From Sunday's NSCLC PR: (found this quite interesting)
<The paclitaxel arm in the U.S. region of the study mirrored recent published experience where 19 percent of patients survived one year compared to 28 percent for XYOTAX recipients (p=0.26).>
STELLAR 3 Trial Results
STELLAR 3, is a phase III clinical trial comparing the effect of standard paclitaxel/carboplatin to XYOTAX/carboplatin in the first-line treatment of PS2 lung cancer. The one-year survival rate was 31 percent for both arms and two-year survival rate was 13 percent for XYOTAX compared to 11 percent for paclitaxel. As specified in the protocol, the outcome was analyzed by regions, i.e. U.S. vs. Canada plus Western Europe vs. other sites (predominantly in Eastern Europe). Patients in Eastern Europe were approximately 10 years younger, had less advanced lung cancer, a lower incidence of other medical conditions, and fewer had received prior radiation. These differences may account for the improved survival in this study when compared to previously reported similar studies in PS2 patients. The paclitaxel arm in the U.S. region of the study mirrored recent published experience where 19 percent of patients survived one year compared to 28 percent for XYOTAX recipients (p=0.26). Compared to the control patients, XYOTAX/carboplatin infusion time was significantly shorter than that required for paclitaxel /carboplatin (48 minutes vs. 224 minutes, p<0.006), did not require routine pre-medications, resulted in significantly less hair loss (14 percent vs. 42 percent, p<0.001), musculoskeletal (14 percent vs. 27 percent, p=0.002), and cardiac side effects (0 percent vs. 3 percent, p=0.01). The overall incidence of neuropathy was lower on the XYOTAX arm (47 percent vs. 56 percent, p=0.09), although grade 3 was numerically higher. There was a significant delay in the onset of neuropathy between the XYOTAX and paclitaxel arms (89 days vs. 54 days, p<0.001). With the exception of more grade 3/4 thrombocytopenia on the XYOTAX arm, there were no significant differences in other grade 3/4 toxicities including severe neuropathy, nausea, vomiting, neutropenia, infection or febrile neutropenia between the two treatment arms. Additional results will be presented at the IASLC meeting in July. |
