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Chapter 6b
Seventeen grade 5 adverse events were reported during induction, 9 in the R-CHOP-14 arm and 8 in the RR-CHOP-14 arm. The main cause of death was infection (4 patients in each arm). Other causes of death in the R-CHOP-14 arm were small-bowel perforation (n = 2), sudden death (n = 2), and progressive multifocal leukoencephalopathy (n = 1). In the RR-CHOP-14 arm, other causes of death were myocardial infarction (n = 1), GI bleeding (n = 1), small-bowel perforation (n = 1), and cardiac arrhythmia (n = 1).
Fig 3. Progression-free survival (PFS) by treatment arm within subgroups: (A) age 18 to 65 years, (B) age 66 to 80 years, (C) male patients, and (D) female patients.
P, progression, relapse, or death; R-CHOP, rituximab on day 1 of each cycle plus cyclophosphamide, doxorubicin, vincristine, and prednisone (arm A); RR-CHOP, rituximab on days 1 and 8 of first 4 cycles and day 1 of remaining cycles plus cyclophosphamide, doxorubicin, vincristine, prednisone (arm B).
Discussion
The primary objective of achieving a significantly superior CR rate with RR- CHOP-14 treatment as compared with standard R-CHOP-14 treatment was not met. RR-CHOP-14 treatment also did not improve FFS, PFS, DFS, or OS. In
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