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?

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.

How expert physicians would wish to be treated if they had genitourinary cancer.

1988 ◽  
Vol 6 (11) ◽  
pp. 1736-1745 ◽  
Author(s):  
M J Moore ◽  
B O'Sullivan ◽  
I F Tannock
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Geographic Location ◽  
The United States ◽  
Medical Oncologists ◽  
Clinical Scenarios ◽  
Differences Of Opinion ◽  
Choice Of Treatment ◽  
Surrogate Method

A questionnaire describing six clinical scenarios was mailed to urologists (in Britain, Canada, and the United States) and to radiation and medical oncologists in the United States, who practice genito-urinary (GU) oncology. In each scenario, the surgeon or physician was asked to consider himself as a patient with bladder, prostate, or kidney cancer, and to select his own treatment. Accompanying each scenario were one or two clinical trials for which the physician would be eligible. He was asked to state if he would agree to be randomized in each trial, and if he refused, to state his reasons. We found that (1) there were major differences of opinion about management for each scenario; (2) choice of treatment was influenced more by specialty training or geographic location than by the results of previous clinical trials (which are available to all); (3) British urologists tended to be less aggressive than their North American colleagues, with respect to the use of radical surgery and chemotherapy; (4) acceptance of clinical trials ranged from 3% to 60%; and (5) agreement to clinical trials was quite poor even when they were designed to compare the most popular options for management. This physician surrogate method is a valuable tool in assessment of the degree of consensus amongst expert physicians and in the determination of whether new clinical trials address important areas of controversy.

Pharmacotherapy of Chronic Heart Failure in the Elderly: A Review of the Evidence

2010 ◽  
Vol 2 ◽  
pp. CMT.S2794
Author(s):  
Toni L. Ripley ◽  
Thomas A. Hennebry
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Older Patients ◽  
The Elderly ◽  
The United States ◽  
Response To Therapy ◽  
Clinical Endpoints ◽  
Age Related ◽  
Prevalent Disease ◽  
To Receive

Heart failure (HF) is a very prevalent disease in the United States and in Europe, with the highest prevalence among older patients. Population estimates suggest substantial growth among the elderly over the next four decades. However, older patients are underrepresented in clinical trials evaluating HF therapies and are less likely to receive the medications shown in these trials to reduce the morbidity and mortality associated with HF. Age-related differences exist in cardiovascular function that may affect disease progression, clinical presentation, and/or response to therapy. Further, medication use in older patients is complicated by physiologic changes in pharmacokinetics and the presence of multiple co-morbidities, which leads to polypharmacy and the related complications. We reviewed the pharmacotherapy clinical trials in HF to review the results specifically in older patients. Trials were included in this review if clinical endpoints were evaluated, if data regarding the participants’ age was reported, and if the intervention studied was in a medication class that is generally recommended for patients with HF by published guidelines. Although some non-randomized data shows benefits of standard therapies may be maintained among patients with HF ≥ 60 years old, the randomized controlled trials that have been published to date showed no benefit and no harm in this group. Cautious HF management among older patients is critical as additional evidence is pursued.

Effect of postoperative complications on adjuvant chemotherapy use in stage III colon cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3608-3608
Author(s):  
Ryan P Merkow ◽  
David J Bentrem ◽  
Mary Frances Mulcahy ◽  
Clifford Y. Ko ◽  
Karl Y. Bilimoria
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Postoperative Complications ◽  
Adjuvant Therapy ◽  
Anastomotic Leak ◽  
The United States ◽  
Stage Iii ◽  
Treatment Gap ◽  
Stage Iii Colon Cancer ◽  
National Quality

3608 Background: The National Quality Forum has endorsed the use of adjuvant chemotherapy in stage III colon cancer, yet a substantial treatment gap exists in the United States. Our objective was to evaluate the contribution of postoperative complications on the use of adjuvant therapy after colectomy for cancer. Methods: Patients from the National Surgical Quality Improvement Program and the National Cancer Data Base who underwent colon resection for cancer were linked (2006-2008). The association of complications on adjuvant chemotherapy use was assessed using multivariable regression models. Results: From 140 hospitals, 2368 patients underwent resection for stage III colon adenocarcinoma. Overall, 36.8% (871/2,368) patients were not treated with adjuvant therapy, of which 47.8% (416/871) had documented severe comorbidities or advanced age (≥80) as the reason for no adjuvant therapy receipt. Of the remaining 455 patients, 21.3% (97/455) had ≥1 serious complication that could account for adjuvant therapy omission. The remaining 41.1% (358/871) patients did not have a documented reason for not recieving adjuvant therapy. Complications associated with adjuvant therapy omission were abscess/anastomotic leak (OR 1.91, 95% CI 1.02-3.59), renal failure (OR 7.16, 95% CI 1.92-26.79), prolonged ventilation (OR 7.92, 95% CI 2.97-21.13), re-intubation (OR 5.69, 95% CI 2.13-15.18), and pneumonia (OR 4.05, 95% CI 2.07-7.90). Abscess/anastomotic leak was associated with a 28-day delay in time to adjuvant chemotherapy (73 vs. 45 days, p<0.05). Superficial surgical site infection did not decrease adjuvant therapy receipt but delayed the time to its use (57 vs. 44 days, p<0.05). The occurrence of postoperative sepsis was associated with a 15-day delay to adjuvant chemotherapy (60 vs. 45 days, p<0.05). Conclusions: Serious postoperative complications explained nearly one quarter of the adjuvant chemotherapy treatment gap among stage III colon cancer patients. Postoperative complications affect treatment utilization and should be considered when calculating adherence with the Stage III adjuvant therapy for colon cancer measure. Judging provider performance using quality metrics is challenging without clinical data.

Comparative effectiveness of treatment options in elderly patients with colon cancer receiving adjuvant chemotherapy.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 470-470
Author(s):  
Sacha Satram-Hoang ◽  
Devi Ramanan ◽  
Luen F. Lee ◽  
Shui Yu ◽  
Carolina M. Reyes ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Propensity Score ◽  
Elderly Patients ◽  
Older Patients ◽  
Randomized Clinical Trials ◽  
Cohort Analysis ◽  
Risk Of Death ◽  
Morbidity Score ◽  
Co Morbidity

470 Background: While colon cancer (CC) is predominantly a disease of the elderly, older patients are underrepresented in clinical trials. We sought to evaluate whether the treatment patterns and benefits realized by trial participants pertain to older patients in the real-world setting. Methods: Using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we conducted a retrospective cohort analysis of 3390 stage II and III CC patients diagnosed between 1/1/ 2004 to 12/31/2007, who were >66 years, enrolled in Medicare Parts A and B, and received adjuvant treatment with 5FU/LV (n=1368), FOLFOX (n=1398), CAP (capecitabine; n=507), and CAPOX (CAP + oxaliplatin; n=117) within 3 months after surgery. Date of last follow-up was 12/31/2007. Chi-square test and ANOVA or t-test assessed differences in patient and disease characteristics by treatment. Propensity score weighted Cox regression assessed the relative risk of death by treatment. Results: Patients treated with CAP were older (mean age 77 years; p<.0001), more likely female (61%; p<.05), more likely non-white (19%; p<.05) and had higher co-morbidity score (p<.0001) compared to the other treatment groups. The mean time to chemo initiation after surgery were similar between the groups (mean 46-49 days) while mean duration of treatment were longer for 5FU/LV (149 days) and FOLFOX (144 days), compared to CAP (121 days) and CAPOX (111 days); p<.0001. The incidence of adverse events (AEs) within 180 days after initiation of treatment were higher in patients treated with FOLFOX (82%) and 5FU/LV (78%) compared to CAP (74%) and CAPOX (71%); p=0.0002. Propensity score adjusted multivariate analysis demonstrated comparable survival for CAP-based regimens vs. 5-FU/LV- based regimens ( table ). Conclusions: Treatment outcomes for elderly patients observed in routine clinical practice were comparable between CAP-based and 5FU/LV-based regimens and consistent with results reported in randomized clinical trials. AEs associated with medical resource utilization were less frequent with CAP-based regimens. [Table: see text]

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.

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