RESUMO
Background: Abiraterone acetate combined with Prednisone/Prednisolone (AA+P) and Enzalutamide (ENZ) have proven survival benefit in men with metastatic castration-resistant prostate cancer (mCRPC) in chemotherapy-naïve and prior chemotherapy patients. There have been no studies directly comparing the effectiveness of ENZ to AA+P in mCRPC patients. Methods: A retrospective, survival analysis study of 143 real-world mCRPC patients (90 in AA+P and 53 in ENZ group) was conducted. Patients who started their treatment between February 2012 and May 2016 were included. The primary end point was biochemical progression-free survival (bPFS). Secondary end points were radiological progression-free survival (rPFS) and overall survival (OS). Toxicity data were also collected. Data were analyzed using Cox proportional hazards (PH) models, adjusting for covariates: prior radical treatment; Gleason score; prostate-specific antigen; age; and chemotherapy naïve or not. Results: After median follow-up of 15 months (interquartile range 7 to 23), 112 events of biochemical progression were observed (71 in AA+P and 41 in ENZ). About 41% in AA+P group and 30% patients in ENZ group received prior chemotherapy. The chance of biochemical progression was significantly lower among ENZ patients than AA+P patients, when adjusting for all covariates in the Cox PH model (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.35 to 0.82, P = .004). There was a trend implying the chance of rPFS could be higher among ENZ patients than AA+P patients (HR 1.24, 95% CI 0.76 to 2.02, P = .4). There is no difference in OS between ENZ and AA+P patients, when adjusting for all covariates in the Cox PH model (HR 0.91, 95% CI 0.59 to 1.41, P = .7). About 38% of ENZ patients reported fatigue compared to 16% of AA+P patients, while hypertension was reported slightly more in AA+P patients. Conclusions: This study showed a statistically significant difference in bPFS, favoring ENZ, but no significant difference in rPFS or OS.
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BACKGROUND: Chemotherapy combined with radiotherapy can improve outcome in locally advanced esophageal cancer. AIM: This study aimed to compare efficacy and toxicity between concurrent chemoradiotherapy (CCRT) and sequential chemoradiotherapy (SCRT) in unresectable, locally advanced, esophageal squamous cell carcinoma (ESSC). MATERIALS AND METHODS: Forty-one patients with unresectable, locally advanced ESCC were randomized into two arms. In the CCRT arm (Arm A), 17 patients received 50.4 Gy at 1.8 Gy per fraction over 5.6 weeks along with concurrent cisplatin (75 mg m(-2) intravenously on day 1 and 5-fluorouracil (1000 mg m(-2) continuous intravenous infusion on days 1-4 starting on the first day of irradiation and given after 28 days. In the SCRT arm (Arm B), 20 patients received two cycles of chemotherapy, using the same schedule, followed by radiotherapy fractionated in a similar manner. The endpoints were tumor response, acute and late toxicities, and disease-free survival. RESULTS: With a median follow up of 12.5 months, the complete response rate was 82.4% in Arm A and 35% in Arm B (P = 0.003). Statistically significant differences in frequencies of acute skin toxicity (P = 0.016), gastrointestinal toxicity (P = 0.005) and late radiation pneumonitis (P = 0.002) were found, with greater in the CCRT arm. A modest but non-significant difference was observed in median time to recurrence among complete responders in the two arms (Arm A 13 months and Arm B 15.5 months, P = 0.167) and there was also no significant difference between the Kaplan Meier survival plots (P = 0.641) of disease-free survival. CONCLUSIONS: Compared to sequential chemoradiotherapy, concurrent chemoradiotherapy can significantly improve local control rate but with greater risk of adverse reactions.
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INTRODUCTION: The prospective interventional single-institution randomized control study was carried out to compare the pain relieving efficacy among different bisphosphonates at the cost of incidence of skeletal-related events (SRE). MATERIALS AND METHODS: During June 2008 and May 2011, 256 patients with painful bone metastasis in solid tumors with a pain score of at least 5 were randomized into three arms: zoledronic acid (4 mg, i.v.), ibandronate (6 mg, i.v.) and pamidronate (90 mg, i.v.). Radiation was given to all patients, either 800 cGy single fraction or 20 Gy in five fractions. The ANOVA test was used for analysis. The Pearson test was used to correlate pain scores with proportions of responders as statistical estimation of pain relief. RESULTS: With a mean baseline pain score of 6.5 ± 1.2, there was no difference in pain scores among the three treatment arms, assessed at 3 months and at the end of the study. However, the pain scores at 6 months were statistically reduced in zoledronic acid-receiving patients (1.5 ± 0.4) unlike the scores in patients receiving ibandronate (3.1 ± 0.5) and pamidronate (2.3 ± 0.4), with a P-value of 0.024. The response was statistically significant at 6 months (0.039) and at the end of the study (0.023), in favor of zoledronic acid. Pearson's correlation demonstrated a statistically significant positive correlation between pain scores and response rates. There were no statistical differences in the narcotic scores among the treatment arms during the study period. The overall duration of pain relief was not different in any of treatment arms. The time of detection of hypercalcemia was no different; however, the incidence of hypercalcemia was significantly less in the zoledronic acid arm (28.3%) against 44.6% and 50% in ibandronate and pamidronate arms, respectively, with a P-value of 0.041. CONCLUSION: The use of bisphosphonates for 6 months or more results in a statistical significant improvement in bone pain, more so with zoledronic acid. Hypercalcemia, an SRE, was significantly less in the zoledronic acid arm.
