Evidence map›Paper›PMID 23733618›Full record

Trial reportCancer2013

A prospective, phase 1/2 study of everolimus and temozolomide in patients with advanced pancreatic neuroendocrine tumor.

Jennifer A Chan, Lawrence Blaszkowsky, Keith Stuart, Andrew X Zhu, Jill Allen, Raymond Wadlow, David P Ryan, Jeffrey Meyerhardt, Marielle Gonzalez, Eileen Regan and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 3% 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Chemotherapy in NEN: still has a role?Reviews in endocrine & metabolic disorders · 2021
    Review
  15. Review
  16. Review
  17. Medical Management of Gastroenteropancreatic Neuroendocrine Tumors.Surgical oncology clinics of North America · 2020
    Review
  18. Review
  19. Article
  20. Review
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 4 institutions in 1 country.

Jennifer A ChanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Lawrence Blaszkowsky
Keith Stuart
Andrew X Zhu
Jill Allen
Raymond Wadlow
David P Ryan
Jeffrey Meyerhardt
Marielle Gonzalez
Eileen Regan
Hui Zheng
Matthew H Kulke
Harvard University · USDana-Farber Cancer Institute · USMassachusetts General Hospital · USLahey Hospital and Medical Center · US

Funding

Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI SICINSKA, · 2007 to 2023
$33.2M
NCI NIH HHS P50 CA127003
6 · The paper itself

Abstract

backgroundBoth everolimus and temozolomide are associated with single-agent activity in patients with pancreatic neuroendocrine tumor (NET). A phase 1/2 study was performed to evaluate the safety and efficacy of temozolomide in combination with everolimus in patients who have advanced pancreatic NET.

methodsPatients were treated with temozolomide at a dose of 150 mg/m(2) per day on days 1 through 7 and days 15 through 21 in combination with everolimus daily in each 28-day cycle. In cohort 1, temozolomide was administered together with everolimus at 5 mg daily. Following demonstration of safety in this cohort, subsequent patients in cohort 2 were treated with temozolomide plus everolimus at 10 mg daily. The duration of temozolomide treatment was limited to 6 months. Patients were followed for toxicity, radiologic and biochemical response, and survival.

resultsA total of 43 patients were enrolled, including 7 in cohort 1 and 36 in cohort 2. Treatment was associated with known toxicities of each drug; no synergistic toxicities were observed. Among 40 evaluable patients, 16 (40%) experienced a partial response. The median progression-free survival duration was 15.4 months. Median overall survival was not reached.

conclusionsTemozolomide and everolimus can be safely administered together in patients with advanced pancreatic NET, and the combination is associated with encouraging antitumor activity. Future studies evaluating the efficacy of combination therapy compared to treatment with either agent alone are warranted.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDacarbazineDisease-Free SurvivalDrug Administration ScheduleEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeuroendocrine TumorsPancreatic NeoplasmsProspective StudiesSirolimusDacarbazineEverolimusSirolimusTemozolomideeverolimusoncologypancreatic neuroendocrine tumorphase 1/2 studytemozolomide

Identifiers

PMID23733618
PMCPMC4308727
OpenAlexW1586545889

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.