Randomized phase III U.S./Canadian intergroup trial (SWOG S9704) comparing CHOP ± R for eight cycles to CHOP ± R for six cycles followed by autotransplant for patients with high-intermediate (H-Int) or high IPI grade diffuse aggressive non-Hodgkin lymphoma (NHL)

8001 Background: This SWOG led intergroup trial investigated the benefit of autotransplant in 1st remission patients with bulky stage II, III, and IV H-Int/High IPI diffuse NHL after 5 cycles of CHOP±R, as previously suggested by European studies. Methods: 397 patients (pts) up to age 65 from 40 sites were enrolled between 9/97-12/07 and induced with 5 cycles of CHOP (n=215) or CHOP-R (after 3/03; n=182). Pts with ≥ PR were randomized between CHOP±R x 1 followed by autotransplant using TBI or BCNU based regimens, vs CHOP±R x 3. Primary endpoints were toxicity, and 2 yr PFS and OS for randomized pts with sample size chosen to detect a hazard ratio between arms 1.50 with 82% power. Results: Of 370 induction eligible pts 253 were randomized to standard (128) or transplant (125) therapies; 35% had High IPI . Reasons for non-randomization included progression (66), and refusal (23). On the transplant arm, 9 never received transplant and 6 had fatal toxicities (lung-3). On the standard arm, 3 did not receive CH...