National Cancer Institute Trial Research Articles

Participation of patients 65 years of age or older in cancer clinical trials.

Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials. Further investigation into the reasons for low elderly participation is warranted. Our objective was to evaluate the participation of the elderly in clinical trials sponsored by the National Cancer Institute (NCI) and assess the impact of protocol exclusion criteria on elderly participation. We conducted a retrospective analysis using NCI data, analyzing patient and trial characteristics for 59,300 patients enrolled onto 495 NCI-sponsored, cooperative group trials, active from 1997 through 2000. Our main outcome measure was the proportion of elderly patients enrolled onto cancer clinical trials compared with the proportion of incident cancer patients who are elderly. Overall, 32% of participants in phase II and III clinical trials were elderly, compared with 61% of patients with incident cancers in the United States who are elderly. The degree of underrepresentation was more pronounced in trials for early-stage cancers than in trials for late-stage cancers (P <.001). Furthermore, protocol exclusion criteria on the basis of organ-system abnormalities and functional status limitations were associated with lower elderly participation. We estimate that if protocol exclusions were relaxed, elderly participation in cancer trials would be 60%. The elderly are underrepresented in cancer clinical trials relative to their disease burden. Older patients are more likely to have medical histories that make them ineligible for clinical trials because of protocol exclusions. Insurance coverage for clinical trials is one step toward improvement of elderly access to clinical trials. Without a change in study design or requirements, this step may not be sufficient.

National Cancer Institute trials website

This is an ambitious website, which tries to provide information to both oncology researchers and patients on clinical trials in cancer. For the latter group, this is obviously an important and emotive subject.

The early identification of lung carcinoma by sputum cytology

BACKGROUND Sputum cytology was considered to be ineffective in previous National Cancer Institute trials for early lung carcinoma detection. However, sputum cytology was effective in identifying roentgenographically occult lung carcinoma in a community lung carcinoma identification program, where lung carcinoma was suspected on the basis of symptoms, smoking, or airflow obstruction. METHODS The community project and the results of a newer lung carcinoma identification program were reviewed. RESULTS Actuarial survival curves from a previously published study where 46 of 51 roentgenographically occult carcinomas could be treated by surgery (n = 27) or curative radiation therapy (n = 19) is presented. Overall survival, taking deaths from all causes at five years, was 54.4%. The serial study of high risk patients with airflow obstruction and more than 30 pack-years of smoking revealed a 1.8% yield of lung carcinoma. This is a higher yield than in mammography (0.3%–0.5%). CONCLUSION Sputum cytology can be useful in identifying lung carcinoma in its early and occult stages, particularly in patients at high risk for this disease. Cancer 2000;89:2461–4. © 2000 American Cancer Society.

The early identification of lung carcinoma by sputum cytology.

Sputum cytology was considered to be ineffective in previous National Cancer Institute trials for early lung carcinoma detection. However, sputum cytology was effective in identifying roentgenographically occult lung carcinoma in a community lung carcinoma identification program, where lung carcinoma was suspected on the basis of symptoms, smoking, or airflow obstruction. The community project and the results of a newer lung carcinoma identification program were reviewed. Actuarial survival curves from a previously published study where 46 of 51 roentgenographically occult carcinomas could be treated by surgery (n = 27) or curative radiation therapy (n = 19) is presented. Overall survival, taking deaths from all causes at five years, was 54.4%. The serial study of high risk patients with airflow obstruction and more than 30 pack-years of smoking revealed a 1.8% yield of lung carcinoma. This is a higher yield than in mammography (0.3%-0.5%). Sputum cytology can be useful in identifying lung carcinoma in its early and occult stages, particularly in patients at high risk for this disease.

Use of fluoroquinolones for empirical management of febrile neutropenia in pediatric cancer patients.

Empiric antibiotic therapy has become a standard of care for the febrile neutropenic patient. Many clinical trials over the previous three decades have demonstrated that a variety of antibiotic combinations and more recently potent antibiotic monotherapies may preserve the patient through the critical time of fever and neutropenia. Recently attempts have been made to identify "low risk" patients who may not require traditional, intensive, hospitalized intravenous antimicrobial therapy. Therefore the need for new treatment alternatives for the febrile neutropenic pediatric cancer patient in particular revolves around the desire for less complex regimens, agents with minimal toxicity and expense and the option of an oral formulation for outpatient management. Fluoroquinolones, especially ciprofloxacin and ofloxacin, are examined in this paper as potential oral alternatives for managing the low risk neutropenic pediatric cancer patient population. Attention must be paid to their antibacterial spectra, however, and in some cases fluoroquinolones should be combined with a second agent for additional Gram-positive coverage. Several studies, including one ongoing trial at the National Cancer Institute, have shown the potential benefits of oral fluoroquinolone therapy among low risk febrile neutropenic patients. Joint complaints in children after ciprofloxacin therapy in the National Cancer Institute trial thus far have been minimal, reversible and felt to be unrelated to ciprofloxacin treatment. The use of outpatient therapy, such as the fluoroquinolones, to manage febrile neutropenic episodes must be approached with caution and should be undertaken only in selected low risk patients.

Hexamethylmelamine (altretamine): Early National Cancer Institute trials

Hexamethylmelamine (altretamine): Early National Cancer Institute trials

Predictive factors for tumor response to preoperative chemotherapy in patients with head and neck squamous carcinoma. The Head and Neck Contracts Program.

The high tumor response rates associated with intensive chemotherapy in previously untreated patients with advanced head and neck squamous cell carcinoma (HNSCC) led to the initiation of a multi-institutional National Cancer Institute trial. This trial used preoperative chemotherapy in patients with resectable Stage III and IV squamous cell carcinoma of the oral cavity or larynx/hypopharynx. Response rates, toxicity, and a variety of patient and tumor characteristics were analyzed to determine which factors might be useful in predicting tumor response to preoperative chemotherapy. Two hundred eighty-two patients received one course of preoperative cisplatin and bleomycin chemotherapy and were evaluable. There were 22 complete responses (CR) and 114 partial responses (PR) at the primary site (48% response rate). Of 197 patients with clinically positive regional adenopathy, 29 CRs and 73 PRs were observed (52%). Toxicity associated with the chemotherapy regimen was minimal. Primary tumor and regional node responses to chemotherapy were strongly correlated. No significant differences were found in primary or nodal response rates with respect to differing tumor site, stage, histologic differentiation, patient performance status, nutritional status, leukocyte count, hemoglobin level, age, sex, or alcohol use. Primary tumor response, however, was significantly related to T classification (P = 0.048). Nodal response was strongly associated with N classification and nodal size (P = 0.02 and P = 0.075, respectively). These findings suggest that, of the patient and tumor characteristics analyzed, none were more useful in predicting tumor response than clinical tumor staging parameters.