Evidence map›Paper›PMID 24989332›Full record

ArticleCancer2014

Phase 1 study of the antimesothelin immunotoxin SS1P in combination with pemetrexed and cisplatin for front-line therapy of pleural mesothelioma and correlation of tumor response with serum mesothelin, megakaryocyte potentiating factor, and cancer antigen 125.

Raffit Hassan, Elad Sharon, Anish Thomas, Jingli Zhang, Alexander Ling, Markku Miettinen, Robert J Kreitman, Seth M Steinberg, Kevin Hollevoet, Ira Pastan

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 2 pooled it
8.9field-weighted citation impact, top 2% 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

106 citing papers in PubMed, 2 syntheses or guidelines pooled it, 168 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Observational
  5. Comparative theranostic efficacy ofEuropean journal of nuclear medicine and molecular imaging · 2026
    Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Target Therapy in Malignant Pleural Mesothelioma: Hope or Mirage?International journal of molecular sciences · 2023
    Review
  18. Review
  19. Article
  20. Article

46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Raffit HassanLaboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Elad Sharon
Anish Thomas
Jingli Zhang
Alexander Ling
Markku Miettinen
Robert J Kreitman
Seth M Steinberg
Kevin Hollevoet
Ira Pastan
Center for Cancer Research · USNational Institutes of Health · USNational Cancer Institute · US

Funding

Immunotherapy for Malignant Mesothelioma, Lung Cancer and Thymic MalignanciesZIABC010816 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HASSAN, RAFFIT · 2009 to 2025
$25.5M
Thoracic and Gastrointestinal Oncology Branch Medical Clinical CoreZIDBC011540 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HASSAN, RAFFIT · 2014 to 2025
$17.7M
Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

backgroundThe primary objective of this study was to determine the safety and maximum tolerated dose (MTD) of the antimesothelin immunotoxin SS1(dsFv)PE38 (SS1P) (a recombinant antimesothelin immunotoxin consisting of a murine antimesothelin variable antibody fragment [Fv] linked to PE38, a truncated portion of Pseudomonas exotoxin A) in combination with pemetrexed and cisplatin in chemotherapy-naive patients with advanced malignant pleural mesothelioma (MPM). Secondary objectives included tumor response, SS1P pharmacokinetics, and serum biomarkers of response.

methodsChemotherapy-naive patients with stage III or IV, unresectable, epithelial or biphasic MPM and normal organ functions were eligible. Pemetrexed (500 mg/m(2) on day 1) and cisplatin (75 mg/m(2) on day 1) were administered every 3 weeks for up to 6 cycles with escalating doses of SS1P administered intravenously on days 1, 3, and 5 during cycles 1 and 2. Tumor response was evaluated every 6 weeks.

resultsTwenty-four patients received SS1P at 4 dose levels from 25 to 55 mcg/kg. Grade 3 fatigue was dose-limiting in 1 patient at 55 mcg/kg. The MTD of SS1P was established as 45 mcg/kg. Other grade 3 toxicities associated with SS1P included hypoalbuminemia (21%), back pain (13%), and hypotension (8%). Of 20 evaluable patients, 12 (60%) had a partial response, 3 had stable disease, and 5 had progressive disease. Of 13 patients who received the MTD, 10 (77%) had a partial response, 1 had stable disease, and 2 had progressive disease. Objective radiologic responses were associated with significant decreases in serum mesothelin (P=.0030), megakaryocyte potentiating factor (P=.0005), and cancer antigen 125 (P < .0001).

conclusionsSS1P given with pemetrexed and cisplatin is safe and well tolerated and exhibits significant antitumor activity in patients with unresectable, advanced pleural mesothelioma. Serum mesothelin, megakaryocyte potentiating factor, and cancer antigen 125 levels correlated with objective tumor responses.

Indexed as

ADP Ribose TransferasesAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBacterial ToxinsCA-125 AntigenCisplatinExotoxinsFemaleGlutamatesGPI-Linked ProteinsGuanineHumansLung NeoplasmsMaleMaximum Tolerated DoseADP Ribose TransferasesAntibodies, MonoclonalBacterial ToxinsCA-125 AntigenCisplatinExotoxinsGlutamatesGPI-Linked ProteinsGuanineMesothelinMSLN protein, humanPemetrexedPseudomonas aeruginosa Exotoxin ASS1(dsFv)PE38Virulence Factorsimmunotoxinmesothelinpleural mesotheliomaSS1P

Identifiers

PMID24989332
PMCPMC6334650
OpenAlexW1503438909

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.