Introduction
Nusrat Rabbee in Biomarker Analysis in Clinical Trials with R, 2020
A few common surrogate endpoints for clinical trials of cancer treatments are [4] as follows: Time to Progression (TTP): The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.Progression-Free Survival: The length of time between treatment and measurable worsening of the disease. Generally, it is used to study advanced diseases that are unlikely to be removed entirely.Response Rate (RR): The percentage of patients whose cancer shrinks or disappears after treatment.
Soft tissue sarcomas
Pat Price, Karol Sikora in Treatment of Cancer, 2014
Multiple reports now suggest clinical and radiographic benefit from the tyrosine kinase inhibitor imatinib (Gleevec\rtm), an effect that is presumably due to tumour expression of activated receptor tyrosine kinases KIT or platelet-derived growth factor receptor (PDGFR).534 In a large multi-institutional phase II trial of 51 patients (45 evaluable), patients were dosed with imatinib based on body surface area (BSA), with patients ≥1.5 m2 receiving 300 mg twice daily, patients 1–1.49 m2 receiving 200 mg twice daily, and those <1 m2 receiving 100 mg twice daily.535 Forty-three (84%) reached the primary endpoint defining clinical benefit (a complete or PR within 16 weeks, or stable disease lasting at least 16 weeks). Three patients had an objective PR. The progression-free survival rate at 3 years was 58%, and 5 patients remained progression-free after 4+ years of treatment.
Soft Tissue Sarcomas
Pat Price, Karol Sikora in Treatment of Cancer, 2020
Multiple reports now suggest clinical and radiographic benefit from the tyrosine kinase inhibitor imatinib, an effect that is presumably due to tumor expression of activated receptor tyrosine kinases KIT or platelet-derived growth factor receptor (PDGFR). In a large multi-institutional phase II trial of 51 patients (45 evaluable), patients were dosed with imatinib based on body surface area (BSA), with patients ≥1.5 m2 receiving 300 mg twice daily, patients 1–1.49 m2 receiving 200 mg twice daily, and those <1 m2 receiving 100 mg twice daily. Forty-three (84%) reached the primary endpoint defining clinical benefit (a complete or PR within 16 weeks, or stable disease lasting at least 16 weeks). Three patients had an objective PR. The progression-free survival rate at 3 years was 58%, and 5 patients remained progression-free after 4+ years of treatment.
Feasibility study of metabolically supported chemotherapy with weekly carboplatin/paclitaxel combined with ketogenic diet, hyperthermia and hyperbaric oxygen therapy in metastatic non-small cell lung cancer
Published in International Journal of Hyperthermia, 2019
Data were analyzed using IBM SPSS Statistics version 20.0 software (SPSS Inc., Chicago, IL). Descriptive data are presented in number (percentage), median (range), mean (95% confidence interval), where appropriate. Categorical variables were compared using Pearson’s chi-square test. Overall survival was defined as the time elapsed between the date of the first administration of the treatment and death from any cause. Progression-free survival was defined as the time elapsed between the date of the first administration of the treatment and death from any cause or progression. Patients without event at the last follow up were censored. Survival rates were estimated using Kaplan–Meier analysis and inter-group comparisons were performed using log-rank test. Two-sided p values <.05 were considered as an indication of statistical significance.
Extent of resection predicts risk of progression in adult pilocytic astrocytoma
Published in British Journal of Neurosurgery, 2019
Andrew J. Nelson, Rasheed Zakaria, Michael D. Jenkinson, Andrew R. Brodbelt
Tumour progression was defined radiologically by RANO criteria and confirmed clinically by review and discussion at MDT. Progression free survival (PFS) was measured as time from diagnosis to first progression and overall survival (OS) was taken as time from diagnosis to patient death. Cases where the patient died before progression were censored at the last brain scan, and those who were lost to follow up or died of other causes were censored at the last clinic appointment recorded. Data were analysed using SPSS version v22 (IBM co., 2011). For analysis of PFS and OS, the Kaplan-Meier product limit method was used and survival curves plotted. Log rank tests were applied to detect differences between paired groups. For multivariate analysis, Cox’s method was used to compare competing hazards. Standard tests were used for comparisons of means and analysis of variance. The level of significance was set at 95% to reject the null hypothesis and all p-values and confidence intervals are stated.
A multicentre retrospective study of primary breast diffuse large B-cell and high-grade B-cell lymphoma treatment strategies and survival
Published in Hematology, 2020
Tingting Zhang, Hongguo Zhao, Zhongguang Cui, Haicang Xu, Xiaodan Liu, Ying Wu, Ying Li, Shuxiang Sun, Peijun Wang, Yanli Wang, Xue Shi
All statistical data were analysed with SPSS software (Version 20, IBM Corporation, Chicago, USA). Overall survival (OS) was measured from the date of diagnosis of PB-DLBCL to the date of death or last follow-up. Progression-free survival (PFS) was calculated from the date of diagnosis to disease progression, death, or loss to follow-up. OS and PFS were analysed by the Kaplan-Meier method. Differences in survival rates were compared by the log-rank test and Fisher's exact test. Prognostic factors with log-rank P values<0.1, were included in the Cox proportional hazards model. Fisher's exact test for 2 × 2 tables was performed to examine correlations among potential prognostic factors. P values<0.05 were considered statistically significant, and all P values corresponded to two-sided significance tests.
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