Abstract
6665 Background: Optimal HDC strategy in breast cancer remains to be defined. This phase III trial evaluates the role of the number of HDC cycles. Methods: From 2/97 to 6/01 we randomised 187 patients to single or to tandem HDC. Patients were eligible if they were hormone refractory and achieved complete or partial remission after 4 to 6 cycles of standard induction chemotherapy. Patients were stratified according to remission status and localisation of metastases (bone or visceral). HDC consisted of once or twice STAMP V with cyclophosphamide, carboplatinum and thiotepa (6000/800/500 mg/m2) the tandem given at an interval of 35 days.Pts. (single/tandem): mean age 45.7/45.1 yrs, prior adjuvant chemotherapy 41%/40%, ER +: 49%/43%, mean recurrence-free interval: 45.4/37.9 months. 11% of patients had isolated bone metastases. Induction chemotherapy consisted in 51% /48 % of a combination of anthracylines and taxanes. 14 % of patients in the single and 43 % of patients in the tandem-HDC arm did not receive the planned treatment. Results: Toxicity data were reported earlier (Proc ASCO 17:141a,1997). Treatment related mortality was 3,6 %. After exclusion of drop outs CR rates are 46% in the tandem and 33% in the single HDC arm. With a median follow-up of 24 months the intent to treat analysis shows progression-free survival rates of 36%/43% after two years and 6%/12% after three years (p=0.055) in favour of the tandem. Overall survival rates were 55% and 48% after two and 18% and 21% at five years with a median overall survival of 29.4 versus 23.5 months (p =0.46) Conclusions: Tandem STAMP V induces higher complete remission rates and non significantly higher progression-free survival rates. Overall survival is not affected. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Angem
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