570 Introduction: Capecitabine (Xeloda [X]) shows synergy with taxanes and adding X to docetaxel (T) extends overall survival (OS), response rate (RR) and progression free-survival (PFS) beyond T alone. Sequential single-agent therapy could confer convenience benefits and may be more appropriate than combination chemotherapy for some pts. Methods: Pts with anthracycline-pretreated MBC received 3-weekly cycles of 1 of the following regimens: X→taxane (X 1250mg/m2 bid d1–14, followed after progression (PD) by T 100mg/m2 or paclitaxel [P] 175mg/m2 day 1; X+P (X 825mg/m2 bid days 1–14 + P 175mg/m2 day 1) or X+T (X 825mg/m2 bid days 1–14 + T 75mg/m2 day 1). Results: Of the 368 pts enrolled, 91 are either still on therapy or not evaluable. The table shows baseline characteristics, efficacy and safety in evaluable pts. Median follow up is 15.5 months. Median doses for X in each arm (1st cycle vs. 8th cycle, mg/m2 bid): 1218 vs. 1054; 948 vs. 900; 846 vs. 751. Median doses for P and T (1st cycle vs. 8th cycle, mg/m2): 173 vs. 169 and 75 vs. 72, respectively. In the X→taxane arm, 58 pts (64%) received sequential taxane; the remainder did not receive a taxane, either because they were still on X, had CR or had rapid PD. Conclusions: RR is higher with XP and XT, but PFS and OS are similar at a median follow-up of 15.5 months. All regimens were well tolerated with minimal grade 4 AEs. Because there is no clear superiority of sequential vs. combined therapy, pt characteristics are likely to be used to decide which regimen is the most appropriate. [Table: see text] [Table: see text]
Background and Methods. Fifty‐one patients with small cell lung cancer (SCLC) were treated with alternating urokinase (UK)‐cyclophosphamide‐doxorubicin (Adriamycin, Adria Laboratories, Columbus, OH)‐vincristine and cisplatin‐etoposide‐vincristine. UK was given as a loading dose of 3000 μg/kg body weight, followed by 3000 μg/kg/h for 6 hours. Thoracic irradiation with split technique (46 Gy) and prophylactic cranial irradiation (25 Gy) were administered to responding patients. A second staging was performed in patients exhibiting a clinical complete response (CR) after 1 year.
Results. In 27 patients with limited disease, there were 23 CR and 8 partial responses (PR) (CR, 85.1%; 66.2‐95.8% at 95% confidence intervals); in 24 patients with extensive disease, there were 17 CR, 4 PR, and 3 cases with progression. Pathologically proven CR were observed in 59.2% patients with limited disease and 33.3% patients with extensive disease. Survival rates were as follows: in patients with limited disease, 1 year, 85.1%; 2 years, 55.5%; and 3 years, 25.9%; in patients with extensive disease, 1 year, 54.1; and 2 years, 16.9%. Median survival times were 26.3 months (patients with limited disease) and 13.3 months (patients with extensive disease). UK‐related toxic effects included four episodes of mild to moderate bleeding, one allergic reaction, and one cerebro‐vascular accident. Myelotoxicity was severe, with a median of two episodes of Grade III‐IV (World Health Organization classification) aplasia per patient.
Conclusions. These results are consistent with a potential benefit of fibrinolytic therapy in combination with chemotherapy in patients with SCLC with limited disease. Additional trials are indicated.
Two cases of complete remission plus one almost complete and another partial response of undifferentiated, invasive epithelial malignant thymoma using the combination of cisplatin, vinblastine, and bleomycin (PVB), are reported in four patients treated with this combination. Radiotherapy was instituted after completing the fourth course of chemotherapy in three patients. One patient died from intercurrent infection after the fourth cycle of combination chemotherapy. Three patients remain free of disease at the end of the treatment program. PVB appears to be highly active in this disease and deserves more extensive evaluation in multicenter clinical trials.
Objectives: To assess the cost-effectiveness of Abiraterone Acetate plus Prednisone (A-P) compared with Cabazitaxel plus Prednisone (C-P) in Dominican Republic, in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) that have failed to chemotherapy with Docetaxel. MethOds: A three-health state cohort simulation Markov Model (progression-free, post-progression and death) was developed based on overall and progression free survival data. The time frame was 10 years. The perspective was that of the Public System of Health of Dominican Republic. The health outcomes of interest were Quality Adjusted Life Years (QALYs) and Life Years (LYs). Efficacy data was taken from clinical trials (COU-AA-301 for A-P and TROPIC for C-P). Utilities for health states and negative utilities for adverse events were estimated based on quality of life endpoints of the COU-AA-301 trial. The base year was 2012. All costs are presented in Dominican currency (Dominican Pesos -RD$). Costs and outcomes were discounted at 5%. Probabilistic sensitivity (PSA) analysis was performed to evaluate uncertainty surrounding the parameters. Results: A-P resulted in 0.79 QALYs and 1.35 LYs, per patient, respectively. C-P resulted in 0.71 QALYs and 1.28 LYs, per patient, respectively. Mean total costs per patient were: RD$ 2.204.289 for A-P and RD$ 2.732.365 for C-P. The results of the probabilistic sensitivity analysis showed that, when compared with C-Z, A-P was found dominant (associated with reduced costs and increased QALYs) in the majority of the iterations. A-P had a 75% probability of being cost effective, independent of the willingness to pay, when compared to C-P. cOnclusiOns: A-P can be considered cost-saving (dominant), when compared with C-P, in patients with Metastatic Castration-Resistant Prostate Cancer that have failed to chemotherapy with Docetaxel, from the perspective of the Public System of Health of Dominican Republic.
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