PURPOSE To assess the safety/tolerability and antitumor activity of enfortumab vedotin (EV), a novel investigational antibody-drug conjugate that delivers the microtubule-disrupting agent, monomethyl auristatin E, to cells that express Nectin-4. METHODS EV-101 is a phase I dose escalation/expansion study that enrolled patients with Nectin-4–expressing solid tumors (eg, metastatic urothelial carcinoma [mUC]) who progressed on ≥ 1 prior chemotherapy regimen and/or programmed death-1 receptor/programmed death ligand-1 [PD-(L)1] inhibitor, including a cohort of patients with mUC who received prior anti–PD-(L)1 therapy. Patients received escalating doses of EV up to 1.25 mg/kg on days 1, 8, and 15 of every 28-day cycle. Primary objectives were evaluation of safety/tolerability and pharmacokinetics; antitumor activity was a secondary objective. RESULTS Enrolled patients with mUC (n = 155) were heavily pretreated, with 96% having prior platinum-based chemotherapy and 29% receiving ≥ 3 lines of prior treatment. Maximum tolerated dose of EV was not established; however, the recommended phase II dose was identified as 1.25 mg/kg. Rash, peripheral neuropathy, fatigue, alopecia, and nausea were the most common treatment-related adverse events (TRAEs); the most common TRAEs were grade 1-2 in severity. Among the 112 patients with mUC treated with single-agent EV 1.25 mg/kg, the investigator-assessed confirmed objective response rate (ORR) was 43%, and duration of response was 7.4 months. Median overall survival (OS) was 12.3 months, and the OS rate at 1 year was 51.8%. Similar ORR and estimated median OS were observed in patients ≥ 75 years of age with and without prior anti–PD-(L)1 treatment, liver metastases, or upper-tract disease. CONCLUSION Single-agent EV was generally well tolerated and provided clinically meaningful and durable responses in patients with mUC; survival data are encouraging. A pivotal phase II and a confirmatory phase III study are ongoing.
ASCENT treatment was associated with shorter survival than the control. This difference might be due to either weekly docetaxel dosing, which, in a prior study, showed a trend toward inferior survival compared with an every-3-weeks regimen, or DN-101 therapy.
PURPOSE This study reports on a mixed methods evaluation conducted within a provincial cancer program in Alberta, Canada. The purpose was to capture key learnings from a rapid virtual care implementation because of the COVID-19 pandemic and to understand the impact on patient and staff experiences. METHODS Administrative data were collected for 21,362 patients who had at least one virtual or in-person visit to any provincial cancer center from April 1, 2020, to June 10, 2020. Patient surveys were conducted with 397 randomly selected patients who had received a virtual visit. Surveys were also conducted with 396 Cancer Care Alberta staff. RESULTS 14,906 virtual visits took place in this period, and about 40% of weekly visits were virtual. Significant differences were observed in both patient-reported symptom questionnaire completion rates and referrals to supportive care services between patients seen in-person and virtually. Patients receiving active treatments reported significantly lower levels of satisfaction with virtual visits than those seen for follow-up, but overall 90% of patients indicated interest in receiving virtual care in the future. Staff thought virtual visits increased patients' access to care but less than one third (31.5%) felt confident meeting patients' emotional needs and having conversations about disease progression and/or end of life virtually. CONCLUSION The COVID-19 pandemic has driven the rapid implementation of virtual visits for cancer care delivery in health care settings. The findings from this mixed methods evaluation provide a concrete set of considerations for organizations looking to develop a large-scale, enduring virtual care strategy.
Background: Following resection of liver metastases from colorectal cancer, 5-year survivals are reportedly 30 -39%. It can be assumed that this clinical situation represents systemic disease. Therefore, it is postulated that systemic chemotherapy would improve outcomes, particularly in those whose disease is sensitive to the agents administered. One potential advantage of neoadjuvant chemotherapy is that it provides in vivo chemosensitivity data. Response to neoadjuvant chemotherapy could therefore guide adjuvant chemotherapy following resection of liver metastases from colorectal cancer.
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