RESUMO
OBJECTIVE: Uterine Papillary Serous Carcinoma (UPSC) is uncommon and accounts for less than 5% of all uterine cancers. Therefore the majority of evidence about the benefits of adjuvant treatment comes from retrospective case series. We conducted a prospective multi-centre non-randomized phase 2 clinical trial using four cycles of adjuvant paclitaxel plus carboplatin chemotherapy followed by pelvic radiotherapy, in order to evaluate the tolerability and safety of this approach. METHODS: This trial enrolled patients with newly diagnosed, previously untreated patients with stage 1b-4 (FIGO-1988) UPSC with a papillary serous component of at least 30%. Paclitaxel (175 mg/m(2)) and carboplatin (AUC 6) were administered on day 1 of each 3-week cycle for 4 cycles. Chemotherapy was followed by external beam radiotherapy to the whole pelvis (50.4 Gy over 5.5 weeks). Completion and toxicity of treatment (Common Toxicity Criteria, CTC) and quality of life measures were the primary outcome indicators. RESULTS: Twenty-nine of 31 patients completed treatment as planned. Dose reduction was needed in 9 patients (29%), treatment delay in 7 (23%), and treatment cessation in 2 patients (6.5%). Hematologic toxicity, grade 3 or 4 occurred in 19% (6/31) of patients. Patients' self-reported quality of life remained stable throughout treatment. Thirteen of the 29 patients with stages 1-3 disease (44.8%) recurred (average follow-up 28.1 months, range 8-60 months). CONCLUSION: This multimodal treatment is feasible, safe and tolerated reasonably well and would be suitable for use in multi-institutional prospective randomized clinical trials incorporating novel therapies in patients with UPSC.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cistadenocarcinoma Papilar/tratamento farmacológico , Cistadenocarcinoma Papilar/radioterapia , Cistadenocarcinoma Seroso/tratamento farmacológico , Cistadenocarcinoma Seroso/radioterapia , Neoplasias Uterinas/tratamento farmacológico , Neoplasias Uterinas/radioterapia , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carboplatina/administração & dosagem , Carboplatina/efeitos adversos , Quimioterapia Adjuvante , Terapia Combinada , Cistadenocarcinoma Papilar/patologia , Cistadenocarcinoma Seroso/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Estudos Prospectivos , Qualidade de Vida , Análise de Sobrevida , Neoplasias Uterinas/patologiaAssuntos
Suplementos Nutricionais/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Estado Nutricional , Deficiência de Vitamina D/etiologia , Vitamina D/uso terapêutico , Adulto , Intervalos de Confiança , Estudos Transversais , Coleta de Dados , Feminino , Humanos , Masculino , Razão de Chances , Queensland/epidemiologia , Neoplasias Cutâneas/epidemiologia , Neoplasias Cutâneas/prevenção & controle , Deficiência de Vitamina D/epidemiologia , Deficiência de Vitamina D/prevenção & controle , Adulto JovemRESUMO
Routine postsurgery assessment of primary total hip arthroplasty (THA) is recommended in many countries. Whether the benefits of this activity are justified by the costs is not known. We used a decision-analytic Markov model to compare the costs and health outcomes of 3 different follow-up strategies after primary THA. If there is no routine follow-up of patients for 7 years after primary THA, there would be cost savings between AU$6.5 and $11.9 million and gains of between 1.8 and 8.8 quality-adjusted life years. Policy makers should investigate less resource-intensive alternatives to common routine postsurgical assessment.