Evidence map›Paper›PMID 22425919›Full record

ArticleJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2012

A phase I trial of the HIV protease inhibitor nelfinavir with concurrent chemoradiotherapy for unresectable stage IIIA/IIIB non-small cell lung cancer: a report of toxicities and clinical response.

Ramesh Rengan, Rosemarie Mick, Daniel Pryma, Mark A Rosen, Lilie L Lin, Amit M Maity, Tracey L Evans, James P Stevenson, Corey J Langer, John Kucharczuk and 4 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
4.8field-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

44 citing papers in PubMed, 73 citations in OpenAlex.

  1. ARCII: A phase II trial of the HIV protease inhibitor Nelfinavir in combination with chemoradiation for locally advanced inoperable pancreatic cancer.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2016
    Trial
  2. Clinical Trial of Oral Nelfinavir before and during Radiation Therapy for Advanced Rectal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
  3. Trial
  4. Risk Assessment for Drug-Induced Hyperbilirubinemia: A Mechanistic Approach.CPT: pharmacometrics & systems pharmacology · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Lipid metabolism and cancer.The Journal of experimental medicine · 2021
    Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Phase I trial of concurrent stereotactic body radiotherapy and nelfinavir for locally advanced borderline or unresectable pancreatic adenocarcinoma.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2019
    Article
  18. Review
  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

14 authors at 1 institution in 1 country.

Ramesh RenganDepartment of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. rengan@uphs.upenn.edu
Rosemarie Mick
Daniel Pryma
Mark A Rosen
Lilie L Lin
Amit M Maity
Tracey L Evans
James P Stevenson
Corey J Langer
John Kucharczuk
Joseph Friedberg
Susan Prendergast
Tiffany Sharkoski
Stephen M Hahn
University of Pennsylvania · US

Funding

DCE-MRI for Assessment of Vascular Normalization by Nelfinavir in Lung CancerR21CA144190 · NCI · UNIVERSITY OF PENNSYLVANIA · PI RENGAN, RAMESH, ROSEN, MARK ALAN · 2010 to 2011
$652k
NCI NIH HHS R21 CA144190NCI NIH HHS R21-CA144190
6 · The paper itself

Abstract

backgroundThe objective of this phase I trial was to determine dose-limiting toxicities (DLT) and the maximally tolerated dose of the radiosensitizer Nelfinavir in combination with concurrent chemoradiotherapy in locally advanced non-small cell lung cancer (NSCLC).

methodsNelfinavir (dose level 1: 625 mg orally [PO] twice a day; dose level 2: 1250 mg PO twice a day) was administered for 7 to 14 days before and concurrently with concurrent chemoradiotherapy to patients with biopsy confirmed IIIA or IIIB unresectable NSCLC. Five patients were treated at dose level 1; eight patients were treated at dose level 2. Patients were treated with concurrent chemoradiotherapy to a dose of 66.6 Gy. DLTs were defined as any treatment-related grade 4 hematologic toxicity requiring a break in therapy or nonhematologic grade 3 or higher toxicity except esophagitis and pneumonitis.

resultsSixteen patients were enrolled and 13 patients received at least one dose of nelfinavir. Twelve patients were treated with nelfinavir and concurrent chemoradiotherapy. No DLTs have been observed at either dose level. The maximum tolerated dose of nelfinavir was therefore 1250 mg PO twice a day. Six patients experienced grade 4 leukopenia. One patient experienced grade 4 thromobcytopenia. Median follow-up for all 12 response-evaluable patients was 31.6 months and for survivors is 23.5 months. Nine of the 12 patients had evaluable posttreatment positron emission tomography/computed tomography with metabolic response as follows: overall response: 9/9 (100%); complete response: 5/9 (56%); and partial response: 4/9 (44%).

conclusionNelfinavir administered with concurrent chemoradiotherapy is associated with acceptable toxicity in stage IIIA/IIIB NSCLC. The metabolic response and tumor response data suggest that nelfinavir has promising activity in this disease.

Indexed as

AgedCarcinoma, Non-Small-Cell LungFemaleFollow-Up StudiesHIV Protease InhibitorsHumansLung NeoplasmsMaleMiddle AgedNelfinavirNeoplasm StagingPhosphoinositide-3 Kinase InhibitorsTomography, X-Ray ComputedHIV Protease InhibitorsNelfinavirPhosphoinositide-3 Kinase Inhibitors

Identifiers

PMID22425919
PMCPMC3310889
OpenAlexW2079046174

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.