Evidence map›Paper›PMID 24037083›Full record

Trial reportInvestigational new drugs2013

Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide.

Changhoon Yoo, Jeeyun Lee, Sun Young Rha, Kyong Hwa Park, Tae Min Kim, Yu Jung Kim, Hyo Jin Lee, Kyung Hee Lee, Jin-Hee Ahn

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02711007 (A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT02711007 phase2 / phase3completednot on this mapstarted 2016, after this paper: background citation

A Phase II Trial of Apatinib in Relapsed and Unresectable High-grade Osteosarcoma After Failure of Standard Multimodal Therapy

TypeinterventionalSponsorGUO WEIRan2016 to 2018Enrolled37ConditionsOsteosarcoma, MetastasisArmsapatinib
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Oncotarget · 2019
    Article
  12. Article
  13. Article
  14. Article
  15. Targeted therapy for soft tissue sarcomas in adolescents and young adults.Adolescent health, medicine and therapeutics · 2017
    Review
  16. Review
  17. Observational
  18. Targeted therapy in sarcomas other than GIST tumors.Journal of surgical oncology · 2015
    Review
  19. Review
  20. Review
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

9 authors at 9 institutions in 1 country.

Changhoon YooDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea, 138-736.
Jeeyun Lee
Sun Young Rha
Kyong Hwa Park
Tae Min Kim
Yu Jung Kim
Hyo Jin Lee
Kyung Hee Lee
Jin-Hee Ahn
Asan Medical Center · KRChungnam National University · KRKorea University Medical Center · KRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRUniversity of Ulsan · KRYeungnam University · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter, phase II trial evaluated the efficacy and safety of everolimus, an mTOR inhibitor, in patients with metastatic or recurrent bone and soft-tissue sarcoma after the failure of anthracycline- and ifosfamide-containing regimens. Everolimus was administered orally as 10 mg once daily. The primary endpoint was the progression-free rate (PFR) at 16 weeks, assessed by computed tomography scan according to RECIST v1.0. Between July 2010 and May 2011, 41 patients were enrolled in this study. Among them, 83% received two or more regimens of chemotherapy prior to study entry. In 38 patients who the primary endpoint was evaluable, 11 patients reached 16 weeks progression-free (one with partial response and 10 with stable disease), indicating a PFR at 16 weeks of 27% (95% confidence interval [CI], 16-42%). The PFR at 16 weeks was highest in patients with angiosarcoma (2 of 3, 67%). With a median follow-up of 10.9 months (range, 2.3-23.9 months) in living patients, the median progression-free survival was 1.9 months (95% CI, 1.3-2.4 months) and the median overall survival was 5.8 months (95% CI, 3.6-8.0 months). Most adverse events were generally mild and tolerable. Grade 3/4 toxicities included hyperglycemia (15%), stomatitis (7%), pain (5%), and asthenia (5%). Everolimus shows modest antitumor activity with manageable toxicities in heavily pretreated patients with bone and soft-tissue sarcoma.

Indexed as

AdolescentAdultAgedAged, 80 and overAnthracyclinesAntineoplastic AgentsBone NeoplasmsEverolimusFemaleHumansIfosfamideMaleMiddle AgedSarcomaSirolimusSoft Tissue NeoplasmsAnthracyclinesAntineoplastic AgentsEverolimusIfosfamideSirolimus

Identifiers

PMID24037083
OpenAlexW1970637515

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.