Literature DB >> 26467385

Taking a Measured Approach to Toxicity Data in Phase I Oncology Clinical Trials.

Manish R Sharma1, Mark J Ratain2.   

Abstract

The standard categorical system for assessing attribution of toxicity to study drug(s) in phase I trials is cumbersome and uninformative. Although a binary system ("related" vs. "unrelated") would be sufficient to define maximum tolerated dose (MTD), a probability estimation would better support dose selection for randomized dose-ranging phase II trials. ©2015 American Association for Cancer Research.

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Year:  2015        PMID： 26467385      PMCID： PMC4738103          DOI： 10.1158/1078-0432.CCR-15-2005

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  7 in total

1.  Is there room for improvement in adverse event reporting in the era of targeted therapies?

Authors:  Maureen Edgerly; Tito Fojo
Journal:  J Natl Cancer Inst       Date:  2008-02-12       Impact factor: 13.506

2.  Evaluation of the value of attribution in the interpretation of adverse event data: a North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation.

Authors:  Shauna L Hillman; Sumithra J Mandrekar; Brian Bot; Ronald P DeMatteo; Edith A Perez; Karla V Ballman; Heidi Nelson; Jan C Buckner; Daniel J Sargent
Journal:  J Clin Oncol       Date:  2010-05-17       Impact factor: 44.544

Review 3.  Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.

Authors:  Channing J Paller; Penelope A Bradbury; S Percy Ivy; Lesley Seymour; Patricia M LoRusso; Laurence Baker; Larry Rubinstein; Erich Huang; Deborah Collyar; Susan Groshen; Steven Reeves; Lee M Ellis; Daniel J Sargent; Gary L Rosner; Michael L LeBlanc; Mark J Ratain
Journal:  Clin Cancer Res       Date:  2014-08-15       Impact factor: 12.531

4.  Targeted therapies: redefining the primary objective of phase I oncology trials.

Authors:  Mark J Ratain
Journal:  Nat Rev Clin Oncol       Date:  2014-08-05       Impact factor: 66.675

Review 5.  Toxicities of Immunotherapy for the Practitioner.

Authors:  Jeffrey S Weber; James C Yang; Michael B Atkins; Mary L Disis
Journal:  J Clin Oncol       Date:  2015-04-27       Impact factor: 44.544

6.  Toxicity Attribution in Phase I Trials: Evaluating the Effect of Dose on the Frequency of Related and Unrelated Toxicities.

Authors:  Anne Eaton; Alexia Iasonos; Mrinal M Gounder; Erika G Pamer; Alexander Drilon; Diana Vulih; Gary L Smith; S Percy Ivy; David R Spriggs; David M Hyman
Journal:  Clin Cancer Res       Date:  2015-08-31       Impact factor: 12.531

7.  RECIST: no longer the sharpest tool in the oncology clinical trials toolbox---point.

Authors:  Manish R Sharma; Michael L Maitland; Mark J Ratain
Journal:  Cancer Res       Date:  2012-09-04       Impact factor: 12.701
  7 in total
  1 in total

1.  Phase I Designs that Allow for Uncertainty in the Attribution of Adverse Events.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  J R Stat Soc Ser C Appl Stat       Date:  2016-11-07       Impact factor: 1.864
  1 in total

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