Inclusion and progression form. Copy of questionnaire completed by clinicians at inclusion and pr... more Inclusion and progression form. Copy of questionnaire completed by clinicians at inclusion and progression. (PDF 79 kb)
Decision aid for second-line irinotecan. Example of information provided in a decision aid. (PDF ... more Decision aid for second-line irinotecan. Example of information provided in a decision aid. (PDF 89 kb)
Changes from published study protocol. Overview of changes in study design compared with the publ... more Changes from published study protocol. Overview of changes in study design compared with the published protocol (PDF 640 kb)
Background Palliative care is becoming increasingly important because the number of patients with... more Background Palliative care is becoming increasingly important because the number of patients with an incurable disease is growing and their survival is improving. Previous research tells us that early palliative care has the potential to improve quality of life (QoL) in patients with advanced cancer and their relatives. According to limited research on palliative care in the Netherlands, patients with advanced cancer and their relatives find current palliative care suboptimal. The aim of the eQuiPe study is to understand the experienced quality of care (QoC) and QoL of patients with advanced cancer and their relatives to further improve palliative care. Methods A prospective longitudinal observational cohort study is conducted among patients with advanced cancer and their relatives. Patients and relatives receive a questionnaire every 3 months regarding experienced QoC and QoL during the palliative trajectory. Bereaved relatives receive a final questionnaire 3 to 6 months after the ...
Sunitinib is an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma... more Sunitinib is an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST). Because of the large interpatient pharmacokinetic variability and established exposure‐response and exposure‐toxicity relationships in clinical trial patients, therapeutic drug monitoring (TDM) seems promising for optimizing sunitinib exposure. We aimed to investigate the relationship between sunitinib exposure and treatment outcome in a real‐world patient cohort.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 10, 2018
Purpose Testicular cancer (TC) treatment increases risk of subsequent malignant neoplasms (SMNs).... more Purpose Testicular cancer (TC) treatment increases risk of subsequent malignant neoplasms (SMNs). It is unknown whether changes in TC treatment over time have affected SMN risk. Methods Solid SMN risk was evaluated in a multicenter cohort comprising 5,848 1-year survivors treated for TC before age 50 years between 1976 and 2007. SMN incidence was compared with cancer incidence in the general population. Treatment-specific risks were assessed using multivariable regression in a case-cohort design. Results After a median follow-up of 14.1 years, 350 solid SMNs were observed, translating into a 1.8-fold (95% CI, 1.6-2.0) increased risk compared with general population rates. Solid SMN risk was increased in patients with seminoma and those with nonseminoma (standardized incidence ratio, 1.52 and 2.21, respectively). Patients with nonseminoma experienced increased risk of SMNs of the thyroid, lung, stomach, pancreas, colon, and bladder and of melanoma and soft tissue sarcoma, whereas tho...
Background: The MINDACT TRIAL investigated the clinical utility of the 70-gene profile (MammaPrin... more Background: The MINDACT TRIAL investigated the clinical utility of the 70-gene profile (MammaPrint®), when confronted to the standard clinical pathological (CP) criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy (CT).Methods: From 2007 to 2011, 11288 patients were screened in 112 centers from 9 countries, of whom 6693 were enrolled. Enrolled patients had undergone successful determination of their genomic risk G (with MammaPrint®) and clinical risk C (modified version Adjuvant! Online). Patients were evaluated as “low clinical risk”, if their 10-year disease specific survival (without CT or endocrine therapy (ET), as estimated by Adjuvant! Online, was greater than 88% for ER-positive patients, and greater than 92% for ER-negative patients. Patients characterized in both assessments as “low- risk” were spared CT while for those “high- risk”, CT was advised. Those with discordant results were randomized to use either C or G risk evaluation to decide...
Treatment evaluation in metastatic castration-resistant prostate cancer is challenging. There is ... more Treatment evaluation in metastatic castration-resistant prostate cancer is challenging. There is an urgent need for biomarkers to discriminate short-term survivors from long-term survivors, shortly after treatment initiation. Thereto, the added value of early RNA biomarkers on predicting progression-free survival (PFS) and overall survival (OS) were explored. The RNA biomarkers: KLK3 mRNA, miR-375, miR-3687, and NAALADL2-AS2 were measured in 93 patients with mCRPC, before and 1 month after start of first-line abiraterone acetate or enzalutamide treatment, in two prospective clinical trials. The added value of the biomarkers to standard clinical parameters in predicting PFS and OS was tested by Harell’s C-index. To test whether the biomarkers were independent markers of PFS and OS, multivariate Cox regression was used. The best prediction model for PFS and OS was formed by adding miR-375 and KLK3 (at baseline and 1 month) to standard clinical parameters. Baseline miR-375 and detectab...
Inclusion and progression form. Copy of questionnaire completed by clinicians at inclusion and pr... more Inclusion and progression form. Copy of questionnaire completed by clinicians at inclusion and progression. (PDF 79 kb)
Decision aid for second-line irinotecan. Example of information provided in a decision aid. (PDF ... more Decision aid for second-line irinotecan. Example of information provided in a decision aid. (PDF 89 kb)
Changes from published study protocol. Overview of changes in study design compared with the publ... more Changes from published study protocol. Overview of changes in study design compared with the published protocol (PDF 640 kb)
Background Palliative care is becoming increasingly important because the number of patients with... more Background Palliative care is becoming increasingly important because the number of patients with an incurable disease is growing and their survival is improving. Previous research tells us that early palliative care has the potential to improve quality of life (QoL) in patients with advanced cancer and their relatives. According to limited research on palliative care in the Netherlands, patients with advanced cancer and their relatives find current palliative care suboptimal. The aim of the eQuiPe study is to understand the experienced quality of care (QoC) and QoL of patients with advanced cancer and their relatives to further improve palliative care. Methods A prospective longitudinal observational cohort study is conducted among patients with advanced cancer and their relatives. Patients and relatives receive a questionnaire every 3 months regarding experienced QoC and QoL during the palliative trajectory. Bereaved relatives receive a final questionnaire 3 to 6 months after the ...
Sunitinib is an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma... more Sunitinib is an oral tyrosine kinase inhibitor approved for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST). Because of the large interpatient pharmacokinetic variability and established exposure‐response and exposure‐toxicity relationships in clinical trial patients, therapeutic drug monitoring (TDM) seems promising for optimizing sunitinib exposure. We aimed to investigate the relationship between sunitinib exposure and treatment outcome in a real‐world patient cohort.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Jan 10, 2018
Purpose Testicular cancer (TC) treatment increases risk of subsequent malignant neoplasms (SMNs).... more Purpose Testicular cancer (TC) treatment increases risk of subsequent malignant neoplasms (SMNs). It is unknown whether changes in TC treatment over time have affected SMN risk. Methods Solid SMN risk was evaluated in a multicenter cohort comprising 5,848 1-year survivors treated for TC before age 50 years between 1976 and 2007. SMN incidence was compared with cancer incidence in the general population. Treatment-specific risks were assessed using multivariable regression in a case-cohort design. Results After a median follow-up of 14.1 years, 350 solid SMNs were observed, translating into a 1.8-fold (95% CI, 1.6-2.0) increased risk compared with general population rates. Solid SMN risk was increased in patients with seminoma and those with nonseminoma (standardized incidence ratio, 1.52 and 2.21, respectively). Patients with nonseminoma experienced increased risk of SMNs of the thyroid, lung, stomach, pancreas, colon, and bladder and of melanoma and soft tissue sarcoma, whereas tho...
Background: The MINDACT TRIAL investigated the clinical utility of the 70-gene profile (MammaPrin... more Background: The MINDACT TRIAL investigated the clinical utility of the 70-gene profile (MammaPrint®), when confronted to the standard clinical pathological (CP) criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy (CT).Methods: From 2007 to 2011, 11288 patients were screened in 112 centers from 9 countries, of whom 6693 were enrolled. Enrolled patients had undergone successful determination of their genomic risk G (with MammaPrint®) and clinical risk C (modified version Adjuvant! Online). Patients were evaluated as “low clinical risk”, if their 10-year disease specific survival (without CT or endocrine therapy (ET), as estimated by Adjuvant! Online, was greater than 88% for ER-positive patients, and greater than 92% for ER-negative patients. Patients characterized in both assessments as “low- risk” were spared CT while for those “high- risk”, CT was advised. Those with discordant results were randomized to use either C or G risk evaluation to decide...
Treatment evaluation in metastatic castration-resistant prostate cancer is challenging. There is ... more Treatment evaluation in metastatic castration-resistant prostate cancer is challenging. There is an urgent need for biomarkers to discriminate short-term survivors from long-term survivors, shortly after treatment initiation. Thereto, the added value of early RNA biomarkers on predicting progression-free survival (PFS) and overall survival (OS) were explored. The RNA biomarkers: KLK3 mRNA, miR-375, miR-3687, and NAALADL2-AS2 were measured in 93 patients with mCRPC, before and 1 month after start of first-line abiraterone acetate or enzalutamide treatment, in two prospective clinical trials. The added value of the biomarkers to standard clinical parameters in predicting PFS and OS was tested by Harell’s C-index. To test whether the biomarkers were independent markers of PFS and OS, multivariate Cox regression was used. The best prediction model for PFS and OS was formed by adding miR-375 and KLK3 (at baseline and 1 month) to standard clinical parameters. Baseline miR-375 and detectab...
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Papers by Tineke Smilde