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switched to two cycles of BEACOPPesc and INRT (superiority design).Primary end point was progression-free survival (PFS).In January 2019, a preplanned analysis on 10y follow-up was launched.So far, out of 1925 patients constituting the original study population, 1419 cases have been updated, and are included in the present analysis; 506 cases showing similar baseline characteristics and 5y OS and PFS than updated patients were excluded so far.Results: After a median follow-up of 9.5 yrs, a total of 57 deaths and 136 events for PFS were reported in the analyzed population, leading to an overall 10-year OS and PFS rates of 96% and 90% respectively.In ePET-positive patients, 10y PFS increased from 79% for standard ABVD + INRT to 85% for intensification to BEACOPPesc + INRT (hazard ratio [HR] = 0.67; 95% CI, 0.37 to 1.20), although the difference was not statistically significant.The 10y OS rates were 90% and 92%, respectively (hazard ratio [HR] = 0.92; 95% CI, 0.43-1.97).In the F ePET negative group the 10y PFS rates were 99% versus 85% (HR = 13.2;95% CI, 3.1-55.8)in favor of ABVD + INRT, and the difference was statistically significant.The 10y OS rates were 100% versus 98% for ABVD + INRT and ABVD only arms, respectively (hazard ratio [HR] = 2.80; 95% CI, 0.3-26.9).Finally, in the U ePET negative group 10y PFS rates were 91% and 87% (HR = 1.52; 95% CI, 0.8-2.8)for standard and experimental arm, respectively.The 10y OS rates were 94% versus 95% for ABVD + INRT and ABVD only arms, respectively (hazard ratio [HR] = 0.84; 95% CI, 0.4-2.0). Conclusion:The present long-term analysis confirms that in F ePETnegative patients, the omission of INRT is associated with lower 10y PFS, although no differences in terms of OS emerged.Moreover, in the U ePET negative and in the ePET positive patients, no significant differences between standard and experimental arms emerged in terms of 10y PFS and OS.
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Dickinson et al. (2023) studied this question.
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