autologous blood and marrow transplantation - Blog Science ...

Gluck et al. 301
anthracycline or taxane based induction chemotherapy". 12
Women with evidence of
metastatic breast cancer who have not received chemotherapy for their
metastatic/recurrent disease are eligible for the study. Women must have complete or
partial responses to induction chemotherapy or have no évaluable disease. Each
patient will receive either four cycles of anthracycline-based chemotherapy or, for
patients who have prior anthracycline exposure, four cycles of paclitaxel- or
docetaxel-containing regimen. After four cycles of induction chemotherapy, patients
will be evaluated and the responders will be randomized to either high-dose
chemotherapy and autologous peripheral blood stem cell therapy or standard therapy.
The standard arm includes at least two cycles of the same induction chemotherapy
followed by maintenance therapy at the discretion of the investigator. The high-dose
arm consists of a further two cycles of induction chemotherapy in conjunction with
hematopoietic growth factors to harvest sufficient numbers of blood stem cells. If the
response is confirmed after these two additional cycles, high-dose chemotherapy
consisting of 6 g/m 2
cyclophosphamide, 70 g/m 2
mitoxantrone, 1800 mg/m 2
CBCDA
will be delivered in four equal doses on four consecutive days. Forty-eight hours later,
the previously harvested stem cell products will be reinfused into the patient. The
patients on this arm will not receive further chemotherapy. Hormonal intervention is
left up to the discretion of the primary physician. The objectives of this trial are to
compare overall survival, the final response rates, and treatment toxicity. Further
objectives include a comparison of health-related quality of life. It is anticipated that
400 patients will be enrolled within 4 years from the date of activation, ~200 of them
randomized. The study was activated in more than 25 centers across Canada and, as
of December 1998, more than 200 patients have been enrolled.
ACKNOWLEDGMENTS
A special thanks to all physicians and nursing staff who shared the clinical
responsibilities of all patients involved; and to Ms. Lorna Dixon and Nadia Krane
for their excellent secretarial support. These studies were supported by grants from
the Northern Ontario Heritage Foundation, Sault St. Marie, Ontario; Sudbury
Regional Credit Union, Sudbury, Ontario; NCI-C CTG, Kingston, Ontario.
REFERENCES
1. Autologous Blood and Marrow Transplant Registry. Milwaukee: Medical College of
Wisconsin.
2. European Bone Marrow Transplantation Group: Personal communication, Dr. Giovanni
Rosti, Ravenna, Italy.
3. Gluck S, des Rochers C, Cano C, Dorreen M, Germond C, Gill K, Lopez P, Sinoff C:
High-dose chemotherapy followed by autologous blood cell transplantation: A safe and