A randomized phase III study of neoadjuvant chemotherapy with docetaxel(D), oxaliplatin(O), and S-1(S) (DOS) followed by surgery and adjuvant S-1 vs. surgery and adjuvant S-1 for resectable advanced gastric cancer (PRODIGY).

Kang, Yoon‐Koo; Yook, Jeong Hwan; Ryu, Min‐Hee; Lee, Jong Seok; Park, Young-Kyu; Chung, Ik‐Joo; Jung, Minkyu; Kim, Young Woo; Kim, Mi‐Jung; Oh, Sang Cheul; Kim, Samyong; Kim, Jong Gwang; Song, Hooyoung; Ryu, Seung Wan; Roh, Sang Young; Kook, Myeong–Cherl; Shim, Kyoo Jung; Lee, Jee Hyun; Kim, Gyunji; Noh, Sung Hoon

doi:10.1200/jco.2015.33.15_suppl.tps4136

Cited by 14 publications

(11 citation statements)

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“…In addition, histological CR was confirmed in 19.5% of the patients, indicating DOS to be an excellent regimen for achieving local control. Based on these results, the phase III PRODIGY study (ClinicalTrials.gov: NCT01515748) was initiated, accrual was completed, and the results are being awaited [12]. In Japan, we have also started a trial with 3 preoperative cycles of DOS (docetaxel 40 mg/m 2 , oxaliplatin 100 mg/m 2 day 1, S-1 80 mg/m 2 day 1-14, q3w; dose intensity of S-1: 373 mg/m 2 /week) for LAGC (JCOG1704; jRCTs031180028), which might be more effective than the DCS in the present study through adjustment of the dose intensity of S-1.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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Background Preoperative chemotherapy 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. In the JCOG1002, we added docetaxel to CS (DCS) to further improve long-term outcomes. However, the primary endpoint, clinical response rate (RR), did not reach the expected level (Ito et al. in Gastric Cancer 20:322-31, 2017). Herein, we report our long-term survival results. Methods Patients with BN and/or PAN metastasis received 2 or 3 cycles of DCS therapy (docetaxel at 40 mg/m 2 and cisplatin at 60 mg/m 2 on day 1 and S-1 at 80 mg/m 2 per day for 2 weeks, followed by a 2-week rest) 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% had both PAN and BN metastasis, and the rest had either PAN (26.4%) or BN (56.6%) metastasis. Among all eligible patients, the 5-year overall survival was 54.9% (95% confidence interval 40.3-67.3%) at the last follow-up in May 2018. Among 44 eligible patients with R0 resection, the 5-year relapse-free survival was 47.7% (95% confidence interval 32.5-61.5%). Conclusions Adding docetaxel to CS in preoperative chemotherapy for extensive nodal metastasis improved neither shortterm outcomes nor long-term survival. Preoperative chemotherapy with CS followed by D2 + PAN dissection and postoperative S-1 remains the standard of care for patients with extensive nodal metastasis.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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“…Third, occult metastasis caused by tumor cell dissemination can be treated at an earlier point when the patient is usually in a better general health condition. In this regard, a recent phase III randomized study (PRODIGY) has indicated that neoadjuvant chemotherapy followed by surgery had favorable results as compared to up-front surgery in resectable advanced GC as evidenced by higher R0 resection rates (96.4% vs. 85.8%; p < 0.0001), lower pathological stage with pathological complete response (10.4% vs. 0%; p < 0.0001) and greater 3-year DFS rates (66.3% vs. 60.2%; HR = 0.70; 95% CI, 0.52–0.95; p = 0.023) [ 27 ]. Furthermore, another study also demonstrated that perioperative chemotherapy was associated with longer median OS than up-front surgery did [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of Pancreatic Resection on Survival in Locally Advanced Resectable Gastric Cancer

Chang

Tang

et al. 2021

Cancers

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Whether gastric adenocarcinoma (GC) patients with adjacent organ invasion (T4b) benefit from aggressive surgery involving pancreatic resection (PR) remains unclear. This study aimed to clarify the impact of PR on survival in patients with locally advanced resectable GC. Between 1995 and 2017, patients with locally advanced GC undergoing radical-intent gastrectomy with and without PR were enrolled and stratified into four groups: group 1 (G1), pT4b without pancreatic resection (PR); group 2 (G2), pT4b with PR; group 3 (G3), positive duodenal margins without Whipple’s operation; and group 4 (G4), cT4b with Whipple’s operation. Demographics, clinicopathological features, and outcomes were compared between G1 and G2 and G3 and G4. G2 patients were more likely to have perineural invasion than G1 patients (80.6% vs. 50%, p < 0.001). G4 patients had higher lymph node yield (40.8 vs. 31.3, p = 0.002), lower nodal status (p = 0.029), lower lymph node ratios (0.20 vs. 0.48, p < 0.0001) and higher complication rates (45.2% vs. 26.3%, p = 0.047) than G3 patients. The 5-year disease-free survival (DFS) and overall survival (OS) rates were significantly longer in G1 than in G2 (28.1% vs. 9.3%, p = 0.003; 32% vs. 13%, p = 0.004, respectively). The 5-year survival rates did not differ between G4 and G3 (DFS: 14% vs. 14.4%, p = 0.384; OS: 12.6% vs. 16.4%, p = 0.321, respectively). In conclusion, patients with T4b lesion who underwent PR had poorer survival than those who underwent resection of other adjacent organs. Further Whipple’s operation did not improve survival in pT3–pT4 GC with positive duodenal margins.

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“…Therefore, 3 cycles of neoadjuvant SOX chemotherapy and 5 cycles of adjuvant SOX followed by 3 cycles of S-1 monotherapy is recommended as the perioperative treatment for locally advanced gastric cancer. In addition, during the same period, the PRODIGY study [96] reported that for locally advanced gastric cancer staged as cT2/3N+M0 or cT4/NxM0, 3 cycles of neoadjuvant docetaxel plus oxaliplatin plus S-1 (DOS) chemotherapy plus 8 cycles of postoperative S-1 monotherapy, compared to surgery followed by 8 cycles of S-1 monotherapy, was associated with tumor downstaging and significant improvement in 3-year DFS. The 2022 MATCH study demonstrated that in preoperative neoadjuvant treatment, the major pathologic response (MPR) rates for the DOS group and SOX group were 25.45% and 11.8%, respectively, and the corresponding R0 resection rates were 78.9% and 61.8%, with 3-year progression-free survival (PFS) rates of 52.3% and 35%, respectively [97].…”

Section: Grade III Recommendationsmentioning

confidence: 98%

The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023

Wang,

Zhang,

Tang

et al. 2023

Cancer Communications

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The 2023 update of the Chinese Society of Clinical Oncology (CSCO) Clinical Guidelines for Gastric Cancer focuses on standardizing cancer diagnosis and treatment in China, reflecting the latest advancements in evidence‐based medicine, healthcare resource availability, and precision medicine. These updates address the differences in epidemiological characteristics, clinicopathological features, tumor biology, treatment patterns, and drug selections between Eastern and Western gastric cancer patients. Key revisions include a structured template for imaging diagnosis reports, updated standards for molecular marker testing in pathological diagnosis, and an elevated recommendation for neoadjuvant chemotherapy in stage III gastric cancer. For advanced metastatic gastric cancer, the guidelines introduce new recommendations for immunotherapy, anti‐angiogenic therapy and targeted drugs, along with updated management strategies for human epidermal growth factor receptor 2 (HER2)‐positive and deficient DNA mismatch repair (dMMR)/microsatellite instability‐high (MSI‐H) patients. Additionally, the guidelines offer detailed screening recommendations for hereditary gastric cancer and an appendix listing drug treatment regimens for various stages of gastric cancer. The 2023 CSCO Clinical Guidelines for Gastric Cancer updates are based on both Chinese and international clinical research and expert consensus to enhance their applicability and relevance in clinical practice, particularly in the heterogeneous healthcare landscape of China, while maintaining a commitment to scientific rigor, impartiality, and timely revisions.

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A randomized phase III study of neoadjuvant chemotherapy with docetaxel(D), oxaliplatin(O), and S-1(S) (DOS) followed by surgery and adjuvant S-1 vs. surgery and adjuvant S-1 for resectable advanced gastric cancer (PRODIGY).

Cited by 14 publications

References 0 publications

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

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

Impact of Pancreatic Resection on Survival in Locally Advanced Resectable Gastric Cancer

The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023

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