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1.  Spontaneous regression of metastatic pulmonary renal cell carcinoma in the setting of sarcomatoid differentiation of the primary tumour 
Canadian Urological Association Journal  2013;7(9-10):E587-E589.
We present a case of spontaneous regression of pulmonary metastases from renal cell carcinoma (RCC) with sarcomatoid differentiation, prior to intervention. The patient presented with conventional type RCC with Furhman Grade 4/4 and sarcomatoid differentiation, complicated by pulmonary metastases. Palliative systemic therapy was planned, but prior to the onset of treatment, serial computed tomography scans demonstrated regression of metastatic disease. Spontaneous regression of metastases is rare, but well-documented in conventional clear cell RCC. To the best of our knowledge, this has not previously been described in the setting of sarcomatoid differentiation of the primary tumour.
doi:10.5489/cuaj.169
PMCID: PMC3776034  PMID: 24069101
3.  Adoption of Adjuvant Chemotherapy for Non–Small-Cell Lung Cancer: A Population-Based Outcomes Study  
Journal of Clinical Oncology  2010;28(21):3472-3478.
Purpose
Since 2004, several clinical trials have demonstrated that adjuvant chemotherapy (ACT) improves survival in patients with early-stage non–small-cell lung cancer (NSCLC). Here, we evaluate the uptake of ACT and its impact on outcomes in the general population of Ontario, Canada.
Methods
All patients diagnosed with NSCLC in Ontario from 2001 to 2006 who underwent surgical resection (n = 6,304) were identified using the Ontario Cancer Registry. We linked electronic records of treatment to the registry. We described uptake of ACT and compared survival of all patients with surgically resected NSCLC diagnosed from 2001 to 2003 with patients diagnosed from 2004 to 2006. As a proxy measure of ACT-related toxicity, we evaluated hospitalizations within 6 months of surgery.
Results
Demographic, disease, and treatment-related characteristics did not differ between the 2001 to 2003 and 2004 to 2006 study cohorts. Over the study period, the proportion of patients receiving ACT increased from 7% (192 of 2,950 patients) to 31% (1,032 of 3,354 patients; P < .001). The proportion of patients admitted to hospital within 6 months of surgery remained stable and (36% in the 2001 to 2003 cohort and 37% in the 2004 to 2006 cohort). However, within 2 years of surgery, there was a 33% reduction in the proportion of patients admitted to hospital with metastatic disease (P < .001). During the study period, there was a substantial improvement in 4-year survival among surgically resected patients, from 52.5% (2001 to 2003) to 56.1% (2004 to 2006; P = .001).
Conclusion
There has been a rapid uptake of ACT for NSCLC, which was not associated with an increased rate of hospitalization. The adoption of ACT was associated with a substantial improvement in overall survival, suggesting that the benefits seen in clinical trials are generalizable to the general population.
doi:10.1200/JCO.2010.28.1709
PMCID: PMC2917211  PMID: 20567022
5.  Evolution of the Randomized Controlled Trial in Oncology Over Three Decades 
Journal of Clinical Oncology  2008;26(33):5458-5464.
Purpose
The randomized controlled trial (RCT) is the gold standard for establishing new therapies in clinical oncology. Here we document changes with time in design, sponsorship, and outcomes of oncology RCTs.
Methods
Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC), and non–small-cell lung cancer (NSCLC) published 1975 to 2004 in six major journals were reviewed. Two authors abstracted data regarding trial design, results, and conclusions. Conclusions of authors were graded using a 7-point Likert scale. For each study the effect size for the primary end point was converted to a summary measure.
Results
A total of 321 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). Over time, the number and size of RCTs increased considerably. For-profit/mixed sponsorship increased substantially during the study period (4% to 57%; P < .001). There was increasing use of time-to-event measures (39% to 78%) and decreasing use of response rate (54% to 14%) as primary end point (P < .001). Effect size remained stable over the study period. Authors have become more likely to strongly endorse the experimental arm (P = .017). A significant P value for the primary end point and industry sponsorship were each independently associated with endorsement of the experimental agent (odds ratio [OR] = 19.6, 95% CI, 8.9 to 43.1, and OR = 3.5, 95% CI, 1.6 to 7.5, respectively).
Conclusion
RCTs in oncology have become larger and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies. For-profit sponsorship and statistically significant results are independently associated with endorsement of the experimental arm.
doi:10.1200/JCO.2008.16.5456
PMCID: PMC2651075  PMID: 18955452
6.  External influences and priority-setting for anti-cancer agents: a case study of media coverage in adjuvant trastuzumab for breast cancer 
BMC Cancer  2007;7:110.
Background
Setting priorities for the funding of new anti-cancer agents is becoming increasingly complex. The funding of adjuvant trastuzumab for breast cancer has brought this dilemma to the fore. In this paper we review external factors that may influence decision-making bodies and present a case study of media response in Ontario, Canada to adjuvant trastuzumab for breast cancer.
Methods
A comprehensive search of the databases of Canadian national and local newspapers and television was performed. Articles pertaining to trastuzumab in adjuvant breast cancer as well as 17 other anti-cancer drugs and indications were retrieved. The search period was from the date when individual trial results were announced to the date funding was made available in Ontario.
Results
During the 2.6 months between the release of the trastuzumab results to funding approval in Ontario, we identified 51 episodes of media coverage. For the 17 other drugs/indications (7 breast and 10 non-breast), the median time to funding approval was 31 months (range 14–46). Other recent major advances in oncology such as adjuvant vinorelbine/cisplatin for resected NSCLC and docetaxel for advanced prostate cancer received considerably less media attention (17 media reports for each) than trastuzumab. The median number of media reports for breast cancer drugs was 4.5 compared to 2.5 for non-breast cancer drugs (p = 0.56).
Conclusion
Priority-setting for novel anti-cancer agents is a complex process that tries to ensure fair use of constrained resources to fund therapies with the best evidence of clinical benefit. However, this process is subject to external factors including the influence of media, patient advocates, politicians, and industry. The data in this case study serve to illustrate the significant involvement one (or all) of these external factors may play in the debate over priority-setting.
doi:10.1186/1471-2407-7-110
PMCID: PMC1925109  PMID: 17598896
7.  Communication in the Toronto critical care community: important lessons learned during SARS 
Critical Care  2003;7(6):405-406.
The SARS outbreak in 2003 pushed Toronto's health care system to its limits. Staffing shortages, transmission of SARS within the ICU, and the influx of critically ill SARS patients were some unique challenges to the delivery of critical care. Communication strategies were a key component in the critical care response to SARS. Regular teleconference calls, web-based training and education, and the rapid coordination of research studies were some of the initiatives developed within the Toronto critical care community during the SARS outbreak. Other critical care communities should consider their communication strategies in advance of similar events.
PMCID: PMC374381  PMID: 14624673
communication; critical care; disease outbreaks; SARS
9.  Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials 
PLoS ONE  2013;8(3):e58711.
Objective
To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials.
Study Design and Settings
We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs) conducted by GlaxoSmithKline (GSK) and the NCIC Clinical Trials Group (CTG). We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1) the proportion of statistically significant trials favouring the experimental treatment, (2) the proportion of the trials in which new treatments were considered superior according to the investigators, and (3) quantitative synthesis of data for primary outcomes as defined in each trial.
Results
GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60) of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37) in the CTG cohort (RR = 1.68; p = 0.04). Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001). Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47–0.78] compared to 0.86 [0.74–1.00]; p = 0.003). However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade.
Conclusions
While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time.
doi:10.1371/journal.pone.0058711
PMCID: PMC3605423  PMID: 23555593

Results 1-9 (9)