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Section 5
Adjuvant Therapy for Low-risk Tumors

Sometimes we neglect using some fairly well-established, reproducible prognostic factors. The SEER data and the American College of Surgeons’ National Cancer Database cannot reliably identify a subset of node-negative patients with tumors under a centimeter with a long-term survival of less than 90 percent.

There’s also very good data showing that patients with histologic grade one tumors that are 1.1 to 2 centimeters have a survival that’s greater than 90 percent. Patients with grade one tumors are overwhelmingly ER-positive, so endocrine therapy is certainly a reasonable choice there. But the added absolute benefit of chemotherapy in this subset is extremely small, and sometimes that is not conveyed to women in a way that they can understand.

Another group is the special histologic subtypes, most notably tubular carcinoma, but also mucinous carcinoma. Even a two to three centimeter tubular cancer has an outstanding prognosis, and, again, these are all receptor-positive. So, if physicians look at old consensus guidelines and just go in lock-step with the greater-than-1-centimeter number, they might potentially over-treat some patients by using chemotherapy.

We consider tamoxifen in these patients not only for the treatment effect, but also the potential prevention benefit in terms of the contralateral breast. If you add in the stabilization of postmenopausal bone loss — if not fracture protection — it’s well worth taking for many patients. If they have some significant reason not to take it — a history of pulmonary embolism, DVT, or if they’re 75 years old with a good-prognosis tumor — we might not recommend tamoxifen, but it should be considered.

—Monica Morrow, MD

Morrow M. Who should not receive chemotherapy? – U.S. databases and trials. NIH Consensus Conference on Early Breast Cancer, 2000. Abstract

Bergh JC. Who should not receive chemotherapy? – International databases. NIH Consensus Conference on Early Breast Cancer, 2000. Abstract

Fisher B. Recent NSABP adjuvant studies in primary (stage one) breast cancer. NIH Consensus Conference on Early Breast Cancer, 2000. Abstract

NIH Consensus Development Conference on Early Breast Cancer, Final Statement Full Text

On the basis of available data, it is accepted practice to offer cytotoxic chemotherapy to most women with lymph node metastases or with primary breast cancers larger than 1 cm in diameter (both node-negative and node-positive). For women with node-negative cancers less than 1 cm in diameter, the decision to consider chemotherapy should be individualized.

NSABP B-21: Phase III Trial of Adjuvant Therapy with Tamoxifen vs Placebo, plus Radiotherapy, in the Management of Patients with Clinically Occult, Invasive, Node-Negative Breast Cancer Treated by Lumpectomy (closed for accrual) Protocol 

Eligibility  Eligibility Invasive < 1 cm, node-neg, treated with lumpectomy & ALND

ARM 1 XRT + placebo x 5 years
ARM 2 XRT + tamoxifen 20 mg qd x 5 yrs
ARM 3 Tamoxifen 20 mg qd x 5 yrs

Wolmark N et al. The role of radiotherapy and tamoxifen in the management of node-negative breast cancer < 1.0 cm treated with lumpectomy: Preliminary results of the NSABP protocol B-21. Proc. ASCO 2000 Abstract 271

(The combination of tamoxifen together with radiotherapy was superior to either treatment alone in controlling ipsilateral breast tumor recurrence even in this highly favorable group. Tamoxifen also reduced the incidence of contralateral breast cancers.) 

SELECT PUBLICATIONS

Bland KI et al. Clinical highlights from the National Cancer Data Base, 2000. CA Cancer J Clin 2000;50:171-183. Full-Text

Diab SG et al. Tumor characteristics and clinical outcome of tubular and mucinous breast carcinomas. J Clin Oncol 1999;17:1442-8. Abstract

Fisher B et al. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: Findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol 2001;19:931-42. Abstract

Fisher B et al. Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes. J Natl Cancer Inst 2001;93:112-20. Abstract

Lundin J et al. Omission of histologic grading from clinical decision-making may result in overuse of adjuvant therapies in breast cancer: Results from a nationwide study. J Clin Oncol 2001;19:28-36. Abstract


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Editor’s Note

Sentinel Node Dissection:
Implications to Medical Oncology


Postmastectomy Radiation
Therapy


Ductal Carcinoma In Situ

ER/PR Results and Endocrine
Therapy


Adjuvant Therapy for Low-risk
Invasive Tumors


ATAC Trial: Arimidex vs
Tamoxifen vs Combination


Bisphosphonates in Primary
Breast Cancer
 

Adjuvant Taxanes: Surgical
Oncology Perspective


Proposed IBIS 2 Prevention Trial:
Arimidex vs Tamoxifen vs Placebo


Predictions of Future Trends
in Breast Cancer Research


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