Evidence map›Paper›PMID 29043412›Full record

Trial reportCancer chemotherapy and pharmacology2017

Randomized study of etirinotecan pegol versus irinotecan as second-line treatment for metastatic colorectal cancer.

Heinz-Josef Lenz, Philip Philip, Mark Saunders, Tatjana Kolevska, Kalyan Mukherjee, Leslie Samuel, Shailesh Bondarde, Tracy Dobbs, Mary Tagliaferri, Ute Hoch and 2 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 46% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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

12 authors at 8 institutions in 3 countries.

Heinz-Josef LenzUSC Norris Comprehensive Cancer Center, 1441 Eastlake Ave Rm 3456, Los Angeles, CA, 90089-9173, USA. lenz@med.usc.edu.ORCID http://orcid.org/0000-0003-2178-9568
Philip PhilipBarbara Ann Karmanos Cancer Institute, 4th Fl, HWCRC 4100 John R Detroit, Detroit, MI, 48201, USA.
Mark SaundersChristie Hospital NHS Foundation Trust, Wilmslow Road, Manchester, M20 4BX, UK.
Tatjana KolevskaKaiser Permanente Medical Center, 2nd Floor, Hallway C, 975 Sereno Drive, Vallejo, CA, 94589, USA.
Kalyan MukherjeeChittaranjan National Cancer Institute, 37 Shyama Prasad Mukherjee Road, Bhawanipur, Kolkata, West Bengal, 700026, India.
Leslie SamuelANCHOR Unit Clinic D, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, UK.
Shailesh BondardeShatabdi Super Specialty Hospital, Suyojit City Center, Mumbai Naka, Nashik, 422 005, India.
Tracy DobbsTennessee Cancer Specialists, 1415 Old Weisgarser Road, Knoxville, TN, 37909-1292, USA.
Mary TagliaferriNektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.
Ute HochNektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.
Alison L HannahNektar Therapeutics, 455 Mission Bay Boulevard South, San Francisco, CA, 94158, USA.
Maurice BerkowitzUCLA Geffen School of Medicine, 201 S. Buena Vista Street, Suite 200, Burbank, CA, 91505, USA.
Nektar Therapeutics (United States) · USAberdeen Royal Infirmary · GBChittaranjan National Cancer Institute · INKaiser Permanente Vallejo Medical Center · USTennessee Cancer Specialists · USThe Christie NHS Foundation Trust · GBUSC Norris Comprehensive Cancer Center · USWayne State University · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

purposeEtirinotecan pegol (EP) is a long-acting topoisomerase-I inhibitor designed to provide sustained exposure to SN-38 (active metabolite of irinotecan). This phase II study compared EP versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC).

methodsPatients were randomized to EP 145 mg/m

resultsThe study was terminated before completing accrual due to evolving standards of care. Eighty-three patients were randomized. Median PFS was longer with EP versus irinotecan (4.0 versus 2.8 months, respectively; HR 0.65; 95% CI 0.40-1.04; P = 0.07). Six-month PFS rates were 32.8 and 15.4%, respectively. Median OS was 9.6 and 8.4 months in EP and irinotecan arms, respectively (HR 0.91; 95% CI 0.56-1.49). ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018). The most common grade-3/4 adverse events for EP and irinotecan were diarrhea (21 vs 20%), neutropenia (10 vs 22%), abdominal pain (14 vs 5%), nausea (14 vs 2%), and vomiting (12 vs 7%), respectively.

conclusionEP is active and safe for second-line treatment of KRAS-mutant, irinotecan-naïve mCRC.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCamptothecinColorectal NeoplasmsDisease-Free SurvivalFemaleHeterocyclic Compounds, 4 or More RingsHumansIrinotecanMaleMiddle AgedNeoplasm MetastasisPolyethylene GlycolsAntineoplastic AgentsCamptothecinetirinotecan pegolHeterocyclic Compounds, 4 or More RingsIrinotecanPolyethylene GlycolsChemotherapyEtirinotecan pegolIrinotecanKRAS mutantMetastatic colorectal cancer

Identifiers

PMID29043412
PMCPMC6863159
OpenAlexW2766580780

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.