Adverse drug reactions and kinetics of cisplatin excretion in urine of patients undergoing cisplatin chemotherapy and radiotherapy for head and neck cancer: a prospective study.

BACKGROUND: Cisplatin is a high-potency anticancer agent; however, it causes significant adverse drug reactions (ADRs). Potential pharmacokinetic markers must be studied to predict or prevent cisplatin-induced ADRs and achieve better prognosis. This study was designed to investigate the relationship between ADRs and kinetics of cisplatin excretion in the urine of patients undergoing high-dose cisplatin chemotherapy and radiotherapy for head and neck cancer. METHODS: Outpatients with head and neck cancer received a first cycle of high-dose cisplatin chemotherapy (80-100 mg/m2) concurrent to radiotherapy. ADRs (haematological, renal, and gastrointestinal reactions) were classified based on severity by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4, grade 0-4). The kinetics of cisplatin excretion in urine was evaluated by high-performance liquid chromatography over three time periods: 0-12, 12-24, and 24-48 h after the administration of cisplatin. Spearman Correlation test and regression analysis were performed to assess the relationship between ADRs and cisplatin excretion in the urine. RESULTS: In total, 59 patients with a mean age of 55.6 ± 9.4 years were analysed; most patients were male (86.4%), white (79.7%), and with pharyngeal tumours in advanced stages (66.1%). The most frequently observed ADRs were anaemia (81.4%), lymphopenia (78%), and nausea (64.4%); mostly grades 1 and 2 of toxicity. The mean cisplatin excretion was 70.3 ± 64.4, 7.3 ± 6.3, and 5 ± 4 µg/mg creatinine at 0-12, 12-24, and 24-48 h, respectively. Statistical analysis showed that the amount of cisplatin excreted did not influence the severity of ADRs. CONCLUSIONS: The most frequent ADRs were anaemia, lymphopenia, and nausea. Grades 1 and 2 were the severities for most ADRs. The period over which the highest cisplatin excretion observed was 0-12 h after chemotherapy, and cisplatin excretion could not predict toxicity.

Quality of Life of Patients with Squamous Cell Carcinoma of the Head and Neck Receiving High-Dose Cisplatin Chemotherapy and Radiotherapy.

OBJECTIVES: The aim of this study was to evaluate the quality of life (QOL) of patients with squamous cell carcinoma of the head and neck before and during treatment with high-dose cisplatin and radiotherapy. METHODS: This was an observational and longitudinal prospective study conducted from June 2011 to March 2013 at the clinical oncology ambulatory unit of a public teaching hospital in São Paulo, Brazil. The University of Washington Quality of Life Questionnaire was used to measure the QOL of patients before and after each chemotherapy cycle with high-dose cisplatin (80-100 mg/m(2), three cycles) and radiotherapy (2 Gy, 5 days/week for 7 weeks). Data were analyzed using Student t tests, and P < 0.05 was considered statistically significant. RESULTS: Thirty-two patients completed the three cycles of treatment. The study population consisted primarily of white men with a mean age older than 50 years, who had a partner, a low education level, and who were heavy smokers and drinkers, Karnofsky Performance Status of 90% to 100%, pharynx tumors, and stage IV cancer, classified as T4 and N2 stages; the minority of them required interventions such as a feeding tube and tracheostomy. We observed a reduction in QOL after treatment initiation; this reduction was significant after the second chemotherapy cycle and the sixth week of radiotherapy. The abilities to taste, swallow, salivate, and participate in activities and recreation were affected significantly. We also observed a significant improvement in pain and anxiety resulting from the chemoradiation. CONCLUSIONS: Healthcare providers need to be aware of the affected domains to provide improved QOL, well-being, and security to cancer patients who are receiving this type of treatment.

Evaluation of the quality of life of patients before treatment of squamous cell carcinoma of the head and neck by means of chemoradiotherapy.

AIM OF THE STUDY: To identify predictors of quality of life (QOL) in head and neck cancer patients prior to cisplatin chemotherapy and radiotherapy treatment. MATERIAL AND METHODS: A cross-sectional study at a Clinical Oncology department of a teaching hospital in the state of São Paulo, Brazil, from September 2011 to October 2012 was performed. QOL was assessed using the University of Washington QOL Questionnaire. Demographic and clinical characteristics were obtained through interviews with patients and collected from medical records. Multivariate linear regression was used to determine the association between QOL scores and patient-related factors. RESULTS: We studied 48 head and neck cancer patients, who were mostly white (77.1%), males (83.3%), with pharyngeal cancers (66.7%), cancers with stage T4 (45.8%) and N1 (31.2%) tumours, and classified with a Karnofsky Performance Status (KPS) of 90% (37.5%). Patients had excellent scores for saliva (96.2 ±13.5) and shoulder (93.6 ±17.9), with pain and anxiety being the most affected domains (59.6 ±32.4 and 57.5 ±39.2, respectively). A significant relationship of KPS and T stage with overall QOL score was noted. The population with lowest overall QOL score was those who had low KPS scores and T4 tumours. CONCLUSIONS: Head and neck cancer patients prior to cisplatin chemotherapy and radiotherapy treatment, with a low KPS and staged as T4 tumours, have worse overall QOL, and special attention should be given to these patients.

Nausea, vomiting and quality of life of patients with cancer undergoing antineoplastic treatment: an evaluation by pharmacists.

OBJECTIVE: This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL) in patients with cancer receiving antineoplastic treatment. METHODS: Severity of chemotherapy-induced nausea and vomiting (CINV) was measured by Common Terminology Criteria for Adverse Events (CTCAE) and a numerical scale. QOL was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. KEY FINDINGS: Of the 50 patients studied, 60.0% reported nausea (40.0% CTCAE grade 1; 66.7% moderate intensity on numerical scale) and 30.0% reported vomiting (46.7% CTCAE grades 1 and 2, each; 66.7% moderate intensity on numerical scale). CINV did not influence overall QOL. CONCLUSION: The frequency of CINV was high. There was no association between nausea/vomiting and overall QOL.