Background
Subgroup analysis of RICOVER-60 (Rituximab with CHOP over 60 years of age) trial examining the value of consolidation radiotherapy. RICOVER-noRTh asked: can consolidation RT be safely omitted in elderly DLBCL patients with bulky or extranodal disease who achieved complete metabolic response (CMR) by FDG-PET after R-CHOP14? Analysis of 98 patients from the RICOVER-60 protocol with bulky or extranodal involvement who did not receive consolidation RT.
Interventions and follow up
Arm A: R-CHOP14 × 6 + 2 R + consolidation RT (RICOVER-60 historical control with RT, n=not directly compared)
Arm B: R-CHOP14 × 6 + 2 R — no RT (RICOVER-noRTh, n=98)
Primary endpoint: Progression-free and overall survival
mFollow up: Not specified
Arm B: R-CHOP14 × 6 + 2 R — no RT (RICOVER-noRTh, n=98)
Primary endpoint: Progression-free and overall survival
mFollow up: Not specified
Results
3-yr PFS (no RT, bulky/extranodal): 73%
Historical control (RT, RICOVER-60, comparable patients): ~86%
Historical control (RT, RICOVER-60, comparable patients): ~86%
Adverse events
Main adverse events: N/A (this is the no-RT arm; RT-related toxicities are reduced by omission).
Conclusions
Conclusion: Omitting RT in bulky/extranodal DLBCL significantly worsens PFS
Conclusions: Omitting consolidation RT in elderly DLBCL patients with bulky (≥7.5 cm) or extranodal disease, even in those achieving CMR after R-CHOP, results in inferior PFS compared with historical controls who received RT. Consolidation RT remains important for this subgroup.
Conclusions: Omitting consolidation RT in elderly DLBCL patients with bulky (≥7.5 cm) or extranodal disease, even in those achieving CMR after R-CHOP, results in inferior PFS compared with historical controls who received RT. Consolidation RT remains important for this subgroup.
Key Limitations
Key Limitations: Non-randomized comparison against historical controls — significant confounding possible. RT decision was not randomized; PET-CMR status selection may differ between groups. RICOVER-60 did not mandate PET imaging for response assessment in all patients.
Clinical Context
RICOVER-noRTh is cited alongside MDACC data to support consolidation RT for bulky/extranodal DLBCL. While Lamy Blood 2018 showed no benefit of RT in non-bulky disease, the RICOVER-noRTh data suggest continued benefit for bulky (≥7.5 cm) sites. Current NCCN guidelines recommend consolidation ISRT 30–36 Gy for bulky limited-stage or bulky advanced-stage DLBCL.
References
References: Held G et al, JCO 2014 (RICOVER-noRTh)