Long-term outcome of preoperative docetaxel with cisplatin plus S-1 therapy for advanced gastric cancer with extensive nodal metastasis (JCOG1002).

Abstract

141 Background: Neoadjuvant chemotherapy (NAC) with cisplatin plus S-1 (CS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection is regarded as a standard treatment in Japan for advanced gastric cancer with bulky lymph node (BN) and/or PAN metastasis based on the results of JCOG0405. In JCOG1002, we added docetaxel to CS (DCS) to further improve the long-term outcome. However the primary endpoint, clinical response rate (RR), did not meet the expected level (Ito S, Gastric Cancer. 2017). Herein we report the long-term survival. Methods: Patients with BN and/or PAN metastasis received two or three cycles of DCS therapy (docetaxel at 40 mg/m2 and cisplatin at 60 mg/m2 on day 1, S-1 at 40 mg/m2 twice daily for 2 weeks, were administered every four weeks) followed by gastrectomy with D2 plus PAN dissection and postoperative S-1 for 1 year. Results: Between July 2011 and May 2013, 53 patients were enrolled. Clinically, 17.0% of patients had both PAN and BN metastasis, and remaining patients had either PAN (26.4%) or BN (56.6%) metastasis. The clinical response rate (RR) was 57.7 % as assessed by RECIST v1.0, and the R0 resection rate was 84.6%, which did not exceed those in JCOG0405 (64.7% and 82.3%, respectively). The pathological RR defined as residual tumor corresponding to less than one-third the size of the original tumor was 34.6% in 52 eligible patients, which was slightly higher than in JCOG0405 (28.6%). Among all eligible patients, 5-year overall survival was 54.9% (95% confidence interval 40.3–67.3%) at the date cut-off of May 2018. Among 44 eligible patients with R0 resection, 5-year progression-free survival was 47.7% (95% confidence interval 32.5–61.5%). These were similar to the results of JCOG0405 (52.8% and 50.0%). Twenty patients developed cancer recurrence. The most frequent site of recurrence was lymph nodes (50.0% of all recurrences). Conclusions: Adding docetaxel to CS in NAC for extensive lymph node metastasis did not improve not only short-term outcomes but also long-term survival. NAC with CS followed by D2 + PAN dissection and postoperative S-1 remains standard for patients with extensive nodal metastasis. Clinical trial information: UMIN000006069.