A randomized phase III trial comparing adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin in patients with node-positive gastric cancer after D2 resection: the ARTIST 2 trial☆

Park, S.H.; Lim, Do Hyoung; Sohn, Tae Sung; Lee, J.; Zang, Dae Young; Kim, S.T.; Kang, Jung Hun; Oh, Sung Yong; Hwang, In Gyu; Ji, Jun Ho; Shin, Dong Bok; Yu, Jeong Il; Kim, K.-M.; An, Ji Yeong; Choi, Min-Gew; Lee, J.H.; Kim, S.; Hong, Jung Yong; Park, J.O.; Park, Y.S.; Lim, Ho Yeong; Bae, Jae Moon; Kang, Won Ki

doi:10.1016/j.annonc.2020.11.017

Cited by 164 publications

(123 citation statements)

References 15 publications

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“…Macroscopic type was assessed by Borrmann classification [ 35 ]. Lauren’s classification was used to define the histological type dividing intestinal from diffuse/mixed tumors [ 36 , 37 ]. The histological grade was established by dividing well-moderately differentiated tumors from poorly differentiated and signet ring cells [ 38 ].…”

Section: Methodsmentioning

confidence: 99%

Naples Prognostic Score Predicts Tumor Regression Grade in Resectable Gastric Cancer Treated with Preoperative Chemotherapy

Lieto¹,

Auricchio²,

Tirino

et al. 2021

Cancers

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Despite recent progresses, locally advanced gastric cancer remains a daunting challenge to embrace. Perioperative chemotherapy and D2-gastrectomy depict multimodal treatment of gastric cancer in Europe, shows better results than curative surgery alone in terms of downstaging, micrometastases elimination, and improved long-term survival. Unfortunately, preoperative chemotherapy is useless in about 50% of cases of non-responder patients, in which no effect is registered. Tumor regression grade (TRG) is directly related to chemotherapy effectiveness, but its understanding is achieved only after surgical operation; accordingly, preoperative chemotherapy is given indiscriminately. Conversely, Naples Prognostic Score (NPS), related to patient immune-nutritional status and easily obtained before taking any therapeutic decision, appeared an independent prognostic variable of TRG. NPS was calculated in 59 consecutive surgically treated gastric cancer patients after neoadjuvant FLOT4-based chemotherapy. 42.2% of positive responses were observed: all normal NPS and half mild/moderate NPS showed significant responses to chemotherapy with TRG 1–3; while only 20% of the worst NPS showed some related benefits. Evaluation of NPS in gastric cancer patients undergoing multimodal treatment may be useful both in selecting patients who will benefit from preoperative chemotherapy and for changing immune-nutritional conditions in order to improve patient’s reaction against the tumor.

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Section: Methodsmentioning

confidence: 99%

Naples Prognostic Score Predicts Tumor Regression Grade in Resectable Gastric Cancer Treated with Preoperative Chemotherapy

Lieto¹,

Auricchio²,

Tirino

et al. 2021

Cancers

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“…10 Three studies have shown chemotherapy intensification to be beneficial. [11][12][13] FLOT4 demonstrated that perioperative docetaxel, oxaliplatin, and fluorouracil (FLOT) was superior to epirubicin plus cisplatin plus fluorouracil, 11 whereas JACCRO GC-07 13 and ARTIST 2 12 showed that intensified postoperative adjuvant chemotherapy regimens were superior to standard regimens in patients with advanced disease.…”

Section: Introductionmentioning

confidence: 99%

PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer

Kang

Yook

Park

et al. 2021

JCO

168

137

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PURPOSE Adjuvant chemotherapy after D2 gastrectomy is standard for resectable locally advanced gastric cancer (LAGC) in Asia. Based on positive findings for perioperative chemotherapy in European phase III studies, the phase III PRODIGY study (ClinicalTrials.gov identifier: NCT01515748 ) investigated whether neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 could improve outcomes versus standard treatment in Korean patients with resectable LAGC. PATIENTS AND METHODS Patients 20-75 years of age, with Eastern Cooperative Oncology Group performance status 0-1, and with histologically confirmed primary gastric or gastroesophageal junction adenocarcinoma (clinical TNM staging: T2-3N+ or T4Nany) were randomly assigned to D2 surgery followed by adjuvant S-1 (40-60 mg orally twice a day, days 1-28 q6w for eight cycles; SC group) or neoadjuvant DOS (docetaxel 50 mg/m2, oxaliplatin 100 mg/m2 intravenously day 1, S-1 40 mg/m2 orally twice a day, days 1-14 q3w for three cycles) before D2 surgery, followed by adjuvant S-1 (CSC group). The primary objective was progression-free survival (PFS) with CSC versus SC. Two sensitivity analyses were performed: intent-to-treat and landmark PFS analysis. RESULTS Between January 18, 2012, and January 2, 2017, 266 patients were randomly assigned to CSC and 264 to SC at 18 Korean study sites; 238 and 246 patients, respectively, were treated (full analysis set). Follow-up was ongoing in 176 patients at data cutoff (January 21, 2019; median follow-up 38.6 months [interquartile range, 23.5-62.1]). CSC improved PFS versus SC (adjusted hazard ratio, 0.70; 95% CI, 0.52 to 0.95; stratified log-rank P = .023). Sensitivity analyses confirmed these findings. Treatments were well tolerated. Two grade 5 adverse events (febrile neutropenia and dyspnea) occurred during neoadjuvant treatment. CONCLUSION PRODIGY showed that neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, is effective and tolerable in Korean patients with LAGC.

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“…The results showed that compared with S-1 single-drug, the SOX regimen alone and in combination with radiotherapy can significantly prolong DFS. However, SOX regimen combined with radiotherapy did not improve survival when compared to SOX regimen alone (8)(9)(10). The results of these clinical studies indicate that surgery is the only possible cure for GC, and postoperative adjuvant chemotherapy is the main way to achieve long-term survival for patients with GC.…”

Section: Introductionmentioning

confidence: 92%

Comparison of the Efficacy of S-1 Plus Oxaliplatin or Capecitabine Plus Oxaliplatin for Six and Eight Chemotherapy Cycles as Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer After D2 Resection

Zhang

Meng

et al. 2021

Front. Oncol.

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ObjectiveTo compare the efficacy of adjuvant chemotherapy with six or eight cycles of S-1 plus oxaliplatin (SOX) or Capecitabine plus oxaliplatin (XELOX) after D2 resection of GC.Design and participantsWe collected 470 cases of patients with TNM stage II and III GC who underwent D2 gastrectomy in the Harbin Medical University Cancer Hospital from January 2007 to December 2017 and received six or eight cycles of SOX or XELOX regimen. This study was designed to evaluate the prognosis of patients receiving six or eight cycles of SOX or XELOX chemotherapy and identify the appropriate number of chemotherapy cycles.ResultsAmong the 470 study participants [340 (72.3%) males; median age, 50 years (range, 24-76 years)], 355 and 115 received XELOX or SOX regimen chemotherapy, respectively. The number of 152 patients included in this study who received 6 and 8 cycles of chemotherapy in stage II and stage III without considering chemotherapy regimens were 125 and 27. The median DFS was, respectively, 14.9 months and 26.8 months (P = 0.08), the median OS was, respectively, 30.2 months and 30.8 months (P = 0.5), the difference was not statistically significant. Comprehensive survival analysis of XELOX and SOX group showed no significant difference for DFS (P = 0.29) and OS (P = 0.61). The total number of stage III GC patients who received six and eight cycles of chemotherapy was 92 and 19, respectively. The median DFS of patients who received six and eight cycles of chemotherapy was 14.6 and 23.2 months (P = 0.3), respectively. The median OS of patients who received six and eight cycles of chemotherapy was 26 and 30.6 months (P = 0.9), respectively. Comprehensive analysis of DFS (P=0.73) and OS (P=0.6) shows no difference between the XELOX group SOX groups. Subgroup analysis revealed significant differences in the gender (P = 0.05) and histological classification (P < 0.05) distribution.ConclusionRegardless of the XELOX regimen or the SOX regimen, similar survival benefits are observed in patients receiving six or eight chemotherapy cycles irrespective of the regimen used. The XELOX and SOX regimens are well tolerated in patients undergoing D2 resection of GC.

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A randomized phase III trial comparing adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin in patients with node-positive gastric cancer after D2 resection: the ARTIST 2 trial☆

Cited by 164 publications

References 15 publications

Naples Prognostic Score Predicts Tumor Regression Grade in Resectable Gastric Cancer Treated with Preoperative Chemotherapy

Naples Prognostic Score Predicts Tumor Regression Grade in Resectable Gastric Cancer Treated with Preoperative Chemotherapy

PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer

Comparison of the Efficacy of S-1 Plus Oxaliplatin or Capecitabine Plus Oxaliplatin for Six and Eight Chemotherapy Cycles as Adjuvant Chemotherapy in Patients With Stage II-III Gastric Cancer After D2 Resection

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