Evidence map›Paper›PMID 22534815›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2012

Phase-I/II study of bortezomib in combination with carboplatin and bevacizumab as first-line therapy in patients with advanced non-small-cell lung cancer.

Bilal Piperdi, William V Walsh, Kendra Bradley, Zheng Zhou, Venu Bathini, Meredith Hanrahan-Boshes, Lloyd Hutchinson, Roman Perez-Soler

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

21 citing papers in PubMed, 32 citations in OpenAlex.

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  7. The Influence of Cell Cycle Regulation on Chemotherapy.International journal of molecular sciences · 2021
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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

8 authors at 4 institutions in 1 country.

Bilal PiperdiDepartment of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine Bronx, NY 10461, USA. bpiperdi@montefiore.org
William V Walsh
Kendra Bradley
Zheng Zhou
Venu Bathini
Meredith Hanrahan-Boshes
Lloyd Hutchinson
Roman Perez-Soler
University of Massachusetts Chan Medical School · USAlbert Einstein College of Medicine · USMontefiore Medical Center · USUMass Memorial Health Care · US

Funding

Paul Calabresis Career Development Award For Clinical Oncology K12CA132783 · NCI · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI PEREZ-SOLER, ROMAN, VERMA, AMIT K. · 2009 to 2019
$8.2M
NCI NIH HHS K12 CA132783
6 · The paper itself

Abstract

backgroundThis study aimed to establish the maximum tolerated dose (MTD) of weekly bortezomib in combination with fixed standard doses of carboplatin and bevacizumab, and to estimate the efficacy (response rate and progression free survival [PFS]) and safety of combination therapy with carboplatin, bortezomib, and bevacizumab as first-line therapy in patients with advanced non-small-cell lung cancer (NSCLC).

methodsPatients were assigned to three dose levels of weekly bortezomib with the fixed standard doses of carboplatin AUC 6 and bevacizumab (15 mg/kg) every 3 weeks using a standard phase-I design. Bortezomib doses were 1.3 mg/m, 1.6 mg/m, and 1.8 mg/m weekly on day 1 and day 8 of every 3-week cycle. A maximum of six cycles was administered. Patients with complete, partial response or stable disease were continued on single-agent bevacizumab (15 mg/kg every 3 weeks) as maintenance therapy. In phase II, either level III or MTD was administered to evaluate the efficacy and safety of the combination in first-line treatment of advanced NSCLC.

resultsSixteen patients were enrolled (three, four, and nine patients in dose level I, II, and III, respectively). There was no predefined dose limiting toxicity in cycle 1 in all 16 patients. The recommended phase-II dose is bortezomib 1.8 mg/m weekly on day 1 and day 8 in combination with carboplatin AUC 6 and bevacizumab 15 mg/kg on every 21-day cycle. Totally 9 patients were treated at the recommended phase-II dose level. The most common treatment related grade-3/4 toxicities during the subsequent cycles were thrombocytopenia (58%), lymphopenia (25%), neutropenia (12%), and diarrhea (25%). The grade-1/2 neuropathy was seen in 7 out of 16 patients (44%). The response rate, PFS, and overall survival in all patients were 37.5% (95%CI 13.8%-61.2%), 5.0 months (95%CI: 3.1-8.4), 9.9 months (95% CI: 8.2-14.1), and among the 9 patients in phase-II portion are 44% (95%CI 15.3%-77.3%), 5.5 months (95%CI: 3.1-2.2) and 10.9 months (95%CI: 8.0-14.1).

conclusionThe recommended phase-II dose for this combination is: carboplatin AUC 6, bevacizumab 15 mg/kg on day 1 and bortezomib 1.8 mg/m on day 1 and day 8 on every 21-day cycle. The regimen was very well tolerated with interesting clinical activity in first-line treatment of NSCLC.

Indexed as

Neoplasm StagingAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabBoronic AcidsBortezomibCarboplatinCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLung NeoplasmsAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabBoronic AcidsBortezomibCarboplatinPyrazinesVascular Endothelial Growth Factor A

Identifiers

PMID22534815
PMCPMC3852685
OpenAlexW1999260523

What OpenQuestion holds

Textmetadata
LicenceTDM
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.