Journal of Clinical Oncology最新文献

The FDA's directive to deal with delayed confirmatory trials: lessons from pralatrexate and belinostat for T-cell lymphoma.

Purpose: Persistent smoking after cancer diagnosis causes adverse outcomes while smoking cessation can improve survival. Thus, integration of smoking assessment and cessation assistance into routine cancer care is critical. Aiming for incremental practice change that could be sustained and built upon through future quality improvement (QI) projects, the American College of Surgeons initiated Just ASK in 2022 to increase implementation of smoking assessment among its accredited Cancer Programs. This manuscript describes outcomes from Just ASK.

Methods: Seven hundred sixty-two programs enrolled in this cohort study, followed Plan Do Study Act methodology, and used local QI teams to facilitate practice change. The primary outcome was the ask rate (ie, patients asked/patients seen). Programs completed three surveys across the 1-year study (89.8% retention), answering questions about their program plus organizational readiness, implementation barriers, implementation strategies, and clinical practices related to assessing smoking among patients newly diagnosed with cancer. Data analysis involved descriptive statistics and analysis of change over time (eg, McNemar chi-squares).

Results: Programs (53.1% community-based) tended to report moderate organizational readiness, multiple implementation barriers, and adoption of 4.63 ± 1.49 of eight possible implementation strategies (eg, training staff/providers). Programs reported frequency of assessing smoking status, documenting it in the electronic health record, advising patients who smoke to quit, and documenting advice and treatment increased over time (all P < .001). The ask rate increased from baseline to mid to final survey (P < .01; 87.79% v 88.65% v 91.92%, respectively).

Conclusion: Just ASK is the latest, and by far the largest, endeavor to improve assessment of cancer patients' smoking status. Participants reported significant advances within a short time span and study results underscore the potential for national accreditation organizations to transform oncology practice.

Purpose: To evaluate the survival benefit of chemotherapy intensification in older patients with AML who have not achieved a measurable residual disease (MRD)-negative remission.

Methods: Five hundred twenty-three patients with AML (median age, 67 years; range, 51-79) without a flow cytometric MRD-negative remission response after a first course of daunorubicin and AraC (DA; including 165 not in remission) were randomly assigned between up to two further courses of DA or intensified chemotherapy-either fludarabine, cytarabine, granulocyte colony-stimulating factor and idarubicin (FLAG-Ida) or DA with cladribine (DAC).

Results: Overall survival (OS) was not improved in the intensification arms (DAC v DA: hazard ratio [HR], 0.74 [95% CI, 0.55 to 1.01]; P = .054; FLAG-Ida v DA: HR, 0.86 [95% CI, 0.66 to 1.12]; P = .270); OS at 3 years was 34%, 46%, and 42% for DA, DAC, and FLAG-Ida, respectively. Early deaths and other adverse events were more frequent with FLAG-Ida (9% day 60 deaths v 4% after DA or DAC; P = .032). Of patients entering random assignment, 131 had MRD unknown status. In this subgroup of patients lacking evidence of residual leukemia by flow cytometry, there was no detectable survival advantage from intensification. A planned sensitivity analysis excluding these patients demonstrated a survival benefit for both DAC (HR, 0.66 [95% CI, 0.46 to 0.93]; P = .018) and FLAG-Ida (HR, 0.72 [95% CI, 0.53 to 0.98]; P = .035); OS at 3 years was 30%, 46%, and 46% for DA, DAC, and FLAG-Ida, respectively. There was a concordant reduction in relapse (DAC v DA: HR, 0.66 [95% CI, 0.45 to 0.98]; P = .039; FLAG-Ida v DA: HR, 0.70 [95% CI, 0.49 to 0.99]; P = .042). DAC benefit was maintained when survival was censored for transplant (P = .042).

Conclusion: In this study of older patients with AML considered fit and with evidence of residual disease after first induction, chemotherapy intensification improved survival. DAC intensification was better tolerated than FLAG-Ida.