ABSTRACT
BACKGROUND: Cigarette smoking and chronic pain are prevalent, comorbid conditions with significant consequences for individuals and society. Despite overlap between smoking and chronic pain, and pain's role as a potential barrier to quitting, there are no validated interventions targeted for smokers with chronic pains (SWCPs). OBJECTIVE: To compare characteristics of urban inpatient smokers with and without chronic pain to inform the development of SWCP-targeted cessation interventions. METHODS: This study reports partial results from a randomized comparative effectiveness trial of two smoking cessation interventions (NCT01363245). Participants were enrolled at two safety net hospitals in New York, NY in 2011-2014. Data were collected from the electronic health record and an interviewer-administered survey. Participants were considered to have chronic pain if they affirmed having "long-lasting, persistent, or chronic pain in the last six months" on survey. RESULTS: Among smokers assessed for pain (n = 1093), the prevalence of chronic pain was 44%. SWCPs were more likely to report depressive symptoms and to have a history of psychiatric diagnosis (nonsubstance related) than smokers without pain. Severe problems with mobility and with performing usual activities were more common in SWCPs. No significant difference was observed in sex, race, education, nicotine dependence level, confidence in quit ability, or history of substance misuse. Conclusions/Importance: Chronic pain in smokers admitted to safety net hospitals is prevalent and associated with hindered mobility, history of psychiatric diagnosis, and prescription opioid use. Urban safety net hospitals are an appropriate setting in which to pilot SWCP-targeted cessation programs, which should be designed with consideration for patients' psychiatric history and mobility status.
Subject(s)
Chronic Pain/epidemiology , Chronic Pain/psychology , Inpatients/psychology , Smokers/psychology , Smoking Cessation/psychology , Smoking/epidemiology , Case-Control Studies , Comorbidity , Female , Humans , Male , Middle Aged , New York/epidemiology , Prevalence , Risk Factors , Surveys and QuestionnairesABSTRACT
Purpose: Epithelial ovarian cancer (EOC) is a molecularly diverse disease. MEK inhibition targets tumors harboring MAPK pathway alterations and enhances paclitaxel-induced apoptosis in EOC. This phase Ib study evaluated the MEK inhibitor binimetinib combined with paclitaxel in patients with platinum-resistant EOC.Patients and Methods: Patients received intravenous weekly paclitaxel with oral binimetinib in three different administration schedules. Outcomes were assessed by RECIST and CGIC CA-125 response criteria. Tumor samples were analyzed using next-generation sequencing.Results: Thirty-four patients received ≥1 binimetinib dose. A 30-mg twice-a-day continuous or 45-mg twice-a-day intermittent binimetinib dose was deemed the recommended phase II dose (RP2D) in combination with 80 mg/m2 i.v. weekly paclitaxel. Rate of grade 3/4 adverse events was 65%. The best overall response rate was 18%-one complete (CR) and four partial responses (PR)-among 28 patients with RECIST-measurable disease. Eleven patients achieved stable disease (SD), yielding a clinical benefit rate (CR+PR+SD) of 57%. Response rates, per both RECIST and CA-125 criteria, were highest in the 45-mg twice-a-day continuous cohort and lowest in the 45-mg twice-a-day intermittent cohort. All four evaluable patients with MAPK pathway-altered tumors experienced clinical benefit.Conclusions: The combination of binimetinib and intravenous weekly paclitaxel was tolerable in this patient population. The RP2D of binimetinib in combination with paclitaxel was 30 mg twice a day as a continuous or 45 mg twice a day as an intermittent dose. Although response rates were modest, a higher clinical benefit rate was seen in patients harboring alterations affecting the MAPK pathway. Clin Cancer Res; 24(22); 5525-33. ©2018 AACR.
