Precision medicine in the real-world: The impact of the genetic testing evolution in metastatic colorectal cancer.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e15612-e15612
Author(s):  
Adrianne Waldman Casebeer ◽  
Charron Long ◽  
Dana Drzayich Antol ◽  
Patrick Racsa ◽  
Teresa Rogstad ◽  
...  
2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 46-46
Author(s):  
Adrianne Waldman Casebeer ◽  
Charron Long ◽  
Dana Angela Drzayich Jankus ◽  
Patrick Racsa ◽  
Teresa Rogstad ◽  
...  

46 Background: Evaluation of real-world data regarding genetic testing for metastatic colorectal cancer (mCRC) highlights the successes and challenges of precision medicine. Guidelines recommend genetic testing to inform mCRC treatment choice. However, there is a lack of real-world evidence regarding genetic testing patterns, including adoption and efficiency. Methods: This retrospective analysis identified adult patients with newly diagnosed mCRC (2015-2106), Medicare Advantage coverage with a pharmacy benefit (MAPD), and claims evidence of CRC-related genetic testing. Inclusion required diagnosis of colon/rectal cancer on ≥2 medical claims and new metastatic disease. Paid and unpaid claims identified genetic testing, which was classified as limited RAS, extended KRAS/NRAS, limited + extended, and BRAF. Efficiency was measured as time-to-testing and time-to-treatment once testing was performed. Results: The study included 4,408 patients with mCRC and MAPD, with a median age of 72 years. Evidence of limited +/- extended testing was noted for 667 (15.1%) of patients. Of these, 78.3% initiated CRC treatment. Limited, extended, and limited + extended testing was observed for 51.7%, 4.5% and 43.8% of patients, respectively. BRAF was observed for 46.4%, 23.3% and 63.7% of patients with limited, extended, or limited + extended testing, respectively. For the 69.2% of patients tested prior to treatment, the median number of days between mCRC diagnosis and first genetic test was 6 [range: 0-31] days, with 25 [13-46] days between testing and treatment. When treatment preceded testing, the median number of days from treatment to test was 72.0 [20-251]. Of patients with > 1 genetic test, most patients had all tests on the same day (96.9%) or within 7 days (97.8%) of diagnosis, with no differences by type of testing. Conclusions: Per guidelines, mCRC-related genetic testing was completed efficiently after diagnosis and prior to treatment initiation for most patients. Genetic testing rates remain low, perhaps indicating barriers to scaling precision medicine. Ongoing research to explore ways to expedite adoption of precision medicine, while maintaining its efficiency, is needed.


2016 ◽  
Vol 93 (1101) ◽  
pp. 395-400 ◽  
Author(s):  
Ka-On Lam ◽  
Kin-Chung Lee ◽  
Joanne Chiu ◽  
Victor Ho-Fun Lee ◽  
Roland Leung ◽  
...  

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 673-673
Author(s):  
Ziwei Wang ◽  
Lindsay Hwang ◽  
James Don Murphy

673 Background: Randomized clinical trials play a central role in clinical research though only a small fraction of patients partake in clinical studies. Questions thus arise regarding the generalizability of clinical trial results to the remainder of the population. This study evaluated whether patient survival from randomized clinical trials in metastatic colorectal cancer reflects real world outcomes. Methods: A Pubmed search was used to identify randomized phase III clinical trials of first-line treatment for metastatic colorectal cancer published between 2005 and 2010. We excluded secondary or pooled analyses, second-line treatments, non-metastatic patients, non-English language, and non-randomized studies. Thirty-one clinical trials met these criteria, comprised of 79 distinct clinical trial arms. Overall survival among clinical trial patients was compared to metastatic colorectal cancer patients within the Surveillance, Epidemiology, and End Results (SEER) program. Within SEER, we restricted the analysis time-period and age of patients to match the enrollment period and age of patients within each individual clinical trial. Results: The clinical trials enrolled a total of 16,614 patients. Among all clinical trial arms the median survival ranged from 6.7-62 months, 1-year survival ranged from 30-97%, and 2-year survival ranged from 6-88%. Compared to SEER, the median survival was higher in 95% of the individual clinical trial arms by an average of 5.4 months (p<0.0001). The 1-year survival was higher in 94% of the clinical trial arms by an average of 16.7% (p<0.0001). The 2-year survival was higher in 71% of the clinical trial arms by an average of 7.2% (p<0.0001). Conclusions: This study found substantially improved survival among clinical trial participants compared to patients in the SEER database suggesting that survival estimates from clinical trials may not generalize to the “real world.” Potential patient factors such as differences in underlying comorbidity, performance status, disease burden, as well as variation in treatment could not be addressed in this study, though these factors likely explain some of the observed survival differences.


2019 ◽  
Vol 30 ◽  
pp. iv90-iv91
Author(s):  
Z. Maravic ◽  
À Benedict ◽  
K. Komlos ◽  
L. Lemmens ◽  
I. Rawicka

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 43-43
Author(s):  
Keigo Chida ◽  
Daisuke Kotani ◽  
Kentaro Sawada ◽  
Yoshiaki Nakamura ◽  
Akihito Kawazoe ◽  
...  

43 Background: Regorafenib (REG) and trifluridine/tipiracil hydrochloride (FTD/TPI) demonstrated overall survival (OS) benefit in patients (pts) with metastatic colorectal cancer (mCRC) in the CORRECT and RECOURSE phase III trials. In Japan, REG and FTD/TPI have been approved in 2013 and 2014, respectively. However, little is known about survival impact on these agents in the real-world setting. Therefore, the aim of this retrospective study was to evaluate the effects of REG and FTD/TPI in pts with mCRC. Methods: We collected medical records from consecutive 1142 pts who had been initiated with first-line chemotherapy for mCRC from 2008 to 2016 at National Cancer Center Hospital East. The survival outcomes were compared between pts from 2008 to 2011 (cohort A) and those from 2012 to 2016 (cohort B). This study excluded pts who have not been refractory or intolerant to standard chemotherapy including fluoropyrimidine, oxaliplatin, irinotecan, and anti-EGFR antibody if KRAS exon 2/ RAS wild-type tumors. Results: A total of 590 pts were analyzed (cohort A; N = 236 and cohort B; N = 354). More patients received at least one of REG or FTD/TPI in cohort B (16.1% vs. 59.9%, p < 0.001). The time from initiation to end of standard chemotherapy was comparable between the two cohort (20.0 vs. 17.5 months, p = 0.266). With a median follow-up period of 34.9 months, salvage-line OS (sOS) after standard chemotherapy was significantly longer in cohort B (4.8 vs. 6.6 months, p = 0.001), while there was only a favorable trend in cohort B in terms of OS from start of first-line treatment (27.3 vs. 28.5 months, p = 0.516). In cohort B, pts who sequentially received both of REG and FTD/TPI showed longest sOS (median, both of REG and FTD/TPI; 11.3 months, either REG or FTD/TPI; 7.0 months, neither REG nor FTD/TPI; 3.1 months). Conclusions: Our study showed that REG and FTD/TPI led to prolongation of sOS in the real-world setting, indicating the importance of strategies which make all active agents available to pts with mCRC.


2021 ◽  
Vol Volume 13 ◽  
pp. 6199-6205
Author(s):  
Yan Song ◽  
Tao Qu ◽  
Honggang Zhang ◽  
Yongkun Sun ◽  
Chengxu Cui ◽  
...  

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