Evidence map›Paper›PMID 19774377›Full record

ArticleCancer chemotherapy and pharmacology2010

A dose-finding and pharmacodynamic study of bortezomib in combination with weekly paclitaxel in patients with advanced solid tumors.

Bhuvaneswari Ramaswamy, Tanios Bekaii-Saab, Larry J Schaaf, Gregory B Lesinski, David M Lucas, Donn C Young, Amy S Ruppert, John C Byrd, Kristy Culler, Diedre Wilkins and 3 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Case Example of Dose Optimization Using Data From Bortezomib Dose-Finding Clinical Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Article
  6. Review
  7. Article
  8. Article
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 1 institution in 1 country.

Bhuvaneswari RamaswamyThe Ohio State University, B401, Starling Loving Hall, 320 W 10th av, Columbus, OH 43210, USA. Bhuvaneswari.Ramaswamy@osumc.edu
Tanios Bekaii-Saab
Larry J Schaaf
Gregory B Lesinski
David M Lucas
Donn C Young
Amy S Ruppert
John C Byrd
Kristy Culler
Diedre Wilkins
John J Wright
Michael R Grever
Charles L Shapiro
The Ohio State University · US

Funding

PHASE I TRIALS OF ANTICANCER AGENTSU01CA076576 · NCI · OHIO STATE UNIVERSITY · PI GREVER, MICHAEL R · 1998 to 2013
$9.1M
NCI NIH HHS U01 CA076576NCI NIH HHS U01-CA76576
6 · The paper itself

Abstract

purposeA phase I study to determine the maximum tolerated dose (MTD) of bortezomib (B) when combined with weekly paclitaxel in patients with advanced solid tumors. PATIENTS AND

methodsEligible patients received escalating doses of intravenous (IV) bortezomib (0.6-2 mg/m(2)) on days 2 and 9 and IV paclitaxel at 100 mg/m(2) on days 1 and 8 of a 21-day cycle. Dose escalation was based on two end-points: not exceeding 80% 20S-proteasome inhibition (20-S PI) and the development of dose-limiting toxicity defined as grade 3 or greater non-hematologic or grade 4 hematologic toxicities.

resultsForty-five patients with advanced solid tumors and a median of 3 prior chemotherapy regimens (range 0-9), received 318 doses (median 5, range 1-34) of bortezomib and paclitaxel. Dose-related inhibition of 20-S PI was observed with a maximum inhibition of 70-80% at the MTD of 1.8 mg/m(2) of bortezomib. At the MTD (N = 9) the following toxicities were observed: grade 4 neutropenia without fever (n = 2) and cerebrovascular ischemia (n = 1); grade 3 neutropenia (n = 3), diarrhea (n = 2), nausea (n = 1), and fatigue (n = 1); grade 2 fatigue (n = 5), diarrhea (n = 4), and dyspnea (n = 2). There was one partial response in a patient with an eccrine porocarcinoma. Stabilization of disease was observed in 7 (16%) patients, 3 of whom had advanced pancreatic cancer.

conclusionSequential paclitaxel and bortezomib in previously treated patients with advanced solid tumors resulted in acceptable toxicity and no evidence of interaction. The recommended phase II dose of bortezomib in combination with weekly paclitaxel was 1.8 mg/m(2).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy Protocolsbcl-2-Associated X ProteinBoronic AcidsBortezomibCytokinesDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasmsbcl-2-Associated X ProteinBoronic AcidsBortezomibCytokinesp27 antigenPaclitaxelProliferating Cell Nuclear AntigenProteasome InhibitorsPyrazines

Identifiers

PMID19774377
PMCPMC3540804
OpenAlexW2082708803

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.