docetaxel than with placebo plus docetaxel. The most common serious adverse event was febrile neutropenia (46/689 [7%] in the vandetanib group vs 38/690 [6%] in the placebo group).

interpretationThe addition of vandetanib to docetaxel provides a significant improvement in PFS in patients with advanced NSCLC after progression following first-line therapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelDouble-Blind MethodFemaleHumansLung NeoplasmsMaleMiddle AgedPiperidinesProportional Hazards ModelsDocetaxelPiperidinesQuinazolinesTaxoidsvandetanib

Identifiers

PMID20570559
PMCPMC3225192
OpenAlexW2115078104

What OpenQuestion holds

Textmetadata
LicenceTDM
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.