A multicenter, phase II study of epirubicin/cyclophosphamide followed by docetaxel and concurrent trastuzumab as primary systemic therapy for HER-2 positive advanced breast cancer (the HER2NAT study)

被引:4
作者
Aogi, Kenjiro [1 ]
Saeki, Toshiaki [2 ]
Nakamura, Seigo [3 ]
Kashiwaba, Masahiro [4 ]
Sato, Nobuaki [5 ]
Masuda, Norikazu [6 ]
Rai, Yoshiaki [7 ]
Ohno, Shinji [8 ]
Kuroi, Katsumasa [9 ]
Nishimura, Reiki [10 ]
Miyakoda, Keiko [11 ]
Akiyama, Futoshi [12 ]
Kurosumi, Masafumi [13 ]
Ikeda, Tadashi [14 ]
机构
[1] Natl Hosp Org Shikoku Canc Ctr, Dept Breast Oncol, Matsuyama, Ehime 7910280, Japan
[2] Saitama Med Univ, IMC, Hidaka, Saitama 3501298, Japan
[3] Showa Univ, Sch Med, Shinagawa Ku, Tokyo 1428666, Japan
[4] Iwate Med Univ, Morioka, Iwate 0208505, Japan
[5] Niigata Canc Hosp, Niigata 9518566, Japan
[6] Osaka Natl Hosp, Chuo Ku, Osaka 5400006, Japan
[7] Hakuaikai Sagara Hosp, Kagoshima 8920833, Japan
[8] Natl Kyusyu Canc Ctr, Minami Ku, Fukuoka 8111395, Japan
[9] Komagome Hosp, Tokyo Metropolitan Canc & Infect Dis Ctr, Bunkyo Ku, Tokyo 1138677, Japan
[10] Kumamoto City Hosp, Kumamoto 8628505, Japan
[11] Fdn Biomed Res & Innovat, Translat Res Informat Ctr, Chuo Ku, Kobe, Hyogo 6500047, Japan
[12] Japanese Fdn Canc Res, Inst Canc, Koto Ku, Tokyo 1358550, Japan
[13] Saitama Canc Ctr, Ina, Saitama 3620806, Japan
[14] Teikyo Univ, Sch Med, Itabashi Ku, Tokyo 1738605, Japan
关键词
Primary systemic therapy; HER-2; Trastuzumab; Advanced breast cancer; PATHOLOGICAL COMPLETE RESPONSE; HER2-OVEREXPRESSING STAGE-II; NEOADJUVANT CHEMOTHERAPY; ADJUVANT CHEMOTHERAPY; MONOCLONAL-ANTIBODY; 1ST-LINE TREATMENT; TRIAL; RECEPTOR; SAFETY; EFFICACY;
D O I
10.1007/s10147-012-0437-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The outcome in patients with human epidermal growth factor receptor-2 (HER-2)-positive locally advanced breast cancer may be improved by integrating trastuzumab with primary systemic therapy (PST). The efficacy and safety of PST comprising EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2), four cycles every 3 weeks) followed by docetaxel (75 mg/m(2), four cycles every 3 weeks) and concurrent trastuzumab (loading dose 4 mg/kg followed by 2 mg/kg, 12 cycles every week) was investigated in a multicenter, prospective, phase II study in patients with HER-2-positive stage IIIB/IIIC/IV breast cancer. The primary endpoint was pathologic complete response (pCR) including the tumor intraductal component confirmed by central pathologic review. In total, 38 patients were enrolled (stage IIIB, 63.2 %; IIIC, 23.7 %; IV, 13.2 %; estrogen receptor- and/or progesterone receptor-positive, 47.4 %). The pCR rate was 16.2 % in the primary tumor (six of 37 patients in the Full Analysis Set) and 56.8 % (21/37) in the ipsilateral axillary lymph nodes. Treatment was given according to protocol in 28 of 37 patients; six of 28 in the Per-Protocol Set achieved pCR (21.4 %). The clinical response rate was 67.6 % (25/37 patients; complete response, 13.5 %; partial response, 54.1 %). No patients developed congestive heart failure; however, three patients had a non-symptomatic decrease of > 10 % of left ventricular ejection fraction. PST including concurrent use of trastuzumab combined with docetaxel is effective and well-tolerated in HER-2-positive advanced breast cancer patients, including those patients requiring mastectomy for local control.
引用
收藏
页码:598 / 606
页数:9
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