Gender influence on weight-loss pattern and survival of nonsmall cell lung carcinoma patients.

BACKGROUND: Gender has recently emerged as a discriminating factor in nonsmall lung carcinoma (NSCLC) patient outcome. Since the potential for interaction among established prognostic factors and gender in this common disease has not been explored, the authors evaluated the role of gender and weight-loss pattern in predicting clinical outcome in a balanced population of men and women presenting with NSCLC. METHODS: From a tumor registry population of 368 NSCLC patients, a gender-balanced sample of 152 cases was randomly selected for review, using prospective inclusion criteria. Study parameters were age, race, tobacco and alcohol history, gender, weight-loss pattern, histology, TNM stage, Eastern Cooperative Oncology Group performance status, and therapy. Influences of study variables on Kaplan-Meier estimates of survival were subsequently determined using univariate and multivariate analyses. RESULTS: Overall median survival after diagnosis was significantly shorter for men with NSCLC than for women with the disease (40 vs. 78 weeks, P = 0.001). Men lost significantly more weight over their disease course than women (12.2 vs. 5.4 pounds, P = 0.006) and experienced an eightfold faster rate of initial weight loss (0.25 vs. 0.03 pounds per week, P = 0.001). In multivariate analysis, the strongest independent predictors of NSCLC patient survival were stage of disease, initial weight-loss rate, and gender (all P < 0.0001). CONCLUSIONS: These results suggest that weight loss may play a role in mediating gender-related differences in NSCLC patient survival and provide an impetus for further studies of gender influence on cancer outcome.

A decade of breast cancer clinical investigation: results as reported in the Program/Proceedings of the American Society of Clinical Oncology.

PURPOSE: To test the hypothesis that clinical research results have driven changes in recent breast cancer management recommendations. METHODS: All breast cancer abstracts in the Program/Proceedings of the American Society of Clinical Oncology (ASCO) from 1984 to 1993 were prospectively reviewed in 31 areas and categorized by study type, study question, whether statistical significance was claimed, and whether the abstract was presented. RESULTS: Of 1,372 abstracts, 54% reported on prospective clinical trials (PCTs) and 17% on randomized clinical trials (RCTs). The total number of published abstracts progressively increased (from 87 in 1984 to 221 in 1993) and author citations nearly quadrupled (from 430 in 1984 to 1,642 in 1993, P < .01); however, RCTs have come to represent a smaller proportion of reports: 37% (33 of 89) in 1986 versus 10% (22 of 221) in 1993 (P < .001). The size of adjuvant-therapy RCTs has progressively increased (mean +/- SEM subjects/trial, 237 +/- 43 in 1984 to 874 +/- 374 in 1993), but has remained small in advanced-disease RCTs (mean +/- SEM subjects/trial, 145 +/- 25 in 1984 to 146 +/- 34 in 1993). For adjuvant therapy, 14 of 90 RCTs (with 51,207 patients) reported a significant (P < .05) survival benefit for investigational therapies (16%). For advanced-disease therapy, only three of 141 RCTs (with 26,281 patients) reported a significant (P < .05) survival benefit for investigational therapies (2%). Randomization was rarely used in trials of dose-intensity with blood-product support (zero of 86 trials) or locally advanced disease. CONCLUSION: For breast cancer ASCO abstracts in the past decade, we determined the following: (1) adjuvant trials have not infrequently supported study hypotheses; and (2) advanced-disease trials have consistently failed to identify new approaches with a significant impact on survival. These results suggest that a critical process evaluation of current policy and procedures involved in directing breast cancer research is warranted, especially for strategies in advanced disease.