373P - Clinical Study evaluating the safety, tolerability and efficacy of weekly nab-paclitaxel dosed at 100 mg/m2 for metastatic breast cancer: HBCC1101...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Presenter Masato Takahashi
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors M. Takahashi1, K. Watanabe1, H. Akabane2, K. Ichinokawa3, K. Ogasawara4, H. Kato5, K. Konishi6, Y. Suzuki7, K. Tanaka8, Y. Narita5, T. Hata8, M. Hosoda3, M. Yamamoto3
  • 1Department Of Breast Surgery, Hokkaido Cancer Center, 003-0804 - Sapporo/JP
  • 2Department Of Surgery, Asahikawa Kosei Hospital, Asahikawa/JP
  • 3Department Of Breast Surgery, Hokkado University Hospital, Sapporo/JP
  • 4Department Of Surgery, Kushiro Rosai Hospital, Sapporo/JP
  • 5Department Of Surgery, Teine Keijinkai Hospital, Sapporo/JP
  • 6Department Of Surgery, NTT East Japan Hospital, Sapporo/JP
  • 7Department Of Surgery, Keiyukai Sapporo Hospital, Sapporo/JP
  • 8Department Of Surgery, Sapporo Kosei Hospital, Sapporo/JP

Abstract

Aim

Nab-paclitaixel, which consists of human albumin stabilized nanoparticle formation, is one of chemotherapy drugs for metastatic breast cancer. In pivotal Phase III trial of metastatic breast cancer, triweekly regimen of nab-paclitaxel was significantly greater efficacy than triweekly regimen of paclitaxel. However, weekly administration of paclitaxel is regarded as standard regimen for metastatic breast cancer. We tend to avoid using triweekly regimen of paclitaxel for metastatic breast cancer. The candidate dosage of weekly nab-paclitaxel treatment is 100, 125 or 150 mg/m2, but we could not determine which becomes the standard regimen. We will confirm the safety of weekly nab-paclitaxel dosed at 100 mg/m2 in Japanese women with HER2 negative metastatic breast cancer and subsidiarily evaluate the effectiveness of this regimen.

Methods

Patients with metastatic breast cancer were pathologically confirmed adenocarcinoma of the breast. Less than 3 regimens for metastatic breast cancer were eligible for inclusion. Patients received nab-paclitaxel dosed at 100 mg/m2 with 3.3 mg of dexamethasone as premedication on day 1, 8 and 15 of 28 day cycle. The primary endpoint was safety, which was defined as the percentage of patients who achieved 2 cycle of this regimen. Secondary endpoint was efficacy.

Results

Thirty-nine patients were enrolled in this trial from plural facilities in Hokkaido, Japan. The mean age of patients was 60 years old (range : 43-77). Seventy-four % of patients have ER positive breast cancer and 41 % of patients have taken adjuvant chemotherapy. We defined the ratio of achieving two cycle of this regimen as the safety. Eighty-seven % of the patients were treated not less than two cycle of this regimen safely. The mean of relative dose intensity was 91.6 %. The most frequent adverse event was neutropenia. Grade 3 or 4 neutropenia was occurred in 44.7 % of the patients. There was no grade 3 or 4 neuropathy.

Conclusions

Weekly nab-paclitaxel dosed at 100 mg/m2 proved to be a safety regimen in this trial. The choice of this regimen is appropriate not only for first-line therapy of metastatic breast cancer but also for heavily pretreated metastatic breast cancer.

Disclosure

All authors have declared no conflicts of interest.