Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial.
- Study type
- Clinical trial
- Study name
- Burris 1997
- Design
- Randomised comparative trial (gemcitabine versus fluorouracil)
- Sample size
- 126 patients
- Source
- JCO · 1997
In plain words
In this study, a drug called gemcitabine was compared with the drug fluorouracil in people with advanced pancreatic cancer who had symptoms such as pain. Gemcitabine eased the symptoms of the disease (such as pain) in more patients, and patients lived a little longer (median 5.65 months versus 4.41 months). The treatment was well tolerated.
Key results
Treatment arms and regimens
63 patients; gemcitabine 1000 mg/m² weekly for 7 weeks, then 1 week of rest, then weekly for 3 weeks out of every 4 weeks.
63 patients; fluorouracil 600 mg/m² once weekly.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with newly diagnosed, advanced, symptomatic pancreatic cancer who had completed a lead-in period to characterise and stabilise their pain.
Endpoints
The primary efficacy endpoint was clinical benefit response, a composite of pain (analgesic consumption and pain intensity), Karnofsky performance status and weight. Clinical benefit required a sustained improvement (at least 4 weeks) in at least one parameter without worsening in any of the others. Other efficacy measures were response rate, time to disease progression and survival.
Safety and side effects
According to the abstract, treatment was well tolerated. Details of grade 3 or higher adverse events are not given in the abstract and are available in the full paper.
Clinical significance and place in guidelines
According to the abstract, gemcitabine was superior to 5-FU both in relieving symptoms and in survival, and its survival advantage was judged modest. The current place of this regimen in clinical guidelines should be checked in up-to-date sources.
Limitations
The survival advantage was modest and the sample size was relatively small (126 patients). The control arm was 5-FU, and no comparison with current regimens was made in this study. Other limitations should be checked in the full paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.