Evidence map›Paper›PMID 19414670›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Phase I study of concurrent weekly docetaxel and repeated samarium-153 lexidronam in patients with castration-resistant metastatic prostate cancer.

Shi-Ming Tu, Paul Mathew, Franklin C Wong, Donnah Jones, Marcella M Johnson, Christopher J Logothetis

Abstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
4.3field-weighted citation impact, top 6% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Reply to 'Single high dose versus repeated bone-targeted radionuclide therapy'.European journal of nuclear medicine and molecular imaging · 2018
    Article
  5. Efficacy and safety ofSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Article
  6. Phase I/II trials ofEuropean journal of nuclear medicine and molecular imaging · 2017
    Article
  7. Review
  8. Review
  9. Article
  10. Beyond Palliation: Therapeutic Applications ofClinical & experimental pharmacology · 2013
    Article
  11. Optimal bone health management strategies in patients with prostate cancer.Indian journal of urology : IJU : journal of the Urological Society of India · 2013
    Article
  12. Targeting bone physiology for the treatment of metastatic prostate cancer.Clinical advances in hematology & oncology : H&O · 2013
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Multimodality therapy: bone-targeted radioisotope therapy of prostate cancer.Clinical advances in hematology & oncology : H&O · 2010
    Review
  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

6 authors at 1 institution in 1 country.

Shi-Ming TuDepartment of Genitourinary Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, 77239-1439, USA. stu@mdanderson.org
Paul Mathew
Franklin C Wong
Donnah Jones
Marcella M Johnson
Christopher J Logothetis
The University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSamarium-153 ((153)Sm) lexidronam is a bone-targeting radiopharmaceutical with a short physical half-life and a favorable toxicity profile. We evaluated the safety and feasibility of a concurrent combination of weekly docetaxel with repeated (153)Sm-lexidronam in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND

methodsA conventional 3 + 3 dose-escalation design was used for this study. Patients were treated in three cohorts comprising two cycles of weekly docetaxel at 25, 30, and 35 mg/m(2), respectively, on days 1, 8, and 15 of a 28-day cycle in combination with (153)Sm (1 mCi/kg) on day 1. Unacceptable hematologic toxicity (UHT) was defined as more than 7 days delay in therapy for inadequate counts: an absolute neutrophil count (ANC) more than 1,000/microL and platelets more than 70,000/microL were required at days 8 and 15 and ANC more than 1,500/microL and platelets more than 100,000/microL were required at cycle 2, day 1. If counts had not recovered by day 56 of either combination cycle, UHT was declared.

resultsEighteen patients were treated in three cohorts. Two patients in separate cohorts experienced UHT; the maximum-tolerated dose for this regimen was not reached. The median interval between (153)Sm doses was 35 days (range, 27 to 57 days). The only significant toxicity was mild, transient myelosuppression. Five patients (28%) experienced grade 3 hematologic toxicity. There were no grade > or = 4 hematologic or nonhematologic toxicities.

conclusionTwo dosing cycles consisting of weekly docetaxel and monthly (153)Sm-lexidronam were well tolerated and feasible in this CRPC population.

Indexed as

AgedAged, 80 and overAnalgesics, Non-NarcoticAntineoplastic AgentsCohort StudiesCombined Modality TherapyConstipationDocetaxelDose-Response Relationship, DrugDrug Administration ScheduleFatigueFeasibility StudiesHumansLeukocyte CountMaleMiddle AgedAnalgesics, Non-NarcoticAntineoplastic AgentsDocetaxelOrganometallic CompoundsOrganophosphorus CompoundsProstate-Specific AntigenRadioisotopessamarium Sm-153 lexidronamTaxoids

Identifiers

PMID19414670
PMCPMC4371137
OpenAlexW2102397607

What OpenQuestion holds

Textmetadata
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.