Evidence map›Paper›PMID 22124101›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma.

Kevin B Kim, Jeffrey A Sosman, John P Fruehauf, Gerald P Linette, Svetomir N Markovic, David F McDermott, Jeffrey S Weber, Hoa Nguyen, Peter Cheverton, Daniel Chen and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02023710 (A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma), which is not on this map. Cited by 92 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 10 pooled it
11.7field-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.

NCT02023710 phase2unknown statusnot on this mapstarted 2013, after this paper: background citation

A Randomized Phase II Study Evaluating the Activity of Bevacizumab in Combination With Carboplatin Plus Paclitaxel in Patients With Previously Untreated Advanced Mucosal Melanoma

TypeinterventionalSponsorPeking University Cancer Hospital & InstituteRan2013 to 2017Enrolled182ConditionsMelanomaArmsPaclitaxel, Carboplatin, Bevacizumab
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 10 syntheses or guidelines pooled it, 196 citations in OpenAlex.

  1. Neoadjuvant treatment for stage III and IV cutaneous melanoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. An independent survival prognostic role for human epidermal growth factor receptor 2 in gastric cancer: evidence from a meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Circulating galectin-1 delineates response to bevacizumab in melanoma patients and reprograms endothelial cell biology.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Trial
  12. Trial
  13. Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2018
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Kevin B KimThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jeffrey A Sosman
John P Fruehauf
Gerald P Linette
Svetomir N Markovic
David F McDermott
Jeffrey S Weber
Hoa Nguyen
Peter Cheverton
Daniel Chen
Amy C Peterson
William E Carson
Steven J O'Day
Vanderbilt University Medical Center · USAcentech (United States) · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposeMetastatic melanoma, a highly vascularized tumor with strong expression of vascular endothelial growth factor, has an overall poor prognosis. We conducted a placebo-controlled, double-blind phase II study of carboplatin plus paclitaxel with or without bevacizumab in patients with previously untreated metastatic melanoma. PATIENTS AND

methodsPatients were randomly assigned in a two-to-one ratio to carboplatin (area under the curve, 5) plus paclitaxel (175 mg/m(2)) and bevacizumab (15 mg/kg; CPB) or placebo (CP) administered intravenously once every 3 weeks. Progression-free survival (PFS) was the primary end point. Secondary end points included overall survival (OS) and safety.

resultsTwo hundred fourteen patients (73% with M1c disease) were randomly assigned. With a median follow-up of 13 months, median PFS was 4.2 months for the CP arm (n = 71) and 5.6 months for the CPB arm (n = 143; hazard ratio [HR], 0.78; P = .1414). Overall response rates were 16.4% and 25.5%, respectively (P = .1577). With 13-month follow-up, median OS was 8.6 months in the CP arm versus 12.3 months in the CPB arm (HR, 0.67; P = .0366), whereas in an evaluation 4 months later, it was 9.2 versus 12.3 months, respectively (HR, 0.79; P = .1916). In patients with elevated serum lactate dehydrogenase (n = 84), median PFS and OS were longer in the CPB arm (PFS: 4.4 v 2.7 months; HR, 0.62; OS: 8.5 v 7.5 months; HR, 0.52). No new safety signals were observed.

conclusionThe study did not meet the primary objective of statistically significant improvement in PFS with the addition of bevacizumab to carboplatin plus paclitaxel. A larger phase III study will be necessary to determine whether there is benefit to the addition of bevacizumab to carboplatin plus paclitaxel in this disease setting.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinDouble-Blind MethodDrug Administration ScheduleFemaleHumansInfusions, IntravenousKaplan-Meier EstimateMaleMelanomaAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinPaclitaxel

Identifiers

PMID22124101
PMCPMC4669379
OpenAlexW2115369775

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.