To assess the efficacy of a risk-adapted treatment policy for patients with stage I seminoma by using universally accepted risk criteria.
Between 1999 and 2003, 314 patients with clinical stage I ...seminoma after orchiectomy were prospectively included. One hundred patients (31.8%) presented no risk factors and were managed with surveillance. In contrast, 131 patients (41.7%) had tumors larger than 4 cm, 33 patients (10.5%) had rete testis involvement, and 50 patients (15.9%) had both risk factors. All the latter received two courses of adjuvant carboplatin.
Chemotherapy was well tolerated, as only 17 patients (7.9%) presented grade 3 to 4 toxicity. Relapses were observed in six patients (6.0%) on surveillance and in seven patients (3.3%) treated with carboplatin (0.8% of tumors larger than 4 cm, 9.1% of those involving the rete testis, and 6.0% of patients with both risk criteria). All were located at the retroperitoneum, except for one at the spermatic cord. Median tumor size was 25 mm (range, 11 to 70 mm), and median time to relapse was 9 months (range, 4 to 28 months). All patients were rendered disease-free with chemotherapy (etoposide plus cisplatin). Median follow-up was 34 months (range, 12 to 72 months). The actuarial 5-year disease-free survival rate was 93.4% for patients on surveillance and 96.2% for patients treated with adjuvant chemotherapy. Overall 5-year survival was 100%.
Adjuvant carboplatin is effective in reducing the relapse rate in patients with stage I seminoma and risk factors. A risk-adapted strategy is safe and feasible and should be considered an alternative to systematic approaches, such as irradiation, chemotherapy, or surveillance.
The functions and workload of medical oncologists are becoming increasingly relevant as cancer is a priority health issue in our country. Taking into account the specific characteristics and ...complexity of caring for cancer patients, the time of physicians attached to Medical Oncology could be distributed as follows: 70% for consultation (including participation in tumour committees and multidisciplinary units), 15% for research and 15% for training, teaching and clinical sessions. The time distribution for Heads of Services or Heads of Units is different, since it must also include their clinical management tasks, team coordination, and relations with other services and institutions. The average time, calculated in minutes, spent on each activity per patient is as follows: first visit and “second visit or results visit” 60–90 min; successive visits at the day hospital 15 min; successive visits of patients for follow-up or checkups 20 min; visits with family members 15–20 min; telephone or e-mail consultations 5–10 min; hospitalisation 20 min; and interconsultation 30–60 min. Also, participation in multidisciplinary committees takes up 60–120 min of an oncologist’s time each week. When new technologies such as electronic medical records, e-mail and other software are used, these times increase with a correction factor that is still to be defined and which could vary according to the centre. Finally, the ratio recommended by SEOM is one medical oncologist for every 83 new patients a year.
Abstract Purpose Several small studies have indicated that the ATM rs1801516 SNP is associated with risk of normal tissue toxicity after radiotherapy. However, the findings have not been consistent. ...In order to test this SNP in a well-powered study, an individual patient data meta-analysis was carried out by the International Radiogenomics Consortium. Materials and methods The analysis included 5456 patients from 17 different cohorts. 2759 patients were given radiotherapy for breast cancer and 2697 for prostate cancer. Eight toxicity scores (overall toxicity, acute toxicity, late toxicity, acute skin toxicity, acute rectal toxicity, telangiectasia, fibrosis and late rectal toxicity) were analyzed. Adjustments were made for treatment and patient related factors with potential impact on the risk of toxicity. Results For all endpoints except late rectal toxicity, a significantly increased risk of toxicity was found for carriers of the minor (Asn) allele with odds ratios of approximately 1.5 for acute toxicity and 1.2 for late toxicity. The results were consistent with a co-dominant pattern of inheritance. Conclusion This study convincingly showed a significant association between the ATM rs1801516 Asn allele and increased risk of radiation-induced normal tissue toxicity.
New advances in the diagnosis and treatment of cancer and the increased incidence and prevalence of this disease have led to an increase in the number and duration of visits in Medical Oncology in ...the last few years. Based on the functions of a medical oncologist and the time recommended for each work activity established by the Spanish Society of Medical Oncology (SEOM), we carried out a pilot study on the three most frequent neoplasias in our country breast cancer (BC), lung cancer (LC) and colorectal cancer (CRC), in order to determine the real time each patient requires from a physician and thus establish a recommendation on the number of medical oncologists necessary. Using the actual itinerary of the first 20 patients of 2009 in each of the three neoplasias seen at the Medical Oncology Service of the Virgen de Valme University Hospital, we measured the number of visits, the antineoplastic treatments received, the number of hospital admissions and average length of stay. During the years following the study, these data were estimated based on the natural history of each neoplasia. During the first year, the average time spent by the medical oncologist was 235, 390 and 265 min on each outpatient with BC, LC and CRC, respectively. In hospitalisation, the average oncologist/patient minutes were 40, 360 and 118 for BC, LC and CRC, respectively. Finally, the time spent on each visit or day of hospitalisation was that recommended by the SEOM, achieving an ultimate ratio of 1 oncologist for every 83 first visits.
There is an underlying feeling in the oncology community that chemotherapy has reached a therapeutic "glass ceiling" in non-small cell lung cancer, and that we will never attain the acceptable ...survival rates that are just beyond our reach. Multiple clinical trials have tested doublets, triplets, and sequential chemotherapy in what is often regarded as a futile attempt to break through this ceiling. Recent large randomized trials have not shown that any of these combinations is superior to any of the others. Nevertheless, the analysis of DNA and RNA from patients' serum can permit us to assess genes that may be specific targets of certain cytotoxic agents and others that may be markers of multidrug resistance. With this information, we will hopefully be able to create guidelines for individualized chemotherapy. With this in mind, the Spanish Lung Cancer Group has designed a trial to test the involvement of various genes in resistance to gemcitabine and cisplatin. With the gene corral that will emerge from this trial, we will create an up-front diagnostic test for selecting the most appropriate gemcitabine plus cisplatin regimen for the treatment of non-small cell lung cancer.
Mitonafide is the lead compound of a new series of antitumor drugs, the 3-Nitronaphthalimides, which have shown antineoplastic activity in vitro as well as in vivo. This phase I Mitonafide study in ...non-small cell lung cancer using a 120-hour continuous infusion (120 h. C.I.) schedule of administration was designed to deliver the maximum amount of drug while avoiding the risk of central nervous system (CNS) toxicity, previously observed in studies with daily short (1 hour) administration schedules. Twenty patients were treated at doses ranging from 107-200 mg/m2 x 120 h. C.I. Dose-limiting toxicity with this schedule of administration was leukopenia. Other toxicities were mild or not relevant. No CNS toxicity was observed. The recommended dose for phase II C.I. Mitonafide studies is 170 mg/m2 x 120 h. C.I. in previously untreated patients. Plasma level monitoring is recommended.
Seventeen patients with small cell lung cancer entered a phase II trial testing the feasibility of adding high dose epirubicin (100-120 mg/m2, day 1) in combination with etoposide (60-80 mg/m2, days ...1-5) and cisplatin (70 mg/m2, day 1) courses repeated every three weeks. Complete responders received thoracic (40 Gy) and prophylactic cranial (30 Gy) irradiation. Sixteen patients were evaluable for response and toxicity. Myelosuppression was the dose-limiting side effect. Neutropenic fever was observed in eight patients (53%) and stomatitis in six (40%). No patient had a greater than 14% decline in the cardiac ejection fraction. Strict adherence to the dose-schedule designed was impossible as doses were trimmed and delayed in 30% of instances. The overall objective response rate was 81% (95% confidence limits, 62% to 100%), in limited disease there were complete remissions in 57%. With a 16 months median follow-up, overall median survival was 13 months. This study was unable to prove the feasibility of epirubicin escalation when added to etoposide-cisplatin combination, hampering the dose-intensification Norton-Simon model test.
Enzyme‐linked immunosorbent assay (ELISA) is an excellent tool for detection of circulating antibodies against the NC16A portion of BP180 antigen. We compared the sensitivity and specificity of a ...commercially available BP180‐NC16a domain ELISA with that of an indirect immunofluorescence (IIF) testing in the evaluation of bullous pemphigoid (BP) and pemphigoid gestationis (PG), and analyzed the relationship between ELISA results and the presence of IgG deposition, in an epidermal or combined pattern, on direct immunofluorescence (DIF) testing of salt‐split skin. ELISA was performed on serum from 28 patients (24 BP, 4 PG) and 50 controls. IIF testing was performed on serum from 27 patients and 98 controls. For the group of 28 patients with BP or PG, ELISA had a sensitivity of 93% and specificity of 96% (P < 0.001), while sensitivity was 74% and specificity 96% (P < 0.001) for IIF testing. In these patients, ELISA has a higher sensitivity than IIF testing, but similar specificity. Evaluation of controls who had IgG deposition on the dermal side of salt‐split skin on DIF testing showed specificity for the ELISA of 100% (all four cases negative) and 80% for IIF testing (one of five positive). Positive ELISA correlated with a diagnosis of BP or PG only in patients who had IgG at the basement membrane zone (BMZ) by DIF testing. Overall, ELISA appears to have greater sensitivity and specificity for BP or PG than does IIF testing.
Background No precise studies have been performed on cutaneous leukocytoclastic vasculitis (LV) to establish whether it is better to obtain a skin biopsy from lesional or from perilesional skin ...for direct immunofluorescence (DIF). There is no agreement on the immunoglobulins most frequently detected and the value of DIF for the classification of cutaneous vasculitis.
Methods A prospective study of DIF in lesional and perilesional skin was performed in 50 leukocytoclastic vasculitis patients and 15 nonvasculitis patients.
Results We detected a higher level of positivity in involved skin than in uninvolved skin for IgG, IgA, IgM, C3 and fibrinogen but not for C1q. In vasculitic patients, IgA was the immunoglobulin most frequently detected in lesional (82%) and perilesional skin (68%), followed by IgM (56 and 34%, respectively) and IgG (20 and 8%, respectively). Only IgA deposits were associated with the diagnosis of vasculitis, with a sensitivity of 82% in lesional and 68% in perilesional skin, and with a specificity of 73 and 66.7%, respectively. The presence of IgA in lesional skin was associated with renal involvement but there was no association with severity. The presence of IgG or IgM, or the absence of IgA in perilesional skin was related to the presence of cryoglobulins. The absence of IgA in lesional and perilesional skin was also related to hepatitis C virus infection.
Conclusions DIF findings in involved skin are more closely related to the diagnosis of vasculitis and can give more information about overall renal involvement than findings in uninvolved skin. However, findings in uninvolved skin are more closely related to the pathogenic factors that trigger the development of vasculitis.
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