Protracted low dose of oral vinorelbine and temozolomide with whole-brain radiotherapy in the treatment for breast cancer patients with brain metastases
Cancer Chemotherapy and Pharmacology, 08/17/2012
Addeo R et al. – The treatment was safe and a significant number of objective responses were observed with a significant improvement in quality of life demonstrated by functional assessment of cancer therapy–breast (FACT–B). On the basis of the present results, a large randomized trial is warranted in breast cancer (BC) patients with previously untreated brain metastases (BM).Methods
- Thirty-six patients with newly diagnosed BM were treated with TMZ orally administered at a dose of 75mg/m2 during whole-brain radiotherapy, followed by 4weeks off-therapy and a subsequent administration of oral 70mg/m2 VNB fractionated in days 1, 3, and 5, weekly for three consecutive weeks plus TMZ at 75mg/m2 on days 1–21, all every 4weeks for up to 12 additional cycles.
- The primary end point was the evaluation of the objective response rate (ORR).
- Three complete responses and 16 partial responses have been achieved with an ORR of 52 % (95 % CI 38–67 %) that exceeded the target activity per study design.
- The median progression-free survival and overall survival were 8 and 11months, respectively.
- The schedule appeared to be well tolerated, and side effects were generally mild.
- The functional assessment of cancer therapy-breast (FACT-B) analysis showed a significant positive change during the study.