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I was surprised to find inaccurate information in the July 2000 issue of Oncology News International, in an article on page 4, “NCI Urges Support of Ongoing Breast Cancer Transplant Trial.”
I was surprised to find inaccurate information in the July 2000 issue of Oncology News International, in an article on page 4, NCI Urges Support of Ongoing Breast Cancer Transplant Trial.
The article starts out, Despite bad press and negative scientific findings to date, the NCI has not written off high-dose chemotherapy. This sentence itself certainly would discourage further accrual. However the section in italics is incorrect.
As shown in the table (below) [references 1-14], a number of the studies show significant differences favoring high-dose chemotherapy (HDC), particularly the Dutch study.[8,9] The Dutch trial with 885 patients is now the largest to date. The planned analysis of the first 284 patients randomized was significantly positive for both disease-free and overall survival.
The largest metastatic trial, the Philadelphia study with 199 randomized patients, has a 20% power to detect a 20% difference in outcome. The other metastatic studies are even smaller (less than 100 patients each) and have less power.
In comparison, the adjuvant CALGB study comparing doxorubicin and cyclophosphamide with or without paclitaxel [Taxol] required about 3,000 patients to show an absolute 2% significant difference in survival.
Certainly, one way of improving accrual onto the US trial is to provide accurate accounting of the data to date.
1. Weiss RB, Rifkin RM, Stewart FM, et al: High-dose chemotherapy for high-risk primary breast cancer: An on-site review of the Bezwoda study. Lancet 355:999-1003, 2000.
2. Stadtmauer EA, ONeill A, Goldstein LJ, et al: Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. Philadelphia Bone Marrow Transplant Group [see comments]. N Engl J Med 342:1069-1076, 2000.
3. Peters W, Jones R, Vredenburgh J, et al: A large prospective randomized trial of high-dose combination alkylating agents (CPB) with autologous cellular support as consolidation for patients with metastatic breast cancer achieving complete remission after intensive doxorubicin-based induction therapy (AFM). Proc Am Soc Clin Oncol 15:121(abstract 149), 1996.
4. Nieto Y, Nieto Y, Champlin R, et al: Status of high dose chemotherapy for breast cancer in the new millennium. Biol Blood Marrow Transplant 6:476-495, 2000.
5. Madan B, Broadwater G, Rubin P, et al: Improved survival with consolidation high-dose cyclophosphamide, cisplatin, and carmustine compared with observation in women with metastatic breast cancer and only bone metastases treated with induction Adriamycin, 5-fluorouracil and methotrexate. Proc Am Soc Clin Oncol 19:48a, 2000.
6. Bezwoda W, Seymour L, Dansey R. et al: High dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer. J Clin Oncol 13:2483-2489, 1995.
7. Lotz JP, Cure H, Janvier M, et al: High-dose chemotherapy with hematopoietic stem cells transplantation for metastatic breast cancer: Results of the French protocol PEGASE 04. Proc Am Soc Clin Oncol 18:43a, 1999.
8. Rodenhuis S, Bontenbal M, Beex L, et al: Randomized phase III study of high-dose chemotherapy with cyclophosphamide, thiotepa and carboplatin in operable breast cancer with 4 or more axillary lymph nodes. Proc Am Soc Clin Oncol 19:74(abstract 286), 2000.
9. McNamee D: High dose chemotherapy positive in breast cancer trial. Lancet 355:1973, 2000.
10. Rodenhuis S, Richel KJ, van der Wall E, et al: Randomized trial of high-dose chemotherapy and hematopoietic progenitor cell support in operable breast cancer with extensive axillary lymph node involvement. Lancet 352:515-521, 1998.
11. Peters WP, Rosner G, Vredenburgh J, et al: A prospective, randomized comparison of two doses of combination alkylating agents as consolidation after CAF in high-risk primary breast cancer involving ten or more axillary lymph nodes: Preliminary results of CALGB 9082/SWOG 9114/NCIC MA-13. Proc Am Soc Clin Oncol 18:1a, 1999.
12. Bezwoda WR: Randomised, controlled trial of high dose chemotherapy versus standard dose chemotherapy for high risk, surgically treated, primary breast cancer. Proc Am Soc Clin Oncol 18:2a, 1999.
13. Hortobagyi GN, Buzdar AU, Theriault RU, et al: Randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma. J Natl Cancer Inst 92:225-233, 2000.
14. Bergh J: Results from a randomized adjuvant breast cancer study with high dose chemotherapy with CTCb supported by autologous bone marrow stem cells versus dose escalated and tailored FEC therapy. Proc Am Soc Clin Oncol 18:2a, 1999.
15. Henderson I, Berry D, Demetri G, et al: Improved disease free and overall survival from the addition of sequential paclitaxel but not from the escalation of doxorubicin dose level in the adjuvant chemotherapy of patients with node positive primary breast cancer. Proc Am Soc Clin Oncol 17:101a(abstract 390a), 1998.