Evidence map›Paper›PMID 23664013›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2013

Feasibility and dose discovery analysis of zoledronic acid with concurrent chemotherapy in the treatment of newly diagnosed metastatic osteosarcoma: a report from the Children's Oncology Group.

Robert E Goldsby, Timothy M Fan, Doojduen Villaluna, Lars M Wagner, Michael S Isakoff, James Meyer, R Lor Randall, Sharon Lee, Grace Kim, Mark Bernstein and 3 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 4% 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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Addition of Zoledronate to Chemotherapy in Patients with Osteosarcoma Treated with Limb-Sparing Surgery: A Phase III Clinical Trial.Medical science monitor : international medical journal of experimental and clinical research · 2019
    Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. The Management of an Open Biopsy Tract Site Infection and Ulceration in the Setting of Osteosarcoma.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2022
    Article
  9. Recent and Ongoing Research into Metastatic Osteosarcoma Treatments.International journal of molecular sciences · 2022
    Review
  10. Review
  11. Review
  12. Review
  13. Bisphosphonate Use in Pediatric Oncology for Pain Management.The American journal of hospice & palliative care · 2019
    Article
  14. Article
  15. Article
  16. Article
  17. MicroRNA-128 inhibits EMT of human osteosarcoma cells by directly targeting integrin α2.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2016
    Article
  18. Article
  19. Article
  20. 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 12 institutions in 3 countries.

Robert E GoldsbyUniversity of California San Francisco, Benioff Children's Hospital, San Francisco, CA, United States. goldsbyr@peds.ucsf.edu
Timothy M Fan
Doojduen Villaluna
Lars M Wagner
Michael S Isakoff
James Meyer
R Lor Randall
Sharon Lee
Grace Kim
Mark Bernstein
Richard Gorlick
Mark Krailo
Neyssa Marina
UCSF Benioff Children's Hospital · USArcadia · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USConnecticut Children's Medical Center · USIzaak Walton Killam Health Centre · CAMontefiore Medical Center · USPrimary Children's Hospital · USStanford University · USUniversity of California, San Francisco · USUniversity of Southern California · USUrbana University · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
NCI NIH HHS U10 CA098543
6 · The paper itself

Abstract

aimPatients with metastatic osteosarcoma (OS) have a poor outcome with conventional therapies. Zoledronic acid (ZA) is a third-generation bisphosphonate that reduces skeletal-related events in many adult cancers, and pre-clinical data suggest a possible benefit in OS. This study assessed the maximum tolerated dose (MTD) and the feasibility of ZA when combined with chemotherapy in patients with metastatic OS. PATIENTS AND

methodsPatients with a histological diagnosis of OS were eligible if they were <40 years of age, had initially metastatic disease and met organ function requirements. Treatment combined surgery and a conventional chemotherapy regimen. ZA was given concurrent with chemotherapy for a total of eight doses over 36 weeks. Three dose levels of ZA were tested: 1.2 mg/m(2) [max 2 mg], 2.3 mg/m(2) [max 4 mg] and 3.5 mg/m(2) [max 6 mg]. The MTD was determined during induction. Six patients were to be treated at each dose level, with an additional six patients treated with the MTD to help assess post-induction feasibility.

resultsTwenty-four patients (median age 13.5 years [range, 7-22]; 16 females) were treated. Five patients experienced dose-limiting toxicities (DLTs) during induction, including three patients treated with 3.5 mg/m(2). DLTs included hypophosphatemia, hypokalemia, hyponatremia, mucositis, limb pain and limb oedema. There were no reports of excessive renal toxicity or osteonecrosis of the jaw. The MTD was defined as 2.3 mg/m(2) (max 4 mg).

conclusionsZA can be safely combined with conventional chemotherapy with an MTD of 2.3 mg/m(2) (max 4 mg) for patients with metastatic osteosarcoma.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsChildDiphosphonatesDose-Response Relationship, DrugDrug Administration ScheduleEdemaExtremitiesFeasibility StudiesFemaleHumansHypokalemiaHyponatremiaHypophosphatemiaImidazolesDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID23664013
PMCPMC3689577
OpenAlexW1998077412

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.