Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study.

BACKGROUND: We recently reported that self-evaluation of the incidence and severity of treatment-related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0-based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self- and doctor-evaluated day of onset and duration of TSEs in the same population. PATIENTS AND METHODS: Six hundred and four patients were enrolled at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity of nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third chemotherapy cycles. At each time-point, information on TSEs was extracted from the medical charts and compared to patient questionnaires. RESULTS: A total of 594 and 573 paired patient and doctor questionnaires were collected after cycles one and three, respectively. TSE duration was significantly longer when reported by patients compared to doctors for six and seven of ten items after cycles one and three, respectively. Due to the combined effect of doctor underreporting of TSE incidence and duration, the mean percentages of cycle days with TSEs were significantly higher for all ten items when based on patient reports. Day of onset could not be evaluated because of insufficient numbers of complete records. CONCLUSIONS: Self-reporting TSE duration is feasible using a CTCAE-derived questionnaire. As doctors tend to underestimate TSE incidence and duration, patient-reported outcomes should be incorporated into clinical practice, perhaps using eHealth technologies, to harness their potential to better estimate total TSE burden.

Port in oncology practice: 3-monthly locking with normal saline for catheter maintenance, a preliminary report.

INTRODUCTION: Patients with cancer need stable venous access using central vascular devices like central venous ports and peripherally inserted central catheters that can be used for a wide range of indications. Numerous flushing protocols exist including different frequencies for catheter locking to maintain catheter patency. The aim of this retrospective study was to evaluate the incidence of lumen occlusion of central venous ports in a group of adult cancer patients, adopting a policy of locking with normal saline every three months. METHODS: This is a single-center retrospective observational study. During follow-up, we analyzed adult cancer patients who had undergone port insertion from January 1st, 2007 to August 31st, 2014. Flushing and locking were performed every three months with a syringe containing normal saline. RESULTS: We collected data from 381 patients with ports inserted in subclavian vein (379 patients) and in the right jugular vein (2 patients). Locking was performed during 3-monthly follow-up visits. Median follow-up was 810 days (90-2700 days). Among 381 ports, 59 were removed; the reasons for removal were: end of use (45 cases), catheter rupture (9 cases), dislocation (3 cases) and catheter-related bloodstream infection (2 cases). We had no reports of lumen occlusion. CONCLUSIONS: Our data suggest that locking ports with normal saline every three months is not associated with an increased risk of lumen occlusion.

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer.

IMPORTANCE: Patient perspective on chemotherapy-related adverse effects is being increasingly acknowledged both in experimental clinical trials and in clinical practice. OBJECTIVE: To evaluate a 10-item, paper questionnaire derived from the US National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for patient-reported chemotherapy-related adverse effects. DESIGN, SETTING, AND PARTICIPANTS: Prospective, single-arm study of 604 women with breast cancer receiving standard adjuvant chemotherapy conducted at 11 outpatient oncology clinics at academic and nonacademic Italian hospitals between January 2011 and October 2013. The CTCAE version 4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third cycle of chemotherapy. Adverse effect information was also extracted from the medical records to compare with patient-reported data. MAIN OUTCOMES AND MEASURES: Differences in adverse effect-reporting between paired questionnaires and agreement between patient and physician adverse effect-reporting (grade 0 vs grade ≥1) were studied. Linear regression was used to study the effect of the number of patients enrolled at each institution on the magnitude of discrepancy in adverse effect-reporting between patients and physicians. RESULTS: A total of 604 women (median age, 53.4 years; interquartile range, 45.0-62.7 years) were enrolled. The number of patients enrolled at each site varied between 6 and 236. Three patients withdrew consent prior to starting the first cycle of adjuvant chemotherapy. After cycle 1 of adjuvant chemotherapy, 596 patient questionnaires were collected, and 581 patient questionnaires were collected after cycle 3. Of the questionnaires collected, 594 and 573 had corresponding questionnaire results extracted from medical records at the same time point. The median (interquartile range) percentage of completed questionnaire fields was 82% (80%-88%) for both the first and third cycle questionnaires, and the results of the 2 patient questionnaires showed a reduction in vomiting (severity), diarrhea (both incidence and severity), and pain (both incidence and severity), as well as a statistically significant increase in dysgeusia (both incidence and severity) and dyspnea (both incidence and severity) in the second patient-completed questionnaire. The frequency and severity of chemotherapy-related adverse effects were consistently greater in patient-reported data than physician-reported data. As a result, interrater agreement was low for most adverse effects, ranging from 0.10 for anorexia to 0.54 for vomiting (Cohen κ statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting adverse effects and the number of patients enrolled at each site. CONCLUSIONS AND RELEVANCE: Adherence to reporting adjuvant chemotherapy-related adverse effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the physician-patient relationship.