As world demographics change and the population of women over the age of 65 grows, optimal treatment of the elderly breast cancer patient becomes an increasingly important issue. The median age of breast cancer diagnosis is 64; however, many key questions in the treatment of elderly women remain. What are the age biases in clinical decision-making, and are they valid? What is the optimal chemotherapy regimen for elderly women in both the adjuvant and metastatic settings? What are the differences in surgical treatments of elderly women? Why are fewer elderly women enrolled in clinical trials?

INTERGROUP TRIAL OF ADJUVANT CHEMOTHERAPY IN OLDER WOMEN

We are currently close to launching a trial for women age 65 and older who have either node-positive or high-risk, node-negative breast cancer. Patients will be randomized to either capecitabine or standard therapy with either CMF or CA. This will be an equivalence trial to see if oral capecitabine for six courses is equivalent to either CMF or CA. Quality of life and the influence of co-morbidity on outcome will also be studied, as will the functional status of the patients. We’re very excited about this, because we believe that if capecitabine is equivalent to more intensive regimens, it might be very attractive for many patients as an adjuvant regimen. I believe that a lot of physicians will be willing to put patients on this trial. The patients are there, and I feel confident we will meet accrual. If you look at Phase II trials in metastatic breast cancer as second- and third-line therapies, there is now a reasonable database for capecitabine demonstrating response rates of about 20 to 30%, which really is comparable to taxanes, vinorelbine and other very active agents. So, if you look at capecitabine as a single agent, it fits in. Taxanes have been extensively compared to regimens like CAF and CMF and have proven to be as good, if not superior, and so if you take a Boolean approach, capecitabine should be reasonable to consider for an equivalence trial to CA or CMF. There is also a very small comparison of capecitabine versus CMF in metastatic disease where the response rate was higher, although not significantly, for capecitabine.

—Hyman Muss, MD

TREATING THE ELDERLY WITH CHEMOTHERAPY: FINDING A LESS TOXIC REGIMEN

The elderly is a group of patients that many physicians have been somewhat hesitant to treat aggressively with chemotherapy because the benefit, although statistically significant, is small in this patient population. Europeans have been very strong in using hormonal therapy instead of cytotoxics in this population. We’re looking for a more gentle but reasonably active drug combination, or, in the case of capecitabine, a single drug. It is interesting to look at capecitabine as an adjuvant treatment in an elderly population, where the options currently available are rather toxic — CMF, AC, etc.... Knowing that capecitabine has activity at least equivalent to CMF in advanced disease, may offer a minimally toxic regimen with benefit in a population of patients that we all are somewhat reticent to treat.

—Daniel Budman, MD

CALGB 49907: A RANDOMIZED TRIAL OF ADJUVANT CHEMOTHERAPY WITH STANDARD REGIMENS, CYCLOPHOSPHAMIDE, METHOTREXATE AND FLUOROCURACIL “CMF” OR DOXORUBICIN AND CYCLOPHOSPHAMIDE “AC,” VERSUS CAPECITABINE IN WOMEN 65 YEARS AND OLDER WITH EARLY STAGE BREAST CANCER OPEN PROTOCOL   MULTICENTER PHASE II TRIAL OF WEEKLY PACLITAXEL FOR METASTATIC BREAST CANCER BASED ON AGE CLOSED PROTOCOL Overall Results: * Mean dose = 77 mg/ m2/week in women < 65 * Mean dose = 76 mg/ m2/week in women > 65 * Well tolerated in both age groups * Similar small incidence of major toxicities in both age groups * Equal efficacy in both age groups Conclusion: Age alone should not be used as a reason to exclude weekly paclitaxel 80 mg/m2 as a reasonable treatment for patients with metastatic breast cancer Adapted from a presentation by Edith Perez, MD at the Chemotherapy Foundation meeting 10/23/01 CNR-9502, EU-95020: PHASE III RANDOMIZED TRIAL OF QUADRANTECTOMY WITH VS WITHOUT AXILLARY LYMPH NODE DISSECTION IN WOMEN OVER 65 YEARS OLD WITH STAGE I BREAST CANCER OPEN PROTOCOL   Patients in both arms receive oral tamoxifen for 5 years   ONCOLOGISTS: What adjuvant therapy would you recommend for the following 77-year-old women with ER-positive, HER2-negative breast cancer? TUMOR SIZE/STATUS ACT FAC AC FEC CMF NONE/ OTHER 2.2 cm tumor 10+ nodes 5% 5% 10% 15% 20% 45% TAMOXIFEN ANASTROZOLE LETROZOLE 50% 40% 10% TUMOR SIZE/STATUS AC CMF NONE 10% 5% 85% 0.8 cm tumor neg nodes TAMOXIFEN ANASTROZOLE LETROZOLE NONE 35% 15% 10% 40% ONCOLOGISTS: What first-line therapy would you recommend for an asymptomatic 78-year-old woman with bone metastases, who received no adjuvant therapy? STATUS NONE 100% ER+/HER2+ ANASTROZOLE LETROZOLE TAMOXIFEN EXEMESTANE 50% 40% 5% 5% TRASTUZUMAB NONE 70% 30%

Balducci L. The geriatric cancer patient: Equal benefit from equal treatment. Cancer Control 2001;8(2 Suppl):1-25. Full-Text

Du X, Goodwin JS. Patterns of use of chemotherapy for breast cancer in older women: Findings from Medicare claims data. J Clin Oncol 2001;19:1455-61. Abstract

Extermann M et al. What threshold for adjuvant therapy in older breast cancer patients? J Clin Oncol 2000;18(8):1709-17. Abstract

Gajdos C et al. The consequence of undertreating breast cancer in the elderly. J Am Coll Surg 2001;192:698-707. Abstract

Kimmick GG, Muss HB. Systemic therapy for older women with breast cancer. Oncology (Huntingt) 2001;15:280-91; discussion 291-2, 295-6, 299. Abstract

Muss HB. Factors used to select adjuvant therapy of breast cancer in the United States: An overview of age, race and socioeconomic status. J Natl Cancer Inst Monogr 2001;30:52-55. Abstract

Home | Meeting Workbook | Educational Supplement | Posters | Opinion Survey |