To evaluate the association between functional status based on a geriatric assessment (GA) and outcomes of tolerance to treatment in patients with lung or head and neck cancer receiving radiation ...therapy (RT) or chemoradiation (CRT).
A prospective cohort study was conducted in patients aged ≥65 years with head and neck cancer or lung cancer undergoing curative intent RT or CRT. Pretreatment GA, health-related quality of life (HRQoL), and patient-reported outcomes (PRO) were obtained. Questionnaires were repeated biweekly during RT and at 6 weeks after treatment. Dysfunction was defined as scores <14 on the Instrumental Activities of Daily Living scale. Poor tolerance to treatment was defined by hospitalization, >3-day treatment delay, change in RT or CRT regimen, or death. Associations of dysfunction with tolerance to radiation therapy, HRQoL changes, and PRO ratings were evaluated.
Of the 50 patients accrued, 46 had evaluable data. Mean age was 72.5 years (range, 65-92 years). At baseline, 37% had dysfunction. Poor tolerance to RT or CRT occurred in 39%. There was no association between dysfunction and tolerance. Patients with dysfunction had lower baseline HRQoL scores. From baseline to end of RT, those with baseline dysfunction had less of a decline in Role Functioning (P=.01) and Global Health Score (P=.04) domains. However, from end of RT to 6-week follow-up, those with dysfunction were more likely to continue to drop in the Physical, Role Functioning, and Social domains (all P<.01). Dysfunction at baseline was also associated with higher severity of certain PROs.
Pretreatment dysfunction was associated with continued decline and lack of recovery of HRQoL in this patient population. Larger studies could further elucidate the GA's predictive value.
Abstract The mononuclear phagocyte system (MPS) has previously been shown to significantly affect the clearance, tumor delivery, and efficacy of nanoparticles (NPs). This study profiled MPS cell ...infiltration in murine preclinical tumor models and evaluated how these differences may affect tumor disposition of PEGylated liposomal doxorubicin (PLD) in models sensitive and resistant to PLD. Significant differences in MPS presence existed between tumor types (e.g. ovarian versus endometrial), cell lines within the same tumor type, and location of tumor implantation (i.e. flank versus orthotopic xenografts). Further, the differences in MPS presence of SKOV-3 ovarian and HEC1A endometrial orthotopic cancer models may account for the 2.6-fold greater PLD tumor exposure in SKOV-3, despite similar plasma, liver and spleen exposures. These findings suggest that profiling the presence of MPS cells within and between tumor types is important in tumor model selection and in tumor types and patients likely to respond to NP treatment.
The purpose of this study was to compare chemoradiation therapy (CRT) with radiation therapy (RT) only in an older patient population with head and neck squamous cell carcinoma (HNSCC).
Using the ...Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database (1992-2007), we identified a retrospective cohort of nonmetastatic HNSCC patients and divided them into treatment groups. Comparisons were made between CRT and RT cohorts. Propensity scores for CRT were estimated from covariates associated with receipt of treatment using multivariable logistic regression. Standardized mortality ratio weights (SMRW) were created from the propensity scores and used to balance groups on measured confounders. Multivariable and SMR-weighted Cox proportional hazard models were used to estimate the hazard ratio (HR) of death for receipt of CRT versus RT among the whole group and for separate patient and tumor categories.
The final cohort of 10,599 patients was 68% male and 89% white. Median age was 74 years. Seventy-four percent were treated with RT, 26% were treated with CRT. Median follow-up points for CRT and RT survivors were 4.6 and 6.3 years, respectively. On multivariable analysis, HR for death with CRT was 1.13 (95% confidence interval CI: 1.07-1.20; P<.01). Using the SMRW model, the HR for death with CRT was 1.08 (95% CI: 1.02-1.15; P=.01).
Although the addition of chemotherapy to radiation has proven efficacious in many randomized controlled trials, it may be less effective in an older patient population treated outside of a controlled trial setting.
Background Multiple clinical trials have shown that neoadjuvant systemic therapy has a benefit in women who are borderline lumpectomy candidates and in those with locally advanced breast cancers by ...reducing the mastectomy rate and making inoperable tumors operable. The study aim was to examine the patterns of neoadjuvant chemotherapy and endocrine therapy use among younger women in the United States treated at different types of cancer centers. Study Design Data from the National Cancer Data Base for 118,086 women younger than 65 years with clinical stage IIA (T2N0 only) to IIIC breast cancer. Following the National Comprehensive Cancer Network guideline categorization, patients were grouped into those who were borderline lumpectomy candidates (clinical stage IIA T2N0 only, IIB, or IIIA T3N1 only) or those with locally advanced disease (clinical stage IIIA T0-3N2 only, IIIB, or IIIC). The main outcome was the proportion of women who received neoadjuvant systemic therapy. Results Use of neoadjuvant chemotherapy ranged from 17% (stage IIA) to 79% (stage IIIB). Across almost all stage and receptor subtypes, the use was lower in community vs academic centers. On multivariable analysis, use of neoadjuvant chemotherapy was decreased in community vs academic centers (borderline lumpectomy candidates: adjusted risk ratio = 0.73; 95% CI, 0.69–0.77; locally advanced disease: adjusted risk ratio = 0.78; 95% CI, 0.74–0.83). Conclusions Use of guideline-concordant neoadjuvant chemotherapy is significantly higher among women treated at academic vs community centers in young and healthy women who do not commonly have contraindications to this treatment. Our study identified a potential disparity in cancer care by type of center where patients receive treatment.
Background Despite rigorous manual counting protocols and the classification of retained surgical items (RSIs) as potential “never events,” RSIs continue to occur in approximately 1 per 1,000 to ...18,000 operations. This study's goals were to evaluate the incorporation of a radiofrequency detection system (RFDS) into existing laparotomy sponge- and Raytec-counting protocols for the detection of RSIs and define associated risk factors. Study Design All patients undergoing surgery at the University of North Carolina Hospitals from September 2009 to August 2010 were enrolled consecutively. The performance of an RFDS-incorporated accounting protocol for detecting RSIs was prospectively evaluated. Several operative metrics were recorded to identify risk factors for miscounts. Results A total of 2,285 patients were enrolled. One near miss was detected by the RFDS. Thirty-five miscounts occurred, for a rate of 1.53%. The ultimate locations of miscounted items were surgical site (n = 11), within operative suite (n = 10), surgical drapes (n = 2), and emergency protocol deviations (n = 12). Perioperative variables associated with miscounts were higher estimated volume of blood lost, longer operations, higher number of laparotomy sponges used, open surgical approach, “after hours” operations, change of surgical team during operation, weekend or holiday operations, unanticipated changes in operative plan during surgery, and emergency operations. Body mass index was not associated with miscounts. Surveys completed by participating surgical staff suggested high confidence in the RFDS for prevention of RSIs. Conclusions The incorporation of the RFDS assisted in the resolution of a near-miss event (1 of 2,285) not detected by manual counting protocols and assisted in the resolution of 35 surgical-sponge miscounts. No known RSIs occurred during the study period. Risk factors for miscounts were identified and can help identify at-risk surgical populations.
Introduction. Fatigue is a distressing symptom for adults with acute leukemia, often impeding their ability to exercise. Objectives. 1) Examine effects of a 4-week mixed-modality supervised exercise ...program (4 times a week, twice a day) on fatigue in adults with acute leukemia undergoing induction chemotherapy. 2) Evaluate effects of exercise program on cognition, anxiety, depression, and sleep disturbance. 3) Evaluate effect of intervention on adherence to exercise. Methods. 17 adults (8 intervention, 9 control), aged 28-69 years, newly diagnosed with acute leukemia were recruited within 4 days of admission for induction treatment. Patient-reported outcomes (PROs) (fatigue, cognition, anxiety, depression, sleep disturbance, mental health, and physical health) and fitness performance-based measures (Timed Up and Go TUG, Karnofsky Performance Status, and composite strength scoring) were assessed at baseline and at discharge. Changes in PRO and performance-based physical function measures from baseline to time of discharge were compared between groups using Wilcoxon Rank Sum tests. Results. With PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue, we found a median change in fatigue (−5.95) for the intervention group, which achieved a minimally important difference that is considered clinically relevant. Intervention group reduced their TUG performance by 1.73 seconds, whereas the control group remained fairly stable. A concerning finding was that cognition decreased for both groups during their hospitalization. 80% adherence of visits completed with a mean of 6 sessions attended per week. Conclusions. Our study provides information on the impact of exercise on symptomatology, with focus on fatigue and other psychosocial variables in acute leukemia.
Abstract Background Local recurrence (LR) rates in patients with retroperitoneal sarcoma (RPS) are high, ranging from 40% to 80%, with no definitive studies describing the best way to administer ...radiation. Intraoperative electron beam radiation therapy (IOERT) provides a theoretical advantage for access to the tumor bed with reduced toxicity to surrounding structures. The goal of this study was to evaluate the role of IOERT in high-risk patients. Methods An institutional review board approved, single institution sarcoma database was queried to identify patients who received IOERT for treatment of RPS from 2/2001 to 1/2009. Data were analyzed using the Kaplan–Meier method, Cox regression, and Fisher Exact tests. Results Eighteen patients (median age 51 y, 25–76 y) underwent tumor resection with IOERT (median dose 1250 cGy) for primary ( n = 13) and recurrent ( n = 5) RPS. Seventeen patients received neoadjuvant radiotherapy. Eight high-grade and 10 low-grade tumors were identified. Median tumor size was 15 cm. Four patients died and two in the perioperative period. Median follow-up of survivors was 3.6 y. Five patients (31%) developed an LR in the irradiated field. Three patients with primary disease (25%) and two (50%) with recurrent disease developed an LR ( P = 0.5). Four patients with high-grade tumors (57%) and one with a low-grade tumor (11%) developed an LR ( P = 0.1). The 2- and 5-y OS rates were 100% and 72%. Two- and 5-y LR rates were 13% and 36%. Conclusions Using a multidisciplinary approach, we have achieved low LR rates in our high-risk patient population indicating that IOERT may play an important role in managing these patients.
Abstract Context Patient-reported outcomes (PROs) provide a way to understand the effects of hematopoietic cell transplantation (HCT)-related stress on patients' lives. We previously reported that ...weekly collection of PROs is feasible. Objectives Here, we report on the feasibility of daily patient-reported symptom collection and examine the relationship between daily vs. weekly symptom reporting over time. Methods We analyzed data from 32 autologous and allogeneic HCT patients obtained until Day (D) +100. We used questions from the PRO version of the Common Terminology Criteria for Adverse Events to capture symptoms. Results We found that overall rates of daily survey completion were moderate to high (range 67%–86%). The effect size of the difference between the maximum daily severity score and the weekly severity score ranged from 0.15 to 0.35, and the concordance correlation coefficient ranged from 0.513 to 0.834. Concordance of daily and weekly surveys was higher for maximum daily severity rating and mean daily severity rating than for minimum daily severity rating or most recent daily severity rating. Conclusion We conclude that a seven-day recall period for symptom severity provides acceptable accuracy and precision in the first 100 days after HCT. Further studies to explore the utility of daily symptom reporting within specific clinical contexts may be warranted.
Patients with chronic myeloid leukemia (CML) can be treated with oral tyrosine kinase inhibitors (TKIs). Pharmacist-led oral chemotherapy programs (POCPs) can improve TKI adherence rates, but ...evaluation of patient satisfaction with such programs is rare. The purpose of this analysis was to compare the satisfaction of patients with CML taking TKIs enrolled in a POCP program with that of those not enrolled. Secondary objectives were to assess adherence rates, patient-reported value, early molecular response (EMR) rates, and major molecular response (MMR) rates. This study utilized an anonymous telephone survey of patients who had taken TKIs for at least 3 months. Molecular response was determined by chart review. Of 40 patients surveyed, 50% were enrolled in the POCP, and the POCP group had more African Americans than the non-POCP group. More patients in the POCP were satisfied with their care than in the non-POCP group (100% vs. 75%, p = .047). There were no differences in high patient-reported adherence (55% vs. 60%, p = 1.000), patient-reported value for integrated services (95% vs. 90%, p = 1.000), achievement of EMR (75% vs. 75%, p = 1.000), or MMR (85% vs. 85%, p = 1.000). Patients in the POCP received more structured clinical pharmacy services; however, both groups felt the clinical pharmacist played a major role in their care (85% vs. 90%, p = 1.000). Patients in the non-POCP group reported lower satisfaction than those enrolled resulting from fragmented care that was likely due to external specialty pharmacies. Irrespective of POCP enrollment, patients reported clinical pharmacists play a major role in their therapy and value integration of their specialty pharmacy and medical team.
Chronic lymphocytic leukemia (CLL) is a B-cell neoplasm with clonal expansion of small lymphocytes. Ibrutinib, an irreversible inhibitor of Bruton tyrosine kinase (BTK), is a first-line treatment ...option, and recent data suggest that strict adherence is directly related to clinical outcomes.
The primary objective of this study was to quantify ibrutinib adherence rates in real-world patients with CLL on ibrutinib; secondary outcomes included progression-free survival and overall survival.
This retrospective study included subjects who were treated at a large academic medical center over approximately 5 years. Subjects were at least 18 years, diagnosed with CLL or small lymphocytic lymphoma, and treated with ibrutinib monotherapy for at least 6 months. Adherence was quantified using the medication possession ratio (MPR), which is the ratio of the sum of days' supply of medication in a period over the number of days in that period, and was based on fill history from the medical center's specialty pharmacy.
For the 32 subjects in this study, the mean ibrutinib adherence rate was 91.7% (range, 84.4%-100%). Only 3 subjects had disease progression, and 1 death was recorded while on therapy (all with MPR < 95%); therefore, analyses of clinical outcomes were unable to be assessed due to a low number of events. There were no statistically significant differences in rates of adherence based on baseline characteristics and adverse drug events.
In patients with CLL treated with ibrutinib, mean adherence was 91.7%, which is lower than rates seen in clinical trials.
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