The Multicenter, Phase II Prospective Study of Paclitaxel Plus Capecitabine as First-Line Chemotherapy in Advanced Gastric Carcinoma

Author:

Gong Jifang1,Hu Bing2,Zhang Xiaotian1,Zhang Fengchun3,Zhang Jun4,Xu Nong5,Fan Qingxia6,Bai Yuxian7,Jiao Shunchang8,Wang Jinwan9,Bai Chunmei10,Zheng Leizhen11,Shi Yingqiang12,Liu Yunpeng13,Liang Jun14,Hu Guoqing15,Cheng Ying16,Xu Ruihua17,Bai Yu18,Shen Lin1

Affiliation:

1. Peking University Cancer Hospital & Institute, Beijing, China;

2. Provincial Hospital, Anhui Medical University, Anhui, China;

3. Suzhou Kowloon Hospital, Shanghai JiaoTong University School of Medicine, Suzhou, China;

4. Ruijin Hospital, Shanghai, China;

5. The First Affiliated Hospital of the Medical School of Zhejiang University, Zhejiang, China;

6. The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;

7. Cancer Hospital, Harbin Medical University, Harbin, China

8. General Hospital of the Chinese People's Liberation Army, Beijing, China;

9. Cancer hospital/institute, Chinese Academy of Medical Sciences, Beijing, China;

10. Peking Union Medical College Hospital. Beijing, China;

11. Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China;

12. Shanghai Cancer Center, Fudan University, Shanghai, China;

13. The First Hospital, China Medical University, Shenyang, China;

14. The Affiliated Hospital of Medical college Qingdao University, Qingdao, China;

15. Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China;

16. Jilin Provincial Tumor Hospital, Changchun, China;

17. Sun Yat-sen University Cancer center, Guangzhou, Guangdong, China;

18. Peking University First Hospital, Beijing, China

Abstract

Abstract Author Summary Background. The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated. Methods. Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety. Results. Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow-up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow-up, with progression-free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty-five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3–4 toxicities were leucopenia and neutropenia. Conclusion. PX as a first-line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation.

Funder

National Natural Science Foundation of China

National High Technology Research and Development Program

Beijing Municipal Science & Technology Commission Program

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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