Effectiveness of adjuvant FOLFOX versus 5FU for colon cancer treatment in community oncology practice using a hybrid study approach.

7067 Background: Treatment effects may differ between trials and community settings, in part due to underrepresentation of certain patient subgroups in trials. We used a hybrid approach combining clinical trial and real-world data to compare the effectiveness of adjuvant FOLFOX vs 5FU for stage II-III colon cancer in community oncology practice. Methods: We used Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer (MOSAIC) combined with patients who met trial eligibility criteria within US Oncology from 1/1/2008-5/31/2019. In the combined data, we used logistic regression to estimate the probability of trial enrollment as a function of age, sex, substage, body mass index (BMI), and performance status. We estimated inverse odds of sampling weights and weighted MOSAIC participants to reflect three US Oncology populations: 1) patients meeting trial eligibility, 2) stage III patients, and 3) stage III patients initiating FOLFOX. Within the weighted trial populations, we estimated mortality hazard ratios (HRs) and bootstrapped 95% confidence intervals (CIs) comparing FOLFOX with 5FU. Results: There were 2246 MOSAIC participants and 9335 US Oncology patients. MOSAIC participants were younger, had more stage II cancer, lower BMI, and worse performance status compared with US Oncology patients. After weighting MOSAIC participants to reflect the US Oncology populations, the HRs were attenuated (Table) compared with the original MOSAIC estimate (HR = 0.84; 0.71,1.00). Conclusions: When differences between trial and clinical populations exist and response to therapy varies across subgroups, treatment efficacy can differ from clinical effectiveness. Compared with trial results, we found that effectiveness of FOLFOX versus 5FU was attenuated in community oncology practice. [Table: see text]

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

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.306 ◽

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.

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Review: Combination therapy in high-risk stage II or stage III colon cancer: current practice and future prospects

Therapeutic Advances in Medical Oncology ◽

10.1177/1758834010367905 ◽

2010 ◽

Vol 2 (4) ◽

pp. 261-272 ◽

Cited By ~ 19

Author(s):

Diogo Assed Bastos ◽

Suilane Coelho Ribeiro ◽

Daniela de Freitas ◽

Paulo M. Hoff

Keyword(s):

Colon Cancer ◽

High Risk ◽

Combination Therapy ◽

Current Practice ◽

Stage Ii ◽

Stage Iii ◽

Future Prospects ◽

Stage Iii Colon Cancer

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Adjuvant therapy for stages II and III colon cancer: risk stratification, treatment duration, and future directions

Current Oncology ◽

10.3747/co.26.5605 ◽

2019 ◽

Vol 26 (1) ◽

Cited By ~ 10

Author(s):

U. Bender ◽

Y.S. Rho ◽

I. Barrera ◽

S. Aghajanyan ◽

J. Acoba ◽

...

Keyword(s):

Colon Cancer ◽

Adjuvant Therapy ◽

Risk Stratification ◽

Disease Risk ◽

Stage Ii ◽

Stage Iii ◽

Future Directions ◽

Duration Of Therapy ◽

Colon Cancer Risk ◽

Genomic Assays

Background To date, the role of adjuvant systemic therapy in stages ii and iii colon cancer remains a topic of interest and debate. The objective of the present review was to assess the most recent data, specifically addressing methods of risk stratification, duration of therapy, and future directions.Methods PubMed and medline were searched for literature pertinent to adjuvant chemotherapy in either stage ii or stage iii colorectal cancer.Summary Locoregional disease, histopathology, age, laterality, and a number of other biologic and molecular markers appear to have a role in disease risk stratification. The duration of adjuvant therapy for stage iii disease can vary based on risk factors, but use of adjuvant therapy and duration of therapy in stage ii disease remain controversial. Future directions should include genomic assays and improved study design to provide concrete evidence about the duration of adjuvant folfox or capox and about other types of chemotherapy and immunotherapy.

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The prognostic impact of primary tumour location in patients with stage II and stage III colon cancer receiving adjuvant therapy. A GISCAD analysis from three large randomised trials

European Journal of Cancer ◽

10.1016/j.ejca.2019.01.020 ◽

2019 ◽

Vol 111 ◽

pp. 1-7 ◽

Cited By ~ 3

Author(s):

S. Cascinu ◽

D. Poli ◽

A. Zaniboni ◽

S. Lonardi ◽

R. Labianca ◽

...

Keyword(s):

Colon Cancer ◽

Adjuvant Therapy ◽

Primary Tumour ◽

Stage Ii ◽

Stage Iii ◽

Prognostic Impact ◽

Randomised Trials ◽

Stage Iii Colon Cancer ◽

Tumour Location

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Predictive potential of tumour-stroma ratio on benefit from adjuvant bevacizumab in high-risk stage II and stage III colon cancer

Annals of Oncology ◽

10.1093/annonc/mdx393.023 ◽

2017 ◽

Vol 28 ◽

pp. v168-v169

Author(s):

S. Zunder ◽

G. van Pelt ◽

H. Gelderblom ◽

R. Tollenaar ◽

C. Mancao ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Stage Ii ◽

Stage Iii ◽

Tumour Stroma ◽

Stage Iii Colon Cancer

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Abstract CT263: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients: The PEGASUS trial

10.1158/1538-7445.am2020-ct263 ◽

2020 ◽

Author(s):

Elena Elez ◽

Filippo Pietrantonio ◽

Andrea Sartore-Bianchi ◽

Clara Montagut ◽

Andres Cervantes ◽

...

Keyword(s):

Colon Cancer ◽

High Risk ◽

Cancer Patients ◽

Liquid Biopsy ◽

Stage Ii ◽

Stage Iii ◽

Stage Ii Colon Cancer

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Single-Incision Laparoscopic Colectomy for Colon Cancer: Experiences with 308 Consecutive Cases

The American Surgeon ◽

10.1177/000313481808400432 ◽

2018 ◽

Vol 84 (4) ◽

pp. 565-569 ◽

Cited By ~ 1

Author(s):

Yasumitsu Hirano ◽

Masakazu Hattori ◽

Kenji Douden ◽

Chikashi Hiranuma ◽

Yasuo Hashizume ◽

...

Keyword(s):

Colon Cancer ◽

Single Incision ◽

Survival Rates ◽

Stage Iv ◽

Stage I ◽

Stage Ii ◽

Stage Iii ◽

Oncologic Outcomes ◽

Single Incision Laparoscopic Surgery ◽

Intention To Treat

Single-incision laparoscopic surgery (SILS) has been developed with the aim to further reduce the invasiveness of conventional laparoscopy. Our experiences with more than 300 consecutive patients with SILS for colon cancer are reviewed, and its outcomes are evaluated to determine the midterm clinical and oncologic safety of SILS for colon cancer in a community hospital. A single surgeon's consecutive experience of SILS for colon cancer is presented. Three hundred and eight patients were treated with the SILS procedure for colon cancer between December 2010 and March 2015. Data were analyzed according to intention to treat. Of these 308 patients, 19 (6.2%) were converted to laparotomy. Intraoperative injury occurred in five patients. Postoperative complications occurred in 19 patients (6.2%). The 2-year relapse-free survival rates of patients with Stage I, Stage II, and Stage III were 97.8, 92.2, and 80.4 per cent, respectively, and the 2-year overall survival rates of patients with Stage I, Stage II, Stage III, and Stage IV were 100, 95.7, 93.0, and 74.4 per cent, respectively. Our initial experiences showed that SILS colectomy for cancer can be performed safely and with good short-term oncologic outcomes by a skilled surgeon.

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