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

Hugo Ford, MD
Published: Tuesday, Jan 29, 2013

Hugo Ford, MD, director of cancer services at Addenbrooke’s Hospital in Cambridge, UK, describes results from the phase III COUGAR-02 study that examined second-line docetaxel in patients with advanced gastroesophageal adenocarcinoma.

Over the course of 4 years, the COUGAR-02 trial enrolled 168 patients who had progressed within 6 months on the standard first-line chemotherapy for advanced or metastatic gastroesophageal adenocarcinoma. These patients were randomized 1:1 to receive docetaxel at 75 mg/m2 every 3 weeks for up to 6 cycles or active symptom control, which could include radiotherapy, steroids, and supportive medications.

Due to the poor prognosis in this group of patients, only 23% of patients completed the full 6 cycles of treatment with docetaxel, notes Ford. However, for patients treated with docetaxel, overall survival was extended to 5.2 months compared to 3.6 (HR = 0.67; 95% CI, 0.49-0.92; P = .01).

Ford notes that docetaxel was reasonably well tolerated with a 7% incidence of febrile neutropenia. However, 30% of patients discontinued docetaxel due to side effects such as lethargy, which Ford explains may have been disease and not treatment related.

<<< View coverage from the 2013 GI Cancers Symposium

Hugo Ford, MD, director of cancer services at Addenbrooke’s Hospital in Cambridge, UK, describes results from the phase III COUGAR-02 study that examined second-line docetaxel in patients with advanced gastroesophageal adenocarcinoma.

Over the course of 4 years, the COUGAR-02 trial enrolled 168 patients who had progressed within 6 months on the standard first-line chemotherapy for advanced or metastatic gastroesophageal adenocarcinoma. These patients were randomized 1:1 to receive docetaxel at 75 mg/m2 every 3 weeks for up to 6 cycles or active symptom control, which could include radiotherapy, steroids, and supportive medications.

Due to the poor prognosis in this group of patients, only 23% of patients completed the full 6 cycles of treatment with docetaxel, notes Ford. However, for patients treated with docetaxel, overall survival was extended to 5.2 months compared to 3.6 (HR = 0.67; 95% CI, 0.49-0.92; P = .01).

Ford notes that docetaxel was reasonably well tolerated with a 7% incidence of febrile neutropenia. However, 30% of patients discontinued docetaxel due to side effects such as lethargy, which Ford explains may have been disease and not treatment related.

<<< View coverage from the 2013 GI Cancers Symposium


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