Oxaliplatin non-inferior to cisplatin for gastric cancer treatment

1. Oxaliplatin plus S-1 was non-inferior in terms of overall survival and progression free survival when compared to cisplatin plus S-1 in the treatment of patients with advanced gastric carcinoma.

2. Patients treated with oxaliplatin experienced significantly less toxicities such as anemia, febrile neutropenia, and leukopenia compared to those treated with cisplatin.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Platinum-based chemotherapy constitutes the backbone of treatment for advanced gastric cancer (AGC).  In Europe and Asia, the standard of care for AGC is platinum-based chemotherapy combined with S-1, which is a triplet of tegafur (a pro-drug of 5-flourouracil) and 2 modulators—typically, gimeracil and oteracil. However, cisplatin is a poorly tolerated drug that causes a range of hematological abnormalities and renal toxicity. Oxaliplatin is a cisplatin-derivative that has a much more favorable safety profile. In this phase III randomized controlled trial, over 600 Japanese patients with AGC were randomized to either oxaliplatin plus S-1 (SOX) or cisplatin plus S-1 (CS).  The SOX group was shown to be statistically non-inferior to the CS group in terms of progression free survival (PFS) and overall survival (OS). While there was an increase in the incidence of sensory neuropathy in patients treated with SOX, they benefitted from decreased rates of leukopenia, neutropenia, anemia, febrile neutropenia, and hyponatremia. Although this study suggests a potential improvement in patient quality of life with SOX therapy, there is limited description of adverse events which may impact how patients live. Furthermore, this study included solely Japanese patients, thereby limiting result generalizability as those studied may have gastric carcinoma that is biologically distinct and may respond differently to treatment when applied to other populations.

Click to read the study in the Annals of Oncology

Relevant Reading: Chemotherapy in Advanced Gastric Cancer: A Systematic Review and Meta-Analysis Based on Aggregate Data

In-Depth [randomized controlled trial]: In this study, 343 patients were randomized to SOX and 342 patients were randomized to CS. All patients had advanced or recurrent gastric cancer with an Eastern Cooperative Oncology Group (ECOG) status of 0-2. Patients were enrolled at 51 centers in Japan from 2010 to 2011. The median PFS for SOX and CS was 5.5 and 5.4 months, respectively, corresponding to an HR of 1.004 (95% CI: 0.840-1.199). The median OS for each arm was 14.1 and 13.1 months, respectively, corresponding to an HR of 0.969 (95% CI: 0.812-1.157). There were 205 and 248 cases of leukopenia in the SOX arm and CS arm (P = 0.002), 233 and 266 cases of neutropenia (P = 0.0019), and 187 and 247 cases of anemia, respectively (P < 0.0001). However, there were 289 and 79 respective cases of sensory neuropathy (P < 0.0001). There were 8 treatment-related deaths in the CS arm and 4 in the SOX arm, which was not statistically significant.

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