RESUMO
BACKGROUND AND STUDY AIMS: The high volume and poor palatability of 4âL of polyethylene glycol (PEG)-based bowel cleansing preparation required before a colonoscopy represent a major obstacle for patients. The aim of this study was to compare two low volume PEG-based preparations with standard 4âL PEG in individuals with a positive fecal immunochemical test (FIT) within organized screening programs in Italy. PATIENTS AND METHODS: A total of 3660 patients with a positive FIT result were randomized to receive, in a split-dose regimen, 4âL PEG or 2âL PEG plus ascorbate (PEG-A) or 2âL PEG with citrate and simethicone plus bisacodyl (PEG-CS). The noninferiority of the low volume preparations vs. 4âL PEG was tested through the difference in proportions of adequate cleansing. RESULTS: A total of 2802 patients were included in the study. Adequate bowel cleansing was achieved in 868 of 926 cases (93.7â%) in the 4âL PEG group, in 872 out of 911 cases in the PEG-A group (95.7â%, difference in proportions â+â1.9â%, 95â% confidence interval [CI] â-â0.1 to 3.9), and in 862 out of 921 cases in the PEG-CS group (93.6â%, difference in proportionsâ -â0.2â%, 95â%CI â-â2.4 to 2.0). Bowel cleansing was adequate in 95.5â% of cases when the preparation-to-colonoscopy interval was between 120 and 239 minutes, whereas it dropped to 83.3â% with longer intervals. Better cleansing was observed in patients with regular bowel movements (95.6â%) compared with those with diarrhea (92.4â%) or constipation (90.8â%). CONCLUSION: Low volume PEG-based preparations administered in a split-dose regimen guarantee noninferior bowel cleansing compared with 4âL PEG. Constipated patients require a personalized preparation. TRIAL REGISTRATION: EudraCT 2012â-â003958â-â82.
Assuntos
Catárticos/administração & dosagem , Colonoscopia , Adulto , Idoso , Ácido Ascórbico/administração & dosagem , Bisacodil/administração & dosagem , Ácido Cítrico/administração & dosagem , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Polietilenoglicóis/administração & dosagem , Simeticone/administração & dosagemRESUMO
BACKGROUND: To the authors' knowledge, there is a scarcity of accurate data regarding the feasibility of standard chemotherapy with procarbazine, lomustine, and vincristine (PCV) in a homogeneous series of patients with primary anaplastic oligodendroglioma (AO) and oligoastrocytoma (AOA) that was recurrent after surgery and standard radiotherapy. The aim of the current study was to evaluate the overall response rate, toxicity, and time to progression (TTP) with the use of standard PCV in this setting. METHODS: Between November 1994 and September 2000, 37 patients were enrolled in the current study. Of these, 23 had AO (62%) and 14 had AOA (38%). All patients received standard PCV comprised of lomustine (110 mg/m2) on Day 1, procarbazine (60 mg/m2) on Days 8-21, and vincristine (1.4 mg/m2, maximum total 2 mg) on Days 8 and 29. Cycles were repeated every 6 weeks. RESULTS: There were 11 complete responses (CR; 29.7%) and 11 partial responses (PR; 29.7%) reported and 8 patients had stable disease (SD; 21.6%). The response rate was higher in patients with AO compared with patients with AOA (77.2% vs. 22.7%; P = 0. 02). The median TTP, which was 12.3 months overall, was 30.3 months in patients who achieved a CR, 19.1 months in patients who achieved a PR, and 6.1 months in patients with SD. The median TTP was 18.6 months in AO patients and 6.14 in AOA patients. There were no cases of severe toxicity reported although in 16 patients (43%) who were free of disease progression, PCV was discontinued because of toxicity or inadequate recovery after 2 weeks of delay. CONCLUSIONS: PCV chemotherapy was reported to achieved a high response rate and TTP but incurred a high risk of persistent toxicity.