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Chemotherapy for patients with advanced gastric cancer with performance status 2.

e15627 Background: S-1 plus cisplatin is considered to be the standard chemotherapy for Japanese patients with advanced gastric cancer (AGC) according to the results of three phase III trials (JCOG9912/SPIRITS/TOP-002). However, since few patients with poor performance status (PS2) were included in these phase III trials (27 of 1317; 2%), the standard treatment of patients with PS2 has not been established yet. In also, the characteristics and prognosis of AGC patients with PS2 has not been reported in detail.


METHODS
We retrospectively analyzed 545 patients with AGC treated by chemotherapy during the period from January 2003 to June 2008. Patients characteristic and treatment results were compared between PS0-1 and PS2.


RESULTS
At the beginning of 1st-line chemotherapy, PS0-1/2/3-4 was 454/69/22 cases respectively. Patients with peritoneal/pleural dissemination was more common in PS2 than PS0-1 (75% vs. 43%, p<0.001). Patients with multiple metastatic places was more common in PS2 (62% vs. 43%; p=0.007). Fewer patients in PS2 were registered in clinical trial (1.4% vs. 25%, p<0.001). First-line chemotherapy using oral drug (S- 1/capecitabine) was significantly fewer in PS2 (43% vs. 75%, P<0.001). Median time to treatment failure was significantly shorter in PS2 (2.3 months vs. 4.2 months, p<0.001). Patients who could receive second-line chemotherapy were significantly fewer in PS2 (50% vs. 75%, p<0.001). With the median follow up time of 42 months, median survival time of patients with PS0-1 was 14.8 months (95% CI;13.1-16.5) and that of patients with PS2 was 6.1 months (4.3 to 7.4 months; hazard ratio for death 3.0: 95% CI2.3-4.0; p<0.001). Mortality rate within 30 days was higher in PS2 (3% vs. 0.2%; p<0.001).


CONCLUSIONS
AGC patients with PS2 had not only had poor prognosis compared with PS0-1 but also had fewer chance of registration in the clinical trial, shorter time to treatment failure, and higher mortality rate within 30 days. Considering these different characteristics and treatment results of PS0-1 and PS2, clinical trial especially targeting AGC patients with PS2 is necessary to evaluate optimal chemotherapeutic regimens for PS2 patients. No significant financial relationships to disclose.