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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 06/19/2009
  • Updated: 08/09/2010

HPV Status Can Predict Outcome in Oropharyngeal Cancer

Adapted from the NCI Cancer Bulletin 1.

Patients with advanced forms of a cancer in the upper portion of their throat have better outcomes if their tumors are positive for the human papillomavirus (HPV), according to new data 2 from a phase III clinical trial presented at the 2009 annual meeting of the American Society of Clinical Oncology. (The findings were subsequently published in the July 1, 2010, issue of the New England Journal of Medicine; see the journal abstract 3.) Although other studies have suggested a link between HPV status and outcome in patients who have oropharyngeal cancer, these new data provide the most definitive evidence, said the study's leader, Maura Gillison, M.D., Ph.D., of Ohio State University, at a press briefing before the meeting.

Oropharyngeal cancer "can now be divided into those linked to prolonged use of tobacco and alcohol, and those linked to HPV," she said. And determining HPV status, she added, "may now be part of routine clinical care…because of its prognostic implications in these patients."

The findings come from a correlative study in the Radiation Therapy Oncology Group 4 (RTOG) 0129 clinical trial 5, a phase III trial in which patients with stage III or IV oropharyngeal cancer were randomly assigned to receive different regimens of radiotherapy and the chemotherapy drug cisplatin 6. Nearly two-thirds of the tumor samples tested HPV positive, Dr. Gillison said. Two years after treatment, 88 percent of the HPV-positive patients were still alive, compared with 66 percent of the HPV-negative patients. The absolute difference in survival increased over time.

Additional analyses ruled out other factors, such as age, performance status, and treatment, that might account for the superior outcomes seen in patients with HPV-positive tumors.

Due to the dramatic differences in treatment response, Dr. Gillison said, from this point forward RTOG and the Eastern Clinical Oncology Group 7 will stratify all of their clinical trials by HPV status, and they will design clinical trials specifically for HPV-positive or -negative patients.

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Glossary Terms

human papillomavirus (HYOO-mun PA-pih-LOH-muh-VY-rus)
A type of virus that can cause abnormal tissue growth (for example, warts) and other changes to cells. Infection for a long time with certain types of human papillomavirus can cause cervical cancer. Human papillomavirus may also play a role in some other types of cancer, such as anal, vaginal, vulvar, penile, oropharyngeal, and squamous cell skin cancers. Also called HPV.
oropharyngeal cancer (OR-oh-fuh-RIN-jee-ul KAN-ser)
Cancer that forms in tissues of the oropharynx (the part of the throat at the back of the mouth, including the soft palate, the base of the tongue, and the tonsils). Most oropharyngeal cancers are squamous cell carcinomas (cancer that begins in flat cells lining the oropharynx).
performance status (per-FOR-munts STA-tus)
A measure of how well a patient is able to perform ordinary tasks and carry out daily activities.
phase III trial (fayz … TRY-ul)
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&
confID=65&abstractID=31969
3http://www.ncbi.nlm.nih.gov/pubmed/20530316
4http://www.rtog.org
5http://www.cancer.gov/clinicaltrials/RTOG-0129
6http://www.cancer.gov/cancertopics/druginfo/cisplatin
7http://ecog.dfci.harvard.edu
8http://www.cancer.gov/clinicaltrials/search
9http://www.cancer.gov/cancertopics/types/throat
10http://www.cancer.gov/cancertopics/factsheet/Risk/HPV