Japanese journal of clinical oncology · 2025
Multicenter phase II trial of trastuzumab and docetaxel for HER2-positive salivary gland cancer.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kano Satoshi, Kiyota Naomi, Kinoshita Ichiro, Tada Yuichiro, Ijichi Kei, Yamazaki Tomoko, Shimizu Yasushi, Hatanaka Yutaka, Tsuda Hitoshi, Morinaga Shojiroh, Matsuno Yoshihiro, Ito Yoichi M, Nishimoto Naoki, Kobayashi Keiko, Isoe Toshiyuki, Noguchi Takuro, Homma Akihiro, Dosaka-Akita Hirotoshi
Аннотация
BACKGROUNDS: Standard systemic chemotherapy remains unestablished for recurrent or metastatic (RM) salivary gland cancer (SGC) due to its rarity. A single institute phase II trial of trastuzumab and docetaxel previously showed efficacy with human epidermal growth factor receptor 2 (HER2)-positive SGC.
METHODS: We conducted a multicenter, single-arm, open-label phase II trial of trastuzumab and docetaxel for HER2-positive RM SGC. Patients received trastuzumab 6 mg/kg (loading dose 8 mg/kg) and docetaxel 70 mg/m2 every 3 weeks up to eight cycles. The primary endpoint was the objective response rate (ORR) by a blinded independent review committee. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Forty-eight patients were screened for HER2 status; 23 were HER2-positive.
RESULTS: Eighteen patients were enrolled, with 16 receiving the protocol treatment. Fourteen patients were diagnosed with salivary duct carcinoma. The ORR was 60.0% (95% confidence interval [CI], 32.3 to 83.7). The median PFS was 8.5 months (95% CI, 6.0 to 12.7), the median OS, 33.8 months (95% CI, 16.9 to not estimable), and the DCR, 93.3% (95% CI, 68.1 to 99.8). The most frequent grade ≥3 treatment-emerged adverse events were neutropenia (100%), leukopenia (93.8%), lymphopenia (18.8%), and febrile neutropenia (12.5%). One treatment-related death occurred (6.3%) due to hypoalbuminemia.
CONCLUSIONS: These results demonstrate the significant efficacy and predictable toxicities of trastuzumab and docetaxel in patients with HER2-positive RM SGC, leading to the simultaneous approval of trastuzumab and HER2 companion diagnostics assay for this setting in Japan.
METHODS: We conducted a multicenter, single-arm, open-label phase II trial of trastuzumab and docetaxel for HER2-positive RM SGC. Patients received trastuzumab 6 mg/kg (loading dose 8 mg/kg) and docetaxel 70 mg/m2 every 3 weeks up to eight cycles. The primary endpoint was the objective response rate (ORR) by a blinded independent review committee. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Forty-eight patients were screened for HER2 status; 23 were HER2-positive.
RESULTS: Eighteen patients were enrolled, with 16 receiving the protocol treatment. Fourteen patients were diagnosed with salivary duct carcinoma. The ORR was 60.0% (95% confidence interval [CI], 32.3 to 83.7). The median PFS was 8.5 months (95% CI, 6.0 to 12.7), the median OS, 33.8 months (95% CI, 16.9 to not estimable), and the DCR, 93.3% (95% CI, 68.1 to 99.8). The most frequent grade ≥3 treatment-emerged adverse events were neutropenia (100%), leukopenia (93.8%), lymphopenia (18.8%), and febrile neutropenia (12.5%). One treatment-related death occurred (6.3%) due to hypoalbuminemia.
CONCLUSIONS: These results demonstrate the significant efficacy and predictable toxicities of trastuzumab and docetaxel in patients with HER2-positive RM SGC, leading to the simultaneous approval of trastuzumab and HER2 companion diagnostics assay for this setting in Japan.