Page 161 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

Rituximab intensification during R-CHOP in DLBCL
Results
Study Patients
Between November 14, 2007, and April 6, 2012, 600 patients were enrolled. Twenty-six patients (R-CHOP-14 arm, n = 14; RR-CHOP-14 arm, n = 12) were considered ineligible in hindsight and excluded from all analyses because of diagnosis other than DLBCL at study entry according to local pathology (n = 12), stage I disease (n = 4), absence of age-adjusted IPI risk factors (n = 4), CNS involvement (n = 2), absence of measurable disease (n = 1), heart disease (n = 1), administrative error (n = 1), or missing data (n = 1). Of 574 patients included in the modified ITT analysis, 286 individuals were allocated to the R-CHOP-14 arm and 288 were assigned to the RR-CHOP-14 arm (Fig 1). Central pathology review was available for 522 (91%) of 574 eligible patients, and diagnosis of CD20+ DLBCL according to the 2008 WHO classification was confirmed for 492 (94%) of 522 patients. Baseline characteristics of patients were well balanced between arms (Table 1; Appendix Table A1, online only).
Treatment
At least 6 cycles were received by 269 (94%) of 286 patients in the R-CHOP-14 arm and 261 (91%) of 288 patients in the RR-CHOP-14 arm; 151 patients (53%) received 7 to 8 cycles of R-CHOP-14, compared with 158 (55%) in the RR- CHOP-14 arm (Fig 1). The median total dose received and median relative dose- intensities achieved for cyclophosphamide (98%) and doxorubicin (98%) were similar in the R-CHOP-14 and RR-CHOP-14 arms. However, for vincristine, in patients age 66 to 80 years, the median total dose and median relative dose- intensities were 12.0 versus 10.0 mg (P = .015) and 92% versus 85% (P = 0.083) for the R-CHOP-14 and RR-CHOP-14 arms, respectively.
Efficacy Outcomes
There was no statistically significant difference in the primary end point of CR rate on induction between the 2 treatment arms. CR was achieved in 254 patients (89%) in the R-CHOP-14 arm and in 249 (86%) in the RR-CHOP-14 arm (HR, 0.82; 95% CI, 0.50 to 1.36; P = .44; adjusted for age and age-adjusted IPI score). Also, CR rates for patients age < 66 years (90% v 85%) and patients age ≥ 66 years (88% v 88%) were not different per treatment arm.
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