Comparison of efficacy and safety of paclitaxel and capecitabine followed by capecitabine as maintenance therapy versus cisplatin and capecitabine therapy for advanced gastric cancer: a multicentre, randomised, active-controlled phase III study

Date

20 Dec 2015

Session

Gastrointestinal tumours 2

Presenters

Xiaotian Zhang

Citation

Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523

Authors

L. Shen¹, X. Zhang¹, Z. Lu¹, W. Liu², T. Liu³, B. Hu⁴, W. Li⁵, Q. Fan⁶, J. Xu⁷, N. Xu⁸, Y. Bai⁹, Y. Pan¹⁰, Q. Xu¹¹, W. Bai¹², L. Xia¹³, Y. Gao¹⁴, W. Wang¹⁵, Y. Shu¹⁶, G. Dai¹⁷, J. Feng¹⁸

Author affiliations

¹ Department Of Gi Oncology, Peking University School Of Oncology, Beijing Cancer Hospital And Institute, Laboratory of Carcinogenesis and Translational Research (Ministry of Education), 100142 - Beijing/CN
² Oncology, 4th Hospital Hebei Medical University, Shijiazhuang/CN
³ Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai/CN
⁴ Oncology, Anhui Provincial Hospital, Hefei/CN
⁵ Oncology, 1st Hospital of Jilin University, Changchun/CN
⁶ Oncology, 1st Affiliated Hospital of Zhengzhou University, Zhengzhou/CN
⁷ Oncology, 307th Hospital of PLA (AMMS China), Beijing/CN
⁸ Oncology, 1st Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou/CN
⁹ Medical Oncology, Cancer Hospital Affiliated to Harbin Medical University,, Harbin/CN
¹⁰ Medical Oncology, the First Affiliated Hospital of Medical University Of Anhui, Hefei/CN
¹¹ Oncology, 10th People's Hospital of Shanghai, Tongji University, Shanghai/CN
¹² Gastrointestinal, Shanxi Tumor Hospital, Taiyuan/CN
¹³ Oncology, People's Hospital of Jilin Province, Changchun/CN
¹⁴ Oncology, Shanghai East hospital, Tongji University, Shanghai/CN
¹⁵ Gastrointestinal, Guizhou Cancer Hospital, Guizhou/CN
¹⁶ Oncology, Jiangsu Provincial PeopleÃ¢â‚¬â„¢s Hospital (The First Affiliated Hospital of Nanjing Medical University), Nanjing/CN
¹⁷ Oncology, Air Force General Hospital (PLA), Beijing/CN
¹⁸ Gastrointestinal, Jiangsu Cancer Institute and Hospital, Nanjing/CN

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Abstract 599

Aim/Background

Effective chemotherapy with mild toxicity for treatment of advanced gastric cancer is still limited. This study aimed to compare the efficacy and safety of combination therapy of paclitaxel and capecitabine followed by capecitabine monotherapy as maintenance therapy (PACX) versus cisplatin and capecitabine combination therapy (XP) for advanced gastric cancer.

Methods

This multicentre, randomised, active-controlled phase III study included 320 patients who were enrolled from 22 clinical sites across different regions of China. Patients were randomly allocated to PACX or XP group in a 1:1 ratio with the following four stratification factors: Karnofsky performance score (≥80/ < 80); resection of primary tumour (yes/no); weight loss within last 3 months (≥5%/ < 5%); and primary tumour site at the gastroesophageal junction (yes/no). The primary endpoint assessed progression-free survival (PFS). The secondary endpoints assessed overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL), and safety.

Results

Comparison of PACX and XP groups showed that both median PFS (5.1 versus 5.3 months, respectively; p = 0.40) and median OS (12.6 versus 11.9 months, respectively; p = 0.21) were not different. ORR in PACX group was significantly higher versus XP group (45.4% vs. 31.7%, p = 0.0115), while DCR was similar in both groups (81.6% vs. 80.0%, p = 0.75). Patients receiving PACX showed significantly improved QoL compared with those receiving XP after three cycles of the regimens. The incidences of treatment-associated leukopenia, thrombocytopenia, nausea, vomiting, and reduction in food intake were significantly lower in PACX group than those in XP group (all p < 0.05).

Conclusions

These findings suggest that combination therapy of paclitaxel and capecitabine as first-line chemotherapy followed by capecitabine monotherapy as maintenance therapy might be effective and safe in treatment of advanced gastric cancer.