Assessment Of Symptom Distress Research Articles

Abstract B81: Phase I/II trial of vorinostat in combination with etoposide in pediatric patients with relapsed/refractory solid tumors.

Abstract Introduction: Vorinostat has been shown to potentiate DNA damage induced by topoisomerase II inhibitors in a sequence dependent fashion. A multi-center, open label phase I study with escalating doses of vorinostat in combination with etoposide was conducted to establish the safety of the combination in pediatric patients with refractory solid tumors to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and recommended phase II dose (RP2D) of this regimen. Methods: Eligible patients were ≤21 years of age with relapsed/refractory solid tumors including central nervous system tumors. Study design consisted of a standard 3+3 dose escalation schema. Vorinostat was administered once daily for days 1-4 of the treatment cycle in escalating doses (125 mg/m2, 160 mg/m2, 210 mg/m2, and 270 mg/m2). Etoposide was administered at a fixed dose of 100 mg/m2/day on days 3-5 of the treatment cycle. Etoposide was administered 4 hours after administration of vorinostat. Each treatment cycle was 21 days. Intrapatient dose escalation was not permitted. The maximum tolerated dose (MTD) was defined as the highest dose level with an observed incidence of dose-limiting toxicity (DLT) in no more than one of six patients within the first treatment cycle. Histone acetylation, histone phosphorylation, and gene expression profiling were performed as correlative studies. Exploratory studies included assessment of symptom distress by self report in children between the ages of 10 and 18 with the MSAS (10-18) instrument. Results: Twenty-one patients (CNS 12, neuroblastoma 6, Wilms’ tumor 1, rhabdomyosarcoma 1, hepatoblastoma 1) were enrolled on study and 19 patients were treated. Median age was 12 years (range 4-20 years); 11 males and 10 females with a median performance status 90% were included. One patient experienced a DLT (Gr 4 platelet count decreased) at the 1stdose level (125 mg/m2 vorinostat,100 mg/m2 etoposide). The predominant Grade 3 and 4 toxicities attributed to the combination included white blood cell count decreased (45%), neutrophil count decreased (55%), lymphocyte count decreased (30%), and platelet count decreased (25%). Grade 3-4 events in ≤10% of patients included anemia (10%), hypophosphatemia (5%), and infection (5%). Stable disease was reported in 4 patients (CNS 3, sarcoma 1). Biologic correlative studies and symptom distress data will be presented. Conclusion: Vorinostat followed in combination with etoposide was found to be safe and well tolerated in children with refractory solid tumors. The recommended phase II dose was established at vorinostat 270 mg/m2 and etoposide 100 mg/m2 and will be evaluated in an ongoing phase II study in pediatric patients with sarcoma. Citation Information: Mol Cancer Ther 2013;12(11 Suppl):B81. Citation Format: Tanya M. Trippett, Amy Smith, Kathleen Neville, Susan Chi, Aru Narendran, Robert Arceci, Jennifer Direnzo, Lia Gore. Phase I/II trial of vorinostat in combination with etoposide in pediatric patients with relapsed/refractory solid tumors. [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2013 Oct 19-23; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2013;12(11 Suppl):Abstract nr B81.

Assessment of Symptom Distress in Cancer Patients Before and After Radiotherapy

Previous literature revealed that cancer patients undergoing radiotherapy commonly experience physical and psychological symptom distress. Except lack of medical information, inadequate communication with physicians also affected patients' willingness and preparation toward radiotherapy. The prognosis consequently becomes worse. This study aimed to evaluate the change in symptom distress in cancer patients after radiotherapy and its predisposing factors. A longitudinal design was conducted on 164 cancer patients who underwent radiotherapy at a medical center in southern Taiwan. The structured questionnaire included sections on demographics, medical conditions, and a symptom distress scale. Of the cancer patients, 35.9% reported an increase in the overall figures of symptom distress after radiotherapy, whereas 32.2% experienced a decrease. Cancer patients 20 to 39 years old or who received radiotherapy on the head and neck reported the greatest increase in bleeding and the overall figure of symptom distress. Patients after radiotherapy on the head and neck experienced significant increase in bowel disturbance. Radiotherapy did not necessarily increase symptom distress in all patients. The development of bleeding and the overall figure of symptom distress were closely related to younger age and site of radiotherapy. For those cancer patients 20 to 39 years old or who received radiotherapy on the head and neck, nurses may strengthen health education before radiotherapy and pay more attention after radiotherapy, especially in bleeding distress, and remind their families of the correct steps for nursing a wound after radiotherapy and the harmful effects of wound odor on patients' interpersonal relations.

Perceptions of symptoms distress in lung cancer patients: II. Behavioral assessment by primary family caregivers

Literature on assessment of symptom distress has focused primarily on patients' and nurses' perceptions in the hospital setting. To date, no research has examined behavioral measurement and cues that primary family caregivers respond to when assessing patients' level of distress arising from individual symptoms in the home setting. The qualitative data obtained from 37 primary family caregivers of patients with lung cancer was designed to augment quantitative results discussed elsewhere. Content analysis was performed on written responses to an open-ended questionnaire in which family caregivers identified cues that they responded to when assessing patients' distress from symptom items. The results identified the categories of impaired functioning and verbal cues as the most frequent indices of symptom distress. This study documents that certain behavioral measures for assessing symptom distress may be clinically useful to observers. Primary family caregivers are shown in this study to take a limited multidimensional approach in the assessment of patients' distress from symptoms.

Use of a modified symptom distress scale in assessment of the cancer patient

Symptom distress was assessed in a heterogeneous sample of cancer patients using a modified version of the McCorkle and Young ( Cancer Nurs. 1, 373–378, 1978) Symptom Distress scale based on a linear analogue self-assessment (LASA) scale. Validity was assessed. Reliability, based on estimation of internal consistency (Cronbach's coefficient alpha), was high (∝ = 0.97) showing the tool to be reliable and effective in assessment of symptom distress. Of the 120 patients included 73% indicated significant distress from at least one symptom, 55% from two or more and 28% from at least five. Only 25% were suffering widespread or advanced disease suggesting that the incidence of symptom distress is not, of necessity, dependent on the extent of disease. The results obtained using the modified index were compared with those previously obtained by McCorkle and Young (1978) and showed marked similarities between the different cancer patient populations. This indicates that the modified scale is no less effective in assessing symptom distress but this has considerable advantages due to its simplicity and ease of administration.