First Report of Oncological Outcome and Prognostic Analysis in a First-Line Setting of Short Hydration Gemcitabine and Cisplatin Chemotherapy for Patients with Metastatic Urothelial Carcinoma

Oncology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Taku Naiki ◽  
Takashi Nagai ◽  
Yosuke Sugiyama ◽  
Toshiki Etani ◽  
Satoshi Nozaki ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Risk Index ◽  
Objective Response ◽  
Oncological Outcome ◽  
Nutritional Risk ◽  
First Line ◽  
Prognostic Analysis ◽  
Nutritional Risk Index ◽  
Metastatic Urothelial Carcinoma ◽  
Gemcitabine And Cisplatin

<b><i>Objectives:</i></b> The aim of the study was to examine the effectiveness of a modified-short hydration gemcitabine and cisplatin (m-shGC) regimen for patients with metastatic urothelial carcinoma (mUC) and to assess the efficacy of a geriatric nutritional risk index (GNRI) with regard to prognosis. <b><i>Patients and Methods:</i></b> From January 2016 to July 2020, 68 patients with mUC underwent first-line m-shGC therapy with 70 mg/m<sup>2</sup> cisplatin and 1,000 mg/m<sup>2</sup> gemcitabine (days 1, 8, and 15), with 2,050 mL fluid replaced on the first day of each 28-day cycle. Prior to the start of treatment, the serum neutrophil-to-lymphocyte ratio (NLR), and levels of albumin and C-reactive protein (CRP) in serum, as well as body heights and weights were measured. Patients were grouped according to GNRI &#x3c;92 (low) or ≥92 (high). The analysis of data was done retrospectively. <b><i>Results:</i></b> Median follow-up was found to be 12.9 (range 1.7–50.2) months and the objective response rate (ORR) was 54.4% after m-shGC treatment. The ORR was significantly different when high and low-GNRI groups were compared (ORR: 28.0 vs. 69.8% in low- vs. high-GNRI groups). Median overall survival (OS) was calculated as 8.6 (95% confidence interval [CI]: 5.4–21.3) and 34.5 (95% CI: 20.5–NA) months for low- and high-GNRI groups, respectively (<i>p</i> &#x3c; 0.0001). Unlike for NLR and CRP, univariate and multivariate analyses revealed that low GNRI and visceral metastases were significant prognostic factors for short OS. <b><i>Conclusions:</i></b> First-line m-shGC showed a survival benefit for mUC, with GNRI a useful prognostic biomarker.

Low Geriatric Nutritional Risk Index as a Poor Prognostic Marker for Second-Line Pembrolizumab Treatment in Patients with Metastatic Urothelial Carcinoma: A Retrospective Multicenter Analysis

Oncology ◽  
2020 ◽  
Vol 98 (12) ◽  
pp. 876-883
Author(s):  
Toshiki Etani ◽  
Taku Naiki ◽  
Yosuke Sugiyama ◽  
Takashi Nagai ◽  
Keitaro Iida ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Urothelial Carcinoma ◽  
Group Performance ◽  
Risk Index ◽  
Nutritional Risk ◽  
Second Line ◽  
Geriatric Nutritional Risk Index ◽  
Platinum Based Chemotherapy ◽  
Nutritional Risk Index ◽  
Metastatic Urothelial Carcinoma

<b><i>Background:</i></b> We evaluated the prognostic efficacy of the Geriatric Nutritional Risk Index (GNRI) in second-line pembrolizumab (PEM) therapy for patients with metastatic urothelial carcinoma (mUC). <b><i>Patients and Methods:</i></b> From January 2018 to October 2019, 52 mUC patients, treated previously with platinum-based chemotherapy, underwent second-line PEM therapy. Peripheral blood parameters were measured at the start of treatment: serum neutrophil-to-lymphocyte ratio (NLR), serum albumin, serum C-reactive protein (CRP), and body height and weight. PEM was intravenously administered (200 mg every 3 weeks). The patients were organized into two groups based on their GNRI (&#x3c;92 [low GNRI] and ≥92 [high GNRI]), and the data were retrospectively analyzed. Adverse events (AEs) were evaluated and imaging studies assessed for all patients. Analyses of survival and recurrence were performed using Kaplan-Meier curves. Potential prognostic factors affecting cancer-specific survival (CSS) were assessed by univariate and multivariate Cox regression analyses. <b><i>Results:</i></b> patients’ baseline characteristics, except for their BMI and objective response rate, did not significantly differ between the two groups. The median total number of cycles of PEM therapy was significantly higher for the high-GNRI group (<i>n</i> [range]: 6 [2–20] vs. 3 [1–6]). The median CSS with second-line PEM therapy was 3.6 months (95% confidence interval [CI]: 2.5–6.1) and 11.8 months (95% CI: 6.2–NA) in the low-GNRI and the high-GNRI group (<i>p</i> &#x3c; 0.01), respectively. Significant differences in CSS between the low- and high-CRP or -NRL groups were not found. Multivariate Cox proportional-hazards regression analysis revealed that a poor Eastern Cooperative Oncology Group performance status, visceral metastasis, and a low GNRI were significant prognostic factors for short CSS (95% CI: 1.62–6.10, HR: 3.14; 95% CI: 1.13–8.11, HR: 3.03; 95% CI: 1.32–8.02, HR: 3.25, respectively). Of the AEs, fatigue showed a significantly higher incidence in the low-GNRI group. <b><i>Conclusions:</i></b> For mUC patients receiving second-line PEM therapy, the GNRI is a useful predictive biomarker for survival outcome.

scholarly journals Geriatric Nutritional Risk Index as a Prognostic Marker for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Docetaxel

2021 ◽  
Vol 11 ◽  
Author(s):  
Li-Wen Chang ◽  
Sheng-Chun Hung ◽  
Jian-Ri Li ◽  
Kun-Yuan Chiu ◽  
Cheng-Kuang Yang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Nutritional Status ◽  
Risk Index ◽  
Nutritional Risk ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Status Group ◽  
Castration Resistant ◽  
Nutritional Risk Index ◽  
Poor Nutritional Status

Purpose: To investigate the prognostic efficacy of the Geriatric Nutritional Risk Index (GNRI) in patients with metastatic Castration–resistant Prostate Cancer (mCRPC) receiving docetaxel as the first line of treatment.Methods: We retrospectively reviewed patients with mCRPC and receiving first line docetaxel in Taichung Veterans General Hospital from 2006 to 2012. The GNRI was calculated using serum albumin and body mass index, with a poor nutritional status defined as GNRI &lt;92.0. Multivariate Cox-regression analysis was used to evaluate the risk of survival.Results: One-hundred seventy patients with mCRPC were included. One-hundred twenty-five patients were of normal nutritional status (GNRI ≥92) and 45 patients were of poor nutritional status (GNRI &lt;92). The cumulative docetaxel dosage was 600 (360–1,185) mg in the normal nutritional status group and 360 (127.5–660) mg in the poor nutritional status group (p &lt; 0.001). The median overall survival from mCRPC was 30.39 months in the good nutritional status group and 11.07 months in the poor nutritional status group (p of log rank &lt;0.001). In a multivariate model, poor nutritional status was an independent risk factor in overall survival (Hazard Ratio [HR] = 5.37, 95% Confidence Interval [CI] 3.27–8.83), together with a high metastatic volume (HR = 4.03, 95% CI 2.16–7.53) and docetaxel cumulative dosage (HR = 0.999, 95% CI 0.999–0.9998).Conclusion: Poor nutritional status with a GNRI &lt;92 is associated with shorter progression free survival and overall survival in mCRPC patients treated with docetaxel. Metastatic volume and cumulative docetaxel dosage are also independent prognostic factors in overall survival.

Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance)

2021 ◽  
pp. JCO.21.00286
Author(s):  
Jonathan E. Rosenberg ◽  
Karla A. Ballman ◽  
Susan Halabi ◽  
Pamela J. Atherton ◽  
Amir Mortazavi ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Controlled Trial ◽  
Objective Response ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Free Survival ◽  
Metastatic Urothelial Carcinoma ◽  
Gemcitabine And Cisplatin

PURPOSE The combination of gemcitabine and cisplatin (GC) is a standard therapy for metastatic urothelial carcinoma. Based on data that angiogenesis plays a role in urothelial carcinoma growth and progression, a randomized placebo-controlled trial was performed with the primary objective of testing whether patients treated with GC and bevacizumab (GCB) have superior overall survival (OS) than patients treated with GC and placebo (GCP). PATIENTS AND METHODS Between July 2009 and December 2014, 506 patients with metastatic urothelial carcinoma without prior chemotherapy for metastatic disease and no neoadjuvant or adjuvant chemotherapy within 12 months were randomly assigned to receive either GCB or GCP. The primary end point was OS, with secondary end points of progression-free survival, objective response, and toxicity. RESULTS With a median follow-up of 76.3 months among alive patients, the median OS was 14.5 months for patients treated with GCB and 14.3 months for patients treated with GCP (hazard ratio for death = 0.87; 95% CI, 0.72 to 1.05; two-sided stratified log-rank P = .14). The median progression-free survival was 8.0 months for GCB and 6.7 months for GCP (hazard ratio = 0.77; 95% CI, 0.63 to 0.95; P = .016). The proportion of patients with grade 3 or greater adverse events did not differ significantly between both arms, although increased bevacizumab-related toxicities such as hypertension and proteinuria occurred in the bevacizumab-treated arm. CONCLUSION The addition of bevacizumab to GC did not result in improved OS. The observed median OS of about 14 months is consistent with prior phase III trials of cisplatin-based chemotherapy.

scholarly journals Association of the Geriatric Nutritional Risk Index with the survival of patients with non-small-cell lung cancer after platinum-based chemotherapy

2021 ◽  
Author(s):  
Masato Karayama ◽  
Yusuke Inoue ◽  
Hideki Yasui ◽  
Hironao Hozumi ◽  
Yuzo Suzuki ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Risk Index ◽  
Small Cell ◽  
Nutritional Risk ◽  
Small Cell Lung ◽  
Geriatric Nutritional Risk Index ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Nutritional Risk Index ◽  
Platinum Chemotherapy

Abstract Background The nutritional status can potentially affect the efficacy of cancer therapy. We evaluated the relationships between the nutritional status and the efficacy of chemotherapy in patients with non-small-cell lung cancer (NSCLC). Methods The Geriatric Nutritional Risk Index (GNRI), calculated from body weight and serum albumin, was retrospectively evaluated in 148 patients with NSCLC who received first-line platinum-based chemotherapy and scored as low or high. Results Patients with a high GNRI had a significantly higher overall response rate (ORR; 61.8% [95% confidence interval {CI} = 52.5–70.3%] vs. 34.2% [95% CI = 21.2–50.1%, p < 0.004), longer median progression-free survival (PFS; 6.3 months [95% CI = 5.6–7.2 months] vs. 3.8 months [95% CI = 2.5–4.7 months], p < 0.001), and longer median overall survival (OS; 22.8 months [95% CI = 16.7–27.2 months] vs. 8.5 months [95% CI = 5.4–16.0 months], p < 0.001) than those with low GNRI. High GNRI was independently predictive of longer PFS and OS, but not ORR, in multivariate Cox proportional hazard analyses. In 71 patients who received second-line non-platinum chemotherapy, patients with high GNRI exhibited significantly longer PFS and OS than those with low GNRI (both p < 0.001). Conclusions GNRI was predictive of prolonged survival in patients with NSCLC who received first-line platinum-based chemotherapy and second-line non-platinum chemotherapy. Assessment of the nutritional status may be useful for predicting the efficacy of chemotherapy.

Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4528-4528
Author(s):  
Terence W. Friedlander ◽  
Matthew I. Milowsky ◽  
Mehmet Asim Bilen ◽  
Sandy Srinivas ◽  
Rana R. McKay ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Objective Response ◽  
Locally Advanced ◽  
Unmet Need ◽  
First Line ◽  
Antibody Drug Conjugate ◽  
Durable Response ◽  
Long Term Outcome ◽  
Metastatic Urothelial Carcinoma

4528 Background: Significant unmet need remains for people with cisplatin-ineligible (cis-ineligible) locally advanced or metastatic urothelial carcinoma (la/mUC). In the first-line (1L) setting, carboplatin-based regimens have demonstrated poor tolerability, modest objective response rate (ORR) and limited durability. PD-1/PD-L1 inhibitors demonstrate durable responses; however, only a minority of pts achieve a response (ORR 24-29%). Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) delivering the microtubule-disrupting agent monomethyl auristatin E (MMAE) to targeted tumor cells expressing Nectin-4. EV has shown an overall survival benefit versus chemotherapy in previously treated la/mUC. Preclinical studies show that ADCs utilizing MMAE can induce immunogenic cell death and may enhance antitumor immunity. Clinical data suggests the combination of EV + pembrolizumab (P) may have the potential to induce greater antitumor activity compared to either agent alone. Preliminary data on EV + P was previously presented, and the FDA granted breakthrough therapy designation to EV + P for the treatment of pts with 1L cis-ineligible la/mUC in Feb 2020. Here we report updated data with 24.9 months median follow-up. Methods: This multi-cohort EV-103 study (NCT03288545) evaluates the safety/activity of EV + P (Dose Escalation/Cohort A). This report highlights 1L cis-ineligible pts treated with 3-week cycles of EV 1.25 mg/kg (Days 1, 8) and P (Day 1). Endpoints include safety/tolerability, investigator response per RECIST v1.1, DOR, PFS, and OS. Results: As of 13 Oct 2020, the median follow-up for the 45 1L la/mUC pts (median age 69 yrs [51-90]) was 24.9 months. The median number cycles of EV + P was 9 (range 1-34). The most common treatment-related adverse events were peripheral sensory neuropathy (56%, 4% ≥G3), fatigue (51%, 11% ≥G3), and alopecia (49%). There was one death reported as possibly related to study treatment (multiple organ dysfunction syndrome) per investigator assessment. Confirmed ORR is 73.3% (95% CI: 58.1, 85.4) including 17.8% CR and an ORR of 57.1% (8/14) in pts with liver metastasis. The median DOR was 25.6 months (95% CI: 8.3, -). Fifty-three percent of the responders had DOR at 24 months. Additionally, the DCR is 93.3%, the median PFS is 12.3 months (95% CI: 8.0, -), and the median OS is not reached. The OS rate at 24 months is 56.3% (95% CI: 39.8, 69.9). Conclusions: EV + P, a platinum-free option, continues to demonstrate promising activity with a durable response profile in 1L cis-ineligible pts with la/mUC. The safety profile is manageable and stable over time with no new safety signals. Cohort K of EV-103 in cis-ineligible pts with la/mUC is actively randomizing pts to EV monotherapy or EV + P to evaluate the contribution of each agent. Clinical trial information: NCT03288545.

scholarly journals Association of the Geriatric Nutritional Risk Index with the survival of patients with non-small-cell lung cancer after platinum-based chemotherapy

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Masato Karayama ◽  
Yusuke Inoue ◽  
Hideki Yasui ◽  
Hironao Hozumi ◽  
Yuzo Suzuki ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Risk Index ◽  
Small Cell ◽  
Nutritional Risk ◽  
Small Cell Lung ◽  
Geriatric Nutritional Risk Index ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Nutritional Risk Index ◽  
Platinum Chemotherapy

Abstract Background The nutritional status can potentially affect the efficacy of cancer therapy. The Geriatric Nutritional Risk Index (GNRI), a simple index for evaluating nutritional status calculated from body weight and serum albumin levels, has been reported to be associated with the prognosis of various diseases. However, the relationships between GNRI and the efficacy of platinum-based chemotherapy in patients with non-small-cell lung cancer (NSCLC) are unknown. Methods The pretreatment levels of GNRI were retrospectively evaluated in 148 chemo-naïve patients with advanced NSCLC who received first-line platinum-based chemotherapy and scored as low or high. Results Patients with a high GNRI had a significantly higher overall response rate (ORR; 44.5% [95% confidence interval {CI} = 35.6%–53.9%] vs. 15.8% [95% CI = 7.4%–30.4%, p = 0.002), longer median progression-free survival (PFS; 6.3 months [95% CI = 5.6–7.2 months] vs. 3.8 months [95% CI = 2.5–4.7 months], p < 0.001), and longer median overall survival (OS; 22.8 months [95% CI = 16.7–27.2 months] vs. 8.5 months [95% CI = 5.4–16.0 months], p < 0.001) than those with low GNRI. High GNRI was independently predictive of better ORR in multivariate logistic regression analysis and longer PFS and OS in multivariate Cox proportional hazard analyses. In 71 patients who received second-line non-platinum chemotherapy, patients with high GNRI exhibited significantly longer PFS and OS than those with low GNRI (both p < 0.001). Conclusions GNRI was predictive of prolonged survival in patients with NSCLC who received first-line platinum-based chemotherapy and second-line non-platinum chemotherapy. Assessment of the nutritional status may be useful for predicting the efficacy of chemotherapy.

scholarly journals Association of the Geriatric Nutritional Risk Index with the survival of patients with non-small-cell lung cancer after platinum-based chemotherapy

2021 ◽  
Author(s):  
Masato Karayama ◽  
Yusuke Inoue ◽  
Hideki Yasui ◽  
Hironao Hozumi ◽  
Yuzo Suzuki ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Risk Index ◽  
Small Cell ◽  
Nutritional Risk ◽  
Small Cell Lung ◽  
Geriatric Nutritional Risk Index ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Nutritional Risk Index ◽  
Platinum Chemotherapy

Abstract Background The nutritional status can potentially affect the efficacy of cancer therapy. We evaluated the relationships between the nutritional status and the efficacy of chemotherapy in patients with non-small-cell lung cancer (NSCLC). Methods The Geriatric Nutritional Risk Index (GNRI), calculated from body weight and serum albumin, was retrospectively evaluated in 148 patients with NSCLC who received first-line platinum-based chemotherapy and scored as low or high. Results Patients with a high GNRI had a significantly higher overall response rate (ORR; 61.8% [95% confidence interval {CI} = 52.5–70.3%] vs. 34.2% [95% CI = 21.2–50.1%, p < 0.004), longer median progression-free survival (PFS; 6.3 months [95% CI = 5.6–7.2 months] vs. 3.8 months [95% CI = 2.5–4.7 months], p < 0.001), and longer median overall survival (OS; 22.8 months [95% CI = 16.7–27.2 months] vs. 8.5 months [95% CI = 5.4–16.0 months], p < 0.001) than those with low GNRI. High GNRI was independently predictive of longer PFS and OS, but not ORR, in multivariate Cox proportional hazard analyses. In 71 patients who received second-line non-platinum chemotherapy, patients with high GNRI exhibited significantly longer PFS and OS than those with low GNRI (both p < 0.001). Conclusions GNRI was predictive of prolonged survival in patients with NSCLC who received first-line platinum-based chemotherapy and second-line non-platinum chemotherapy. Assessment of the nutritional status may be useful for predicting the efficacy of chemotherapy.

Serum Thiamine Values in End-Stage Renal Disease Patients under Maintenance Hemodialysis

2015 ◽  
Vol 85 (5-6) ◽  
pp. 348-355 ◽  
Author(s):  
Masamitsu Ubukata ◽  
Nobuyuki Amemiya ◽  
Kosaku Nitta ◽  
Takashi Takei
Keyword(s):  
Thiamine Deficiency ◽  
Risk Index ◽  
Nutritional Risk ◽  
Maintenance Hemodialysis ◽  
Dialysis Patients ◽  
Significant Difference ◽  
Nutritional Risk Index ◽  
Serum Aspartate Aminotransferase ◽  
Stage Renal Disease ◽  
End Stage

Abstract. Objective: Hemodialysis patients are prone to malnutrition because of diet or many uremic complications. The objective of this study is to determine whether thiamine deficiency is associated with regular dialysis patients. Methods: To determine whether thiamine deficiency is associated with regular dialysis patients, we measured thiamine in 100 patients undergoing consecutive dialysis. Results: Average thiamine levels were not low in both pre-hemodialysis (50.1 ± 75.9 ng/mL; normal range 24 - 66 ng/mL) and post-hemodialysis (56.4 ± 61.7 ng/mL). In 18 patients, post-hemodialysis levels of thiamine were lower than pre-hemodialysis levels. We divided the patients into two groups, the decrease (Δthiamine/pre thiamine < 0; - 0.13 ± 0.11) group (n = 18) and the increase (Δthiamine/pre thiamine> 0; 0.32 ± 0.21)) group (n = 82). However, there was no significance between the two groups in Kt/V or type of dialyzer. Patients were dichotomized according to median serum thiamine level in pre-hemodialysis into a high-thiamine group (≥ 35.5 ng/mL) and a low-thiamine group (< 35.4 ng/mL), and clinical characteristics were compared between the two groups. The low-thiamine value group (< 35.4 ng/ml; 26.8 ± 5.3 ng/ml) exhibited lower levels of serum aspartate aminotransferase and alanine aminotransferase than the high-thiamine value group (≥ 35.4 ng/ml; 73.5 ± 102.5 ng/ml) although there was no significance in nutritional marker, Alb, geriatric nutritional risk index , protein catabolic rate and creatinine generation rate. Conclusion: In our regular dialysis patients, excluding a few patients, we did not recognize thiamine deficiency and no significant difference in thiamine value between pre and post hemodialysis.

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