A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

被引:1
|
作者
Lee, Guk Jin [1 ]
Kim, Hyunho [2 ]
Cho, Sung Shim [2 ]
Park, Hyung Soon [2 ,3 ]
An, Ho Jung [2 ]
Woo, In Sook [3 ]
Byun, Jae Ho [4 ]
Hong, Ji Hyung [5 ]
Ko, Yoon Ho [5 ]
Sun, Der Sheng [6 ]
Won, Hye Sung [6 ]
Jin, Jong Youl [1 ]
Park, Ji Chan [7 ]
Kim, In-Ho [8 ]
Roh, Sang Young [8 ]
Shim, Byoung Yong [2 ]
机构
[1] Catholic Univ Korea, Bucheon St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[2] Catholic Univ Korea, St Vincents Hosp, Coll Med, Dept Internal Med,Div Med Oncol, 222 Banpo Daero, Seoul 06591, South Korea
[3] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[4] Catholic Univ Korea, Incheon St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[5] Catholic Univ Korea, Eunpyeong St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[6] Catholic Univ Korea, Uijeongbu St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[7] Catholic Univ Korea, Daejeon St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
[8] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Internal Med,Div Med Oncol, Seoul, South Korea
关键词
Stomach neoplasm; Capecitabine; Maintenance chemotherapy; Clinical trial; ESOPHAGOGASTRIC CANCER; 1ST-LINE CHEMOTHERAPY; THERAPY; S-1; TRIAL; COMBINATION; EFFICACY; SAFETY;
D O I
10.5230/jgc.2023.23.e16
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.
引用
收藏
页码:315 / 327
页数:13
相关论文
共 50 条
  • [41] Efficacy of preoperative chemotherapy regimens in patients with initially unresectable locally advanced gastric adenocarcinoma: capecitabine and oxaliplatin (XELOX) or with epirubicin (EOX)
    Wang, Yan
    Zhuang, Rong-yuan
    Yu, Yi-yi
    Yu, Shan
    Hou, Jun
    Ji, Yuan
    Sun, Yi-hong
    Shen, Kun-tang
    Shen, Zhen-bin
    Liu, Feng-lin
    Zhao, Nai-qing
    Liu, Tian-shu
    ONCOTARGET, 2016, 7 (46) : 76298 - 76307
  • [42] Efficacy of preoperative chemotherapy regimens in patients with initially unresectable locally advanced gastric adenocarcinoma: Capecitabine and oxaliplatin (XELOX) or with epirubicin (EOX)
    Wang, Yan
    Yu, Yiyi
    Zhuang, Rongyuan
    Yu, Shan
    Hou, Jun
    Ji, Yuan
    Sun, Yihong
    Shen, Kuntang
    Shen, Zhenbin
    Liu, Fenglin
    Zhao, Naiqing
    Liu, Tianshu
    JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (15)
  • [43] Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials
    Xu, Hong-Bin
    Huang, Fang
    Su, Rui
    Shen, Fu-Ming
    Lv, Qian-Zhou
    EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2015, 71 (05) : 589 - 601
  • [44] OXALIPLATIN PLUS CAPECITABINE (XELOX) AS FIRST-LINE CHEMOTHERAPY FOR ELDERLY PATIENTS WITH ADVANCED GASTRIC CANCER: RESULTS OF A MONOCENTRIC EXPERIENCE
    Rozzi, A.
    Corona, M.
    Nardoni, C.
    Restuccia, M.
    Lanzetta, G.
    ANNALS OF ONCOLOGY, 2009, 20 : 90 - 90
  • [45] Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials
    Hong-Bin Xu
    Fang Huang
    Rui Su
    Fu-Ming Shen
    Qian-Zhou Lv
    European Journal of Clinical Pharmacology, 2015, 71 : 589 - 601
  • [46] A randomized phase III study of fractionated docetaxel, oxaliplatin, capecitabine (low-tox) vs epirubicin, oxaliplatin and capecitabine (eox) in patients with locally advanced unresectable or metastatic gastric cancer: the lega trial
    Rosati, Gerardo
    Cella, Chiara Alessandra
    Cavanna, Luigi
    Codeca, Carla
    Prisciandaro, Michele
    Mosconi, Stefania
    Luchena, Giovanna
    Silvestris, Nicola
    Bernardini, Ilaria
    Casaretti, Rossana
    Zoratto, Federica
    Amoroso, Domenico
    Ciarlo, Andrea
    Barni, Sandro
    Cascinu, Stefano
    Davite, Cristina
    Di Sanzo, Alessandro
    Casolaro, Alessia
    Bilancia, Domenico
    Labianca, Roberto
    GASTRIC CANCER, 2022, 25 (04) : 783 - 793
  • [47] Phase II multicenter study of capecitabine plus oxaliplatin (XELOX) sequentially followed by capecitabine and irinotecan (XELIRI) in first-line therapy for metastatic colorectal cancer (MCRC)
    Cassinello, J.
    Alvarez, J. V.
    Garcia-Lopez, M. J.
    Pujol, E.
    Colmenarejo, A.
    De Segovia, F.
    Marcos, F.
    Filipovich, E.
    EJC SUPPLEMENTS, 2005, 3 (02): : 199 - 200
  • [48] A randomized phase III study of fractionated docetaxel, oxaliplatin, capecitabine (low-tox) vs epirubicin, oxaliplatin and capecitabine (eox) in patients with locally advanced unresectable or metastatic gastric cancer: the lega trial
    Gerardo Rosati
    Chiara Alessandra Cella
    Luigi Cavanna
    Carla Codecà
    Michele Prisciandaro
    Stefania Mosconi
    Giovanna Luchena
    Nicola Silvestris
    Ilaria Bernardini
    Rossana Casaretti
    Federica Zoratto
    Domenico Amoroso
    Andrea Ciarlo
    Sandro Barni
    Stefano Cascinu
    Cristina Davite
    Alessandro Di Sanzo
    Alessia Casolaro
    Domenico Bilancia
    Roberto Labianca
    Gastric Cancer, 2022, 25 : 783 - 793
  • [49] Randomized phase II study of oxaliplatin and S-1 (OS) versus oxaliplatin and capecitabine (XELOX) in patients with advanced or recurrent colorectal cancer.
    Zang, Dae Young
    Chung, Ik-Joo
    Oh, Ho-Suk
    Park, Keon Uk
    Lee, Kyung Hee
    Han, Boram
    JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (04)
  • [50] Secondary resectability rates observed in a multicenter randomized phase II study of modified capecitabine/ irinotecan (mXELIRI) plus bevacizumab (bev) followed by capecitabine/oxaliplatin (XELOX) plus bev or the reverse sequence in patients with metastatic colorectal cancer (mCRC)
    Scheithauer, W.
    Prager, G.
    Greil, R.
    Mlineritsch, B.
    Schaberl-Moser, R.
    Gerger, A.
    Laengle, F.
    Viragos-Toth, I.
    Andel, J.
    Pichler, A.
    Pecherstorfer, M.
    Kretschmer, A.
    Seebacher, A.
    Jagdt, B.
    Eisterer, W.
    Krippl, P.
    ANNALS OF ONCOLOGY, 2016, 27