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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 06/24/2008
  • Updated: 10/19/2011

Gemcitabine after Pancreatic Cancer Surgery Improves Survival

Adapted from the NCI Cancer Bulletin 1.

Patients who received the chemotherapy drug gemcitabine 2 after surgery for pancreatic cancer lived two months longer than patients who had surgery alone, according to the final results 3 of a large, randomized clinical trial presented at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

Less than 20 percent of patients with pancreatic cancer are candidates for surgery, because the disease is often detected in the late stages. Gemcitabine has been a standard treatment for patients with advanced (and inoperable) pancreatic cancer for a decade. The new findings support use of the drug in the adjuvant setting.

"We have shown that this treatment more than doubles the overall survival five years after treatment," said Dr. Helmut Oettle of the Charité School of Medicine in Berlin, Germany, who presented the results.

The study included 368 patients who underwent surgery followed by six months of adjuvant gemcitabine treatment or surgery alone. In the gemcitabine group, 21 percent were alive at five years compared with 9 percent in the control group. Median survival in the gemcitabine group was 22.8 months compared with 20.2 months in the control group.

Preliminary results from the trial were reported at ASCO in 2005 and showed that post-surgery gemcitabine could delay a recurrence of the disease. These findings led to an increase in the use of the drug in the United States and Europe, according to the researchers.

"We can now say that giving this agent after surgery to patients with early stage disease will improve a patient's survival," commented Dr. Nicholas Petrelli of the Helen F. Graham Cancer Center (Wilmington, Del.) at the meeting. "We couldn't say that before."

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Glossary Terms

control group (kun-TROLE groop)
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.
median survival time (MEE-dee-un ser-VY-vul …)
The length of time from either the diagnosis or the treatment of a disease, such as cancer, to the point at which half of the patients diagnosed with the disease are still alive. In a clinical trial, measuring the median survival time is one way to see how well a new treatment works. Also called median overall survival and median survival.
randomized clinical trial (RAN-duh-mized KLIH-nih-kul TRY-ul)
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
recurrence (ree-KER-ents)
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrent cancer.
standard therapy (... THAYR-uh-pee)
Treatment that experts agree is appropriate, accepted, and widely used. Also called best practice, standard medical care, and standard of care.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.cancer.gov/cancertopics/druginfo/gemcitabinehydrochloride
3http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&
confID=55&abstractID=34749
4http://www.cancer.gov/clinicaltrials/search
5http://www.cancer.gov/cancertopics/types/pancreatic
6http://www.cancer.gov/cancertopics/druginfo/alphalist