Evidence map›Paper›PMID 28526720›Full record

Trial reportThe oncologist2017

Efficacy of Trabectedin in Patients with Advanced Translocation-Related Sarcomas: Pooled Analysis of Two Phase II Studies.

Mitsuru Takahashi, Shunji Takahashi, Nobuhito Araki, Hideshi Sugiura, Takafumi Ueda, Tsukasa Yonemoto, Hideo Morioka, Hiroaki Hiraga, Toru Hiruma, Toshiyuki Kunisada and 3 more

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

Trial report in The oncologist, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
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.

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

14 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. 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 13 institutions in 2 countries.

Mitsuru TakahashiDivision of Orthopaedic Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan m.takahashi@scchr.jp.
Shunji TakahashiDepartment of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Nobuhito ArakiDepartment of Orthopaedic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
Hideshi SugiuraDepartment of Physical Therapy, Nagoya University School of Health Sciences, Nagoya, Japan.
Takafumi UedaDepartment of Orthopaedic Surgery, Osaka National Hospital, Osaka, Japan.
Tsukasa YonemotoDivision of Orthopaedic Surgery, Chiba Cancer Center, Chiba, Japan.
Hideo MoriokaDepartment of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
Hiroaki HiragaDepartment of Orthopaedic Surgery, Hokkaido Cancer Center, Hokkaido, Japan.
Toru HirumaDepartment of Musculoskeletal Tumor Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Toshiyuki KunisadaDepartment of Medical Materials for Musculoskeletal Reconstruction, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Akihiko MatsumineDepartment of Orthopedic Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
Masashi ShimuraData Science Department, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
Akira KawaiDepartment of Musculoskeletal Oncology, Rare Cancer Center, National Cancer Center Hospital, Tokyo, Japan.
Chiba Cancer Center · JPHokkaido University Hospital · JPJapanese Foundation For Cancer Research · JPKanagawa Cancer CenterKeio University · JPMie University · JPNagoya University · JPNational Cancer Centre Japan · JPOkayama University · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka National Hospital · JPShizuoka Cancer Center · JPTaiho Pharmaceutical (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrabectedin is reported as effective, especially against translocation-related sarcomas (TRSs) after failure of or intolerance to standard chemotherapy. We conducted two phase II studies of TRS, confirming high efficacy of 1.2 mg/m

methodsTrabectedin was administered on day one of a 21-day cycle. Efficacy was assessed using progression-free survival (PFS), OS, and best overall response. An analysis of OS and PFS was performed for subgroups divided by baseline lymphocyte count (<1,000/μL, ≥1,000/μL) or number of previous chemotherapy regimens (0, 1, 2, ≥3 regimens), and a Weibull parametric model was used to estimate the numerical relationship between lymphocyte count and PFS and OS.

resultsMedian PFS and OS in overall patients were 5.6 (95% confidence interval [CI]: 4.1-7.3) and 17.5 months (95% CI: 12.6-23.6), respectively. PFS in the myxoid and round-cell liposarcoma (MRCL) group (7.4 months [95% CI: 5.6-11.1]) was longer than in the other subtypes. The response rate was also highest in the MRCL group. Median OS was longer in patients with baseline lymphocyte counts ≥1,000/μL than in those with counts of <1,000/μL, but median PFS was not different between the two subgroups.

conclusionOur updated and pooled data showed that trabectedin exerted prolonged disease control and antitumor effects in patients with advanced TRS, especially in MRCL. We consider that the subgroup analyses also provide important information for trabectedin treatment in patients with TRS. IMPLICATIONS FOR PRACTICE: The progression-free survival (PFS) for the integrated data of 66 patients with translocation-related sarcomas (TRSs) in two phase II studies of trabectedin 1.2 mg/m

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingDioxolesDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateLiposarcoma, MyxoidMaleMiddle AgedNeoplasm StagingSarcomaTetrahydroisoquinolinesTrabectedinTreatment OutcomeAntineoplastic Agents, AlkylatingDioxolesTetrahydroisoquinolinesTrabectedinHistological subtypeLymphocyte countNumber of previous chemotherapy regimenTrabectedinTranslocation‐related sarcoma

Identifiers

PMID28526720
PMCPMC5553952
OpenAlexW2614805278

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.