Sanofi has published the results of a clinical trial PRODIGY, which evaluated the effects of Eloxatin and Taxotere in neoadjuvant chemotherapy in patients with advanced gastric cancer.
|Sanofi's gastric cancer treatment Eloxatin|
Professor Kang Yoon-koo at Asan Medical Center presented the trial data at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.
The study found that the three-year progression-free survival (PFS) for resection-able advanced gastric cancer patients, who received Eloxatin, Taxotere, and TS-1 as neoadjuvant chemotherapy, was significantly improved after surgery compared to patients that did not receive the neoadjuvant chemotherapy. The neoadjuvant chemotherapy group also showed reduced tumor size and a higher complete resection rate.
The company conducted the PRODIGY clinical study at major clinical centers in Korea and targeted only Korean gastric cancer patients. Sanofi designed the trial to evaluate whether neoadjuvant chemotherapy can affect surgical outcomes.
The trial randomly assigned 530 patients with advanced gastric or gastroesophageal adenocarcinoma who underwent surgery into two groups -- neoadjuvant chemotherapy treatment group and non-neoadjuvant chemotherapy treatment group.
Patients in the neoadjuvant chemotherapy treatment group received Taxotere 50 mg/m² and Eloxatin 100 mg/m² once a day and TS-1 40 mg/m² twice a day up to two weeks and then three times at three-week intervals afterward.
Both groups received standard chemotherapy after surgery.
The primary endpoint was a three-year progression-free survival (PFS), and the secondary endpoints included overall survival, complete resection rate, pathologic stage, and safety profile.
“Currently, postoperative adjuvant chemotherapy for advanced gastric cancer patients is recommended as standard therapy in guidelines for Asian countries, including Korea, but the basis of preoperative neoadjuvant chemotherapy was insufficient,” Professor Kang said. “It is very encouraging that neoadjuvant chemotherapy, which uses Eloxatin and Taxotere, improved PFS in Koreans.”
The company believes that the study has proved a strong basis to recognize neoadjuvant chemotherapy as one of the standard therapies in the field of gastric cancer treatment in Korea and Asia. Kang added.
Sanofi Genzyme Korea General Manager Christine Park said, “We are happy that Korean researchers have confirmed that the neoadjuvant chemotherapy, which uses Eloxatin and Taxotere, improves PFS and complete resection rate in Korean gastric cancer patients.”
The company will do its best to improve the quality of life of Korean cancer patients and suggest effective treatment options, Park added.
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