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
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
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.