Sanofi-Aventis Korea (hereinafter referred to as Sanofi) announced on the 28th that the anti-cancer drugs Eloxatin and Taxotere have been approved for the expansion of indications for adjuvant therapy before gastric cancer surgery.
The company explained on the 13th that its anti-cancer drugs, Eloxatin (ingredient: oxaliplatin) and Taxotere (ingredient: docetaxel), have been expanded as adjuvant therapy before surgery for locally advanced resectable gastric cancer by the Food and Drug Administration . MFDS) on the 13th.
Eloxatin has indications for advanced or metastatic gastric cancer △ inoperable △ adjuvant therapy after surgery for stage 2/3 gastric cancer in combination with casepitabine, and Taxotere △ as monotherapy for advanced and metastatic gastric cancer or cancer that locally recurrent △metastatic Or, has indications for combination therapy with cisplatin and fluorouracil as first-line treatment for locally recurrent gastric cancer.
According to the company, according to the approval for the expansion of this indication, Eloxatin and Taxotere can be used in combination with S-1 (Tegafur, Gimeracil, Oteracil Potassium) as a 3-drug to be used as adjuvant operative therapy for resectable locally advanced gastric cancer.
The company analyzes that the reason for approving the indication is that it has secured positive results in PRODIGY, a clinical study of eloxatin, taxotere, and S-1 combination therapy. The clinical trial was conducted on 530 Korean patients with operable advanced gastric cancer or adenocarcinoma of the gastroesophageal junction The patient group who received DOS therapy as adjuvant therapy before surgery and the control group who received only surgery and adjuvant chemotherapy after surgery without adjuvant preoperative therapy. evaluate it comparatively.
Consequently, the 3-year progression-free survival (PFS) rate of the patient group (neoadjuvant chemotherapy plus surgery plus adjuvant chemotherapy; CSC) that received DOS therapy in combination with eloxatin, taxotere, and S-1 as adjuvant therapy of before surgery was 66.3%, There was a significant improvement (60.2%) compared to the group of patients who did not receive adjuvant therapy before surgery (Surgery plus adjuvant Chemotherapy; SC).[CSC 66.3% vs SC 60.2% / HR 0.70 (95% CI 0.52–0.95), P=0.023].
The complete resection rate (R0 resection rate) was 89% in the CSC patient group, which was significantly higher than that of the SC patient group (84%). (p<0.0001) The pathological complete response stage in the CSC patient group was 10.4%, confirming the effect of lowering the cancer stage compared to the SC patient group (P<0.0001).
