Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer.

AIMS: This study reports the symptom and HRQOL results in which standard treatment was compared to standard therapy plus Bec2, an anti-idiotypic antibody that mimics GD3, a ganglioside antigen. METHODS: Five hundred and fifteen LD SCLC patients were randomised to receive five vaccinations of Bec2 (2.5mg)/BCG vaccine arm (VA) or an observational arm (OA) administered over a 10-week period. Survival was the primary end-point; HRQOL was a secondary end-point, assessed using the EORTC QLQ-C30/LC 13. RESULTS: There was no improvement in survival or progression-free survival in the vaccination arm. At baseline patients in both arms demonstrated significantly impaired scores on the global QOL scale, when compared to a normative population. However, HRQOL and symptom scores between the two treatment arms were not statistically different at any time point. CONCLUSION: We found no benefits to patient HRQOL by additional vaccination with Bec2/BCG to LD SCLC for patients who have been undergoing standard therapy.

Changes associated with a quota-based approach on a walking program for individuals with fibromyalgia.

STUDY DESIGN: Single-subject, multiple-baseline design across 3 subjects. OBJECTIVE: To investigate the use of a quota-based approach to prescribing a walking program for individuals with fibromyalgia (FM). BACKGROUND: Exercise has been found to be beneficial for individuals with FM. What has not been determined is the best way to implement an exercise program that does not increase FM symptoms. METHODS AND MEASURES: Three women with FM were randomly assigned a baseline period of 5, 6, or 7 weeks, which served as the control phase, followed by an intervention period consisting of an 8-week walking program. The walking program progression was prescribed using a quota-based approach. Weekly outcome measures were the Fibromyalgia Impact Questionnaire (FIQ), Arthritis Self-Efficacy Scale (ASES), and SF-36v2 (acute). A 6-minute walk test was recorded twice: at the start of the baseline phase (after a trial phase) and at the end of the intervention phase. RESULTS: Subjects 1 and 3 had a significant decrease in the symptoms associated with FM during the intervention phase (FIQ, P<.05), but no significant increase in self-efficacy (ASES). They increased their walking distances used for exercise by 640 and 480 m, respectively. Subject 2 had no significant improvements in her symptoms of FM. Despite a significant decrease in ASES (P<.05), walking distance used for exercise by subject 2 increased by 2080 m. Six-minute walk test distances increased 76, 32, and 106 m for subjects 1, 2, and 3, respectively. CONCLUSIONS: Prescribing a walking program using a quota-based exercise prescription resulted in increasing the distance walked for 3 subjects. It also decreased symptoms associated with FM in 2 of the 3 subjects, but did not increase self-efficacy.

Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study).

PURPOSE: Bec2 is an anti-idiotypic antibody that mimics GD3, a ganglioside that is expressed on the surface of tumor cells and is of neuroectodermal origin. We assessed whether Bec2/bacille Calmette-Guerin (BCG) vaccination prolongs survival in patients with limited-disease small-cell lung cancer (SCLC) after a major response to chemotherapy and chest radiation. PATIENTS AND METHODS: Patients were randomly assigned to receive five vaccinations of Bec2 (2.5 mg)/BCG vaccine or follow-up. Vaccination was given over a 10-week period. The sample size was targeted to detect an increase in median survival of 40% after random assignment, and stratification was by performance status, response, and institution. Quality of life was assessed by using the European Organisation for Research and Treatment of Cancer instrument. Humoral response was assessed in patients who received vaccination. RESULTS: A total of 515 patients were randomly assigned. The primary toxicities of vaccination were transient skin ulcerations and mild flu-like symptoms. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Median survival from randomization was 16.4 and 14.3 months in the observation and vaccination arms (P = .28), respectively. Among vaccinated patients, a trend toward prolonged survival was observed in those (one third) who developed a humoral response (P = .085). Multivariate analysis showed a positive impact on survival by prior treatment with concomitant chemoradiotherapy, prophylactic cranial irradiation, female sex, low lactate dehydrogenase, and normal platelets. CONCLUSION: Vaccination with Bec2/BCG has no impact on outcome of patients with limited-disease SCLC responding to combined-modality treatment. Vaccination strategies in SCLC may still be warranted using vaccines that produce a better immunologic response.