10 research outputs found
Comparison of two doses of intravenous temsirolimus in patients with relapsed/refractory mantle cell lymphoma
Phase I study of sunitinib plus S-1 and cisplatin in Japanese patients with advanced or metastatic gastric cancer
Heterogeneity of intermediate prognosis patients (pts) with metastatic renal cell cancer (mRCC) treated with sunitinib.
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Exploratory analysis of the platelet-to-lymphocyte ratio prognostic value in the adjuvant renal cell cancer setting
Aim: To examine the prognostic value of the platelet-to-lymphocyte ratio (PLR) in the adjuvant renal cell carcinoma setting. Materials & methods: Patients received adjuvant sunitinib (50 mg/day; 4 weeks on/2 weeks off) or placebo. The primary end point was disease-free survival (DFS). Results: In 609 patients, DFS was similar for baseline PLR <140 versus ≥140 overall (median: 6.4 vs 5.9 years; hazard ratio: 0.9; 95% CI: 0.7-1.2). A ≥25% decrease in PLR at week 4 overall was associated with longer DFS versus no change (hazard ratio: 0.8; 95% CI: 0.6-1.0). Conclusion: Baseline PLR was not prognostic for DFS with adjuvant sunitinib treatment in patients with renal cell carcinoma. Clinical Trials Registration: NCT00375674 (ClinicalTrials.gov)
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Neutrophil-to-Lymphocyte Ratio as a Prognostic Factor of Disease-free Survival in Postnephrectomy High-risk Locoregional Renal Cell Carcinoma: Analysis of the S-TRAC Trial
PurposeIn the S-TRAC trial, adjuvant sunitinib improved disease-free survival (DFS) compared with placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence. This post hoc exploratory analysis investigated the neutrophil-to-lymphocyte ratio (NLR) for predictive and prognostic significance in the RCC adjuvant setting.Experimental designKaplan-Meier estimates and Cox proportional analyses were performed on baseline NLR and change from baseline at week 4 to assess their association with DFS. Univariate P values were two-sided and based on an unstratified log-rank test.Results609 of 615 patients had baseline NLR values; 574 patients had baseline and week 4 values. Sunitinib-treated patients with baseline NLR <3 had longer DFS versus placebo (7.1 vs. 4.7; HR, 0.71; P = 0.02). For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91). A ≥25% NLR decrease at week 4 was associated with longer DFS versus no change (6.8 vs. 5.3 years; HR, 0.71; P = 0.01). A greater proportion of sunitinib-treated patients had ≥25% NLR decrease at week 4 (71.2%) versus placebo (17.4%). Patients with ≥25% NLR decrease at week 4 received a higher median cumulative sunitinib dose (10,137.5 mg) versus no change (8,168.8 mg) or ≥25% increase (6,712.5 mg).ConclusionsIn the postnephrectomy high-risk RCC patient cohort, low baseline NLR may help identify those most suitable for adjuvant sunitinib. A ≥25% NLR decrease at week 4 may be an early indicator of those most likely to tolerate treatment and derive DFS benefit
Disease-free survival in patients at highest risk of recurrent renal cell carcinoma in S-TRAC.
Neutrophil-to-lymphocyte ratio as a potential prognostic factor of disease-free survival in high-risk renal cell carcinoma: Analysis of the S-TRAC trial.
Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results
Background: Adjuvant sunitinib significantly improved disease-free survival (DFS)
versus placebo in patients with locoregional renal cell carcinoma (RCC) at high risk
of recurrence after nephrectomy (hazard ratio [HR] 0.76, 95% confidence interval [CI]
0.59–0.98; p = 0.03).
Objective: To report the relationship between baseline factors and DFS, pattern of
recurrence, and updated overall survival (OS).
Design, setting, and participants: Data for 615 patients randomized to sunitinib
(n = 309) or placebo (n = 306) in the S-TRAC trial.
Outcome measurements and statistical analysis: Subgroup DFS analyses by baseline risk
factors were conducted using a Cox proportional hazards model. Baseline risk factors
included: modified University of California Los Angeles integrated staging system
criteria, age, gender, Eastern Cooperative Oncology Group performance status (ECOG
PS), weight, neutrophil-to-lymphocyte ratio (NLR), and Fuhrman grade.
Results and limitations: Of 615 patients, 97 and 122 in the sunitinib and placebo arms
developed metastatic disease, with the most common sites of distant recurrence being
lung (40 and 49), lymph node (21 and 26), and liver (11 and 14), respectively. A benefit of
adjuvant sunitinib over placebo was observed across subgroups, including: higher risk
(T3, no or undetermined nodal involvement, Fuhrman grade 2, ECOG PS 1, T4 and/or nodal involvement; hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.55–0.99; p = 0.04),
NLR 3 (HR 0.72, 95% CI 0.54–0.95; p = 0.02), and Fuhrman grade 3/4 (HR 0.73, 95% CI 0.55–
0.98; p = 0.04). All subgroup analyses were exploratory, and no adjustments for multiplicity
were made. Median OS was not reached in either arm (HR 0.92, 95% CI 0.66–1.28; p = 0.6);
67 and 74 patients died in the sunitinib and placebo arms, respectively.
Conclusions: A benefit of adjuvant sunitinib over placebo was observed across subgroups.
The results are consistent with the primary analysis, which showed a benefit for adjuvant
sunitinib in patients at high risk of recurrent RCC after nephrectomy.
Patient summary: Most subgroups of patients at high risk of recurrent renal cell carcinoma
after nephrectomy experienced a clinical benefit with adjuvant sunitinib.
Trial registration: ClinicalTrials.gov NCT00375674.</p