Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial.

PURPOSE: The addition of checkpoint inhibitors to first-line treatment has prolonged survival of patients with non-small-cell lung cancer (NSCLC), but prognosis remains poor, with new treatment options needed. Canakinumab, a human, monoclonal anti-interleukin (IL)-1ß antibody, has potential to enhance the activity of PD-L1 inhibitors and chemotherapy (CT) by inhibiting protumor inflammation. METHODS: CANOPY-1 was a phase III, randomized, double-blind study comparing canakinumab (200 mg subcutaneously once every 3 weeks) versus placebo, both combined with pembrolizumab (200 mg intravenously once every 3 weeks) and platinum-based doublet CT, as first-line treatment for advanced/metastatic NSCLC without EGFR or ALK mutations. The primary end points were progression-free survival (PFS) and overall survival (OS). The secondary endpoints included overall response rate, safety, and patient-reported outcomes. RESULTS: Overall, 643 patients were randomly assigned to canakinumab (n = 320) or placebo (n = 323). With a median study follow-up of 6.5 months, the median PFS was 6.8 months with canakinumab versus 6.8 months with placebo (hazard ratio [HR], 0.85; 95% CI, 0.67 to 1.09; P = .102). With a median study follow-up of 21.2 months, the median OS was 20.8 months with canakinumab versus 20.2 months with placebo (HR, 0.87; 95% CI, 0.70 to 1.10; P = .123). No unexpected safety signals were observed for canakinumab combination. Infection rates were comparable between treatment and control arms. A higher frequency of neutropenia and ALT increase (grade ≤2) were reported in the treatment arm. Higher baseline C-reactive protein and IL-6 levels were associated with shorter PFS and OS. Patients treated with canakinumab had clinically meaningful delays in deterioration of lung cancer symptoms, including chest pain and coughing per LC13 and dyspnea per LC13 and C30. CONCLUSION: The addition of canakinumab to first-line pembrolizumab and CT did not prolong PFS or OS in patients with NSCLC.

Changes in quality of life for pregnant women in substance user treatment: developing a quality of life index for the addictions.

UNLABELLED: Using preference weights from a community sample, items from the Addiction Severity Index (ASI) were converted into a quality of life index (QOLI) and used to compare the cost-effectiveness of five addiction treatment modalities for pregnant women. METHODS: Interviews using the time trade-off methodology were conducted with 143 members of Massachusetts local health planning boards to determine preference weights for different health states resulting from active addiction. A multi-attribute utility formula was used to convert these seven preference weighted scores into a single QOLI. To apply the QOLI, these preference weights were combined with the number of problem days reported in each ASI domain by a sample of 439 pregnant women in MA in five treatment modalities, 1992-1996. RESULTS: Starting at 10 years with an addiction problem, board members indicated that they would give up between 0.83 and 3.96 years to avoid the problems in one domain caused by addiction. The average QOLI was 0.68 at intake but increased by 0.19 points by 6-month follow-up to 0.87. All five treatment groups showed notable improvement in their quality of life. Mean improvements ranged from a high of 0.23 QOLIs for clients who received both residential and outpatient treatment to a low of 0.16 for clients who received only detoxification. Treatment costs ranged from 10,187 dollars for residential and outpatient combined to 2535 dollars for detoxification only, with costs per QOLI ranging from 14,912 dollars to 44,291 dollars. CONCLUSIONS: Although this QOLI could benefit from further refinement and development, it showed promise as a single outcome measure for CEAs in the chemical dependency field. This QOLI was sensitive enough to distinguish between the treatment groups, it correlated well with other outcome measures and can be easily converted from the ASI using spreadsheet software and a simple formula.

Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing.

OBJECTIVES: This study was undertaken to develop a new questionnaire, the Cancer Therapy Satisfaction Questionnaire (CTSQ), to focus on the issues oncology patients consider when evaluating chemotherapy in terms of expectations and satisfaction. METHODS: Items of the CTSQ were generated through the review of responses from interviews with oncology patients, physicians, and nurses. Analysis of the data was stratified by disease stage, disease type, and country to explore potential differences between these groups. Two rounds of face and content validity testing were then conducted. RESULTS: Patients explained their hopes for efficacy and factors related to treatment satisfaction. Content validity testing in 30 patients, followed by additional testing in 10 patients on oral therapy, suggested that patients felt the questionnaire was clear, comprehensive, relevant, and easy to complete. Minor revisions were implemented to improve clarity, resulting in deletion of 12 items, modification of 17 items and the rewording of "chemotherapy" to "cancer therapy" to ensure patients on oral therapy were able to respond. The CTSQ contains 21 items and assesses seven domains: Expectations of cancer therapy, Feelings about side effects, Oral cancer therapy adherence, Convenience, Satisfaction with cancer therapy, Stopping cancer therapy, and Reasons for nonadherence. CONCLUSIONS: The CTSQ was designed for adults with a wide range of cancer types and stages, receiving a variety of cancer treatment formulations. A validation study is currently underway to examine the psychometric properties, further refine the questionnaire and develop scoring methods for the CTSQ.