Randomized trials of omission vs. delivery of radiotherapy in breast conserving surgery: pooled analysis for risks of recurrence and mortality.
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Breast-conserving surgery
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Urothelial cancer
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4642 Background: The magnitude of the benefit of adding adjuvant hormonal treatment to radiotherapy for locally advanced prostate cancer is still unclear. We performed a pooled-analysis of phase III trials, to quantify the eventual benefit in recurrence decrease. Methods: All prospective phase III trials were considered eligible. A pooled analysis was accomplished, and event-based relative risk ratios (RR) with 95% confidence interval (CI) were derived through both a fixed- (FEM) and a random-effect model (REM) approach. Significant differences in primary outcome (recurrence rate), and secondary outcomes (overall survival), were explored. Magnitude outcome measures were: absolute benefits and number of patients needed to treat (NNT) for 1 patient to benefit. Heterogeneity test was applied as well. Results: Six trials designed to look if hormonal treatment plus radiotherapy decreases recurrence rate (3,571 patients) were gathered. In the primary outcome, the combined approach significantly improves the recurrence rate when applying the FEM (RR 0.72, 95% CI 0.68, 0.77, p < 0.0001), with an absolute benefit of 10.7%. The NNT was 9 patients. Although significant heterogeneity was found (p = 0.00001), the benefit remains significant at the REM as well (RR 0.67, 95% CI 0.54, 0.82, p < 0.0001). Although significant at FEM (RR 0.93, 95% CI 0.86, 1.00, p = 0.039) but heterogeneous (p = 0.0007), the overall survival demonstrated a not-significant trend in favour of the combined strategy at REM (RR 0.90, 95% CI 0.75, 1.10, p = 0.263). Conclusions: Considered all the available phase III trials, the combination of adjuvant hormonal treatment with radiotherapy over standard exclusive radiotherapy significantly decreases the recurrence rate in patients affected by localized prostate cancer. The significant heterogeneity in the analysis underscores the existing difference in patient’ characteristics. No significant benefit in overall survival was found. No significant financial relationships to disclose.
Hormonal Therapy
Absolute risk reduction
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Lumpectomy
Cosmesis
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Objective To evaluate the prognostic value of adjuvant chemotherapy after operation or / and radiation.Methods We searched for randomized trials(published from 2002 to 2006) in women with cervical cancer that compared adjuvant chemotherapy after operation or / and radiation versus surgery alone or radiotherapy alone through CBMdisc,MEDLINE,and Cochrane Gynaecological Cancer Group's Specialized Register CENTRAL.Results for survival were combined with fixed and random effects models.RevMan 4.2.10 software was applied to process data.Results Pooled survival rates from six randomized trials that evaluated the role of adjuvant chemotherapy after operation or / and radiation to patients with cervical cancer demonstrated no statistically significant difference compared with surgery alone or radiotherapy alone(relative risk of death,0.87;95% confidence interval,0.58 to 1.32,P 0.05).Conclusions This meta-analysis confirms that treatment with adjuvant chemotherapy after operation or / and radiation can not improve overall survival versus surgery alone or radiotherapy alone in women with cervical cancer.The further studies in prospective,multicentre and randomized trials may be warranted.
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Neoadjuvant Therapy
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1) What is the role of different schedules or doses of radiotherapy in patients with unresected, clinical or pathological, stage III non-small-cell lung cancer (NSCLC)? 2) Does chemotherapy combined with radiotherapy provide improved survival compared with radiotherapy alone in patients with unresected NSCLC?To make recommendations about the role of chemotherapy and radiotherapy in the treatment of unresected stage III NSCLC.Survival is the primary outcome of interest. Quality of life is a secondary outcome.Evidence was selected and reviewed by 5 members of the Provincial Lung Cancer Disease Site Group (Lung DSG) of the Ontario Cancer Treatment Practice Guidelines Initiative. The Lung DSG comprises medical and radiation oncologists, pathologists, surgeons, epidemiologists, a psychologist and a medical sociologist. No community representative participated in the development of this guideline.Two meta-analyses were available for review. The specific analysis of interest examined the role of combined chemotherapy plus radiotherapy v. radiotherapy alone in locally advanced disease. The first meta-analysis included combined data from 22 randomized controlled (RCTs) involving a total of 3033 patients. The second included combined data from 14 RCTs involving a total of 2589 patients. Also reviewed were 4 RCTs of radiotherapy alone, 1 trial of combined chemotherapy and radiotherapy that was not included in the meta-analysis, 4 abstracts of studies of combined chemotherapy and radiotherapy, and 4 trials examining the role of hyperfractionated radiotherapy.In the first meta-analysis, an overall benefit was detected at 2 years for the use of combined chemotherapy and radiotherapy. A hazard ratio of 0.90 (p = 0.006), or a 10% reduction in the risk of death, translated into an absolute benefit of 3% at 2 years and 2% at 5 years. A subgroup analysis of cisplatin-based chemotherapy plus radiotherapy versus radiotherapy alone demonstrated a 13% reduction in the risk of death in the combined treatment arm (pooled hazard ratio 0.87, 95% confidence interval [CI] 0.79-0.96), for an absolute benefit of 4% at 2 years. In the second meta-analysis, there was a 13% reduction in the risk of death in the combined therapy arm at 2 years (pooled relative risk [RR] 0.87, 95% CI 0.81-0.94) and a 17% reduction at 3 years (pooled RR 0.83, 95% CI 0.77-0.90). Subgroup analysis of cisplatin-based chemotherapy plus radiotherapy versus radiotherapy alone showed similar results: a 15% reduction in the risk of death in the combined therapy arm at 2 years (pooled RR 0.85, 95% CI 0.79-0.92) and a 19% reduction at 3 years (pooled RR 0.81, 95% CI 0.74-0.88).For patients with unresected stage III NSCLC, the combination of cisplatin-based chemotherapy and radical radiotherapy provides a survival benefit compared with radiotherapy alone. This guideline is based on high-quality evidence from 2 meta-analyses of RCTs. Patients with good performance status (Eastern Cooperative Oncology Group [ECOG] 0-1) and minimal weight loss (less than 5% in the preceding 3 months) have been shown to have a survival benefit from treatment with combined chemotherapy and radiotherapy and should be considered for this type of treatment approach (see section V). For these patients, thoracic irradiation of 60 Gy in 30 fractions over 6 weeks, in combination with cisplatin-based chemotherapy, should be recommended as a treatment option. The patient and physician should discuss fully the benefits, limitations and toxic effects of therapy. Patients not meeting these criteria are not candidates for combined therapy; those experiencing symptoms amenable to treatment should receive palliative thoracic irradiation. At this time, hyperfractionated radiotherapy is not recommended outside of the context of a clinical trial. (ABSTRACT TRUNCATED)
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Breast-conserving surgery
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Background The existing randomized evidence has failed to conclusively demonstrate the benefit or otherwise of preoperative radiotherapy in treating patients with potentially resectable esophageal carcinoma. Objectives This meta‐analysis aimed to assess whether there is benefit from adding radiotherapy prior to surgery and whether or not any pre‐defined patient subgroups benefit more or less from preoperative radiotherapy Search methods Medline and CancerLit searches were supplemented by information from trial registers and by hand searching relevant meeting proceedings and by discussion with relevant trialists, organisations and industry. The search strategy was run again in Medline, Embase and the Cochrane Library on 30th April 2001, two years after original publication. No new trials were found. The search strategy was re‐run 8th August 2002 and August 2003 on Medline, Embase, CancerLit and The Cochrane Library, and and July 2004 on Medline, Embase and the Cochrane Library. No new relevant trials identified on any of these occasions. Selection criteria Trials were eligible for inclusion in this meta‐analysis provided they randomized patients with potentially resectable carcinoma of the esophagus (of any histological type) to receive radiotherapy or no radiotherapy prior to surgery. Trials must have used a randomization method which precluded prior knowledge of treatment assignment and completed accrual by December 1993, to ensure sufficient follow‐up by the time of the first analysis (September 1995). Data collection and analysis A quantitative meta‐analysis using updated data from individual patients from all properly randomized trials (published or unpublished) comprising 1147 patients (971 deaths) from five randomized trials. This approach was used to assess whether preoperative radiotherapy improves overall survival and whether it is differentially effective in patients defined by age, sex and tumour location. Main results With a median follow‐up of 9 years, in a group patients with mostly squamous carcinomas, the hazard ratio (HR) of 0.89 (95% CI 0.78‐1.01) suggests an overall reduction in the risk of death of 11% and an absolute survival benefit of 3% at 2 years and 4% at 5 years. This result is not conventionally statistically significant (p=0.062). No clear differences in the size of the effect by sex, age or tumor location were apparent. Authors' conclusions Based on existing trials, there was no clear evidence that preoperative radiotherapy improves the survival of patients with potentially resectable esophageal cancer. These results indicate that if such preoperative radiotherapy regimens do improve survival, then the effect is likely to be modest with an absolute improvement in survival of around 3 to 4%. Trials or a meta‐analysis of around 2000 patients (90% power, 5% significance level) would be needed to reliably detect such an improvement (from 15 to 20%).
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