RESUMO
PURPOSE: To describe the dosing patterns of regorafenib in a real-world population of patients with metastatic colorectal cancer (mCRC) in a routine clinical practice setting in Spain, focusing on the starting dose of regorafenib. METHODS: An observational, retrospective, multicenter study that included patients ≥ 18 years old who had histologically documented mCRC and who had initiated treatment with regorafenib since January 2017. Post hoc categorization of dosing patterns revealed the following: initial dose < 160 mg and dose escalation, initial dose < 160 mg and maintenance, initial dose equal to 160 mg and maintenance, and initial dose equal to 160 mg and dose reduction. RESULTS: Most patients (152/241, 63.8%) initiated treatment with regorafenib at doses < 160 mg. There was large variation in the starting dose of regorafenib over time: in 2017, most patients (59%) initiated regorafenib at a dose of 160 mg, this proportion decreased to 6% in 2021. There were no significant differences in the median progression-free survival according to the regorafenib dose patterns during the first two cycles. The proportion of patients who reported at least one adverse event (AE), had a grade 3-4 AE or had an AE leading to dose reduction was greater in the group of patients who received an initial dose equal to 160 and reduction. CONCLUSIONS: Our results indicate that physicians in Spain have gradually adopted a dose-escalation approach during cycle 1, which is a common practice for starting treatment with a reduced dose (< 160 mg/day), a strategy that seems to improve tolerability while maintaining efficacy. TRIAL REGISTRATION: Not applicable.
RESUMO
Colorectal cancer (CRC) is one of the most common tumours worldwide, and 70% of CRC patients are over 65 years of age. However, the scientific evidence available for these patients is poor, as they are underrepresented in clinical trials. Therefore, a group of experts from the Oncogeriatrics Section of the Spanish Society of Medical Oncology (SEOM), the Spanish Cooperative Group for the Treatment of Digestive Tumours, (TTD) and the Multidisciplinary Spanish Group of Digestive Cancer (GEMCAD) have reviewed the scientific evidence available in older patients with CRC. This group of experts recommends a multidisciplinary approach and geriatric assessment (GA) before making a therapeutic decision because GA predicts the risk of toxicity and survival and helps to individualize treatment. In addition, elderly patients with localized CRC should undergo standard cancer resection, preferably laparoscopically. The indication for adjuvant chemotherapy (CT) should be considered based on the potential benefit, the risk of recurrence, the life expectancy and patient comorbidities. When the disease is metastatic, the possibility of radical treatment with surgery, radiofrequency (RF) or stereotactic body radiation therapy (SBRT) should be considered. The efficacy of palliative CT is similar to that seen in younger patients, but elderly patients are at increased risk of toxicity. Clinical trials should be conducted with the elderly population and include GAs and specific treatment plans.
Assuntos
Neoplasias Colorretais , Humanos , Idoso , Neoplasias Colorretais/tratamento farmacológico , Quimioterapia Adjuvante/efeitos adversosRESUMO
INTRODUCTION: Recent studies have suggested a rise in the incidence of testicular germ-cell tumors (TGTs) in the last years, mainly due to an increase of early stage cases. We analysed the time trends in biological features of these patients in order to confirm this tendency in our environment. MATERIALS AND METHODS: The clinical records of 136 consecutive patients with TGTs treated at a single institution over a 20-year period (1984-2003) were retrospectively reviewed. Pathological, clinical, therapeutic and outcome data were collected. Patients were allocated into four consecutive 5- year intervals and their characteristics were compared by means of the chi-squared test. The survival analysis was performed with the method of Kaplan and Meier. RESULTS: A progressive increase in the incidence of new cases, and a more frequent diagnosis of stage I versus stage II-IV disease was confirmed within this time period. It was also observed a greater use of postorchiectomy chemotherapy, mainly due to an increase in the adjuvant indications. A significant decrease in the recurrence rate was noted. Ten-year overall survival was 86.5%. There was a trend for improved outcome, but the differences among the two decades were not statistically significant. CONCLUSIONS: A real increase in the incidence of TGTs and in the proportion of early stages was confirmed. This may be due to an epidemiological change or to an earlier diagnosis. This new pattern is associated with a more frequent use of adjuvant chemotherapy and with a reduction in the relapse rate.
Assuntos
Neoplasias Embrionárias de Células Germinativas/epidemiologia , Neoplasias Testiculares/epidemiologia , Adolescente , Adulto , Diagnóstico Precoce , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Embrionárias de Células Germinativas/patologia , Neoplasias Embrionárias de Células Germinativas/terapia , Estudos Retrospectivos , Análise de Sobrevida , Neoplasias Testiculares/patologia , Neoplasias Testiculares/terapiaRESUMO
INTRODUCTION: We undertook a prospective study to determine the feasibility, toxicity, response and survival rate of simultaneous chemotherapy (CT) and radiotherapy (RT) for locally-advanced head and neck cancer. MATERIAL AND METHODS: Fifty eight patients were treated with carboplatin (i.e. 100 mg/m(2)) weekly, tegafur-uracil (UFT) (oral 400 mg/m(2)) daily and simultaneous treatment with a cobalt-60 source of radiation (total dose 65-70 Gy). RESULTS: Forty six patients (79%) received the total dose of RT while CT was delayed or reduced in 31 patients (53%). Grade 3-4 toxicity observed was mucositis in 27 (47%), leukopenia in 10 (17%), anaemia in 5 (9%), and diarrhoea in 4 (7%) patients. The objective response rate was 74%; 24 complete response (41%) and 19 partial response (33%). Overall, there are 11 patients (19%) disease-free, 7 (12%) alive with disease, 35 have died of progressive disease (60%) and 3 (5%) from other causes. There were 2 toxic deaths (3%). Median time to progression was 10 months and median survival was 18.4 months. CONCLUSIONS: The use of carboplatin and UFT concomitant with radiotherapy has, in our study, a slightly lower activity than other chemo-radiotherapy protocols, especially with respect to complete responses, but with no significant differences in overall survival or disease-free survival rates.