Introduction: We sought to evaluate the discrepancies between primary pathology report and second pathology review of radical orchiectomy (RO) specimens. Methods: A retrospective review was performed of RO specimens from the Ontario Cancer Registry. All cases required both a primary pathology report and a second pathology review from another institution. Histopathological variables assessed included histological subtype and components of mixed germ cell tumor (GCT), pathological tumor (pT) stage, lymphovascular invasion (LVI), spermatic cord invasion, and surgical margin. Results: Between 1994 and 2015, 5048 ROs were performed with 2719 (53.9%) seminoma and 2029 (40.2%) non-seminoma. Of these, 519 (10.3%) received a second pathology review. There was concordance between primary pathology report and second pathology review in 326 (62.8%) cases. The most common discrepancies involved a change in pT stage (n=148, 28.5%), with upstaging in 83 (16%) and downstaging in 65 (12.5%) cases relative to the original pT stage. The second most common discrepancy regarded the reporting of LVI (n=121, 23.3%), with 62 (11.9%) reporting presence of LVI when the primary pathology report did not. Other discrepancies included a change in the histological subtype in 28 (5.4%) cases and spermatic cord margin status in 5 (9.6%) cases. Conclusions: Only 10% of orchiectomy specimens underwent a second pathology review, with nearly 40% of reviews leading to a meaningful change in parameters. Such variation could lead to incorrect tumor staging, estimate of relapse risk, and inappropriate treatment decisions. Expert pathology review of RO specimens should be considered, as it has significant implications for decision making.

40 Background: Continued smoking after a diagnosis of cancer negatively impacts cancer outcomes but the impact of tobacco on many innovative treatments has not yet been well established. Collecting and evaluating tobacco use in cancer clinical trials may advance understanding of the consequences of tobacco use on specific treatment modalities. We performed a systematic scoping review of the frequency of reporting and analysis of tobacco use in clinical trials run by cancer cooperative clinical trial groups. Methods: A comprehensive literature search was conducted to identify cancer cooperative group clinical trials published from January 2017 to October 2019 using Medline, Epub Ahead of Print and In-Process & Other Non-Indexed Citations, Embase, Cochrane Central Register of Controlled Trials using OvidSP. Eligible studies evaluated either systemic and/or radiation therapies, involved at least one cancer cooperative group, included > 100 adult patients and reported on at least one primary or secondary endpoint, which included overall survival (OS), disease/progression-free survival (DFS/PFS), response rates, toxicities/adverse events, or quality of life (QoL). Secondary analyses of previously published trials were excluded. Results: Among 14843 identified studies, 91 studies representing 90 trials met inclusion criteria. 24% were phase II trials, 2% phase II/III and 74% phase III. Trial start dates ranged from 1995-2015 with most (29%) between 2007-2008; median trial sample size was 406 (range: 100-4994); 86% involved systematic therapy, 35% involved radiation; 14% were lung and 5% were head and neck trials. 51% of trials had a curative intent, 33% were palliative and 16% involved hematologic cancers. 74 studies reported on OS, 73 DFS/PFS, and 88 toxicity/QoL. 19 studies reported baseline tobacco use information, while two reported collecting follow-up tobacco use. Of those collecting baseline tobacco use, only 7 reported any analysis of the impact of tobacco on clinical outcomes. There was significant heterogeneity in the reporting of baseline tobacco use: 5 reported never/ever status, 10 reported never/ex-smoker/current smoker status; 4 reported some measure of smoking intensity; none reported on verifying smoking status or second hand smoke exposure. Trials of tobacco related (lung and head and neck) cancers were more likely to report baseline tobacco use compared to non-tobacco related cancers (83% vs 6% p < 0.001). Conclusions: Few cancer cooperative group clinical trials report and analyze trial participants’ baseline tobacco use, and even fewer collect follow up information. Significant heterogeneity exists in reporting tobacco use. Routine standardized collection and reporting of tobacco use, both at baseline and follow up in clinical trials, should be implemented to enable investigators to evaluate the clinical impact of tobacco use on new cancer therapies.

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