Background Adjuvant chemotherapy is standard treatment for patients with resected colon cancer who are at high risk for recurrence, but the efficacy and toxicity of such treatment in patients more than 70 years of age are controversial Methods We performed a pooled analysis, based on the intention to treat, of individual patient data from seven phase 3 randomized trials (involving 3351 patients) in which the effects of postoperative fluorouracil plus leucovorin (five trials) or fluorouracil plus levamisole (two trials) were compared with the effects of surgery alone in patients with stage II or III colon cancer The patients were grouped into four age categories of equal size, and analyses were repeated with 10-year age ranges (≤50, 51 to 60, 61 to 70, and >70 years), with the same conclusions The toxic effects measured in all trials were nausea or vomiting, diarrhea, stomatitis, and leukopenia Patients in the fluorouracil-plus-leucovorin and fluorouracil-plus-levamisole groups were combined for the ef

https://www.nejm.org/doi/pdf/10.1056/NEJMoa010957

A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients.

Purpose Older patients are significantly underrepresented in cancer clinical trials. A literature review was undertaken to identify the barriers that impede the accrual of this vulnerable population onto clinical trials and to determine what specific strategies are needed to improve the representation of older patients in research studies. Methods A systematic literature search was undertaken using several different strategies to identify relevant articles. Results Nine of 31 relevant papers from 159 citations were included. Age is a significant barrier to recruitment; only a quarter to one third of potentially eligible older patients are enrolled onto trials. Physicians' perceptions, protocol eligibility criteria with restrictions on comorbid conditions, and functional status to optimize treatment tolerability are the most important reasons resulting in the exclusion of older patients. Other barriers include the lack of social support and the need for extra time and resources to enroll these patients. Co...

Systematic Review of Barriers to the Recruitment of Older Patients With Cancer Onto Clinical Trials

Background. Breast-conserving surgery followed by radiation therapy is as effective as modified radical mastectomy in treating women with localized breast cancer, as demonstrated by clinical trials reported during the 1980s. The extent to which breast-conserving surgery has been adopted in various regions of the United States is not known. Methods. We assessed variations in the use of breast-conserving surgery from 1983 to 1986 in 18,399 non-Hispanic white, 324 Hispanic, and 1174 black women with breast cancer in nine areas of the United States, using data from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute. Results. The proportion of white women with localized breast cancer who underwent breast-conserving surgery ranged from 9.2 percent (Iowa) to 32.1 percent (Seattle) in 1983–1984 and from 19.6 percent (Iowa) to 41.5 percent (Seattle) in 1985–1986. Between 1983 and 1986, the use of breast-conserving surgery increased in each area, but the relative ranki...

https://www.nejm.org/doi/pdf/10.1056/NEJM199204233261701

Geographic variation in the treatment of localized breast cancer.

BACKGROUND

Colon carcinoma primarily affects older-aged persons 65 years and older. Seventy-five percent of the incident tumors affect persons in this age group. Because of their advanced age, older patients already may be coping with other concomitant major physical illnesses. This article documents preexisting diseases in older colon carcinoma patients at diagnosis and evaluates the effects of their comorbidity burden on early mortality.



METHODS

Prevalence of comorbid conditions was assessed by a retrospective medical records review of an age-stratified random sample of male and female patients aged 55-64 years, 65-74 years, and 75+ years (males, n = 799; females, n = 811). Data were collected on comorbidity by the National Institute on Aging (NIA) and National Cancer Institute (NCI) and merged with NCI Surveillance, Epidemiology, and End Results (SEER) tumor registry data.



RESULTS

Hypertension, high impact heart conditions, gastrointestinal problems, arthritis, and chronic obstructive pulmonary disease emerged as the most prominent comorbid conditions in the NIA/NCI SEER study sample. The prevalence of comorbidity in the number and type of conditions similar for both men and women (e.g., 40% of each gender had ≥ 5 comorbidities). Within 2 years of diagnosis, 28% (n = 454) of the patients had died. The number of comorbid conditions was significant in predicting early mortality in a model including age, gender, and disease stage (P = 0.0007). Certain comorbidities, classified as "current problem," added significantly to a basic model (e.g., heart problems, alcohol abuse, liver disease, and deep vein thrombosis).



CONCLUSIONS

Although disease stage at time of diagnosis of colon carcinoma is a crucial determinant of patient outcome, comorbidity increases the complexity of cancer management and affects survival duration. Cancer control and treatment research questions should address comorbidity issues pertinent to the age group primarily afflicted with colon carcinoma (i.e., the elderly). Cancer 1998;82:2123-2134. © 1998 American Cancer Society.

https://acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/%28SICI%291097-0142%2819980601%2982%3A11%3C2123%3A%3AAID-CNCR6%3E3.0.CO%3B2-W

Comorbidity and age as predictors of risk for early mortality of male and female colon carcinoma patients : A population-based study

We used data on 22,899 cancer cases collected by the New Mexico Tumor Registry to examine the relationship between patient age and the use of potentially curative therapy for cancers of selected sites and acute leukemias. For cancers of most sites, either local or regional stage, the proportion of cases receiving potentially curative therapy declined with age. For local-stage cancers, the proportion not given any treatment increased with age. Overall mortality rates during the first year after diagnosis were much higher for local-stage cases without treatment than for those who received treatment. These data show that cancer therapy varies with age and suggest that decision making regarding therapy is influenced by the presence of other diseases. ( JAMA 1986;255:3385-3390)

Choice of cancer therapy varies with age of patient.

Increases in cancer incidence and mortality reflect the larger numbers of elderly in the population. Using a mortality sample of 1891 biopsy-confirmed cancer patients, analyses reveal older breast, prostate, and cervical-uterine cancer victims were more likely to be diagnosed with metastases. Logistic regression analyses of subsamples of breast (N = 224), lung (N = 513), and colorectal (N = 299) cancer patients indicate that age is significantly inversely related to receipt of both subsequent chemotherapy and radiation therapy, controlling for stage of disease and presence of co-morbid disease. Exceptions to this relationship are the use of radiation therapy among nonmetastatic lung cancer patients and all breast cancer patients. The implications of these findings for current cancer control programs are discussed.

Relationship between age at diagnosis and treatments received by cancer patients.

Treatment with continuous infusions of cisplatin results in increased filterable drug exposures as measured by the area under the curve (AUC) of nonprotein-bound plasma platinum levels. To determine the dose-limiting toxicity and optimal method of administration, 24 patients were treated with continuous infusions of cisplatin at a dose rate of 25 mg/M2/day in a limited Phase I trial. A total of 47 courses were given. Nine patients received 13 courses of 4 days duration, 19 received 29 courses of 5 days duration, and five received courses of 6 or 7 days duration. Dose-limiting toxicity was found to be leukopenia: 42% of patients receiving the 5-day treatment developed a nadir count of less than 3000 cells/mm3. Nausea and vomiting were easily controlled. Minimal nephrotoxicity occurred in five patients and was associated with daily volume expansion with 2 l of 0.9% NaCl solution in four patients. All other patients were given 3 l of daily volume expansion during treatment. Responses were seen in 6 of 22 evaluable patients (27%). It is concluded that continuous infusion cisplatin at a dose rate of 25 mg/M2/day can be given safely for 5 days as a single agent if concomitant volume expansion with at least 3 l of 0.9% NaCl solution is given daily. Phase III comparative trials with a conventional bolus and newer high-dose regimens for response and toxicity are indicated. Cancer 59:15–18, 1987.

Francis J. Cummings

Papers

Relationship between age at diagnosis and treatments received by cancer patients.

A phase I trial of continuous infusion cisplatin.

Influence of Nonmedical Factors in the Choice of Lung Cancer Treatment