Evidence map›Paper›PMID 19704058›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Randomized phase II trial of docetaxel plus cetuximab or docetaxel plus bortezomib in patients with advanced non-small-cell lung cancer and a performance status of 2: CALGB 30402.

Rogerio Lilenbaum, Xiaofei Wang, Lin Gu, Jeffrey Kirshner, Keith Lerro, Everett Vokes

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  13. Nuclear factor-κB: a key regulator in health and disease of lungs.Archivum immunologiae et therapiae experimentalis · 2011
    Review
  14. The role of proteasome inhibition in nonsmall cell lung cancer.Journal of biomedicine & biotechnology · 2011
    Review
  15. Article
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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

6 authors at 4 institutions in 1 country.

Rogerio LilenbaumMount Sinai Cancer Center, 4306 Alton Rd, Miami Beach, FL 33140, USA. rlilenba@msmc.com.
Xiaofei Wang
Lin Gu
Jeffrey Kirshner
Keith Lerro
Everett Vokes
Southeast Clinical Oncology Research Consortium · USHematology Oncology Associates of Central New York · USMount Sinai Medical Center · USUniversity of Chicago · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
MOUNT SINAI COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045564 · NCI · MOUNT SINAI MEDICAL CENTER (MIAMI BEACH) · PI SCHWARTZ, MICHAEL ALAN · 1987 to 2014
$9.2M
SYRACUSE HEMATOLOGY-ONCOLOGY CCOPU10CA045389 · NCI · HEMATOLOGY-ONCOLOGY ASSOCIATES/CTL NY · PI KIRSHNER, JEFFREY JAY · 1987 to 2014
$7.4M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
CANCER AND LEUKEMIA GROUP BU10CA047577 · NCI · DUKE UNIVERSITY · PI CRAWFORD, JEFFREY · 1988 to 2013
$2.2M
NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS CA41287NCI NIH HHS CA45389NCI NIH HHS CA45564NCI NIH HHS CA45808NCI NIH HHS CA47577NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA045389NCI NIH HHS U10 CA045564NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA047577
6 · The paper itself

Abstract

purposeA randomized phase II trial of two novel treatment strategies in the first-line management of advanced non-small-cell lung cancer patients with performance status (PS) 2. PATIENTS AND

methodsPatients were assigned to docetaxel 30 mg/m(2) on days 1, 8, and 15 every 28 days in combination with either cetuximab 400 mg/m(2) loading dose followed by 250 mg/m(2) weekly (D + C) or bortezomib 1.6 mg/m(2) on days 1, 8, and 15 every 28 days (D + B) for up to 4 cycles. Patients with responding or stable disease continued cetuximab or bortezomib until progression. The primary end point was progression-free survival (PFS) rate at 6 months.

resultsSixty-four patients were enrolled and 59 were included in this analysis. Complete or partial response rates were 13.3% and 10.3% for D + C and D + B, respectively. Median PFS was 3.4 months in the D + C arm and 1.9 months in the D + B arm. Corresponding figures for 6-month PFS were 27.8% and 13.8% and 5.0 and 3.9 months for median survival, respectively. Grade 3/4 hematologic toxicity was 16% for D + C and 21% for D + B, whereas nonhematologic toxicities were observed in 63% and 44% of patients, respectively. There was one treatment-related death in each arm.

conclusionThese results confirm the poor prognosis associated with a PS of 2 and the difficulty in translating recent advances in targeted therapy to this subset of patients. While the results in the D + C arm are numerically superior, neither combination met the prespecified PFS end point to justify further research in this setting.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCarcinoma, Non-Small-Cell LungCetuximabDocetaxelFemaleHealth StatusHumansLung NeoplasmsMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBoronic AcidsBortezomibCetuximabDocetaxelPyrazinesTaxoids

Identifiers

PMID19704058
PMCPMC2754901
OpenAlexW2127061733

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.