| Older
women with node positive (N+) breast cancer (BC) get similar benefits
from adjuvant chemotherapy (Adj) as younger patients (pts): The
Cancer and Leukemia Group B (CALGB) experience
Category:
Adjuvant Therapy
Authors:
H. B. Muss, S. H. Woolf, D. A. Berry, R. B. Weiss, D. R. Budman,
W. C. Wood, C. I. Henderson, C. Hudis, E. P. Winer, L. Norton, for
Cancer and Leukemia Group B (CALGB); Univ of Vermont, Burlington,
VT; Duke University, Durham, NC; Univ. of Texas, Houston, TX; Georgetown
University Medical Ctr., Washington, DC; New York University, Manhasset,
NY; Emory University Hospital, Atlanta, GA; Univ. of California
San Francisco, San Francisco, CA; Memorial Sloan-Kettering Cancer
Ctr., New York, NY; Dana-Farber Cancer Institute, Boston, MA
Abstract:
Purpose: To determine
benefits and toxicities of Adj chemotherapy by age group for N+
BC for pts on CALGB trials. Methods: Data from 6,489 pts entered
on CALGB 7581, 8082, 8541 and 9344 were analyzed. In all four trials
patients were randomized to differing doses and schedules of Adj,
and some of the arms involved doses that were regarded at the time
to be "high." Toxicity data is available for all trials.
Results: Median follow-up for
all trials is 9.6 years (yrs) (range 6-23.5 yrs). Tumor size for
all patients: 34% T1, 55% T2, 11% T3. Nodal status: 48% 1-3, 37%
4-9, 15% 10+. 61% of pts tested were ER+, 56% PR+, and 57% received
tamoxifen (T). 3506 (54%) of pts were 50 yrs or less, 2439 (38%)
were 51-64 yrs, 542 (8%) were 65+ yrs and 159 (2%) 70+ yrs. Pts
65+ had significantly (p<.05) more positive lymph nodes (+LN).
Multivariate analysis showed that ↓T size,↓ number +LN, high vs
low doses of Adj, and T use were all significantly (p<.05) related
to longer relapse-free survival (RFS). Age was not. 31 deaths (0.5%
of all pts) were due to Rx. Conclusion: Older women compared to
younger women with N+ BC entered onto these Adj trials had: higher
stage BC, similar dose-related benefits in reducing BC-related relapse
and mortality, and as expected, significantly (p<.05) higher
overall mortality due to an increase in non-BC related deaths. Moreover,
since 50% of all new BC diagnoses are in women 65+, older pts were
greatly under-represented in these clinical trials.
Results
| AGE |
<=50 |
51-64 |
65+ |
All
Patients |
| Number Pts (%) |
3506 (100%) |
2439 (100%) |
542 (100%) |
6489 (100%) |
| Total Alive |
2156 (61%) |
1300 (53%) |
214 (39%) |
3670 (57%) |
| Alive with no BC |
1902(54%) |
1153 (47%) |
190 (35%) |
3245 (50%) |
| Died |
1257 (36%) |
1085 (44%) |
314 (58%) |
2657 (41%) |
| Died of Breast Cancer (BC) |
1133 (32%) |
871 (36%) |
229 (42%) |
2234 (34%) |
| Died of non-BC cause |
73 (2%) |
140 (6%) |
59 (11%) |
272 (4%) |
| Treatment-related death |
8 (<1%) |
15 (1%) |
7 (1%) |
31 (<1%) |
| Cause unknown or lost to follow
|
166 (5%) |
113 (5%) |
33 (6%) |
282 (4%) |
| Risk reduction in RFS for high
vs low dose Adj |
11% (0-20%) |
14% (1-25%) |
31% (9-47%) |
12% (4-19%) |
| Survival-median in years |
16.0 |
11.5 |
9.0 |
12.7 |
|
