Open AccessPhase II clinical trial of S‐1 plus nanoparticle albumin‐bound paclitaxel in untreated patients with metastatic gastric cancer
Author(s) -
He Mingming,
Wang Feng,
Jin Ying,
Yuan Shuqiang,
Ren Chao,
Luo Huiyan,
Wang Zhiqiang,
Qiu Miaozhen,
Wang Zixian,
Zeng Zhaolei,
Li Yuhong,
Wang Fenghua,
Zhang Dongsheng,
Xu Ruihua
Publication year - 2018
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.13813
Subject(s) - medicine , gastroenterology , neutropenia , anemia , clinical endpoint , cancer , vomiting , leukopenia , phases of clinical research , chemotherapy , surgery , clinical trial
The present study is the first phase II clinical trial aimed to evaluate the efficacy and safety of S‐1 plus nanoparticle albumin‐bound paclitaxel (Nab‐ PTX ) as first‐line chemotherapy for advanced gastric cancer ( AGC ). Previously untreated patients with metastatic gastric adenocarcinoma received S‐1 in oral doses of 40 mg ( BSA <1.25 m 2 ), 50 mg (1.25 ≤ BSA < 1.50 m 2 ) and 60 mg ( BSA ≥1.50 m 2 ) b.i.d. on days 1‐14 in combination with Nab‐ PTX (120 mg/m 2 , on days 1 and 8) for each 21‐day cycle. Primary endpoint was progression‐free survival ( PFS ), and secondary endpoints were overall response rate ( ORR ), overall survival ( OS ), disease control rate ( DCR ), and toxicity. A total of 73 gastric cancer patients with metastatic and measurable lesions were enrolled in the first‐line setting. Median PFS and OS were 9.63 months and 14.60 months, respectively. Four (5.5%) patients had complete responses, 39 (53.4%) had partial responses ( PR s), 21 (28.8%) had stable disease, four (5.5%) progressed and five (6.8%) were not evaluable. ORR and DCR were 58.9% and 87.7%, respectively. Most toxicities were mild, and no treatment‐related deaths occurred. Grade 3 to 4 toxicities occurred in 22 patients (30.1%) as follows: leukopenia (13.7%), neutropenia (12.3%), anemia (5.5%), thrombocytopenia (1.4%), diarrhea (6.8%), vomiting (2.7%), stomatitis (1.4%), peripheral neuropathy (1.4%), and hand‐foot syndrome (1.4%). Seven patients achieved good responses and underwent gastrectomy plus metastasectomy. Thirty (41.1%) patients had S‐1 maintenance with a median of four cycles. S‐1 plus Nab‐ PTX is an efficient and safe regimen as first‐line treatment for patients with AGC .