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Docetaxel extended OS for patients with relapsed esophageal, stomach cancers

Second-line treatment with docetaxel significantly improved OS among patients with advanced esophago-gastric cancer, according to results of a phase 3 study presented at the Gastrointestinal Cancers Symposium.

Approximately 39,000 new cases of esophago-gastric cancers are diagnosed in the United States each year, and current treatments are associated with poor outcomes.

Patients with advanced disease at diagnosis commonly relapse after first-line chemotherapy. Without second-line therapy, the median survival time among this patient population is 3 months, according to background information provided by researchers.

“Current practice in the United States and a lot of Europe is to give second-line chemotherapy to patients with esophago-gastric cancers, even though the evidence isn’t as strong as we would like,” said Hugo Ford, MD, director of cancer services at Addenbrooke’s Hospital in Cambridge, United Kingdom. “This is the first trial to show second-line chemotherapy extends survival without causing deterioration in quality of life.”

In the current multicenter, open-label, randomized controlled trial, Ford and colleagues enrolled 168 patients with locally advanced or metastatic esophago-gastric adenocarcinoma whose disease progressed within 6 months of initial chemotherapy.

Median patient age was 65 years.

OS served as the primary endpoint. Secondary endpoints included response rate, toxicity, health related quality of life and healthcare resource use.

The researchers randomly assigned patients 84 patients to receive docetaxel 75 mg/m2 every 3 weeks for up to six cycles. The other 84 patients received active symptom control, which consisted of radiotherapy, steroids and/or supportive medications.

Patients assigned to docetaxel experienced significantly longer median OS (5.2 months vs. 3.6 months; HR=0.67; 95% CI, 0.49-0.92) compared with those assigned to active symptom control. Patients in the docetaxel arm also reported improved pain scores and comparable quality of life, according to preliminary analysis.

Twenty-one percent of patients assigned to docetaxel experienced grade 4 toxicity, according to researchers.

“We conclude as a result of this trial that docetaxel should be a standard second-line treatment for esophago-gastric cancer,” Ford said. “It is likely to be the standard arm in which cancer treatments are likely to be compared.”

For more information:

Ford H. Abstract #LBA4. Presented at: Gastrointestinal Cancers Symposium; Jan. 24-26, 2013; San Francisco.

Disclosure: The researchers report serving as consultants/advisers for and receiving research funding from Sanofi.

Second-line treatment with docetaxel significantly improved OS among patients with advanced esophago-gastric cancer, according to results of a phase 3 study presented at the Gastrointestinal Cancers Symposium.

Approximately 39,000 new cases of esophago-gastric cancers are diagnosed in the United States each year, and current treatments are associated with poor outcomes.

Patients with advanced disease at diagnosis commonly relapse after first-line chemotherapy. Without second-line therapy, the median survival time among this patient population is 3 months, according to background information provided by researchers.

“Current practice in the United States and a lot of Europe is to give second-line chemotherapy to patients with esophago-gastric cancers, even though the evidence isn’t as strong as we would like,” said Hugo Ford, MD, director of cancer services at Addenbrooke’s Hospital in Cambridge, United Kingdom. “This is the first trial to show second-line chemotherapy extends survival without causing deterioration in quality of life.”

In the current multicenter, open-label, randomized controlled trial, Ford and colleagues enrolled 168 patients with locally advanced or metastatic esophago-gastric adenocarcinoma whose disease progressed within 6 months of initial chemotherapy.

Median patient age was 65 years.

OS served as the primary endpoint. Secondary endpoints included response rate, toxicity, health related quality of life and healthcare resource use.

The researchers randomly assigned patients 84 patients to receive docetaxel 75 mg/m2 every 3 weeks for up to six cycles. The other 84 patients received active symptom control, which consisted of radiotherapy, steroids and/or supportive medications.

Patients assigned to docetaxel experienced significantly longer median OS (5.2 months vs. 3.6 months; HR=0.67; 95% CI, 0.49-0.92) compared with those assigned to active symptom control. Patients in the docetaxel arm also reported improved pain scores and comparable quality of life, according to preliminary analysis.

Twenty-one percent of patients assigned to docetaxel experienced grade 4 toxicity, according to researchers.

“We conclude as a result of this trial that docetaxel should be a standard second-line treatment for esophago-gastric cancer,” Ford said. “It is likely to be the standard arm in which cancer treatments are likely to be compared.”

For more information:

Ford H. Abstract #LBA4. Presented at: Gastrointestinal Cancers Symposium; Jan. 24-26, 2013; San Francisco.

Disclosure: The researchers report serving as consultants/advisers for and receiving research funding from Sanofi.

    Perspective

    It is extremely difficult to conduct studies that compare an active therapy like chemotherapy treatment vs. a supportive care approach because patients and their physicians tend to have biases that make random assignment particularly difficult to accept. That being said, there are important questions in oncology for which a supportive care arm is appropriate. Treatments often have side effects, and there is concern for worsening quality of life. There are situations where treatment is commonly given, but there may not be the level of evidence that you like to see in front-line therapy. This very important study shows two things: first, second-line therapy in patients with esophagus and gastric cancers prolongs survival, and second, a quality-of-life benefit. There is no detriment to the patient due to the side effects of this treatment.

    • Neal J. Meropol, MD
    • Chief of hematology and oncology Case Western Reserve University School of Medicine and University Hospitals

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