Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors

Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase-III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice

Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population

Clinicopathological Characteristics and Oncological Outcomes of Non-urothelial Bladder Carcinomas: A Multicenter Study

Objective: The incidence of non-urothelial bladder cancers is very low, so our knowledge about their treatment protocols and prognosis is limited. We evaluated the clinicopathological characteristics of 26 patients in three different clinics and aimed to determine the prognostic factors affecting oncological outcomes

Risk factors for thrombosis risk in patients with cancer

Aim: To evaluate the factors associated with Deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE) in cancer patients. Materials and Methods: A total of 237 cancer patients who underwent lower extremity venous Doppler Ultrasonography (USG) and/or pulmonary computed tomography angiography (PCTA) were included. Patients’ demographic characteristics; chemotherapy data; immobilization status; use of central venous catheter; histories of 4-day-long bed rest, surgery within the last 6 months, long anesthesia for at least 2 hours, smoking, patients’ laboratory tests, ABO blood group, PCTA and lower extremity Doppler USG results were retrospectively reviewed through the hospital information management system. Results: The median age was 62 (age range 25 to 89). Thrombosis was detected in 83 patients according to the results of venous Doppler USG and/or PCTA of those patients who underwent imaging. Immobilization status (p=0.019), history of surgery within the last 6 months (p=0.02), anesthesia more than 2 hours (p=0.012) and 4-day-long bed rest (p=0.03) were found to be significantly associated with related risk of thrombosis. Additionally, thrombosis was found more frequently in the non-O group (especially group B) than in O group (p:0.024). Conclusions: Besides well-known risk factors, blood group may be related with risk of thrombosis in the patients with the cancer diagnosis Keywords: ABO blood group, Cancer, Pulmonary thromboembolism, Deep vein thrombosi

Adjuvant chemotherapy for invasive bladder cancer: a 2013 updated systematic review and meta-analysis of randomized trials

CONTEXT: The role of adjuvant chemotherapy remains poorly defined for the management of muscle-invasive bladder cancer (MIBC). The last meta-analysis evaluating adjuvant chemotherapy, conducted in 2005, had limited power to fully support its use. OBJECTIVE: To update the current evidence of the benefit of postoperative adjuvant cisplatin-based chemotherapy compared with control (ie, surgery alone) in patients with MIBC. EVIDENCE ACQUISITION: A comprehensive literature review was performed to identify all randomized controlled trials (RCTs) comparing adjuvant cisplatin-based chemotherapy with control for patients with MIBC. The search included the Medline, Embase, Cochrane Central Register of Controlled Trials databases, and abstracts from the American Society of Clinical Oncology meetings up to May 2013. An updated systematic review and meta-analysis was performed. EVIDENCE SYNTHESIS: A total of 945 patients included in nine RCTs (five previously analyzed, one updated, and three new) were examined. For overall survival, the pooled hazard ratio (HR) across all nine trials was 0.77 (95% confidence interval [CI], 0.59-0.99; p=0.049). For disease-free survival, the pooled HR across seven trials reporting this outcome was 0.66 (95% CI, 0.45-0.91; p=0.014). This disease-free survival benefit was more apparent among those with positive nodal involvement (p=0.010). CONCLUSIONS: This updated and improved meta-analysis of randomized trials provides further evidence of an overall survival and disease-free survival benefit in patients with MIBC receiving adjuvant cisplatin-based chemotherapy after radical cystectomy