Objectives
To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to ‘standard’ treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP).
To compare the following secondary endpoints between the two arms: patient‐reported outcomes, adverse events, biochemical failure‐free survival, overall survival, disease‐specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation.
Patients and Methods
The Radiotherapy – Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).
In all, 470 patients are planned to be randomised 1:1 to either ART commenced at ≤4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm).
Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs ± extraprostatic extension ± seminal vesicle involvement. The postoperative PSA level must be ≤0.10 ng/mL.
Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients.
Results
Trial is currently underway, with 258 patients randomised as of 31 October 2013.
International collaborations have developed, including a planned meta‐analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho‐oncology sub‐study to investigate a patient decision aid resource.
Conclusion
On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.
Purpose: Multidisciplinary meetings (MDMs) are increasingly being mandated as essential to oncology practice. However, there is a paucity of data on their effectiveness. The aim of this study was to assess whether MDM recommendations were concordant with guidelines in the treatment of lung cancer.
Patients and Methods: The Lung Cancer MultidisciplinaryMeeting in South West Sydney, Australia, prospectively collects data on all patients whose cases have been presented. New patients with lung cancer who presented between December 1, 2005, and December 31, 2007, were reviewed. Patients were assigned to treatment on the basis of evidencebased guidelines according to pathology, stage, and Eastern Cooperative Oncology Group (ECOG) performance status. MDM recommendations were compared with guideline treatment, and reasons for discrepancy were noted.Results: There were 335 patients with a median age of 69 years.Of these, 82% had non-small-cell lung cancer (NSCLC), 14% had small-cell lung cancer, and 4% had no pathologic diagnosis. Eightyfour percent had locally advanced or metastatic disease. Concordance of MDM recommendations with guideline treatment existed in 29 (58%) of 50 cases for surgery, 201 (88%) of 228 cases for radiotherapy, and 200 (77%) of 260 cases for chemotherapy. Overall concordance with guideline treatment was 71% (239 of 335 cases). On multivariate analysis, age greater than 70 years, ECOG performance status of 2 or higher, and stage III NSCLC were associated with the MDM not recommending guideline treatment. The primary reasons for this were physician decision (39%), comorbidity (25%), and technical factors (22%).
Conclusion:MDM recommendations were largely concordant with guidelines. Physician discretion in not recommending guideline treatment was most often exercised in older patients and those with borderline performance status. Individual factors that may preclude guideline treatment cannot be accounted for by guidelines.
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