RESUMO
OBJECTIVE: To compare response rate and survivals of locally advanced stage cervical cancer patients who had standard concurrent chemoradiation therapy (CCRT) alone to those who had adjuvant chemotherapy (ACT) after CCRT. METHODS: Patients aged 18–70 years who had International Federation of Gynecology and Obstetrics stage IIB–IVA without para-aortic lymph node enlargement, Eastern Cooperative Oncology Group scores 0–2, and non-aggressive histopathology were randomized to have CCRT with weekly cisplatin followed by observation (arm A) or by ACT with paclitaxel plus carboplatin every 4 weeks for 3 cycles (arm B). RESULTS: Data analysis of 259 patients showed no significant difference in complete responses at 4 months after treatment between arm A (n=129) and arm B (n=130): 94.1% vs. 87.0% (p=0.154) respectively. With the median follow-up of 27.4 months, 15.5% of patients in arm A and 10.8% in arm B experienced recurrences (p=0.123). There were no significant differences of overall or loco-regional failure. However, systemic recurrences were significantly lower in arm B than arm A: 5.4% vs. 10.1% (p=0.029). The 3-year progression-free survival (PFS) and 3-year overall survival (OS) of the patients in both arms were not significantly different. The hazard ratio of PFS and OS of arm B compared to arm A were 1.26 (95% CI=0.82–1.96; p=0.293) and 1.42 (95% CI=0.81–2.49; p=0.221) respectively. CONCLUSIONS: ACT with paclitaxel plus carboplatin after CCRT did not improve response rate and survival compared to CCRT alone. Only significant decrease of systemic recurrences with ACT was observed, but not overall or loco-regional failure. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02036164 Thai Clinical Trials Registry Identifier: TCTR 20140106001
Assuntos
Humanos , Braço , Povo Asiático , Carboplatina , Quimiorradioterapia , Quimioterapia Adjuvante , Cisplatino , Intervalo Livre de Doença , Seguimentos , Ginecologia , Linfonodos , Obstetrícia , Paclitaxel , Recidiva , Estatística como Assunto , Neoplasias do Colo do ÚteroRESUMO
Background: Several studies have demonstrated that anemia is one of the poor prognostic factors for cervical cancer patients treated with radiotherapy. We questioned the necessity of weekly hemoglobin level monitoring in these patients. This study was conducted to evaluate the value of weekly hemoglobin level measurement in cervical cancer patients receiving radiotherapy.Objective: To evaluate the value of weekly hemoglobin (Hb) level measurement in cervical cancer patients receiving radiotherapy.Materials and Methods: The medical records of cervical cancer patients admitted in gynecologic oncology ward between May 2000 and May 2002 were reviewed to evaluate the clinical characteristics and weekly Hb level. Measurement outcomes include grade 2-4 hematologic toxicity, Hb nadir, week of Hb nadir and the number of blood transfusion. Design: Descriptive study.Setting: Chiang Mai University Hospital.Results: There were 113 cervical cancer patients receiving radiotherapy in the study period. Fifty-four patients (47.8%) had Hb level at presentation \< 10 g/dL. Among these patients, grade 2-4 anemia was found in 21-30 patients per week with a mean of 23.5 (43.5%) in week 1-4. Between week 5-8, grade 2-4 anemia was found in 5-22 patients per week with a mean of 15.3 (28.3%). Among 59 patients with Hb level at presentation \> 10 g/dL, grade 2-4 anemia was found in 7-9 patients per week with a mean of 7.5 (12.7%) in the first 4 week. After week 4, grade 2-4 anemia was found in 3-8 patients per week with a mean of 5.8 (9.8%). Patients with Hb level at presentation \> 11 g/dL, grade 2-4 anemia was found in only 0.8% and 4.9% in week 1-4 and week 5-8, respectively. Fourty-seven patients (41.6%) received a blood transfusion. Among these patients, 42 patients (89.4%) had a Hb level at presentation \< 10 g/dL, the remaining 5 patients (10.6%) had a Hb level at presentation \> 10 g/dL(P \< 0.001). Only one patient with Hb level at presentation \> 11 g/dL received a blood transfusion. No blood transfusion was administered in patients with Hb at presentation \> 12 g/dL.Conclusions: For cervical cancer patients with Hb level at presentation \< 10 g/dL, weekly Hb level should be checked during radiotherapy. Among those with Hb level at presentation \> 11 g/dL, Hb level may be checked less frequently.Key words: Hemoglobin level, cervical cancer, radiotherapy