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Biochemical Outcome (biochemical + outcome)
Selected AbstractsBiochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen eraCANCER, Issue 2 2002Anthony V. D'Amico M.D., Ph.D. Abstract BACKGROUND To the authors' knowledge, consensus is lacking regarding the relative long-term efficacy of radical prostatectomy (RP) versus conventional-dose external beam radiation therapy (RT) in the treatment of patients with clinically localized prostate carcinoma. METHODS A retrospective cohort study of 2635 men treated with RP (n = 2254) or conventional-dose RT (n = 381) between 1988,2000 was performed. The primary endpoint was prostate specific antigen (PSA) survival stratified by treatment received and high-risk, intermediate-risk, or low-risk group based on the serum PSA level, biopsy Gleason score, 1992 American Joint Commission on Cancer clinical tumor category, and percent positive prostate biopsies. RESULTS Estimates of 8-year PSA survival (95% confidence interval [95% CI]) for low-risk patients (T1c,T2a, a PSA level , 10 ng/mL, and a Gleason score , 6) were 88% (95% CI, 85, 90) versus 78% (95% CI, 72, 83) for RP versus patients treated with RT, respectively. Eight-year estimates of PSA survival also favored RP for intermediate-risk patients (T2b or Gleason score 7 or a PSA level > 10 and , 20 ng/mL) with < 34% positive prostate biopsies, being 79% (95% CI, 73, 85) versus 65% (95% CI, 58, 72), respectively. Estimates of PSA survival in high-risk (T2c or PSA level > 20 ng/mL or Gleason score , 8) and intermediate-risk patients with at least 34% positive prostate biopsies initially favored RT, but were not significantly different after 8 years. CONCLUSIONS Intermediate-risk and low-risk patients with a low biopsy tumor volume who were treated with RP appeared to fare significantly better compared with patients who were treated using conventional-dose RT. Intermediate-risk and high-risk patients with a high biopsy tumor volume who were treated with RP or RT had long-term estimates of PSA survival that were not found to be significantly different. [See editorials on pages 211,4 and 215,8, this issue. Cancer 2002;95:281,6. © 2002 American Cancer Society. DOI 10.1002/cncr.10657 [source] Does hormonal manipulation in conjunction with permanent interstitial brachytherapy, with or without supplemental external beam irradiation, improve the biochemical outcome for men with intermediate or high-risk prostate cancer?BJU INTERNATIONAL, Issue 1 2003G.S. Merrick OBJECTIVE To determine whether hormonal manipulation improves the biochemical outcome for men with intermediate or high-risk prostate cancer and undergoing permanent brachytherapy with or without supplemental external beam radiation therapy. PATIENTS AND METHODS From April 1995 to August 2000, 350 patients with intermediate-risk (225 men; a Gleason score of , 7 or a prostate specific antigen, PSA, level of , 10 ng/mL or clinical stage , T2b) or high-risk features (125 men; two or three of a Gleason score of , 7 or PSA , 10 ng/mL or clinical stage , T2b) underwent transperineal ultrasonography-guided permanent brachytherapy. No patient underwent pathological lymph node staging. Of these patients, 293 received supplemental external beam radiation therapy (EBRT), 141 received hormonal manipulation, with 82 having hormonal therapy for , 4 months (median 4) for cytoreduction, while 59 had neoadjuvant and adjuvant hormonal manipulation (median 8 and 12 months for intermediate- and high-risk, respectively). The median patient age was 68.5 years. No patient was lost to follow-up. The mean (sd) and median follow-up was 50 (18) and 49 months (calculated from the day of implantation). Biochemical disease-free (BDF) survival was defined using a consensus definition. The clinical variables evaluated for BDF survival included risk group, Gleason score, patient age, clinical T-stage and pretreatment PSA. Treatment variables included use of hormonal manipulation stratified into cytoreductive (, 4 months) vs adjuvant (> 4 months) regimens, supplemental EBRT, isotope and dosimetric variables. RESULTS For intermediate-risk patients, the 6-year actuarial BDF survival rates were 98%, 96% and 100% for hormone naïve, cytoreductive and adjuvant treatment, respectively (P = 0.693); for high-risk patients the respective values were 79%, 94% and 92% (P = 0.046). When stratified by pretreatment PSA, hormonal manipulation improved the outcome for patients with a PSA of , 10 ng/mL (P = 0.019), but not for those with < 10 ng/mL (P = 0.661). Hormonal status was not statistically significant in predicting biochemical outcome when stratified by Gleason score. The follow-up in hormone-naïve patients was significantly longer than that in hormonally manipulated patients, at 55 (20) vs 43 (15) months (P < 0.001). In a multivariate analysis only the Gleason score predicted failure in intermediate-risk patients, while pretreatment PSA, the use of hormonal manipulation and Gleason score predicted the outcome in high-risk patients (P = 0.035). For both hormone-naïve and hormonally manipulated BDF patients, the median PSA level after implantation was < 0.1 ng/mL. CONCLUSION In patients treated by permanent prostate brachytherapy, hormonal manipulation improved the biochemical outcome for those at high-risk and those with an initial PSA of , 10 ng/mL, but not for those with intermediate-risk features. The use of hormonal therapy for> 4 months conferred no additional biochemical advantage over short-course regimens. Because the follow-up in hormone-naïve patients was longer than that for those receiving hormonal manipulation, additional follow-up will be mandatory to confirm the durability of these findings. [source] Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patientsJOURNAL OF VIRAL HEPATITIS, Issue 2010G. B. Yao Summary., Hepatitis B virus (HBV) infection has a high prevalence in China. Entecavir has shown superior efficacy over lamivudine in Chinese nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with continued clinical benefit to 96 weeks. The present study evaluates the long-term efficacy of entecavir in Chinese CHB patients who continued entecavir treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n = 258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized, double-blind, controlled efficacy study. Patients who did not achieve a consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25 × upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at baseline, loss of HBeAg for ,24 weeks] or who experienced viral breakthrough or relapse entered a 48-week entecavir rollover study. A total of 160 patients received continuous entecavir for 144 weeks; of these, 89% had undetectable serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8% experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and seroconversion were 36% and 27% at Week 144, respectively. The development of resistance was low, with three patients up to Week 96 and an additional two patients in Weeks 96,144 showing evidence of associated genotypic mutations. Entecavir was well tolerated. Adverse event rates were similar to those in lamivudine-treated patients, but patients receiving entecavir experienced fewer ALT flares. This study demonstrates that entecavir provides durable, long-term suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is associated with low rates of emerging resistance. The results are consistent with the findings using entecavir globally and in Japan. [source] Differences in histopathological and biochemical outcomes in patients with low Gleason score prostate cancerBJU INTERNATIONAL, Issue 6 2010Hendrik Isbarn Study Type , Diagnosis (case series) Level of Evidence 4 OBJECTIVE To test whether the number or percentage of positive biopsy cores can be used to discriminate between patients with prostate cancer of a favourable and less favourable Gleason score (GS) ,3 + 3, as prognostically, not all GS 3 + 3 prostate cancers are the same. PATIENTS AND METHODS In all, 1106 consecutive patients with a prostate-specific antigen (PSA) level of ,10 ng/mL and a biopsy GS of ,3 + 3 or 3 + 4 had an open radical prostatectomy. The number of positive biopsy cores (,2 vs ,3) were stratified into low- vs high-risk groups. Subsequently, we stratified patients according to the GS and the percentage of positive biopsy cores (<50% vs ,50%). The pathological stage and the 5-year biochemical recurrence (BCR)-free survival rates were examined in univariable and multivariable models. RESULTS Based on the number of positive cores, the rate of extraprostatic disease was 11.7% and 23.3%, respectively, in the low-and high-risk GS ,3 + 3 groups (P < 0.001). The 5-year BCR-free survival rates were 95.0%, 77.8%, 81.2% and 66.5% for, respectively, low- and high-risk GS ,3 + 3 and for low- and high-risk GS 3 + 4 patients. Univariable and multivariable intergroup BCR rate differences were statistically significant between low- vs high-risk GS 3 + 3 patients (P < 0.001), but not significant between high-risk GS ,3 + 3 vs low-risk GS 3 + 4 patients (P = 0.6). Comparable results were obtained when comparisons were made according to the percentage of positive biopsy cores. CONCLUSIONS Our results corroborate the finding that not all patients with a biopsy GS of ,3 + 3 prostate cancer have low-risk disease. High-risk GS ,3 + 3 patients have a similar risk profile as more favourable GS 3 + 4 patients. This finding warrants consideration when deciding on treatment. [source] | ||||||||||