Page 76 - Demo

Chapter 474Response rate, overall survival and time to progression Response rateThirty-eight supplemented patients and 37 unsupplemented patients were evaluable for response. The RR was 42.1% (n=16) for supplemented patients, all partial responses (PR). The RR for unsupplemented patients was 32.4% (n=12), and consisted of PR in 29.7% (n=11) and a complete response (CR) in 2.7% (n=1) of patients. The RR was not significantly different between the two treatment groups, p=0.4.Overall survival and time to progressionThe median OS in this study was 10.0 months (range 0.3-42.6) for the supplemented arm vs 7.7 months (range 0.03-46.7) for the unsupplemented arm. This difference was not statistically significant (p=0.9). One patient was lost to follow up and was censored for the OS analysis. According to the prespecified intention to treat analysis all other randomized patients were included in the survival analysis, including one patient who deceased between randomization and the start of study treatment and one patient who was treated with epirubicin and oxaliplatin instead of cisplatin-gemcitabine due to renal impairment. This patient was not included in the TTP analysis. Vitamin supplementation did not lead to a significantly different median TTP, 5.9 months (range 1.4-33.5) for supplemented patients vs 5.4 months (range 1.4-30.9) for unsupplemented patients (p=0.9). The Kaplan-Meier curves for OS and TTP are shown in figure 2.Figure 2. Kaplan-Meier curve for OS and TTP. The dotted line represents the supplemented arm while the black line represents the unsupplemented arm. OS and TTP were not significantly different between the supplemented vs. the unsupplemented patients (median OS 10.0 months; range 0.3-42.6 vs. 7.7 months; range 0.03-46.7; p=0.9; median TTP 5.9 months; range 1.4-33.5 vs. 5.4 months; range 1.4-30.9; p=0.9).