Background Renal cell carcinoma (RCC) represents only 2-3% of all cancers. Sunitinib is a standard initial therapy in advanced and metastatic renal cell carcinoma. Purpose A retrospective review was performed to assess the safety of sunitinib in RCC. Materials and methods RCC patients undergoing sunitinib treatment and follow-up for at least one month were included. Variables: sex, age, nephrectomy status, histology, risk group, metastatic sites, sunitinib starting dose, % adverse events (AEs) from Common Terminology Criteria for Adverse Events (CTCAE version 4.0), % grade 3-4 AE, % starting dose reduction, % extra week rest period and % colony stimulating factors (CSF) used for toxicity management. Statistical analysis by SPSS 18.0. Results 19 patients were analysed: 73.7% male, median age 62 years, 94.7% previously nephrectomised (78.9% radical nephrectomy and 15.8% partial nephrectomy), median time to sunitinib treatment 60.5 months. By histology, 79.0% was clear cell carcinomas. Grouped according to their risk (57.9% of patients could be assessed for risk): 15.8% were assessed as favourable, 26.3% intermediate and 15.8% unfavourable. Median metastatic sites were 3, sorted by frequency: lung 68.4%, liver 47.4%, soft tissues 26.3%, bone and pleura 21.1%, brain, skin and heart 10.5%. Starting dose of sunitinib were 68.4% 50 mg/day, 26.3% 37.5 mg/day and 5.3% 25 mg/day administered for four consecutive weeks and followed by a two-week rest period. 100% patients reported at least one AE. The most frequent AEs were asthenia 11.6%, neutropenia or thrombocytopenia 10.7%, hypertension or diarrhoea 9.9%. Grade 3-4 events were neutropenia 4.1%, anaemia 2.5%, bleeding 1.6%, hypertension, hand-foot syndrome or diarrhoea <1.0%. In addition, one case of toxic hepatitis and a cerebral oedema event were reported. Median cycles sunitinib received were 4.3. Toxicity management consisted of dose reduction 38.4%, extra week rest period 57.6%, no patients required CSF as filgrastim or epoetin α. Conclusions With sunitinib, adverse events such as hematologic toxicity, asthenia, hypertension and gastrointestinal events were common. Toxicity management included dose reduction or additional rest period.
Background Bendamustine is an alkylating agent recently approved in several European countries for non-Hodgkin's lymphoma (NHL) refractory to rituximab (R). Purpose To describe bendamustine use in lymphomas and review safety in our clinical practice. Materials and methods Retrospective study carried out during 2010. The following data were collected: sex, age, previous treatment, bendamustine dosage, treatment duration, % adverse reactions (ARs), % colony-stimulating factor required and reduction of the initial dose of bendamustine. Results 7 patients received bendamustine: 71.4% male, age 53.9 at the beginning of bendamustine treatment. 42.8% Hodgkin's lymphoma (HL) and 57.2% NHL, 50.0% were mucosa-associated lymphoma tissue (MALT) and 50.0% follicular NHL. An average of 3 treatment lines were used before bendamustine was used. In NHL patients (n=4), first-line treatment was CHOP±R; several schemes were used in the second line (BEACOPP-14, DHAP). Bendamustine was used as third line: 50% combined with rituximab and 50.0% in monotherapy. There were no standard dose criteria for bendamustine: 90 mg/m2 (2 patients), 100 mg/m2 and 120 mg/m2 one each. In HL patients (n=3), 2 patients received ABVD followed by bone marrow transplant and 1 patient BEACOPP-14 at first. In second and third-line treatment different schemes were administered (BEACOPP-14, GEMOX, DHAP and CNOP). As the fourth line bendamustine was requested as off-label at 110-120 mg/m2. In this study, bendamustine treatment was continued for 22.85 weeks (95% CI 19.11 to 26.60). The most common AR was haematological toxicity (85.7%); grade 3-4 neutropenia appeared in 9.5% and anaemia in 4.8% of patients. Use of colony-stimulating factor and epoetin alfa were essential in 71.4% patients; it was not necessary to reduce the dose of bendamustine. Other ARs were fatigue 14.3%, fever, nausea or vomiting 9.5%. Conclusions Experience with bendamustine in Hodgkin's and Non-Hodgkin's lymphoma in our institution is limited. Haematological toxicity is common and can be managed with colony-stimulating factor.
BackgroundCancer patients receiving chemotherapy may be at risk of drug interactions between antineoplastic agents and drugs prescribed in primary care, which can lead to an increase in the number and severity of adverse drug events or a reduction in treatment effectiveness.PurposeTo assess the incidence of potential interactions between chemotherapy drugs prescribed by oncologists in hospital care and any other drugs prescribed by general practitioners in primary care.Material and methodsRetrospective and observational study. Patients diagnosed with any type of cancer between 1st May and 30th September 2014 who received oral and intravenous chemotherapy were included. Data were obtained from two computerised order entry systems: Oncowin (hospital setting) and electronic medical history (Primary Care setting). Potential interactions were checked with Micromedex 2.0: minor (limited clinical effects), moderate (interaction may exacerbate the patient’s condition and/or require an alteration of treatment) and major (can lead to hospitalisation/death).Results340 patients. Median age 66 years old (28–89) [51.2% >65 years old, 39.1% 45–65 years old and 9.7% <45 years old]. 54.5% men. 1,634 revised drugs, 4.8 drugs/patient (13.8% of patients did not take medicine at home). Potential interactions detected: 67 in 49 different patients (14.4% of patients studied); 1.5% minor interactions, 22.4% moderate and 76.1% major interactions. Interactions detected were more frequent in metastatic setting (52.2%): 85.7% major and 14.3% moderate, followed by adjuvant treatment (19.4%) and neoadjuvant treatment (10.4%). Interactions were most frequent with erlotinib, paclitaxel, pemetrexed, methotrexate, capecitabine and pazopanib as cytostatic drugs and omeprazole, simvastatin, dexketoprofen and acetylsalicylic acid as usual drugs. Highest frequency of severe interactions was between erlotinib with proton pump inhibitors and NSAIDs (11.8% each).ConclusionThe vast majority of potential drug interactions are major and could be reduced by encouraging communication between the pharmacist, oncologist and primary care doctor.ReferenceFlockhart DA. Drug Interactions: Cytochorme P450 Drug Interaction Table. Indiana Universitiy School of Medicine (2007) http://medicine.iupui.edu/clinpharm/ddis/clinical-table/, Accessed [2014 Aug]No conflict of interest.
Background KRAS gene mutations are associated with a worse metastatic colorectal cancer (mCRC) prognosis. Purpose To assess the effectiveness of the first-line treatment of mCRC according to KRAS mutational status. Materials and methods Retrospective and observational study. It included patients who started chemotherapy for mCRC between October 2011 and June 2012. Effectiveness measure was the median progression-free survival (PFS) and response rate measured by RECIST criteria. Results 79 patients. Mean age at diagnosis: 66 years old, 54% men. Median PFS was 11 months. The KRAS mutational status was determined for 88.6% of the patients, of which 52.9% was mutated. Median PFS was 13 and 10 months in wild-type and mutated KRAS patients respectively. Although statistically significant differences were not found for a 95% confidence interval (CI) (p = 0.058), they were considered a trend. A response was detected in 50% and 54.5% of wild-type and mutated KRAS patients respectively. In the mutated KRAS group, median PFS was 9 and 10 months in bevacizumab and other regimes without targeted treatment respectively (p = 0.740). 51.9% and 20% of patients treated with bevacizumab and other regimes without targeted treatment respectively responded. In the wild-type KRAS group, median PFS was 14 and 10 months in cetuximab/panitumumab and bevacizumab treated patients respectively (p = 0.136). 50% and 54.5% of patients treated with cetuximab/panitumumab and bevacizumab respectively responded. In both groups, treatment was mostly associated with oxaliplatin and 5-fluorouracil or capecitabine. Conclusions There was a trend to higher median PFS in wild-type KRAS patients, fitting with the worse prognosis in mutated KRAS patients. Response rate and median PFS were similar in wild-type and mutated KRAS patients regardless of the targeted therapy used. No conflict of interest.
Background Non-small cell lung cancer (NSCLC) accounts for most cases of lung cancer. Approximately 40% of patients with NSCLC present with advanced-stage disease at the time of diagnosis. Purpose To analyse the median overall survival in patients with NSCLC stage IIIB or IV. Materials and MethodsRetrospective observational study. Patients with NSCLC stage IIIB or IV who started treatment between 01/01/2011 and 30/06/2011. Data source: Patient medical records, oncology programme (Oncowin) and outpatient dispensing record programme (SAVAC and Farmatools). Data recorded: age, gender, age at diagnosis, stage, histology, chemotherapy, number of chemotherapy cycles and number of prior chemotherapy regimens. Results Thirty patients were included with a median age at diagnosis of 63 years (IC95% 60–66). 73.3% were male. The stage at time of diagnosis was IV in 80% of patients. The most common histology was adenocarcinoma (50%), 30% squamous cell carcinoma, 10% large cell and another 10% other histological type. Platinum-based chemotherapy was the first line treatment in 66.7% of the patients and for the remaining 23.3% it was vinorelbine alone or in combination. Six patients received maintenance treatment, three with erlotinib, two with pemetrexed and one with bevacizumab. The median progression-free survival time was 4 months (IC95% 2.9–5.1) in patients receiving maintenance treatment and 3 months (IC95% 0.8–5.2) in patients who were not given maintenance treatment. The median overall survival time was 6 months (IC95% 1.2–10.8) for patients with maintenance treatment and also 6 months (IC95% 3.1–8.8) in patients without maintenance treatment. Conclusions Platinum-based chemotherapy remains the standard treatment. According to the latest guidelines issued by ESMO the role of maintenance is not yet defined. In our study only a few patients were candidates for this treatment. The median overall survival time found in our study was similar in the two groups. No conflict of interest.
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