Financial relationships between industry and principal investigators of US cooperative group randomized cancer clinical trials.

Financial conflicts of interest (FCOIs) could bias the potentially practice-changing oncologic randomized clinical trials (RCTs) of tomorrow. This investigation characterized the FCOIs of the principal investigators (PIs) of all currently accruing trials of the four (adult) cooperative groups of the National Clinical Trials Network. For our study, the PI list was first compiled, and each name was then searched in the CMS Open Payments database. For each transaction (general payments (GPs) or research funding (RF)), the amount/number/source of payments was recorded. Results showed that from 2014 to 2019, the 91 PIs collectively accepted nearly one-third of a billion dollars ($10 477 023 GPs and $320 096 233 RF). The mean and median GP was $6505 and $945, respectively, and $301 693 and $49 824 RF, respectively. Multivariable Gamma regression analysis revealed that higher GP sums were associated with RCTs involving any type of systemic therapy, and higher RF sums with medical oncologist PIs, trials with phase III components, and RCTs involving radiotherapy (P < .05 for all). Both higher-volume GPs and RF were predicted by PIs having accepted payment(s) from the manufacturer of the drug utilized in their RCT (P < .001 GP, P = .008 RF). Taken together, the main message of this investigation is that FCOIs may be particularly high in PIs of phase III systemic therapy trials, especially if the PI accepted payments from the manufacturer of the drug utilized in their trial. Such RCTs should be thoroughly scrutinized by medical journals, the FDA, and insurance companies for potential "industry bias" that could influence the integrity of their conclusions.

Patterns of care and outcomes in small cell carcinoma of the prostate: A national cancer database analysis.

BACKGROUND: Small cell carcinoma (SCC) of the prostate is a rare, aggressive disease. Evidence is limited; however, the current standard of care is chemotherapy. The benefit of local treatment modalities is unknown. METHODS: We queried the National Cancer Database identifying all SCC/neuroendocrine cases of the prostate, excluding those with unknown nodal or metastatic status, unknown treatment, or those not receiving chemotherapy. Overall survival (OS) was calculated using Kaplan-Meier curves. Multivariable Cox proportional hazards model was used to identify factors associated with survival. A further subgroup analysis was performed on the utility of local therapy on survival in the nonmetastatic setting. RESULTS: Our final cohort included 657 patients with a median age of 68. Most patients had positive lymph nodes (60.1%) and metastatic disease (70.0%). Median survival was 12 months (95% confidence interval [95% CI], 11.1-13.3 months) with a median follow-up of 11.8 months. Metastatic disease, age greater than or equal to 70, omission of androgen deprivation therapy (ADT), and lower income (P < .05 for all) were all associated with reduced OS. Patients with prostate-specific antigen (PSA) greater than or equal to 33 ng/mL and those receiving ADT had better survival (P < .05). Those with nonmetastatic disease were more likely to undergo prostatectomy and/or prostatic/pelvic radiation (P < .0001). Prostatic/pelvic radiation in the nonmetastatic setting was associated with longer survival (P = .02). Though well powered, our study is limited by the selection bias inherent to all observational studies, despite the statistical methods utilized to reduce this effect. CONCLUSIONS: Although chemotherapy is the mainstay of treatment, radiation to the prostate/pelvis may be beneficial in the nonmetastatic setting. In addition to chemotherapy, ADT may benefit patients with an elevated PSA.