Second-Line Docetaxel Improves Survival and Quality of Life in Patients with Advanced Esophageal and Stomach Cancers

Hugo Ford, MD

Patients with advanced esophagogastric adenocarcinoma who received the chemotherapy drug docetaxel as a second-line therapy after progressing after their first line of treatment experienced a longer period of overall survival as well as a better quality of life compared with patients who received active symptom control.

The results of the phase III study, presented at the 2013 Gastrointestinal Cancers Symposium, held January 24—26 in San Francisco, California, represent some of the first definitive evidence that this widely used method of second-line therapy for esophagogastric cancer does have measurable benefits in a disease characterized by poor prognoses and a low median survival.

“Because of the aggressive nature of the disease, all patients who present with advanced disease and up to 70% of patients who present with early stage disease will ultimately progress after their chemotherapy,” said Hugo Ford, MD, director of cancer services at Addenbrooke’s Hospital in Cambridge, UK, and lead author of the study. “For these patients, we know that the average survival time is only 3 or 4 months.” He added that although second-line chemotherapy is commonly prescribed, “there’s very little good evidence to show that treatment improves quality of life.”

In this trial, 168 patients with locally advanced or metastatic esophagogastric adenocarcinoma whose disease progressed within 6 months of initial chemotherapy were randomized to receive either docetaxel 75 mg/m2 every 3 weeks for up to 6 cycles (n = 84) or active symptom control, which could include any treatment that the physician deemed an appropriate choice to manage the disease (n = 84). The primary endpoint of the study was overall survival (OS), with secondary endpoints including response rate, toxicity, health-related quality of life (HRQL) and healthcare resource use.

The study found that patients who received docetaxel as second-line treatment experienced a median OS of 5.2 months (95% confidence interval [CI], 4.1-5.9), a significant improvement over the median OS of 3.6 months (95% CI, 3.3-4.4) in the active symptom control arm (HR = 0.67; 95% CI, 0.49-0.92; P = .01).

Additionally, Ford reported that there were no significant differences observed in global quality of life or function between the two groups, and those who received docetaxel had a significantly better symptom score for pain than those who received active symptom control. Ford also said that very fit patients with the longest interval between previous chemotherapy and relapse or progression fared better, as was expected. Benefits were observed across all patient groups, and no cohort appeared to do worse if they received chemotherapy, Ford said.

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Dr. Hugo Ford on the Phase III COUGAR-02 Study

“We conclude as a result of this trial that docetaxel should be the standard second-line treatment for esophagogastric cancer, and we think it’s likely to be the standard arm against which future treatments should be compared,” Ford said.

According to the National Cancer Institute, approximately 39,000 new cases of cancer of the esophagus, stomach, and esophagogastric junction were diagnosed in the United States in 2012.

Ford H, Marshall A, Wadsley J, et al. Cougar-02: a randomized phase III study of docetaxel versus active symptom control in advanced esophagogastric adenocarcinoma. Presented at: 10th Annual Gastrointestinal Cancer Symposium; January 24—26, 2013; San Francisco, California. Abstract LBA4.

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