Abstract
Background: The addition of rituximab (R) to bi-weekly CHOP (CHOP-14) in the RICOVER-60 trial resulted in improved time to treatment failure in 828 elderly (61–80 years) DLBCL patients (
Methods: A phase II trial including pts >60 yrs with stage II-IV, CD20-positive DLBCL was performed between 2003 and 2007. Pts received 6x R-CHOP-14 and 2 x R alone followed by LTBI given as 2 courses of 4 daily fractions of 0,2 Gy separated by 2 weeks of rest.
Results: We report the results of the first 36 patients. The median age was 69 years; 56% had ≥ 1 extranodal lesion; 67% had stage III or IV; 48% had B symptoms and 37% had Bulky (> 7.5 cm) disease; 54% had ECOG score ≥ 1; 75% had elevated LDH and 63% had IPI of >2, while 73% stained positive for BCL2 in pre-therapeutic histological samples. One patient got off study because of the discovery of breast cancer and one patient refused to get LTBI. Twenty one pts achieved a CR or CRu at the end of chemotherapy (58%), 10 (27%) were in PR while only one patient progressed under chemotherapy. All 10 PR pts achieved CR in the first follow up after LTBI. Four pts relapsed within 12 months after achieving CR. All treatment failures occurred in patients with IPI 3&4. Of the administered R-CHOP-14, Rituximab and LTBI cycles, 95%, 100% and 96%, respectively, were given in full dose and on time. CTC Gr 3–4 neutropenia occurred following 50 of 250 R-CHOP-14 cycles (20%). There were 3 toxic deaths (7.8%) due to sepsis occurring during chemotherapy. CTC Gr. 3–4 thrombocytopenia was seen in 8 pts following the last LTBI cycle (22%) and could be prolonged. The 2-Y Overall survival (OS) was found to be 79% (SE ± 8%) while the 2-Y disease free survival (DFS) was 74% (SE ± 10%).
Conclusion: In a selected DLBCL group of elderly patients with high-risk prognostic profile, R-CHOP-14 followed by LTBI, although sometimes associated with severe infections and thrombocytopenia, seems to achieve high response rates and provide correspondingly high OS and DFS values.
Author notes
Disclosure: No relevant conflicts of interest to declare
