PictureGenomic structure of HPV
The National Cancer Institute released a pair of major news stories yesterday, each with potentially major benefits for patients.

First, researchers have found that antibodies against the human papillomavirus (HPV) may help identify individuals who are at greatly increased risk of HPV-related cancer of the oropharynx, which is a portion of the throat that contains the tonsils.

The findings in this study led researchers to believe that a blood test may eventually be available to identify patients, which could lead to advanced screening procedures.

“Although promising, these findings should be considered preliminary,” said Paul Brennan, Ph.D., the lead investigator from International Agency for Research on Cancer (IARC). “If the predictive capability of the HPV16 E6 antibody holds up in other studies, we may want to consider developing a screening tool based on this result.”

The results of this study, carried out by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, in collaboration with the IARC, were published online June 17,  2013, in the Journal of Clinical Oncology.

Second, the NCI announced that they plan to take serious measures to speed up the clinical trials process. This is a vital necessity, as trials that move slowly to register patients rarely succeed. Among the institute’s Operational Efficiency Working Group’s (OEWG) recommendations: 

  • the ideal, or target, time to open a clinical trial should be 210 days for phase I and phase II trials; and 300 days for phase III trials
  • absolute deadlines—which, when surpassed, lead to cancellation of the trial— should be set at 540 days for phase I and II trials; and 720 days for phase III trials.

The study showed that the OEWG recommendations resulted in a median 18.3 percent reduction (from 541 to 442 days) in the time it takes to initiate phase I and phase II trials. The decrease seen in phase III trials was even more encouraging, with a median reduction time of 45.7 percent (from 727 days to 395 days).

It still isn’t an ideal solution, as the deadlines are still a bit longer than most patients would like, but these are major steps in the right direction. This study of OWEG outcomes appeared online in the Journal of the National Cancer Institute, June 17, 2013.

• NIH scientists find promising biomarker for predicting HPV-related oropharynx cancer (Cancer.gov, June 17, 2013)
• Reforms speed initiation of NCI-sponsored clinical trials (Cancer.gov, June 17, 2013)