Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer
Mené au Japon sur 132 patients atteints d'un cancer de l'estomac de stade localement avancé, cet essai de phase II évalue l'efficacité, du point de vue de la survie globale à 3 ans, et la toxicité de l'ajout du docétaxel à une chimiothérapie néoadjuvante combinant cisplatine et S-1
Backgrounds: Neoadjuvant chemotherapy (NAC) is a promising method of improving the survival of resectable gastric cancer. Cisplatin/S-1 (CS) and docetaxel/cisplatin/S-1 (DCS) are both effective against metastatic gastric cancer. This report clarified the impact of these regimens on early endpoints, including the pathological responses, chemotherapy-related toxicities, and surgical results. Methods: Patients with M0 and either T4 or T3 in case of junctional cancer or schirrhous type received 2 or 4 courses of cisplatin (60 mg/m2 at day 8)/S-1 (80 mg/m2 for 21 days with 1 week rest) or docetaxel (40 mg/m2 at day 1)/cisplatin (60 mg/m2 at day 1)/S-1 (80 mg/m2 for 14 days with 2 weeks rest) as neoadjuvant chemotherapy. Patients then underwent D2 gastrectomy and adjuvant S-1 chemotherapy for one year. The primary endpoint was the three-year overall survival. Results: Between October 2011 and September 2014, 132 patients were assigned to receive CS (n = 66; 33 in 2 courses and 33 in 4 courses) or DCS (n = 66; 33 in 2 courses and 33 in 4 courses). The respective major grade 3 or 4 hematological toxicities (CS/DCS) were leukocytopenia (14.1%/26.2%), neutropenia (29.7%/47.7%), anemia (14.1%/12.3%) and platelet reduction (3.1%/1.5%). The rate of pathological response, defined as a complete response or less than 10% residual cancer remaining, was 19.4% in the CS group and 15.4% in the DCS group, and 15.6% in the 2-course group and 19.0% in the 4-course group. The R0 resection rate was 72.7% in the CS group and 81.8% in the DCS group and 80.3% in the 2-course group and the 74.2% in the 4-course group. No treatment-related deaths were observed. Conclusions: Our results do not support three drug therapy with a taxane over two drug therapy, or any further treatment beyond two cycles as an attractive candidate for the test arm of NAC
Annals of Oncology 2017