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Common Terminology Criteria (common + terminology_criterion)
Selected AbstractsIntraperitoneal chemotherapy for advanced epithelial ovarian malignancy: Lessons learnedAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 6 2009Michael BUNTING Background:, The administration of intraperitoneal (IP) chemotherapy as first-line adjuvant treatment for women with optimally debulked advanced ovarian malignancy results in improved median and overall survival when compared with intravenous (IV) chemotherapy. However, the number of adverse events and toxicities are increased in patients treated with IP chemotherapy. In addition, the administration of IP chemotherapy is technically more challenging and the schedule is more demanding in terms of time and resources. Aims:, We report on our initial experience with the administration of IP chemotherapy at two gynaecological oncology units in Australia. Methods:, We collected retrospective data from a series of 23 women undergoing IP chemotherapy as adjuvant treatment for advanced ovarian cancer. In addition to standard (Common Terminology Criteria for Adverse Events v3.0, CTCAE) toxicity data, we collected technical data specific to the administration of IP chemotherapy. Results:, The average number of IP chemotherapy cycles received was 4.3. Forty-three per cent of patients received all six planned IP chemotherapy cycles. Thirty-nine per cent of patients discontinued their IP treatment. Of those, 22% were discontinued because of drug-related toxicities and the remaining 17% experienced a port complication or toxicity directly related to the route of administration. Conclusions:, This study demonstrates the feasibility and practicality of and lessons learned from initial experiences with IP chemotherapy for ovarian cancer in Australia. [source] Effects of epidermal growth factor receptor inhibitor-induced dermatologic toxicities on quality of life,CANCER, Issue 16 2010Smita S. Joshi MD Abstract BACKGROUND: Epidermal growth factor receptor (EGFR) inhibitors frequently result in dermatologic toxicities, including rash, xerosis, pruritus, and paronychia. Although the frequency and severity of these events have been described, their effect on health-related quality of life (QoL) remains poorly understood. By using a dermatology-specific questionnaire, the authors examined the effect of these toxicities on QoL. METHODS: Patients completed the Skindex-16, a questionnaire that measures the effects on 3 domains of QoL: symptoms, emotions, and functioning. The severity of dermatologic toxicities was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE). Correlations of dermatology QoL scores with NCI-CTCAE grade, skin phototype (SPT), sex, age, type of EGFR inhibitor, and cancer type were investigated. RESULTS: Concordant with greater severity of rash grade, there was an increase in median scores for symptoms (P = .0006), emotions (P < .0001), function (P = .001), and overall score (P < .0001). There was an inverse correlation between age and emotions (r = ,0.26; P = .03) and overall score (r = ,0.25; P = .04). There was a significant difference between patients aged ,50 years and patients aged >50 years with regard to symptoms (P = .02), emotions (P = .03), functioning (P = .04), and overall score (P = .02). There were no significant differences between QoL and SPT, sex, treatment type, or cancer type (P > .05). CONCLUSIONS: Toxicities, including rash, xerosis, paronychia, and pruritus, adversely affected QoL, and rash was associated with a QoL greater decrease. Younger patients reported lower overall QoL than older patients who had the same toxicities. The current results support using the NCI-CTCAE as a correlative tool for measuring the effects of rash on dermatology-specific QoL. Cancer 2010. © 2010 American Cancer Society. [source] Radioembolization of colorectal hepatic metastases using yttrium-90 microspheresCANCER, Issue 9 2009Mary F. Mulcahy MD Abstract BACKGROUND: The objective of the current study was to determine the safety and efficacy of Yttrium-90 (Y90) microsphere treatment in patients with liver-dominant colorectal metastases. METHODS: Seventy-two patients with unresectable hepatic colorectal metastases were treated at a targeted absorbed dose of 120 Gray (Gy). Safety and toxicity were assessed using version 3 of the National Cancer Institute Common Terminology Criteria. Response was assessed by anatomic imaging and positron emission tomography (PET). Survival from the diagnosis of hepatic metastases and first treatment were estimated using the Kaplan-Meier method. Substratification analyses were performed. RESULTS: The median dose delivered was 118 Gy. Treatment-related toxicities included fatigue (61%), nausea (21%), and abdominal pain (25%). Grade 3 and 4 bilirubin toxicities were observed in 9 of 72 patients (12.6%). The tumor response rate was 40.3%. The median time to hepatic progression was 15.4 months, and the median response duration was 15 months. The PET response rate was 77%. Overall survival from the first Y90 treatment was 14.5 months. Tumor replacement (,25% vs >25%) was associated with significantly greater median survival (18.7 months vs 5.2 months). The presence of extrahepatic disease was associated negatively with overall survival (7.9 months vs 21 months). Overall survival from the date of initial hepatic metastases was 34.6 months. A subset analysis of patients who had an Eastern Cooperative Oncology Group performance status of 0 demonstrated a median survival of 42.8 months and 23.5 months from the time of hepatic metastases and Y90 treatment, respectively. CONCLUSIONS: Y90 liver therapy appears to provide sustained disease stabilization with acceptable toxicity. Asymptomatic patients with preserved liver function at the time of Y90 appeared to benefit most from treatment. Cancer 2009. © 2009 American Cancer Society. [source] Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes,CANCER, Issue 4 2008Results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB) Abstract BACKGROUND. Epidermal growth factor receptor (EGFR) inhibitors are effective cancer therapies, but they are reported to cause a rash in >50% of patients. In the current study, the authors examined the use of tetracycline for rash prevention. METHODS. This placebo-controlled, double-blinded trial enrolled patients who were starting cancer treatment with an EGFR inhibitor. Patients could not have had a rash at the time of enrollment. All patients were randomly assigned to receive either tetracycline at a dose of 500 mg orally twice a day for 28 days versus a placebo. Patients were monitored for rash (through monthly physician assessment and weekly patient-reported questionnaires), quality of life (using the SKINDEX-16, a skin-specific quality of life index), and adverse events. Monitoring occurred during the 4-week intervention and then for an additional 4 weeks. The primary objective of the current study was to compare the incidence of rash between the study arms, and the enrollment of 30 patients per arm provided a 90% probability of detecting a 40% difference in incidence with a P value of .05 (2-sided). RESULTS. A total of 61 evaluable patients were enrolled. The 2 treatment arms were well balanced with regard to baseline characteristics, dropout rates, and rates of discontinuation of the EGFR inhibitor. The incidence of rash was found to be comparable across treatment arms. Physicians reported that 16 patients treated with tetracycline (70%) and 22 patients treated with placebo (76%) developed a rash (P = .61). Tetracycline appears to have lessened the rash severity, although the high dropout rates invite caution when interpreting these findings. By Week 4, physician-reported grade 2 rash (using the National Cancer Institute's Common Terminology Criteria for Adverse Events [version 3.0]) occurred in 17% of tetracycline-treated patients (n = 4 patients) and in 55% of placebo-exposed patients (n = 16 patients) (P = .04). Patients treated with tetracycline reported better scores, as per the SKINDEX-16, on certain quality-of-life parameters such as skin burning or stinging, skin irritation, and being bothered by the persistence/recurrence of a skin condition. Adverse events were found to be comparable across treatment arms. CONCLUSIONS. In the current study, tetracycline was not found to prevent EGFR inhibitor-induced rashes and therefore cannot be clinically recommended for this purpose. However, preliminary observations of diminished rash severity and improved quality of life suggest this antibiotic merits further study. Cancer 2008. © 2008 American Cancer Society. [source] | ||||||||||