• Title/Summary/Keyword: multivariable process

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Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • v.17 no.2
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

Association of the initial level of enteral nutrition with clinical outcomes in severe and multiple trauma patients (초기 경장영양 공급 수준과 다발성 외상 중환자의 임상 경과와의 상관성 연구)

  • Yang, Suyoung;Jung, Seungyoun;Lee, Ji-hyun;Kwon, Junsik;Kim, Yuri
    • Journal of Nutrition and Health
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    • v.55 no.1
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    • pp.85-100
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    • 2022
  • Purpose: This study is aimed to examine the association between initial enteral nutrition (EN) and the clinical prognosis among patients with severe and multiple traumatic injuries, and to investigate whether this association is modified by the patients' catabolic status. Methods: This was a retrospective study of 302 adult patients with severe and multiple traumatic injuries admitted between January 2017 and September 2020 at Ajou University hospital in Suwon, Korea. The initial nutritional support by EN and parenteral nutrition were monitored up to day 7 after admission. Patients were classified into "No", "Low", and "High" EN groups according to the level of initial EN. Multivariable-adjusted logistic regression and linear regression models were used to estimate the association of the initial EN levels at hospital admission with the risk of mortality, morbidities, and levels of nutrition-associated biochemical markers. Results: High EN support was associated with reduced mortality (odds ratio, 0.07; 95% confidence interval [CI], 0.02, 0.32) and lower levels of C-reactive protein (β, -0.22; 95% CI, -8.66, 1.48), but longer stay in the intensive care unit (β, 0.19; 95% CI, 1.82, 11.32). In analyses stratified by catabolic status, there were fewer incidences of hospital-acquired infections with increasing EN levels in the moderate or higher nitrogen balance group than in the mild nitrogen balance group. Conclusion: Our observation of the inverse association between levels of initial EN administration with mortality risk and inflammatory markers may indicate the possible benefits of active EN administration to the recovery process of severe and multiple trauma patients. Further studies are warranted on whether the catabolic status modifies the association between the initial EN and prognosis.