RESUMEN
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
Asunto(s)
Humanos , Brazo , Pueblo Asiatico , Carboplatino , Quimioradioterapia , Quimioterapia Adyuvante , Cisplatino , Supervivencia sin Enfermedad , Estudios de Seguimiento , Ginecología , Ganglios Linfáticos , Obstetricia , Paclitaxel , Recurrencia , Estadística como Asunto , Neoplasias del Cuello UterinoRESUMEN
PURPOSE: High-fidelity simulation training is effective for learning crisis resource management (CRM) skills, but cost is a major barrier to implementing high-fidelity simulation training into the curriculum. The aim of this study was to examine the cost-effectiveness of self-debriefing and traditional instructor debriefing in CRM training programs and to calculate the minimum willingness-to-pay (WTP) value when one debriefing type becomes more cost-effective than the other. METHODS: This study used previous data from a randomized controlled trial involving 50 anesthesiology residents in Canada. Each participant managed a pretest crisis scenario. Participants who were randomized to self-debrief used the video of their pretest scenario with no instructor present during their debriefing. Participants from the control group were debriefed by a trained instructor using the video of their pretest scenario. Participants individually managed a post-test simulated crisis scenario. We compared the cost and effectiveness of self-debriefing versus instructor debriefing using net benefit regression. The cost-effectiveness estimate was reported as the incremental net benefit and the uncertainty was presented using a cost-effectiveness acceptability curve. RESULTS: Self-debriefing costs less than instructor debriefing. As the WTP increased, the probability that self-debriefing would be cost-effective decreased. With a WTP ≤Can$200, the self-debriefing program was cost-effective. However, when effectiveness was priced higher than cost-savings and with a WTP >Can$300, instructor debriefing was the preferred alternative. CONCLUSION: With a lower WTP (≤Can$200), self-debriefing was cost-effective in CRM simulation training when compared to instructor debriefing. This study provides evidence regarding cost-effectiveness that will inform decision-makers and clinical educators in their decision-making process, and may help to optimize resource allocation in education.