BackgroundMerkel cell carcinoma (MCC) is a rare, aggressive skin cancer associated with poor survival outcomes in patients with distant metastatic disease (mMCC). In an initial analysis from JAVELIN Merkel 200, a phase 2, prospective, open-label, single-arm trial in mMCC, avelumab—a human anti–programmed death-ligand 1 (PD-L1) monoclonal antibody—showed promising efficacy and a safety profile that was generally manageable and tolerable. Here, we report the efficacy of avelumab after ≥1 year of follow-up in patients with distant mMCC that had progressed following prior chemotherapy for metastatic disease.Patients and methodsPatients received avelumab 10 mg/kg by 1-h intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was best overall response. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS).ResultsPatients (N = 88) were followed for a minimum of 12 months. The confirmed objective response rate was 33.0% (95% CI, 23.3%-43.8%; complete response: 11.4%). An estimated 74% of responses lasted ≥1 year, and 72.4% of responses were ongoing at data cutoff. Responses were durable, with the median DOR not yet reached (95% CI, 18.0 months-not estimable), and PFS was prolonged; 1-year PFS and OS rates were 30% (95% CI, 21%-41%) and 52% (95% CI, 41%-62%), respectively. Median OS was 12.9 months (95% CI, 7.5-not estimable). Subgroup analyses suggested a higher probability of response in patients receiving fewer prior lines of systemic therapy, with a lower baseline disease burden, and with PD-L1–positive tumors; however, durable responses occurred irrespective of baseline factors, including tumor Merkel cell polyomavirus status.ConclusionsWith longer follow-up, avelumab continues to show durable responses and promising survival outcomes in patients with distant mMCC whose disease had progressed after chemotherapy.Trial registrationClinicaltrials.gov identifier: NCT02155647.

clinicaltrials.gov Identifier: NCT02155647.

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CRLX101 combined with bevacizumab is safe in mRCC. This combination fulfilled the protocol's predefined threshold for further examination with responses and prolonged PFS in a heavily pretreated population. A randomized phase II clinical trial in mRCC of this combination is ongoing.

Background: Hospices are now mandated to perform routine quality assessment under the final Medicare Hospice Conditions of Participation, creating an opportunity to explore standardized approaches to monitoring hospice quality. Objective: We report hospice staff experiences using a standardized symptom assessment instrument, the Edmonton Symptom Assessment System (ESAS), in a pilot study designed to develop and test quality measures on symptom management. Use of the ESAS illustrates the benefits and challenges arising with standardized symptom assessment for quality monitoring in hospice. Methods: We interviewed 24 individuals representing 8 hospices involved with the National Association for Home Care & Hospice Quality Assessment Collaborative, which pilot tested the ESAS as a source of standardized data for quality assessment. Transcripts were analyzed using the constant comparative method. Results: Participants reported benefits and challenges with the ESAS. Benefits were that the ESAS was a brief and easy tool that identified areas of concern, engaged patients in symptom assessment, and monitored symptom changes over time. Additionally, the ESAS was viewed as a useful teaching tool for less experienced staff. Challenges included lack of clarity about inclusion rules and frequency of assessments; difficulty interpreting the numeric symptom rating scale, difficulty incorporating patient preferences with symptoms, and a sense that the use of standard assessment instruments was ''unnatural.'' Discussion: Recommendations to promote effective use of ESAS data for quality monitoring of hospice care include standardizing implementation procedures, adding patients' preferences to the ESAS form, and staff education to enhance comfort with the instrument before implementation.