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In Reply:

Virginia Commonwealth University School of Medicine, Richmond, VA

We appreciate the interest of Drs Shahab and Haider in our recent report, and their concern about publication of these admittedly preliminary results (as noted in the title).¹ By reporting these data, we do not wish to imply or recommend specific changes in clinical practice for the treatment of breast cancer patients, as overall survival is the most important end point on which to base such decisions. Nonetheless, in an era when several studies have been reported to show a survival or disease-free survival advantage from the addition of taxanes to anthracycline-based adjuvant therapy for breast cancer, our results are certainly of interest, and consistent with changes in practice that are already ongoing.^2-4 Since primary tumor response to induction chemotherapy, and pathologic response in particular, has been consistently predictive of survival outcome, the results reported in our paper were widely anticipated and of major interest.^5-8 While the survival data are not yet available for the B-27 trial, the clinical and pathologic response data are mature and complete at the time of the report, and will not change. Although not definitive from a clinical standpoint, the results are biologically significant. As noted in their letter, whether this will translate into a survival advantage is yet to be seen. We have commented repeatedly that, despite the correlation between response and survival, no study to date has shown that a change in primary systemic treatment that increases primary tumor response will necessarily result in improved survival.

Having said that, our results do have some potential impact on treatment decisions, particularly for patients with large tumors who receive primary chemotherapy with the goal of permitting breast conservation rather than a mastectomy. Based on the B-27 results, our standard practice for such patients is to give anthracycline-based therapy followed by taxane therapy, similar to Group II in B-27. Since this results in the best chance of a pathologic complete response, we feel that this offers the best opportunity to achieve breast conserving surgery with negative margins and good cosmetic results. Moreover, recent studies suggest that less residual tumor after neoadjuvant chemotherapy predicts lower local recurrence rates in the breast, and that patients who have a complete response may eventually be able to avoid surgery altogether.^9,10 Although B-27 did not show a higher rate of breast conservation with adjuvant chemotherapy followed by docetaxel, the rate of mastectomy was fairly low in all groups. Again, we do not know whether the additional chemotherapy will improve local control or survival, but most patients considered to be at high risk (with large tumors and/or positive nodes) are likely to receive similar chemotherapy anyway, either preoperatively or postoperatively. We have simply reported the admittedly preliminary results of a large and potentially important trial; we have not said what medical oncologists should do. They must still, as always, read the literature critically and use good clinical judgment for managing each patient in their practices.

Authors' Disclosures of Potential Conflicts of Interest

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Acted as a consultant within the last 2 years: Harry D. Bear, Aventis. Received more than $2,000 a year from a company for either of the last 2 years: Harry D. Bear, Aventis.

REFERENCES

1. Bear HD, Anderson S, Brown A, et al: The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: Preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 21:4165-4174, 2003[Abstract/Free Full Text]

2. Henderson IC, Berry DA, Demetri GD, et al: Improved outcomes from adding sequential paclitaxel but not from the escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 21:976-983, 2003[Abstract/Free Full Text]

3. Citron ML, Berry DA, Cirrincione C, et al: Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 21:1431-1439, 2003[Abstract/Free Full Text]

4. Nabholtz JM, Pienkowski T, Mackey J, et al: Phase III trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer (BC) patients: Interim analysis of the BCIRG 001 study. Proc Am Soc Clin Oncol 21:36a, 2002 (abstr 141)

5. Bonadonna G, Valagussa P, Brambilla C, et al: Primary chemotherapy in operable breast cancer: Eight-year experience at the Milan Cancer Institute. J Clin Oncol 16:93-100, 1998[Abstract/Free Full Text]

6. Fisher B, Bryant J, Wolmark N, et al: Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol 16:2672-2685, 1998[Abstract]

7. Ferriere JP, Assier I, Cure H, et al: Primary chemotherapy in breast cancer: Correlation between tumor response and patient outcome. Am J Clin Oncol 21:117-120, 1998[CrossRef][Medline]

8. Machiavelli MR, Romero AO, Perez JE, et al: Prognostic significance of pathological response of primary tumor and metastatic axillary lymph nodes after neoadjuvant chemotherapy for locally advanced breast carcinoma. Cancer J Sci Am 4:125-131, 1998[Medline]

9. Chen AM, Meric F, Hunt KK, et al: Breast-conserving therapy after neoadjuvant chemotherapy: The M.D. Anderson Cancer Center experience. Breast Cancer Res Treat 82:S7–S8, 2003 (abstr 6)

10. Ring A, Webb A, Ashley S, et al: Is surgery necessary after complete clinical remission following neoadjuvant chemotherapy for early breast cancer? J Clin Oncol 21:4540-4545, 2003[Abstract/Free Full Text]

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