Evidence map›Paper›PMID 29044496›Full record

Trial reportCancer2018

NCCTG N0879 (Alliance): A randomized phase 2 cooperative group trial of carboplatin, paclitaxel, and bevacizumab ± everolimus for metastatic melanoma.

Robert R McWilliams, Jacob B Allred, Jessica A Slostad, Rajini Katipamula, Roxana S Dronca, Kandelaria M Rumilla, Lori A Erickson, Alan H Bryce, Richard W Joseph, Lisa A Kottschade and 3 more

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

Trial report in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% 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

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

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Mayo Clinic proceedings. Innovations, quality & outcomes · 2021
    Article
  9. Hypoxia-dependent drivers of melanoma progression.Journal of experimental & clinical cancer research : CR · 2021
    Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. 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 6 institutions in 1 country.

Robert R McWilliamsDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0002-8199-5040
Jacob B AllredAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Jessica A SlostadDepartment of Medicine, Mayo Clinic, Rochester, Minnesota.
Rajini KatipamulaMinnesota Oncology, Coon Rapids, Minnesota.
Roxana S DroncaDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota.
Kandelaria M RumillaDivision of Molecular Genetics, Mayo Clinic, Rochester, Minnesota.
Lori A EricksonDivision of Anatomic Pathology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0002-3666-2546
Alan H BryceDivision of Hematology/Oncology, Mayo Clinic in Arizona, Scottsdale, Arizona.
Richard W JosephDivision of Hematology/Oncology, Mayo Clinic in Florida, Jacksonville, Florida.
Lisa A KottschadeDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota.
David M KingUnity Hospital, Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota.
John M LeitchSanford Clinic North-Fargo, Fargo, North Dakota.
Svetomir N MarkovicDivision of Medical Oncology, Mayo Clinic, Rochester, Minnesota.
Mayo Clinic · USJacksonville College · USMayo Clinic in Arizona · USMetro-Minnesota Community Oncology Research Consortium · USMinnesota Oncology · USSanford Medical Center · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
Sanford Community Cancer Program of the North Central Plains (NCORP)UG1CA189825 · NCI · SANFORD RESEARCH/USD · PI Daniel Almquist, SAMUEL J. MILANOVICH · 2014 to 2026
$13.6M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA189825NCI NIH HHS UG1 CA189863
6 · The paper itself

Abstract

backgroundDespite the success of immune checkpoint and targeted therapy, many patients with melanoma ultimately require further treatment. The combination of carboplatin, paclitaxel, and bevacizumab (CPB) has demonstrated promising activity in a single-arm study. In the current study, the authors performed a randomized phase 2 study to confirm efficacy and to determine whether adding everolimus would increase the activity of the combination.

methodsThrough the North Central Cancer Treatment Group, a total of 149 patients with unresectable AJCC 6th edition stage IV melanoma were randomized from May 2010 to May 2014 to either CPB or CPB with everolimus (CPBE). The primary endpoint was progression-free survival (PFS), with secondary endpoints of overall survival (OS), response rate, and tolerability.

resultsThe CPB and CPBE treatment arms were balanced with regard to age (median age: 59 years vs 58 years) and high lactate dehydrogenase (48% vs 51%), but were unbalanced with regard to sex (male sex: 72% vs 55%; P = .03). Overall, there was no difference noted with regard to PFS, with a median PFS of 5.6 months for CPB versus 5.1 months for CPBE (hazard ratio [HR], 1.14; 95% confidence interval [95% CI], 0.81-1.62 [P = .44]), or for OS, with a median OS of 14.5 months for CPB versus 10.8 months for CPBE (HR, 1.16; 95% CI, 0.84-1.84). The confirmed response rate was 13% for CPB and 23% for CPBE (P = .13). Toxicity was higher for CPBE compared with CPB (83% for grade 3 + and 14% for grade 4 + vs 63% for grade 3 + and 11% for grade 4+, respectively) (toxicities were graded using the Cancer Therapy Evaluation Program of the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). Common grade 3 + toxicities were neutropenia, leukopenia, and fatigue, which occurred in both treatment arms with comparable frequency.

conclusionsBoth experimental arms demonstrated activity, with a PFS of >5 months. However, the addition of everolimus to CPB failed to improve outcomes, with increased toxicity noted. These findings replicate the moderate antitumor activity of CPB, with future development possibly in combination with targeted or immunotherapy. Cancer 2018;124:537-45. © 2017 American Cancer Society.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinDisease-Free SurvivalEverolimusFemaleHumansMaleMelanomaMiddle AgedMutationPaclitaxelProto-Oncogene Proteins B-rafBevacizumabBRAF protein, humanCarboplatinEverolimusPaclitaxelProto-Oncogene Proteins B-rafchemotherapyeverolimusmelanomauveal

Identifiers

PMID29044496
PMCPMC5780191
OpenAlexW2765775340

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.