S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial

被引:21
作者
Kim, Seung Tae [1 ]
Hong, Yong Sang [2 ]
Lim, Ho Yeong [1 ]
Lee, Jeeyun [1 ]
Kim, Tae Won [2 ]
Kim, Kyu-Pyo [2 ]
Kim, Sun Young [3 ]
Baek, Ji Yeon [3 ]
Kim, Jee Hyun [4 ]
Lee, Keun-Wook [4 ]
Chung, Ik-Joo [5 ]
Cho, Sang-Hee [5 ]
Lee, Kyung Hee [6 ]
Shin, Sang Joon [7 ]
Kang, Hye Jin [8 ]
Shin, Dong Bok [9 ]
Lee, Jae Won [10 ]
Jo, Sook Jung [11 ]
Park, Young Suk [1 ]
机构
[1] Sungkyunkwan Univ, Dept Med, Samsung Med Ctr, Sch Med, Seoul 135710, South Korea
[2] Univ Ulsan, Dept Oncol, Asan Med Ctr, Coll Med, Seoul, South Korea
[3] Natl Canc Ctr, Ctr Colorectal Canc, Goyang, South Korea
[4] Seoul Natl Univ, Bundang Hosp, Dept Internal Med, Coll Med, Songnam, South Korea
[5] Chonnam Natl Univ, Sch Med, Dept Internal Med, Hwasun Hosp, Jeollanamdo, South Korea
[6] Yeungnam Univ, Yeungnam Univ Hosp, Dept Internal Med, Coll Med, Taegu, South Korea
[7] Yonsei Univ, Coll Med, Dept Internal Med, Canc Metastasis Res Ctr, Seoul, South Korea
[8] Korea Inst Radiol & Med Sci, Dept Internal Med, Korea Canc Ctr Hosp, Seoul, South Korea
[9] Gachon Univ, Dept Internal Med, Gil Hosp, Inchon, South Korea
[10] Korea Univ, Dept Stat, Seoul, South Korea
[11] ICON Clin Res, Seoul, South Korea
来源
BMC CANCER | 2014年 / 14卷
关键词
Capecitabine; S-1; Colorectal cancers; ADVANCED GASTRIC-CANCER; ORAL FLUOROPYRIMIDINES; ELDERLY-PATIENTS; PROGRESSION-FREE; NON-INFERIORITY; II TRIAL; THERAPY; FLUOROURACIL; LEUCOVORIN; XELOX;
D O I
10.1186/1471-2407-14-883
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: We report updated progression-free survival (PFS) and overall survival (OS) data from a trial that compared capecitabine plus oxaliplatin (CapeOX) versus S-1 plus oxaliplatin (SOX) for the first-line treatment of metastatic colorectal cancer. Methods: This trial was a randomized, two-armed, non-inferiority phase 3 comparison of CapeOX (capecitabine 1000 mg/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) on day 1) versus SOX (S-1 40 mg/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) on day 1). The primary end point was to show non-inferiority of SOX relative to CapeOX in terms of PFS. Thus, a follow-up exploratory analysis of PFS and OS was performed. Results: The intention to treat (ITT) population was comprised of 340 patients (SOX arm: 168 and CapeOX arm: 172). The updated median PFS was 7.1 months (95% CI 6.4-8.0) in the SOX group and 6.3 months (95% CI 4.9-6.7) in the CapeOX group (hazard ratio [HR], 0.83 [0.66-1.04], p = .10). The median OS was 19.0 months (95% CI 15.3-23.0) in the SOX group and 18.4 months (95% CI 14.1-20.7) in the CapeOX group (HR, 0.86 [0.68-1.08], p = .19). Subgroup analyses according to principal demographic factors such as sex, age, ECOG (Eastern Cooperative Oncology Group) performance status, primary tumor location, measurability, previous adjuvant therapy, number of metastatic organs, and liver metastases showed no interaction between any of these characteristics and the treatment. Conclusions: Updated survival analysis shows that SOX is similar to CapeOX, confirming the initial PFS analysis. Therefore, the SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer.
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页数:7
相关论文
共 27 条
[1]   Detecting an Overall Survival Benefit that Is Derived From Progression-Free Survival [J].
Broglio, Kristine R. ;
Berry, Donald A. .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2009, 101 (23) :1642-1649
[2]   Ora treatment for gastric cancer: new choices, better choices? [J].
Cascinu, Stefanu .
LANCET ONCOLOGY, 2008, 9 (03) :188-189
[3]   XELOX (capecitabine plus oxaliplatin):: Active first-line therapy for patients with metastatic colorectal cancer [J].
Cassidy, J ;
Tabernero, J ;
Twelves, C ;
Brunet, R ;
Butts, C ;
Conroy, T ;
Debraud, F ;
Figer, A ;
Grossmann, J ;
Sawada, N ;
Schöffski, P ;
Sobrero, A ;
Van Cutsem, E ;
Diaz-Rubio, E .
JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (11) :2084-2091
[4]   XELOX vs FOLFOX-4 as first-line therapy for metastatic colorectal cancer: NO16966 updated results [J].
Cassidy, J. ;
Clarke, S. ;
Diaz-Rubio, E. ;
Scheithauer, W. ;
Figer, A. ;
Wong, R. ;
Koski, S. ;
Rittweger, K. ;
Gilberg, F. ;
Saltz, L. .
BRITISH JOURNAL OF CANCER, 2011, 105 (01) :58-64
[5]   Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer [J].
Cassidy, Jim ;
Clarke, Stephen ;
Diaz-Rubio, Eduardo ;
Scheithauer, Werner ;
Figer, Arie ;
Wong, Ralph ;
Koski, Sheryl ;
Lichinitser, Mikhail ;
Yang, Tsai-Shen ;
Rivera, Fernando ;
Couture, Felix ;
Sirzen, Florin ;
Saltz, Leonard .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (12) :2006-2012
[6]   Current questions for the treatment of advanced gastric cancer [J].
Cervantes, A. ;
Roda, D. ;
Tarazona, N. ;
Rosello, S. ;
Perez-Fidalgo, J. A. .
CANCER TREATMENT REVIEWS, 2013, 39 (01) :60-67
[7]   Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer [J].
de Gramont, A ;
Figer, A ;
Seymour, M ;
Homerin, M ;
Hmissi, A ;
Cassidy, J ;
Boni, C ;
Cortes-Funes, H ;
Cervantes, A ;
Freyer, G ;
Papamichael, D ;
Le Bail, N ;
Louvet, C ;
Hendler, D ;
de Braud, F ;
Wilson, C ;
Morvan, F ;
Bonetti, A .
JOURNAL OF CLINICAL ONCOLOGY, 2000, 18 (16) :2938-2947
[8]   A Randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer [J].
Goldberg, RM ;
Sargent, DJ ;
Morton, RF ;
Fuchs, CS ;
Ramanathan, RK ;
Williamson, SK ;
Findlay, BP ;
Pitot, HC ;
Alberts, SR .
JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (01) :23-30
[9]   S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial [J].
Hong, Yong Sang ;
Park, Young Suk ;
Lim, Ho Yeong ;
Lee, Jeeyun ;
Kim, Tae Won ;
Kim, Kyu-pyo ;
Kim, Sun Young ;
Baek, Ji Yeon ;
Kim, Jee Hyun ;
Lee, Keun-Wook ;
Chung, Ik-Joo ;
Cho, Sang-Hee ;
Lee, Kyung Hee ;
Shin, Sang Joon ;
Kang, Hye Jin ;
Shin, Dong Bok ;
Jo, Sook Jung ;
Lee, Jae Won .
LANCET ONCOLOGY, 2012, 13 (11) :1125-1132
[10]   Role of Survival Post-Progression in Phase III Trials of Systemic Chemotherapy in Advanced Non-Small-Cell Lung Cancer: A Systematic Review [J].
Hotta, Katsuyuki ;
Kiura, Katsuyuki ;
Fujiwara, Yoshiro ;
Takigawa, Nagio ;
Hisamoto, Akiko ;
Ichihara, Eiki ;
Tabata, Masahiro ;
Tanimoto, Mitsune .
PLOS ONE, 2011, 6 (11)