Evidence map›Paper›PMID 23324131›Full record

Trial reportBMC cancer2013

Phase II trial of neoadjuvant pemetrexed plus cisplatin followed by surgery and radiation in the treatment of pleural mesothelioma.

Rea Federico, Favaretto Adolfo, Marulli Giuseppe, Spaggiari Lorenzo, DePas Tommaso Martino, Ceribelli Anna, Paccagnella Adriano, Crivellari Gino, Russo Francesca, Ceccarelli Matteo and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00087698 (A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.0field-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.

NCT00087698 phase2completednot on this map

A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

TypeinterventionalSponsorEli Lilly and CompanyRan2003 to 2008Enrolled77ConditionsPleural NeoplasmsArmspemetrexed, cisplatin
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. The role of radical radiotherapy in the management of malignant pleural mesothelioma: A systematic review.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2017
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Percutaneous Image-Guided Ablation of Lung Tumors.Journal of clinical medicine · 2021
    Review
  7. Non-incisional pleurectomy/decortication for malignant pleural mesothelioma.General thoracic and cardiovascular surgery · 2021
    Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Extra-pleural pneumonectomy.Journal of thoracic disease · 2019
    Review
  13. Use of Immune Checkpoint Inhibitors in Mesothelioma.Current treatment options in oncology · 2019
    Review
  14. Review
  15. Biodistribution and Tumor Uptake ofMolecules (Basel, Switzerland) · 2018
    Article
  16. Review
  17. Scientific Advances and New Frontiers in Mesothelioma Therapeutics.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2018
    Review
  18. Review
  19. Consensus Report of the 2015 Weinman International Conference on Mesothelioma.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2016
    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 10 institutions in 3 countries.

Rea FedericoAzienda Ospedaliera-Università di Padova, U.O. Chirurgia Toracica, Via Giustiniani 2, 35121 Padova, Italy. federico.rea@unipd.it
Favaretto Adolfo
Marulli Giuseppe
Spaggiari Lorenzo
DePas Tommaso Martino
Ceribelli Anna
Paccagnella Adriano
Crivellari Gino
Russo Francesca
Ceccarelli Matteo
Kazeem Gbenga
Marchi Paolo
Facciolo Francesco
Eli Lilly (United States) · USOspedale dell' Angelo · ITAzienda Ospedaliera di Padova · ITEli Lilly (Italy) · ITEuropean Institute of Oncology · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITInstituto Nazionale Tumori Regina ElenaIstituto Oncologico Veneto · ITRipamonti · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalignant pleural mesothelioma is an aggressive tumor that has a poor prognosis and is resistant to unimodal approaches. Multimodal treatment has provided encouraging results.

methodsPhase II, open-label study of the combination of chemotherapy (pemetrexed 500 mg/m²+cisplatin 75 mg/m² IV every 21 days × 3 cycles), followed by surgery (en-bloc extrapleural pneumonectomy, 3-8 weeks after chemotherapy) and hemithoracic radiation (total radiation beam 54 Gy, received 4-8 weeks post-surgery). The primary endpoint was event-free survival, defined as the time from enrollment to time of first observation of disease progression, death due to any cause, or early treatment discontinuation.

resultsFifty-four treatment-naïve patients with T1-3 N0-2 malignant pleural mesothelioma were enrolled, 52 (96.3%) completed chemotherapy, 45 (83.3%) underwent surgery, 22 (40.7%) completed the whole treatment including 90-day post-radiation follow-up. The median event-free survival was 6.9 months (95%CI: 5.0-10.5), median overall survival was 15.5 months (95%CI 11.0-NA) while median time-to-tumor response was 4.8 months (95%CI: 2.5-8.0). Eighteen (33.3%) and 13 (24.1%) patients were still event-free after 1 and 2 years, respectively. The most common treatment-emergent adverse events were nausea (63.0%), anemia (51.9%) and hypertension (42.6%).Following two cardiopulmonary radiation-related deaths the protocol was amended (21 [38.9%] patients were already enrolled in the study): the total radiation beam was reduced from 54 Gy to 50.4 Gy and a more accurate selection of patients was recommended.

conclusionsThe combination of pemetrexed plus cisplatin followed by surgery and hemithoracic radiation is feasible and has a manageable toxicity profile in carefully selected patients. It may be worthy of further investigation.

trial registrationClinicaltrial.com registrationID #NCT00087698.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinDisease-Free SurvivalFemaleGlutamatesGuanineHumansKaplan-Meier EstimateMaleMesotheliomaMiddle AgedNeoadjuvant TherapyPemetrexedPleural NeoplasmsCisplatinGlutamatesGuaninePemetrexed

Identifiers

PMID23324131
PMCPMC3722081
OpenAlexW2048594514

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.