© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 12, 993,
June 16, 1999
© 1999 Oxford University Press
NEWS |
Substantial Differences Exist in How Trials Were Designed
At the American Society of Clinical Oncology meeting, researchers had their first
opportunity to analyze and critique the results of the following five high-dose chemotherapy
trials for breast cancer:
|
• Eastern Cooperative Oncology Group Study
ECOG conducted a study on metastatic breast cancer to examine overall survival, time to treatment failure, toxicity, and quality of life. Although the trial originally treated 553 women, eventually 101 women were assigned to the high-dose chemotherapy arm, while 83 patients were treated with maintenance chemotherapy. After a median follow-up time of 37 months, 3-year survival was 32% for the HDC group and 38% for the maintenance chemotherapy group. Median time to progression was 9.6 months for the HDC arm, and 9 months for the conventional chemotherapy arm.
This study shows that the use of HDC and autologous stem cell transplantation is not justified in patients who partially respond to standard chemotherapy, said Robert Livingston, M.D., from the University of Washington. Livingston added that the study size was too small to detect if high-dose treatment would benefit patients with a complete response to initial standard chemotherapy.
• French Study
The other metastatic breast cancer trial, conducted in France, treated 61 women with four to six courses of conventional chemotherapy before randomizing patients into standard or HDC groups. In the standard dose arm, the survival rate was 18.5% and the relapse rate at 3 years was 79.3%. In the HDC arm, 29.8% of the women survived 3 years past treatment, and 50.8% had relapsed by 3 years post-treatment. Neither of these comparisons were statistically significant.
• Cancer and Leukemia Group B Study
The largest study for women at high risk for recurrence of breast cancer was carried out by the CALGB cooperative group. The study treated 783 women with four cycles of standard chemotherapy, who were then treated with either HDC and bone marrow and peripheral blood stem cell support or intermediate-dose chemotherapy. In the high-dose group, event-free survival at 3 years was 68%, and 3-year survival was 78%. The women receiving intermediate-dose chemotherapy had an event-free survival rate of 64% at 3 years, and an overall survival rate of 80%.
• Scandinavian Study
The largest international study, conducted by the Scandinavian Breast Cancer Study Group, treated 525 women with either standard chemotherapy followed by HDC, or standard chemotherapy tailored to the individual. This study had the shortest follow-up time; after a median of 23.7 months, 66 women in the standard-dose group relapsed and 47 died, while in the high-dose group, 92 women relapsed and 54 died.
• South African Study
The only study that yielded statistically significant results in favor of high-dose therapy was at the University of Witwatersrand Medical School in Johannesburg, South Africa. This trial directly compared HDC to standard chemotherapy; women in the high-dose arm did not receive standard chemotherapy prior to beginning high-dose treatment. High-dose treatment was given to 75 women, and 79 women were treated with standard chemotherapy. After a median follow-up of 5 years, the relapse rate was 25% in the HDC arm, and 66% in the standard dose arm. Mortality was 35% in the standard-dose group versus 17% in the high-dose group.
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||