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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.

Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS - BMC Cancer (2014)

Bottom Line: 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.Updated survival analysis shows that SOX is similar to CapeOX, confirming the initial PFS analysis.NCT00677443 and May 12 2008.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea. pys27hmo@skku.edu.

ABSTRACT

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/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1) versus SOX (S-1 40 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 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.

Trial registration: NCT00677443 and May 12 2008.

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Related in: MedlinePlus

CONSORT diagram.
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Fig1: CONSORT diagram.

Mentions: Between May 14, 2008 and September 23, 2009, we enrolled 348 patients from 11 institutions. We randomly assigned 340 patients who met the eligibility criteria to treatment (ITT). Of the 340 patients, 168 were assigned to the SOX group, and 172 were assigned to the CapeOX group (Figure 1). This updated analysis used data collected by December 24, 2013, by which time, 301 (SOX group: 150, CapeOX group: 151) PFS events, and 279 (134; SOX group, 145; CapeOX group) OS events had occurred. In the previous analysis, 207 (98; SOX group, 109; CapeOX group) PFS events, and 179 (84; SOX group, 95; CapeOX group) OS events had occurred. Of note, the baseline characteristics were much the same between the two groups (Table 1).Figure 1


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.

Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS - BMC Cancer (2014)

CONSORT diagram.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4289339&req=5

Fig1: CONSORT diagram.
Mentions: Between May 14, 2008 and September 23, 2009, we enrolled 348 patients from 11 institutions. We randomly assigned 340 patients who met the eligibility criteria to treatment (ITT). Of the 340 patients, 168 were assigned to the SOX group, and 172 were assigned to the CapeOX group (Figure 1). This updated analysis used data collected by December 24, 2013, by which time, 301 (SOX group: 150, CapeOX group: 151) PFS events, and 279 (134; SOX group, 145; CapeOX group) OS events had occurred. In the previous analysis, 207 (98; SOX group, 109; CapeOX group) PFS events, and 179 (84; SOX group, 95; CapeOX group) OS events had occurred. Of note, the baseline characteristics were much the same between the two groups (Table 1).Figure 1

Bottom Line: 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.Updated survival analysis shows that SOX is similar to CapeOX, confirming the initial PFS analysis.NCT00677443 and May 12 2008.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea. pys27hmo@skku.edu.

ABSTRACT

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/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1) versus SOX (S-1 40 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 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.

Trial registration: NCT00677443 and May 12 2008.

Show MeSH
Related in: MedlinePlus