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  • December 2016
    Joao Incio on mechanisms to explain why obesity promotes cancer.
  • November 2016
    Mike Stratton on how mutational changes in a cancer genome can point to the cause of the cancer.
  • October 2016
    Ruth Muschel on a new target for treatments for colorectal cancer.
  • September 2016
    Freddie Hamdy on the effectiveness of treatments for prostate cancer.
  • August 2016
    Moshe Oren discusses the effects of the microenvironment on cancer cells.
  • July 2016
    Richard Gilbertson on the 'bad luck hypothesis' for the cause of cancer.
  • June 2016
    Key advances in clinical trials.
  • May 2016
    Mark Lemmon on the underlying biochemistry of cancer.
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    Roger Stupp on using alternating electric fields as treatment.
  • March 2016
    Charlotte Vrinten on public perception of deaths from cancer.
  • February 2016
    Guillermo Garcia-Manero on myelodysplastic syndromes (MDS).
  • December 2015/January 2016
    Nazneen Rahman on germline genetic screening in ovarian cancer.

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EJC News Focus – July/August 2014

Loading EJC News Focus video

New recommendations for design of phase 1 trials

Traditional phase 1 trial design was established for cytotoxic chemotherapies and has remained almost unchanged for more than 40 years. In an era of molecularly targeted agents, experts believe this design is no longer fit for purpose.

An international survey of phase 1 trialists, published in EJC, found the vast majority thought changes are needed, though there was no consensus on which toxicities should be considered dose-limiting. A further study, also in EJC, gathered the first and largest toxicity dataset of phase 1 trials evaluating molecularly targeted agents. Researchers found that half the dose-limiting adverse events presented after the first cycle – and would not have been taken into account in determining the recommended phase 2 dose. They make recommendations for an overhaul of the design of phase 1 trials.

In this month's EJC News Focus, first author Sophie Postel-Vinay (IGR, France) discusses these papers, and the new recommendations, with Helen Saul.


Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents DLT-TARGETT, an EORTC-led study; Sophie Postel-Vinay et al.

Defining dose-limiting toxicity for phase I trials of molecularly targeted agents: results of a DLT-TARGETT international survey; Paoletti X et al.

An (only) partially established paradigm of drug development of targeted therapies; Jordi Rodon.