Eligibility of Real-World Patients With Stage II and III Colon Cancer for Adjuvant Chemotherapy Trials

2020 ◽  
Vol 19 (4) ◽  
pp. e226-e234 ◽  
Author(s):  
Atul Batra ◽  
Shiying Kong ◽  
Winson Y. Cheung
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Real World ◽  
Stage Ii

scholarly journals Real-world evidence on adjuvant chemotherapy in older adults with stage II/III colon cancer

2020 ◽  
Vol 12 (6) ◽  
pp. 604-618
Author(s):  
Atul Batra ◽  
Rodrigo Rigo ◽  
Dropen Sheka ◽  
Winson Y Cheung
Keyword(s):  
Older Adults ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Real World ◽  
Stage Ii ◽  
Real World Evidence

Assessing the representativeness of trial populations for contemporary real-world cancer patients: A case study of adjuvant chemotherapy for colon cancer.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 306-306
Author(s):  
Jennifer Leigh Lund ◽  
Michael Webster-Clark ◽  
Emily W. Bratton
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Real World ◽  
Performance Status ◽  
Stage Ii ◽  
Phase Iii ◽  
Stage Iii ◽  
Marketing Approval ◽  
Trial Participants

306 Background: Randomized controlled trials are the gold standard for assessing the efficacy of new cancer therapies and are required for marketing approval. However, participants enrolled into trials are often not representative of the more diverse populations in whom treatment will ultimately be delivered. Real-world data can be used to potentially bridge this gap by evaluating the effectiveness and safety of therapies in more generalizable populations. In this study, we describe differences in demographic and clinical characteristics between participants enrolled in a phase III trial of adjuvant chemotherapy for colon cancer and a contemporary comparator cohort using structured oncology electronic medical records (EMR) data. Methods: We drew upon publications from the Multicenter International Study of Oxaliplatin/5 Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) recruiting patients primarily from Western Europe with stage II or III colon cancer from October 1998-January 2001. This trial established FOLFOX (oxaliplatin + 5-FU) as the standard of care over 5FU alone in treating stage III colon cancer and led to US marketing approval. For comparison, we identified patients diagnosed with stage II or III colon cancer (September 2014-2020) who received FOLFOX in the IQVIA US Oncology EMR database via E360, IQVIA’s Real World Discovery and Analytics platform. In the two populations, we described distributions of prognostic factors including age, sex, stage of disease, body mass index (BMI), and Eastern Cooperative Group (ECOG) performance status. Results: The MOSAIC trial included 2,246 participants; we identified 4,566 patients starting FOLFOX in the EMR comparator. Median age was similar: 61 versus 62 years, but the range differed (19-75 years versus 18-85 years) in the trial and EMR comparator, respectively. Female sex was similar at 44% and 48%, while the proportion of patients with stage III disease differed considerably at 60% and 84% for trial and EMR comparator, respectively. Half (51%) of all EMR patients were missing ECOG status; among those with a reported ECOG status, 96% had a score of 0-1, while 87% of trial participants had an ECOG of 0-1. BMI was missing in 34% of patients in the EMR comparator; among those with a reported BMI, 28% had a BMI < 25, while 54% of trial participants had a BMI < 25. Conclusions: Colon cancer patients receiving FOLFOX in an EMR comparator had a similar age and sex distribution as MOSAIC trial participants, but were more likely to have stage III disease. Missing ECOG and BMI data were common in the EMR comparator, which limited comparisons. Structured oncology EMR data represent an important resource for generating real-world evidence; future data enrichment efforts focused on critical patient-level variables via unstructured EMR extraction may improve data completeness and quality.

Age Determines Adjuvant Chemotherapy Use in Resected Stage II Colon Cancer

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Brendan L. Hagerty ◽  
John G. Aversa ◽  
Dana A. Dominguez ◽  
Jeremy L. Davis ◽  
Jonathan M. Hernandez ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Resected Stage ◽  
Stage Ii Colon Cancer

Microsatellite Status and Adjuvant Chemotherapy in Patients with Stage II Colon Cancer

2010 ◽  
Vol 6 (3) ◽  
pp. 148-157 ◽  
Author(s):  
Jean-Baptiste Bachet ◽  
Pierre Laurent-Puig ◽  
Aimery de Gramont ◽  
Thierry André
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Stage Ii Colon Cancer

Real-world survival outcomes associated with completion of adjuvant chemotherapy for stage III colon cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3596-3596
Author(s):  
Jemma Megan Boyle ◽  
Angela Kuryba ◽  
Thomas E Cowling ◽  
Jan van der Meulen ◽  
Nicola S Fearnhead ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Dose Reduction ◽  
Real World ◽  
Survival Rates ◽  
Stage Iii ◽  
World Population ◽  
Early Discontinuation ◽  
Subdistribution Hazard ◽  
Stage Iii Colon Cancer

3596 Background: The optimal duration of adjuvant combination chemotherapy administered to patients with stage III colon cancer is debated. Our study assessed the effect of completed chemotherapy cycles on 3-year colon cancer-specific mortality, as well as the effect of dose reduction and early discontinuation of oxaliplatin in patients with 100% completion, within a real-world population. Methods: 4,147 patients undergoing major resection between 01 June 2014 and 30 April 2017 with pathological stage III colon cancer in the English National Health Service were identified. Chemotherapy data were obtained from linked administrative hospital records and a national chemotherapy dataset. Patients were stratified according to completion of < 50% ( < 6 FOLFOX cycles or < 4 CAPOX cycles), 50-92% (6-11 FOLFOX cycles or 4-7 CAPOX cycles) or 100% of cycles (12 FOLFOX cycles or 8 CAPOX cycles). Competing-risk regression analysis for 3-year colon cancer-specific death was performed with adjustment for patient, tumour and hospital-level characteristics to estimate subdistribution hazard ratios (sHR) as a measure of relative risk. Results: Patients included within our study were less fit and had increased rates of high-risk disease (T4 and/or N2 pathological staging) compared to the IDEA study. For FOLFOX, the 3-year cumulative incidence of colon cancer-specific death in patients completing 100% of cycles was 15.1% (95% CI, 12.8% to 17.6%), 18.2% (95% CI, 15.3% to 21.3%) for 50-92% of cycles and 26.4% (95% CI, 20.6% to 32.5%) for < 50% of cycles. For CAPOX, this was 12.0% (95% CI, 10.2% to 14.0%) for 100% completion of cycles, 18.2% (95% CI, 15.6% to 21.0%) for 50-92% of cycles, and 19.8% (95% CI, 15.8% to 24.1%) for < 50% cycles. Compared to 100% completion of FOLFOX cycles, colon cancer-specific death was higher in patients recorded as completing < 50% (sHR 2.17; 95% CI, 1.56 to 3.03; P = < 0.001) and 50-92% of FOLFOX cycles (sHR 1.40; 95% CI, 1.09 to 1.78; P = 0.007). Compared to 100% completion of CAPOX cycles, colon cancer-specific death was higher in patients recorded as completing < 50% (sHR 2.02; 95% CI 1.53 to 2.67; P< 0.001) and 50-92% of CAPOX cycles (sHR 1.63; 95% CI 1.27 to 2.10; P< 0.001). Dose reduction and early discontinuation of oxaliplatin did not have a statistically significant effect on mortality. Conclusions: Patients within the real world setting were more likely to have poor prognostic factors. Those who completed adjuvant chemotherapy for stage III colon cancer had improved survival rates regardless of dose reduction or early discontinuation of oxaliplatin.

scholarly journals Analysis of the benefit of the adjuvant chemotherapy in stage II colon cancer according to the presence of classic poor risk factors: Our experience in Ramon y Cajal Hospital

2018 ◽  
Vol 29 ◽  
pp. v64
Author(s):  
C. Saavedra Serrano ◽  
M. Villamayor Delgado ◽  
E. Corral de la Fuente ◽  
A. Barquín García ◽  
J. Serrano Domingo ◽  
...  
Keyword(s):  
Risk Factors ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Poor Risk ◽  
Stage Ii Colon Cancer ◽  
Ramón Y Cajal
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