Almost all oncologists would give endocrine therapy to asymptomatic, ER-positive, premenopausal patients with bone metastases — primarily tamoxifen alone or combined with ovarian ablation/suppression or an aromatase inhibitor combined with ovarian ablation / suppression. It is noteworthy that 16-40% of oncologists would use single-agent aromatase inhibitors in premenopausal women, while 16-25% would use it in conjunction with ovarian ablation/suppression. A romatase inhibitors are not indicated in the treatment of premenopausal women.

Aebi S et al. Is chemotherapy alone adequate for young women with oestrogen receptor-positive breast cancer? Lancet 2000;355(9218):1869-74. Abstract

Buzdar AU. Endocrine therapy in the treatment of metastatic breast cancer. Semin Oncol 2001;28(3):291-304. Abstract

Cheung KLet al. The combined use of goserelin and anastrozole as second-line endocrine therapy in premenopausal women with advanced breast cancer - a study of its clinical and endocrine effects. Proc ASCO 2001; Abstract 1937.

Forward D et al. Combined use of goserelin (Zoladex) and anastrozole (Arimidex) in premenopausal women with metastatic breast cancer (MBC). Proc ASCO 2000; Abstract 582.

Hoffken K, Kath R. The role of LH-RH analogues in the adjuvant and palliative treatment of breast cancer. Recent Results Cancer Res 2000;153:61-70. Abstract

In very ill women with visceral metastases, 80% of oncologists would utilize chemotherapy alone or combined with endocrine therapy. Whether or not endocrine therapy alone is adequate in an asymptomatic patient with visceral metastases is a topic of controversy. Research leaders often note that endocrine therapy usually takes somewhat longer than chemotherapy to elicit a tumor response, so that clinical judgment involves assessing whether the patient is stable enough to wait for a response to endocrine treatment. In the adjuvant setting, chemotherapy and endocrine therapy have been proven to have an additive or synergistic effect.

Ingle JN et al. Evaluation of tamoxifen plus letrozole with assessment of pharmacokinetic interaction in postmenopausal women with metastatic breast cancer. Clin Cancer Res 1999;5(7):1642-9. Abstract

Jordan C. Historical perspective on hormonal therapy of advanced breast cancer. Clin Ther 2002; 24 Suppl A:A3-A16. Abstract

Klijn JG et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: A meta-analysis of four randomized trials. J Clin Oncol 2001;19(2):343-53. Abstract

Michaud LB et al. Combination endocrine therapy in the management of breast cancer. Oncologist 2001;6(6):538-46. Abstract

With an increasing fraction of breast cancer patients receiving taxane-based adjuvant systemic therapy, the dilemma of the patient presenting shortly t h e reafter with metastatic disease is becoming more common. There is considerable variation in choice of chemotherapy regimen in this situation. About one year after the initial results of the capecitabine/docetaxel study were first reported — demonstrating a survival advantage and a relatively favorable side - effect profile — more than half of attendees to the Miami meeting would choose this regimen, but relatively few physicians in practice follow this approach.

Crown J. Nonanthracycline-containing docetaxel-based combinations in metastatic breast cancer. Oncologist 2001;6 Suppl 3:17-21. Abstract

Domenech GH, Vogel CL. A review of vinorelbine in the treatment of breast cancer. Clin Breast Cancer 2001 Jul;2(2):113-28. Abstract

Miles D. Survival benefit with Xeloda (capecitabine)/docetaxel vs docetaxel: Analysis of post-study therapy. Breast Cancer Res Treat 2001; Abstract 442.

Seidman AD. The evolving role of gemcitabine in the management of breast cancer. Oncology 2001;60(3):189-98. Abstract

Vukelja SJ et al. Xeloda (capecitabine) plus docetaxel combination therapy in locally advanced/metastatic breast cancer: Latest results. Breast Cancer Res Treat 2001; Abstract 352.

The older patient relapsing after taxane-based adjuvant systemic therapy is commonly treated with capecitabine, either alone or in combination with a taxane. Over one-half of the oncologists attending the 2002 Miami Breast Cancer Conference would treat a 63 - year-old woman with visceral metastases with the combination of capecitabine / docetaxel. Another agent commonly utilized in this situation is vinorelbine.

Maher JF, Villalona-Calero MA. Taxanes and capecitabine in combination: Rationale and clinical results. Clin Breast Cancer 2002;2(4):287-93. Abstract

Proponents of sequential single-agent chemotherapy in metastatic breast cancer believe there is no survival advantage for combination chemotherapy, and that patients are exposed to less toxicity with single agents.

Oncologists are more likely to use combination chemotherapy for patients with rapidly progressing, visceral metastases in whom a rapid response to therapy is critical. Since earlier and more effective disease control may translate into a better quality of life, some breast cancer research leaders use combination regimens earlier in the metastatic setting. If clinical trial results with newer, rationally derived, synergistic and relatively less toxic combinations demonstrate progression - free and overall survival advantages, more oncologists may adopt these combinations. Most recently, a survival advantage was observed for capecitabine /docetaxel in a trial comparing it to docetaxel alone.

In this survey, three-quarters of oncologists reported that 60% or more of their patients receive combination chemotherapy at some point in the treatment of their metastatic disease.

Sledge GW Jr et al. Phase III trial of doxorubicin versus paclitaxel versus doxorubicin plus paclitaxel as first-line therapy for metastatic breast cancer: An Intergroup trial. Proc ASCO 1997; Abstract 2.

A number of clinical trials have demonstrated improved efficacy and less toxicity with the third-generation aromatase inhibitors compared to tamoxifen as first-line therapy for metastatic breast cancer. Currently, two-thirds of oncologists use a romatase inhibitors as first-line therapy with anastrozole and letrozole utilized about equally. About half of oncologists use a combination of chemotherapy and hormonal therapy in the highly symptomatic patient with visceral disease.

Mouridsen H et al. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: Results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol 2001;19(10):2596-606. Abstract

Nabholtz JM et al. Anastrozole is superior to tamoxifen as first-line therapy for advanced breast cancer in postmenopausal women: Results of a North American multicenter randomized trial. Arimidex Study Group. J Clin Oncol 2000;18(22):3758-67. Abstract

Oncologists are reluctant to expose elderly patients to the morbidity associated with chemotherapy. Depending on the ER and HER2 status, 5-55% of oncologists would treat a 78-year-old woman with chemotherapy, most often employing single-agent therapy. In ER-positive patients 90-100% of physicians would utilize endocrine therapy, and nearly all would use an aromatase inhibitor. In ER-negative, HER2-positive patients, nearly two-thirds of oncologists would use trastuzumab, alone or in combination with chemotherapy; however, they were still more likely to use endocrine therapy in the ER-positive, HER2-positive patient. Research leaders believe HER2 over expression may confer only partial resistance to endocrine therapies, and this effect may be more evident with tamoxifen rather than the aromatase inhibitors.

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

Hurria A et al. Factors influencing treatment patterns of breast cancer (BC) patients (Pts) age 75 and older. Proc ASCO 2001; Abstract 1577.

Kimmick GG, Muss HB. Systemic therapy for older women with breast cancer. Oncology (Huntingt) 2001;15(3):280-91. Abstract

Lichtman SM, Villani G. Chemotherapy in the elderly: Pharmacologic considerations. Cancer Control 2000;7(6):548-56. Full-Text

Clinical data have demonstrated an advantage for LHRH agonists plus tamoxifen when compared to LHRH agonists alone in premenopausal patients with metastatic disease. Unfortunately, there are no data comparing the combination to tamoxifen alone. Among oncologists surveyed, over one-third would treat a premenopausal woman with an LHRH agonist/tamoxifen regimen, and one-quarter would utilize tamoxifen alone. Interestingly, nearly 20% would combine an aromatase inhibitor with ovarian ablation to treat a 43-year-old patient with asymptomatic bone metastases — a maneuver that has been utilized by 70% of oncologists in certain patients at some point in their practice.

Celio L et al. Premenopausal breast cancer patients treated with a gonadotropin-releasing hormone analog alone or in combination with an aromatase inhibitor: A comparative endocrine study. Anticancer Res 1999;19:2261-8. Abstract

Cheung KLet al. The combined use of goserelin and anastrozole as second-line endocrine therapy in premenopausal women with advanced breast cancer — a study of its clinical and endocrine effects. Proc ASCO 2001; Abstract 1937.

Forward D et al. Combined use of goserelin (Zoladex) and anastrozole (Arimidex) in premenopausal women with metastatic breast cancer (MBC). Proc ASCO 2000; Abstract 582.

Ingle JN et al. Combination hormonal therapy involving aromatase inhibitors in the management of women with breast cancer. Endocr Relat Cancer 1999;6:265-9. Abstract

While 2500 mg/m2/day is the approved dose for capecitabine, retrospective studies have demonstrated no decrement in response associated with reducing the dose to 2000 mg/m2/ day. While nearly half of respondents would start a 55-year-old woman at full-dose capecitabine, three-quarters would reduce this to 2000 mg/m2/day for a 75 - year-old woman. A current adjuvant capecitabine trial in elderly women will utilize this reduced dose. The primary dose-limiting toxicity for capecitabine use is hand-foot syndrome.

Fujimoto-Ouchi K et al. Schedule dependency of antitumor activity in combination therapy with capecitabine/5’-deoxy-5-fluorouridine and docetaxel in breast cancer models. Clin Cancer Res 2001;7(4):1079-86. Abstract

Michaud LB et al. Improved therapeutic index with lower-dose capecitabine in metastatic breast cancer (MBC) patients (Pts). Proc ASCO 2000; Abstract 402.

O’Shaughnessy J. Clinical experience of capecitabine in metastatic breast cancer. Eur J Cancer 2002;38 Suppl 2:10-4. Abstract

O’Shaughnessy J et al. A retrospective evaluation of the impact of dose reduction in patients treated with Xeloda (capecitabine). Proc ASCO 2000; Abstract 400.

In a patient who is tolerating capecitabine but not responding, 25% of oncologists would dose-escalate. Although stable disease in the asymptomatic patient with metastases is widely viewed as a positive effect of therapy, about two-thirds of oncologists would make some change in such a patient.

In the patient developing mild symptoms of hand-foot syndrome, early intervention with dose reductions or changes in schedule are usually recommended by research leaders, who also emphasize the importance of educating patients to notify physicians about these symptoms. Two-thirds of the oncologists report that less than half of their patients on capecitabine develop side effects requiring some type of intervention.

O’Shaughnessy J. Clinical experience of capecitabine in metastatic breast cancer. Eur J Cancer 2002;38 Suppl 2:10-4. Abstract

Over one-third of physicians surveyed utilize tumor markers to detect recurrence after primary therapy in patients with node-positive disease. Although there is one well-designed study, which demonstrated that CA 27.29 could predict recurrence 5.3 months before other symptoms or tests, the 2000 update to the American Society of Clinical Oncology guidelines for the use of tumor markers does not recommend their routine use in this setting, because the clinical benefit and options for therapy are not significantly impacted. Another consideration in determining whether or not to use tumor markers in this situation is the psychological effect on the patient of rising tumor levels.

One-half of physicians reported the use of tumor markers in following a patient with metastatic breast cancer. The ASCO guidelines do not support the routine use of CEA to monitor response to treatment; however, CEA may be useful in determining t reatment failure for patients without readily measurable disease or those with elevated CA 15-3 and/or CA 27.29.

Bast RC Jr et al. 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: Clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001;19(6):1865-78. Abstract

Cheung KLet al. Tumour marker measurements in the diagnosis and monitoring of breast cancer. Cancer Treat Rev 2000;26(2):91-102. Abstract

Duffy MJ. Clinical uses of tumor markers: A critical review. Crit Rev Clin Lab Sci 2001; 38 (3):225-62. Abstract

Nicolini A, Carpi A. Postoperative follow-up of breast cancer patients: Overview and progress in the use of tumor markers. Tumour Biol 2000;21(4):235-48. Abstract

Sakorafas GH et al. Follow-up after primary treatment for breast cancer. Acta Oncol 2000;39(8):935-40. Abstract

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