The Trials (and Tribulations) of Complementary and Alternative Medicine in Oncology.

Two decades following the creation of the Office of Cancer Complementary and Alternative Medicine at the National Cancer Institute, the status of complementary and alternative medicine (CAM) research within oncology remains opaque. To better understand the landscape of CAM studies in oncology, we identified CAM-related phase III randomized controlled trials (RCTs) through ClinicalTrials.gov and compared these CAM trials to all non-CAM oncologic RCTs. Pearson χ2 testing was used to compare proportions across groups; all tests were two-sided. Comparing the 25 identified CAM RCTs with 739 non-CAM RCTs, CAM studies were more likely to be sponsored by a cooperative group (64.0% vs 28.6%, P < .001) and less likely to be industry funded (8.0% vs 76.5%, P < .001). CAM trials disproportionately excluded disease-related outcomes as endpoints (8.0% vs 84.6%, P < .001), were unsupported by prior early-phase data (55.0% vs 96.1%, P < .001), and did not meet the primary endpoint (8.7% vs 53.0%, P < .001). Given the observed relationship between encouraging pilot data and subsequent phase III trial success, we contend that future CAM RCTs may yield more promising findings if better supported by appropriately designed and well-characterized early-phase signals.

Adherence to National Comprehensive Cancer Network Guidelines is Associated with Improved Survival for Patients with Stage 2A and Stages 2B and 3 Extremity and Superficial Trunk Soft Tissue Sarcoma.

BACKGROUND: The National Comprehensive Cancer Network (NCCN) has instituted treatment guidelines for stage 2A and stages 2B and 3 extremity and superficial trunk soft tissue sarcomas (ETSTS). This study examined adherence to the NCCN guidelines and factors associated with nonadherent treatment and survival outcomes. METHODS: Patients with stage 2A and stages 2B and 3 ETSTS (n = 15,957) were categorized as undergoing adherent or nonadherent treatment based on the 2014 NCCN guidelines. Multivariate logistic regression models were used to determine factors associated with nonadherent treatment. Overall survival (OS) and disease-specific survival (DSS) were calculated, and Cox models were used to generate adjusted survival curves and hazard ratios (HRs). RESULTS: The findings showed that 87.2% of the patients with stage 2A disease and 58.3% of the patients with stage 2B or 3 disease received adherent treatment. Community treatment facilities and uninsured or unknown insurance status were associated with nonadherent treatment for both stage groups. Adherent treatment was associated with higher 5-year adjusted OS and DSS for stage 2A and stage 2B or 3 patients. In Cox models, nonadherent treatment was associated with worse survival for both stage 2A disease (HR, 2.31; 95% confidence interval [CI], 2.02-2.63) and stages 2B and 3 disease (HR, 1.63; 95% CI, 1.53-1.73). Increasing age and non-private insurance were associated with poorer outcomes. For stages 2B and 3 disease, treatment at a community center and African American race were associated with worse survival. CONCLUSIONS: Adherence to NCCN guidelines is excellent for stage 2A and poor for stages 2B and 3 ETSTS. Adherent treatment was associated with improved survival outcomes, highlighting the importance of adherence to NCCN guidelines.