Classification of early-stage colon cancer with Immunoscore®: clinical evidence and case studies

Immunoscore® is a digital pathology diagnostic immunoassay used to complement tumor node metastasis staging for the prediction of recurrence risk in patients with early-stage colon cancer. In combination with standard clinicopathological features, Immunoscore® informs adjuvant chemotherapy decision-making for patients with early-stage colon cancer. Immunoscore® has been validated in patients with stage II/III colon cancer and demonstrated to be a stronger prognostic factor for survival than tumor node metastasis staging alone. Immunoscore® improves the prognostic definition of patients with colon cancer, the identification of those patients at high risk of tumor recurrence, and the ability to predict which patients will derive most benefit from the use of adjuvant chemotherapy. Immunoscore® has robust analytical performance characteristics which include good interlaboratory reproducibility and overall assay precision.

Download Full-text

Clinical utility of Oncotype DX in early stage colon cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15076 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15076-e15076

Author(s):

Mohammed Adam Ibrahim Dawod ◽

Jane Sze Yin Sui ◽

Deirdre Kelly ◽

Lynda M. McSorley ◽

Claire Brady ◽

...

Keyword(s):

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Early Stage ◽

Treatment Plan ◽

Recurrence Risk ◽

Stage Ii ◽

Polymerase Chain Reaction Test ◽

Stage Iiia ◽

Absolute Benefit ◽

Early Stage Colon Cancer

e15076 Background: With the advent of colon cancer screening, patients with early stage colon cancer will be more common in our clinics. The evidence supporting the absolute benefit of chemotherapy in resected Stage II and (to a lesser extent) Stage IIIA disease is poor. Not all patients benefit from chemotherapy and toxicity is a problem. There is a need for validated biomarkers to assess individual patient recurrence risk and discriminate absolute treatment benefit. Several studies have validated the role of the OncotypeDX testing in Stage II/IIIA disease. Our objective is to characterize whether this test impacted oncologists’ decisions in treating patients with Stage II/IIIA in the adjuvant setting. Methods: :The Onco typeDX assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction test that analyses the expression of 12 genes involved in key biologic pathways in colon cancer. Stage II and Stage IIIA colon cancers were studied in affiliated hospitals of our region in southwest Ireland. All data collected is prospective and each colon cancer was assigned a recurrence risk score. Oncologists were blinded to this score and the decision to prescribe adjuvant chemotherapy was recorded. After un-blinding the score, a second decision was recorded and comparisons made. Results: :From August 2015 to September 2016, 70 patients have been recruited with M: F of 2:1. Median age at diagnosis was 65 years. Most patients (80%) had stage II disease, 11 of whom had mismatch repair loss on IHC. OncotypeDX testing has been carried out and reported for 59 patients (85%), MMR intact. Recurrence scores: < 30 in 46 patients (77.9%), 30-40 in 10 patients, and > 40 in 3 patients. The treatment plan was altered in 16 patients (27%), of whom 12 patients (20%) received none or less intense chemotherapy. Conclusions: We have shown that the decision to prescribe adjuvant chemotherapy was changed in 27% of patients. This test has helped to define patients with low scores, where chemotherapy-related toxicity is a concern especially in older patients. Absolute benefit of adjuvant chemotherapy versus the risk of toxicity should be discussed. . Hospital managers may be interested in cost savings due to a reduction in chemotherapy use.

Download Full-text

Comparative clinical efficacy of adjuvant chemotherapy regimens in randomized controlled trials (RCTs) of early-stage colon cancer: Systematic review and meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.498 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 498-498

Author(s):

J. Cassidy ◽

H. Schmoll ◽

E. Chu ◽

N. Hawkins ◽

I. Tatt ◽

...

Keyword(s):

Systematic Review ◽

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Assessment Tool ◽

Early Stage ◽

Meta Analysis ◽

Group Analysis ◽

Significant Difference ◽

Early Stage Colon Cancer

498 Background: A systematic review was conducted to identify RCTs of adjuvant chemotherapy regimens for early-stage colon cancer and a network meta-analysis performed to compare efficacy of oxaliplatin/fluoropyrimidine regimens. Methods: A systematic review identified RCTs recruiting adult patients with early-stage (adjuvant) stage II/III colon cancer. Outcome measures included hazard ratios for DFS and OS. Only publications in English were considered. Study quality was assessed using the Cochrane Collaboration “risk of bias” assessment tool. A single reviewer screened abstracts/titles using predefined selection criteria, with critical appraisal and data extraction conducted independently by two reviewers. A Bayesian network meta-analysis was used to estimate comparative efficacy of adjuvant chemotherapy across RCTs. Results: 56 articles describing 40 trials were selected, of which six reported data on regimens accepted as current standard of care (capecitabine/X-ACT, XELOX/NO16968, FOLFOX/MOSAIC, FLOX/C-07) or common comparators: bolus 5FU/LV and LV5FU2 (C-96-1, PETACC-2). Statistical assessment of heterogeneity was not possible due to the limited study network. Baseline characteristics were similar across trials with the exception of three trials recruiting only stage III patients; sub-group analysis on these trials was not possible due to lack of common comparators. There was no significant difference in DFS at a median follow-up of 3-years (or closest reported analysis) for XELOX vs. FLOX (HR=0.99, 95% CI 0.80–1.22) or FOLFOX (HR=1.00, 95% CI 0.72–1.41). There was also no significant difference in OS at a median follow-up of at least 5 years. Taken as a class, oxaliplatin-containing regimens (XELOX, FOLFOX, FLOX) improved DFS vs. non-oxaliplatin-containing regimens (HR=0.80, 95% CI 0.73–0.87). This result was confirmed for OS. Conclusions: Despite the limited number of available trials, the results of these analyses demonstrate a clear benefit of incorporating oxaliplatin into combination regimens for early-stage colon cancer. XELOX, FOLFOX and FLOX appear to be equivalent in terms of efficacy in this setting. [Table: see text]

Download Full-text

Evaluation of Recurrence Risk in Patients with Papillary Thyroid Cancer through Tumor-Node-Metastasis Staging: A Single-Center Observational Study in Taiwan

Biomedical Journal ◽

10.1016/j.bj.2021.11.009 ◽

2021 ◽

Author(s):

Jui-Hung Sun ◽

Yan-Rong Li ◽

Kuo-Hsuan Chang ◽

Miaw-Jene Liou ◽

Shu-Fu Lin ◽

...

Keyword(s):

Thyroid Cancer ◽

Observational Study ◽

Papillary Thyroid Cancer ◽

Recurrence Risk ◽

Papillary Thyroid ◽

Single Center ◽

Tumor Node Metastasis ◽

Node Metastasis ◽

Tumor Node Metastasis Staging ◽

Single Center Observational Study

Download Full-text

Translating IDEA to Practice and Beyond: Managing Stage II and III Colon Cancer

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_237443 ◽

2019 ◽

pp. 226-235 ◽

Cited By ~ 1

Author(s):

Sharlene Gill ◽

Jeffrey A. Meyerhardt ◽

Monica Arun ◽

Christine M. Veenstra

Keyword(s):

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Early Stage ◽

Standard Of Care ◽

Stage Ii ◽

Stage Iii Colon Cancer ◽

Optimal Duration ◽

Accepted Standard ◽

Early Stage Colon Cancer ◽

Resected Stage

Adjuvant fluoropyrimidine-based chemotherapy has been the standard of care for resected stage III colon cancer since the 1990s; the evolution from 12 to 6 months of fluoropyrimidine therapy and the addition of oxaliplatin to fluoropyrimidine therapy have led to the current accepted standard. However, controversies remain. What is the benefit of adjuvant chemotherapy in stage II disease, and in whom? What is the optimal duration of adjuvant chemotherapy? How should patients with early-stage colon cancer be followed after surgery and adjuvant treatment? Recent evidence has emerged to help inform these important questions, including the International Duration Evaluation of Adjuvant therapy (IDEA) collaboration, which is the largest, prospective study in colon cancer with 12,834 patients. This review discusses current and future risk stratification strategies in stage II disease: the optimal duration of adjuvant oxaliplatin-containing chemotherapy in stage II and III disease according to the IDEA study, and the recent evidence and updated recommendations for surveillance of early-stage colon cancer after resection.

Download Full-text

Completion of adjuvant chemotherapy with Cape/CAPOX in colon cancer: A retrospective database study.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15116 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15116-e15116

Author(s):

Edward Chu ◽

Xue Wang ◽

Maxfield Frohlich ◽

Melody Tran ◽

Won Chan Lee

Keyword(s):

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Adjuvant Treatment ◽

Healthcare Costs ◽

Early Stage ◽

Unmet Need ◽

Oral Chemotherapy ◽

Completion Rates ◽

Eligibility Criteria ◽

Early Stage Colon Cancer

e15116 Background: Fluorouracil-based adjuvant chemotherapy has been shown to improve survival of patients with early-stage colon cancer. Suboptimal adherence to oral chemotherapy, such as capecitabine, remains a serious issue and reduces treatment efficacy. Patient barriers to adherence include adverse effects and high medical costs. This study assesses the completion rates and associated factors in patients on capecitabine monotherapy (Cape) and capecitabine with oxaliplatin (CAPOX) for adjuvant treatment of early-stage colon cancer. Methods: Patients with a primary/secondary diagnosis of early-stage colon cancer between April 2013-March 2017, and 1+ claim of Cape or CAPOX within 60 days of colectomy were identified from the MarketScan Commercial/Medicare Database. Therapy completion rates (treatment ≥7 cycles) were calculated. Multivariate logistic regressions analyses were used to assess the factors (patients’ age, gender, payer type, geography, comorbidities, healthcare costs, etc.) associated with treatment completion. Results: A total of 679 patients met the eligibility criteria (mean age ± SD: 57.3 ± 11.5 years, 54% male), of which 382 (56%) were on Cape (mean age ± SD: 60.2±12.4) and 297 (44%) on CAPOX (mean age ± SD: 53.6±9.0). Completion rates were 43% in Cape and 42% in CAPOX. The baseline overall mean monthly healthcare cost was significantly higher in non-completers vs. completers (Cape: $9,870 vs $7,169, P=0.003; CAPOX: $10,009 vs $8,068, P=0.01). Multivariate logistic regression showed that patients <65 years of age on CAPOX were more likely to complete treatment than patients ≥65 years on CAPOX (Odds Ratio=5.1, P=0.03). Conclusions: Cape and CAPOX completion rates are suboptimal in patients with early-stage colon cancer. Non-completion of therapy is associated with significantly higher baseline healthcare costs for both Cape and CAPOX, as is older age for CAPOX. The low completion rates highlight the unmet need for more effective strategies to optimize oral chemotherapy for the adjuvant treatment of early-stage colon cancer. [Table: see text]

Download Full-text