397P - Study comparing trastuzumab plus vinorelbine with trastuzumab plus capecitabine in heavily pretreated HER-2 positive metastatic breast cancer

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Presenter Tao Wang
Citation Annals of Oncology (2014) 25 (suppl_4): iv116-iv136. 10.1093/annonc/mdu329
Authors T. Wang, W. Li, H.S. Zhang, L. Bian, T.S. Song, Z. Jiang
  • Breast Cancer Department, 307th Hospital of PLA (AMMS China), 100071 - Beijing/CN

Abstract

Aim

Anthracyclines and taxanes are the most active agents in breast cancer, with increasing usage in adjuvant therapy setting, treatment failures occur in substantial number of patients, and resistance to anthracyclines and/or taxanes is becoming a limiting factor in breast cancer therapy. For these patients, doctors may choose the other active agents,such as vinorelbine, capecitabine and so on. We compared the efficacy and tolerability of trastuzumab plus vinorelbine with trastuzumab plus capecitabine after taxanes and/or anthracyclines failure and prior trastuzumab exposure.

Methods

We collected 163 patients data in our center. All the patients were HER-2 positive metastatic breast cancer. Eighty-one patients were assigned to trastuzumab(H) 8-mg/kg loading dose and 6-mg/kg maintenance dose on day 1 every 3 weeks plus vinorelbine(N) 25 mg/m2 on days 1 and day 8. Eighty-two patients were assigned to trastuzumab(H) 8-mg/kg loading dose and 6-mg/kg maintenance dose on day 1 every 3 weeks plus capecitabine(X) 2000 mg/m 2 day 1 to day 14. Therapy was not stopped until the disease developed progression(PD) or the patient had unacceptable toxicity. The primary endpoint was progression-free survival(PFS). Second endpoints were response rate, safety and overall survival (OS).

Results

Patients characteristics were balanced between HN arm and HX arm : median age 51y/50y, median disease-free survival (DFS) 18m/14m, visceral metastases rate 79.0%/ 74.4%, second-line and beyond second-line treatment 67.9%/ 64.6%. The median PFS was 4.9 months and 6.5 months for HN arm and HX arm ( P = 0.005), respectively. The median OS was 28.6 months and 34.4 months for HN arm and HX arm (P = 0.115), respectively. But the objective response rate was 45.7% and 26.8% for HN arm and HX arm(P = 0.012). Clinical benefit rate( CR + PR + SD ≥ 6months) was 54.3% and 58.5% for HN arm and HX arm(P = 0.820). Grade 3 and 4 hematologic toxicities were more common in tHN arm than HX arm, especially neutropenia 58%/19% (P < 0.001), leucopenia 56%/12% (P < 0.001). Hand-foot syndrome was more common in HX arm.

Conclusions

Our study indicate tratuzumab plus capecitabine has longer PFS than trastuzumab plus vinorelbine in heavily pretreated HER-2 positive metastatic breast cancer. Trastuzumab plus capecitabine has better tolerability.

Disclosure

All authors have declared no conflicts of interest.