Journal of Clinical Oncology, Vol 12, 1789-1795, Copyright © 1994 by American Society of Clinical Oncology
A decade of breast cancer clinical investigation: results as reported in the Program/Proceedings of the American Society of Clinical Oncology
RT Chlebowski and LM Lillington
Division of Medical Oncology, Harbor-University of California at Los Angeles Medical Center, Torrance 90509.
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.
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