Validation of the JCOG prognostic index in advanced gastric cancer using individual patient data from the SPIRITS and G-SOX trials

180 Background: In advanced gastric cancer (AGC), there are many reports about prognostic factors for overall survival (OS), and we have proposed a prognostic index using four prognostic factors (PS, number of metastatic sites, prior gastrectomy and ALP; Oncologist 2014) based on a phase III trial JCOG 9912 for the first-line treatment (Lancet Oncol. 2009). However, there is no report about prognostic factors for progression free survival (PFS). In this ancillary study, we explored whether prognostic factors are similar or not between OS and PFS. Methods: The subjects of this study were selected from the JCOG9912 which intended to confirm the superiority of irinotecan plus cisplatin (IP) and the non-inferiority of S-1 to5-FU for patients with AGC. Of all enrolled patients in JCOG9912, those who had target lesions and whose complete data were available were analyzed with multivariate analysis using Cox proportional hazard model. Results: 492 out of the 703 pts of JCOG9912 were analyzed, who received either 5-FU (n=163), IP (n=164) or S-1(n=165). The median PFS was 3.7 months for all the subjects, and 2.2 months for 5-FU, 4.9 months for IP and 3.8 months for S-1. Multivariate analysis in all 492 analyzed patients demonstrated seven independent prognostic factors for PFS (Table). Prognostic factors in each treatment were; sex (HR 1.66, 95%CI 1.11-2.49), PS (1.51, 1.04-2.18), Ca (0.39, 0.17-0.86), GPT (2.46, 1.30-4.66) and LDH (1.67, 1.16-2.48) in 5-FU, sex (1.77, 1.10-2.86) in IP, and Na (2.00, 1.01-3.99) and creatinine clearance (0.37, 0.15-0.93) in S-1. Conclusions: There were no common prognostic factors among the three treatment regimens. Prognostic factors for PFS may be different by treatment regimen, although further investigations with larger sample size are needed. [Table: see text]

Download Full-text

Three-Tier Prognostic Index in Young Adults With Advanced Gastric Cancer

Frontiers in Oncology ◽

10.3389/fonc.2021.667655 ◽

2021 ◽

Vol 11 ◽

Author(s):

Guang-Liang Chen ◽

Yan Huang ◽

Wen Zhang ◽

Xu Pan ◽

Wan-Jing Feng ◽

...

Keyword(s):

Gastric Cancer ◽

Young Adults ◽

Prognostic Factors ◽

Advanced Gastric Cancer ◽

Prognostic Index ◽

Risk Groups ◽

Radical Gastrectomy ◽

Cox Regression Analysis ◽

Poor Risk ◽

Number Of Patients

PurposeTo characterize clinical features and identify baseline prognostic factors for survival in young adults with advanced gastric cancer (YAAGC).Materials and MethodsA total of 220 young inpatients (age less than or equal to 40 years) with an initial diagnosis of advanced gastric cancer were retrospectively enrolled in this study.ResultsOf a consecutive cohort of 220 patients with YAAGC, the median overall survival (OS) time was 16.3 months. One-year survival rate was 43.6% (95% CI: 36.5 to 50.7). In this cohort, a female (71.4%, n = 157) predominance and a number of patients with poorly differentiated tumors (95.9%, n = 211) were observed. In the univariate analysis, OS was significantly associated with neutrophil–lymphocyte ratio (NLR) (≥3.12), hypoproteinemia (<40 g/L), presence of peritoneal or bone metastases, and previous gastrectomy of primary tumor or radical gastrectomy. In multivariate Cox regression analysis, hypoproteinemia [hazard ratio (HR) 1.522, 95% CI 1.085 to 2.137, p = 0.015] and high NLR level (HR 1.446, 95% CI 1.022 to 2.047, p = 0.021) were two independent poor prognostic factors, while previous radical gastrectomy was associated with a favorable OS (HR 0.345, 95% CI 0.205 to 0.583, p = 0.000). A three-tier prognostic index was constructed dividing patients into good-, intermediate-, or poor-risk groups. Median OS for good-, intermediate-, and poor-risk groups was 36.43, 17.87, and 11.27 months, respectively.ConclusionsThree prognostic factors were identified, and a three-tier prognostic index was devised. The reported prognostic index may aid clinical decision-making, patient risk stratification, and planning of future clinical studies on YAAGC.

Download Full-text

An individual patient data meta-analysis of the immunochemotherapy using lentinan in patients with advanced gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.15136 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 15136-15136

Author(s):

K. Oba ◽

S. Morita ◽

T. Matsui ◽

M. Kobayashi ◽

K. Kondo ◽

...

Keyword(s):

Gastric Cancer ◽

Treatment Effects ◽

Tumor Response ◽

Individual Patient Data ◽

Meta Analysis ◽

Patient Data ◽

Control Group ◽

Significant Heterogeneity ◽

Inclusion Criteria ◽

Objective Tumor Response

15136 Background: An anti-tumor effect of lentinan (LNT), a non-specific immunomodulator, via an immunological response has been reported and combination immunochemotherapy has been examined. However, the survival benefit of LNT for patients with advanced or recurrent gastric cancer (AGC) was unclear in the world. We performed an individual patient data (IPD) meta-analysis in order to evaluate the survival effect of immunochemotherapy using LNT. Methods: A computerized and a manual search procedure were performed to identify all randomized clinical trial (RCT) for chemotherapy in patients (pts) with AGC. Inclusion criteria were RCTs for AGC and to compare any chemotherapy (control group) with the same plus LNT (LNT group). The primary endpoint was overall survival, secondary endpoints includes objective tumor response and toxicity. All analyses were based on IPD. Treatment effects were displayed as hazard ratios estimated by Cox proportional hazard model. A ratio less than unity indicated benefit from LNT. Results: We analyzed IPD of 5 randomized clinical trials for AGC, which met the predetermined inclusion criteria. These 5 trials had a combined total of 650 pts (LNT: 339 pts median age=63, control: 311 pts median age=63). The number of deaths was 83.8% (286/334) in LNT group and 84.8% (262/309) in control group. The overall hazard ratio was 0.83 (95%CI, 0.70–0.98; p=0.03) with no significant heterogeneity between the treatment effects in different trials (χ2 for heterogeneity=3.69; p=0.45). Three hundred and fifty five pts were evaluable for objective tumor response and the response rate was 18.4% (21/185) in LNT group (CR, 0 pts; PR, 21 pts) and 6.3% (5/173) in control (CR, 0 pts; PR, 5 pts). There were no significant differences in the toxicity. Conclusions: This IPD meta-analysis demonstrated that LNT significantly improves both OS and tumor response in pts with AGC. No significant financial relationships to disclose.

Download Full-text

Progression-free survival as surrogate endpoint of overall survival in patients with advanced/recurrent gastric cancer: Individual patient data analysis on 4,102 patients from 20 randomized trials.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.4095 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. 4095-4095 ◽

Cited By ~ 2

Author(s):

K. Shitara ◽

T. Burzykowski ◽

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Data Analysis ◽

Randomized Trials ◽

Individual Patient Data ◽

Progression Free Survival ◽

Surrogate Endpoint ◽

Patient Data ◽

Free Survival ◽

Recurrent Gastric Cancer

Download Full-text

Prognostic factor of nivolumab for advanced gastric cancer patients with poor performance status patients.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.391 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 391-391

Author(s):

Toshihiko Matsumoto ◽

Ukyo Okazaki ◽

Yusuke Kurioka ◽

Shogo Kimura ◽

Takao Tsuzuki ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Prognostic Factor ◽

Advanced Gastric Cancer ◽

Performance Status ◽

Prognostic Index ◽

Poor Performance ◽

Poor Performance Status ◽

Good Group ◽

Poor Group

391 Background: Nivolumab has changed the treatment of advanced gastric cancer (AGC). Nivolumab shows better outcome compared to best supportive care in AGC patients who received at least two prior regimen. Although there is not reliable date of poor performance status(PS) AGC patients who received nivolumab. We investigated efficacy and safety of nivolumab for AGC patients with poor PS. Methods: We retrospectively collected clinicopathologic data from patients with AGC who received nivolumab monotherapy in Himeji Red Cross Hospital from October 2017 to June 2019. Results: 49 AGC patients who received nivolumab were analyzed. 27 patients were PS 0 or 1(Good Group), and 22 patients were PS 2 or 3(Poor Group). Median progression free survival and overall survival was 61 days and 180 days in Good Group and 36 days and 85 days in Poor Group. Overall survival (OS) was significantly shorter in Poor group(180 days vs 85 days, p = 0.0255). Disease control rate was 23% in Good group and 9% in Poor group. 33% patients were experienced immune related adverse event (iRAE) in Good Group, and 18% in Poor Group. We investigated prognostic factor of OS in Poor Group such as Royal Marsden Hospital Score(RMH score), modified Glasgow prognostic score(mGPS), and Japan Clinical Oncology Group (JCOG) prognostic index. RMH score and JCOG prognostic index good or moderate group was significantly longer overall survival than poor group (93 days vs 35 days (p = 0.0214)). JCOG prognostic index was most correlated with OS among these tools. Conclusions: This study suggested that nivolumab has a modest effect and is feasible as third line or later line for AGC patients. JCOG prognostic index was suggested to be effective in predicting prognosis in AGC patients who received nivolumab.

Download Full-text