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In February, in the journal Haematologica, Gregor Verhoef from the University Hospital Leuven, Leuven, Belgium, and colleagues published a post-hoc analysis study of the multi-center, international, randomized, phase III LYM-3002 study comparing R-CHOP to VR-CAP. The study recruited patients who were newly diagnosed with MCL but ineligible or not considered for stem cell transplantation. The purpose of the post-hoc analysis was to study the relationship between outcome, response, and response quality in patients treated with R-CHOP or VR-CAP. Patients were stratified according to response classification, Complete Response (CR/CRu) and Partial Response (PR), and by MIPI risk status.
In conclusion, the authors stated that VR-CAP resulted in an improved duration, and quality, of response than R-CHOP, which became more obvious in patients with low- or intermediate-risk MIPI. Furthermore, they state that their data showed that disease elimination, as measured in this study by lymph node lesion size reduction, is potentially a better predictor of outcome than type of response. The authors also suggest that the addition of maintenance rituximab to the VR-CAP treatment regimen could potentially extend the PFS of some patients.
In the phase III LYM-3002 study comparing intravenous VR-CAP with R-CHOP in patients with newly-diagnosed, measurable stage II-IV mantle cell lymphoma, not considered, or ineligible for, transplant, median progression-free survival was significantly improved with VR-CAP (24.7 vs R-CHOP 14.4 months; P<0.001). This post-hoc analysis evaluated the association between the improved outcomes and quality of responses achieved with VR-CAP versus R-CHOP in LYM-3002. Patients were randomized to 6-8 21-day cycles of VR-CAP or R-CHOP. Outcomes included progression-free survival, duration of response (both IRC assessed), and time-to-next anti-lymphoma treatment, evaluated by response (complete response/unconfirmed complete response and partial response), MIPI risk status, and maximum reduction of lymph-node measurements expressed as the sum of the product of the diameters. Within each response category, median progression-free survival by independent review committee was longer for patients receiving VR-CAP versus R-CHOP who achieved complete response/unconfirmed complete response (40.9 vs 19.8 months) compared with those achieving partial response (17.1 vs 11.7 months); similarly, for median time-to-next anti-lymphoma treatment (complete response/unconfirmed complete response: not evaluable vs 26.6 months; partial response: 35.3 vs 24.3 months). Within the complete/unconfirmed complete and partial response categories, progression-free survival, duration of response and time-to-next anti-lymphoma treatment were more pronounced in patients with low- and intermediate-risk MIPI with VR-CAP versus R-CHOP. In each response category, more VR-CAP than R-CHOP patients had a sum of the product of the diameters nadir of 0 during serial radiological assessments. Results of this post-hoc analysis suggest a greater duration and quality of response in VR-CAP versus R-CHOP patients, which was more evident in patients with low- and intermediate-risk MIPI.
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