scholarly journals Benefits and Adverse Events in Younger Versus Older Patients Receiving Adjuvant Chemotherapy for Colon Cancer: Findings From the Adjuvant Colon Cancer Endpoints Data Set

2012 ◽  
Vol 30 (19) ◽  
pp. 2334-2339 ◽  
Author(s):  
Joleen Hubbard ◽  
David M. Thomas ◽  
Greg Yothers ◽  
Erin Green ◽  
Charles Blanke ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Adjuvant Therapy ◽  
Adverse Events ◽  
Older Patients ◽  
Stage Ii ◽  
Phase Iii ◽  
Data Set ◽  
Younger Patients ◽  
Cutoff Points

Purpose Limited data exist regarding the outcomes of adjuvant therapy in younger patients with stage II and III colon cancer. We examined disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and grade 3+ adverse events (AEs) in younger patients in the 33,574 patient Adjuvant Colon Cancer Endpoints Group data set. Patients and Methods Individual patient data from 24 randomized phase III clinical trials were obtained for survival outcomes, which included 10 clinical trials for AE outcomes. Two age-based cutoff points were used to define younger patients: age younger than 40 years and younger than 50 years. Adjuvant therapy benefit analyses were limited to the nine clinical trials in which the investigational chemotherapeutic arm demonstrated benefit. Results One thousand seven hundred fifty-eight patients (5.2%) were younger than 40 years, 5,817 patients (17.3%) were younger than 50 years, and only 299 patients (0.9%) were younger than 30 years. No meaningful differences in sex or stage were noted in younger versus older patients. Younger and older patients did not differ in RFI (age, < 40 years: hazard ratio [HR], 1.0; P = .62 and age < 50 years: HR, 1.02; P = .35). Younger patients (both cutoff points), had longer OS and DFS than older patients. In trials demonstrating adjuvant therapy benefit, similar DFS benefit was observed by age. Younger patients experienced less leukopenia and stomatitis, but more frequent nausea/vomiting. Conclusion Among patients on clinical trials, younger and older patients with stage II and III colon cancer had similar RFI and adjuvant therapy benefit. Younger patients have longer OS and DFS, which is likely primarily because of fewer competing causes of death. Adjuvant therapy is beneficial for colon cancer in patients younger than 50 years who meet typical clinical trial eligibility criteria.

Uptake of adjuvant chemotherapy for colon cancer in older and younger patients in the Irish population.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 478-478
Author(s):  
Seamus Coyle ◽  
Zia Rehman ◽  
Chalen Lee ◽  
Sandra Deady ◽  
Harry Comber ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Practice ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Older Patients ◽  
The Elderly ◽  
Stage Ii ◽  
Stage Iii ◽  
Younger Patients ◽  
The Impact

478 Background: Colon cancer is predominantly a disease of the elderly, with recent evidence supporting the use of adjuvant chemotherapy in the older population. However, it remains unclear to what degree such patients are receiving adjuvant therapy in clinical practice. We examined uptake of adjuvantchemotherapy and it’s impact on survival in older patients with stage II and stage III colon cancer in a national cohort. Methods: Using the National cancer Registry of Ireland, we identified 3,486 patients with stage II and III colon cancer who were treated with curative resection from 2004-2009. Clinopathological features and chemotherapy use were compared between those ≥70 years and those < 70 years. Results: A total of 2,026 patients with stage II disease were identified, 56% male and 60% ≥ 70 years. T3 tumors accounted for 81%, T4 19% and 89% were grade 2/3. Adjuvant chemotherapy was utilized in 10% and 40% of ≥ 70 and <70 years, respectively (p<0.0001). A benefit for chemotherapy over observation alone was seen in both the older [HR 0.36; 95% CI 0.36 – 0.68; p <0.0001] and younger patient groups [HR 0.43; 95% CI 0.2701 - 0.6881; p<0.0004]. Of 1,460 patients with stage III disease, 51% were ≥ 70 years, 54% male. 34% of older and 83% of younger patients received adjuvant therapy (p<0.0001). A similar magnitude of benefit from chemotherapy compared to observation was seen in patients ≥ 70 years [HR 0.30; 95% CI 0.29 - 0.45 ; p <0.0001] and <70 years [HR 0.22 95%CI 0.1 – 0.2; p<0.0001] with stage III disease. Conclusions: Adoption of adjuvant chemotherapy appears to be associated with significant survival benefit in older patients (age ≥ 70 years), however, is still underutilized in clinical practice. The impact of sociodemographic and clinicopathological features as potential drivers of treatment decisions in a cohort of this population will be reported.

Managing Choices for Older Patients with Colon Cancer: Adjuvant Therapy

2013 ◽  
pp. e190-e193
Author(s):  
Christina Wu ◽  
Richard M. Goldberg
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Adjuvant Therapy ◽  
Older Patients ◽  
Tumor Biology ◽  
The United States ◽  
Individual Risk ◽  
Definitive Evidence ◽  
Medical Oncologists ◽  
Population Treatment

Colon cancer is among the most common cancers in the United States, and the median age of patients at diagnosis is 70. Medical oncologists are commonly asked to comprehensively evaluate elderly patients to estimate individual risk/benefit ratios for adjuvant treatment. Although 40% of patients with colon cancer are elderly, clinical trials enroll mainly younger patients. Consequently, we are forced to depend on subgroup analyses, observational studies, and personal experience to guide recommendations. Decision-making in adjuvant therapy for colon cancer is increasingly complex, as we subdivide patients with stage II to III colon cancer by molecular as well as anatomic staging to predict which are likely to benefit from chemotherapy and then whether the addition of oxaliplatin to 5-fluorouracil (5-FU) is worth the toxicity. It is likely that the tumor biology of younger and older patients differs, and more research is needed to dissect out the biologic heterogeneity of both the tumors and their elderly hosts to help guide treatment. We recognize that our evaluations should not solely be based on temporal age and factor physiology, pharmacology, psychology, functional status, and social support into these considerations. Older patients who are treated must be monitored closely for toxicities when undergoing treatment. Although there is a clear need for clinical trials in this population, treatment decisions confront us today in the absence of definitive evidence. How can we help our patients navigate through these important choices?

Age distribution of tumor gene expression in patients with stage II/III colon cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 552-552
Author(s):  
Howard S. Hochster ◽  
Anna Lau ◽  
Michelle Turner ◽  
Christy Ann Russell
Keyword(s):  
Gene Expression ◽  
Colon Cancer ◽  
Older Patients ◽  
Clinical Laboratory ◽  
Stage Ii ◽  
Age Group ◽  
Younger Patients ◽  
Incidence And Mortality ◽  
Tumor Gene Expression ◽  
Tumor Gene

552 Background: Colorectal cancer (CRC) incidence and mortality have been rising in the US among adults <55 y. Younger patients with CRC are more likely than older patients to receive postoperative systemic chemotherapy, despite lack of consensus on the prognostic value of age in this disease. CRC diagnosed in younger patients may be biologically different from that in older patients, but characteristics are unknown. Thus, we examined whether age-specific differences were measurable by tumor gene expression using the 12-gene Oncotype DX Colon Recurrence Score (RS) test (Genomic Health, Inc. [GHI]; Redwood City, CA). The Colon RS test is validated to predict risk of recurrence in patients with stage II/III colon cancer. Methods: We analyzed Colon RS test results and single-gene results for the 12 genes by age group (age <40, 40-54, 55-64, and ≥65) using data from the GHI clinical laboratory dated 1/2010 to 7/2017. Results: As of 7/2017, 21,925 Colon RS reports have been delivered. Median age was 63 y; 50% were male. About 23% of patients were <55 y (Table). Mean (SD) RS result was 25 (11). Colon RS result distributions were similar by age group (Table). Expression of individual tumor genes measured in the Colon RS test were also similar by age group (data to be presented). Conclusions: The etiology of the increase in both incidence and mortality from CRC in adults <55 y is poorly understood. Our findings suggest that colon cancer in younger patients is not biologically different from that in older patients, as measured by the Colon RS test in a large cohort referred for testing. As shown by this test in the GHI clinical laboratory experience, most patients with stage II/III colon cancer have low-risk disease, including patients <55 years. Our findings support a biology-driven approach to disease management of patients with stage II/III colon cancer regardless of age. This well-validated genomic assay may identify a group of younger patients for whom adjuvant chemotherapy might represent overtreatment. [Table: see text]

Survival Following Recurrence in Stage II and III Colon Cancer: Findings From the ACCENT Data Set

2008 ◽  
Vol 26 (14) ◽  
pp. 2336-2341 ◽  
Author(s):  
Michael J. O'Connell ◽  
Megan E. Campbell ◽  
Richard M. Goldberg ◽  
Axel Grothey ◽  
Jean-François Seitz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Colon Cancer ◽  
Prognostic Factors ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Stage Ii ◽  
Data Set ◽  
Initial Stage ◽  
Recurrent Colon Cancer ◽  
Therapy Clinical Trial

Purpose This study was undertaken to examine five possible prognostic factors in patients with recurrent stage II and III colon cancer: time from randomization on an adjuvant therapy clinical trial to tumor recurrence (< 1 year, 1 to 2 years, 2 to 3 years, 3 to 4 years, > 4 years), initial stage (II v III), initial adjuvant treatment (fluorouracil [FU]-based v surgery alone), the era in which the patient entered an adjuvant therapy clinical trial (1978 to 1985, 1986 to 1992, 1993 to 1999), and patient age at recurrence. Methods The Adjuvant Colon Cancer End Points (ACCENT) data set was analyzed using univariate and multivariate Cox proportional hazards models, stratified by study. Results 5,722 (32.9%) of 17,381 patients experienced recurrence. Median survival following recurrence was 13.3 months. Time from randomization to recurrence was highly prognostic of survival following recurrence (P < .0001). Longer survival following recurrence was seen in patients with initial stage II versus III disease (P < .0001; 14.3% 6-year overall survival after recurrence in initial stage II patients), patients entered more recently onto trials (P < .0001), and patients initially treated with surgery alone versus FU adjuvant treatment (P = .0005). All relationships were maintained in multivariate models. Conclusion Time from initial treatment to recurrence and initial stage are important prognostic factors in patients with recurrent colon cancer. Survival following recurrence increased modestly from 1978 to 1999. Patients who had a recurrence following adjuvant therapy had poorer prognosis than those who progressed after surgery alone. These prognostic factors may be useful for clinical trial design and treatment decisions in patients with recurrent colon cancer.

Pooled Analysis of Fluorouracil-Based Adjuvant Therapy for Stage II and III Colon Cancer: Who Benefits and by How Much?

2004 ◽  
Vol 22 (10) ◽  
pp. 1797-1806 ◽  
Author(s):  
Sharlene Gill ◽  
Charles L. Loprinzi ◽  
Daniel J. Sargent ◽  
Stephan D. Thomé ◽  
Steven R. Alberts ◽  
...  
Keyword(s):  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Disease Free Survival ◽  
Nodal Status ◽  
Stage Ii ◽  
Data Set ◽  
Free Survival ◽  
T Stage ◽  
Disease Free

Purpose Although it is well-established that fluorouracil- (FU-) based adjuvant therapy improves survival for patients with resected high-risk colon cancer, the magnitude of adjuvant therapy benefit across specific subgroups and for individual patients has been uncertain. Patients and Methods Using a pooled data set of 3,302 patients with stage II and III colon cancer from seven randomized trials comparing FU + leucovorin or FU + levamisole to surgery alone, we performed an analysis based on a Cox proportional hazards regression model. Treatment, age, sex, tumor location, T stage, nodal status, and grade were tested for both prognostic and predictive significance. Model derived estimates of 5-year disease-free survival and overall survival (OS) for surgery alone and surgery plus FU-based therapy were calculated for a range of patient subsets. Results Nodal status, T stage, and grade were the only prognostic factors independently significant for both disease-free survival and OS. Age was significant only for OS. In a multivariate analysis, adjuvant therapy showed a beneficial treatment effect across all subsets. Treatment benefits were consistent across sex, location, age, T-stage, and grade. A significant stage by treatment interaction was present, with treatment benefiting stage III patients to a greater degree than stage II patients. Conclusion Patients with high-risk resected colon cancer obtain benefit from FU-based therapy across subsets of age, sex, location, T stage, nodal status, and grade. Model estimates of survival stratified by T stage, nodal status, grade, and age are available at http://www.mayoclinic.com/calcs . This information may improve patients' and physicians' understanding of the potential benefits of adjuvant therapy.

Adjuvant Therapy with Edrecolomab versus Observation in Stage II Colon Cancer: A Multicenter Randomized Phase III Study*

2005 ◽  
Vol 28 (6-7) ◽  
pp. 347-350 ◽  
Author(s):  
G. Hartung ◽  
R-D. Hofheinz ◽  
Y. Dencausse ◽  
J. Sturm ◽  
A. Kopp-Schneider ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Therapy ◽  
Stage Ii ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Stage Ii Colon Cancer
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