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High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study)

View Article: PubMed Central - PubMed

ABSTRACT

To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2 days 2, 16, 30), procarbazine (60 mg/m2 days 2–11) and lomustine (110 mg/m2, day 2)—R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3% R-MP 34.9% R-MPL 38.8%) and overall survival (All 47.0% R-MP 47.7% R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.

No MeSH data available.


Related in: MedlinePlus

Survival analyses. (a) PFS of the entire cohort, (b) OS of the entire cohort, (c) PFS stratified by R-MPL, (d) OS stratified by R-MPL, (e) cumulative incidence of death owing to lymphoma with other causes of death as competing risk and (f) cumulative incidence of death owing to other causes but lymphoma with lymphoma-associated death as competing risk.
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fig2: Survival analyses. (a) PFS of the entire cohort, (b) OS of the entire cohort, (c) PFS stratified by R-MPL, (d) OS stratified by R-MPL, (e) cumulative incidence of death owing to lymphoma with other causes of death as competing risk and (f) cumulative incidence of death owing to other causes but lymphoma with lymphoma-associated death as competing risk.

Mentions: Considering best response achieved, 45 of the 107 achieved CR (42.1%), 34 PR (31.8%), one SD and 2 patients suffered PD (Table 3). Twenty-five (23.4%) patients did not have any response assessment as per protocol, because of: death (N=10), toxicity (N=9), lack of compliance (N=2), patients' wish (N=2), and progression (N=2) during the first cycle. Of those 53 patients who proceeded with maintenance treatment, 37 had a CR (69.8%), 14 PR (26.4%) and one PD (1.9%) before commencing procarbazine. After a median follow-up of 33.7 months, 70 (65.4%) patients experienced relapse/progression or died (59 (55.1%) patients died). This translated into a median PFS of 10.3 months with 1- and 2-year PFS rates of 46.3% and 37.3%, respectively (Figure 2a). The respective OS rates after 1 and 2 years were 56.7% and 47.0% median OS was 20.7 months (Figure 2b). Although follow-up is shorter in the R-MP group, the associated PFS and OS rates are similar compared with R-MPL (Table 3, Figures 2c and d). Of those seven patients aged ⩾80 years, five are still alive at latest follow-up. In multivariable analysis, age and all other factors had no prognostic influence on OS (Table 4).


High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study)
Survival analyses. (a) PFS of the entire cohort, (b) OS of the entire cohort, (c) PFS stratified by R-MPL, (d) OS stratified by R-MPL, (e) cumulative incidence of death owing to lymphoma with other causes of death as competing risk and (f) cumulative incidence of death owing to other causes but lymphoma with lymphoma-associated death as competing risk.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5383936&req=5

fig2: Survival analyses. (a) PFS of the entire cohort, (b) OS of the entire cohort, (c) PFS stratified by R-MPL, (d) OS stratified by R-MPL, (e) cumulative incidence of death owing to lymphoma with other causes of death as competing risk and (f) cumulative incidence of death owing to other causes but lymphoma with lymphoma-associated death as competing risk.
Mentions: Considering best response achieved, 45 of the 107 achieved CR (42.1%), 34 PR (31.8%), one SD and 2 patients suffered PD (Table 3). Twenty-five (23.4%) patients did not have any response assessment as per protocol, because of: death (N=10), toxicity (N=9), lack of compliance (N=2), patients' wish (N=2), and progression (N=2) during the first cycle. Of those 53 patients who proceeded with maintenance treatment, 37 had a CR (69.8%), 14 PR (26.4%) and one PD (1.9%) before commencing procarbazine. After a median follow-up of 33.7 months, 70 (65.4%) patients experienced relapse/progression or died (59 (55.1%) patients died). This translated into a median PFS of 10.3 months with 1- and 2-year PFS rates of 46.3% and 37.3%, respectively (Figure 2a). The respective OS rates after 1 and 2 years were 56.7% and 47.0% median OS was 20.7 months (Figure 2b). Although follow-up is shorter in the R-MP group, the associated PFS and OS rates are similar compared with R-MPL (Table 3, Figures 2c and d). Of those seven patients aged ⩾80 years, five are still alive at latest follow-up. In multivariable analysis, age and all other factors had no prognostic influence on OS (Table 4).

View Article: PubMed Central - PubMed

ABSTRACT

To investigate immuno-chemotherapy for elderly immuno-competent patients (⩾65 years) with newly diagnosed primary central nervous system lymphoma, we conducted a multicentre single-arm trial. One cycle consisted of rituximab (375 mg/m2, days 1, 15, 29), high-dose methotrexate (3 g/m2 days 2, 16, 30), procarbazine (60 mg/m2 days 2–11) and lomustine (110 mg/m2, day 2)—R-MPL protocol. Owing to infectious complications, we omitted lomustine during the study and consecutive patients were treated with the R-MP protocol. Three cycles were scheduled and repeated on day 43. Subsequently, patients commenced 4 weekly maintenance treatment with procarbazine (100 mg for 5 days). Primary end point was complete remission (CR) after 3 cycles. We included 107 patients (69 treated with R-MPL and 38 with R-MP). In all, 38/107 patients achieved CR (35.5%) and 15 (14.0%) achieved partial remission. R-MP was associated with a lower CR rate (31.6%) compared with R-MPL (37.7%), but respective 2-year progression-free survival (All 37.3% R-MP 34.9% R-MPL 38.8%) and overall survival (All 47.0% R-MP 47.7% R-MPL 46.0%) rates were similar. R-MP was associated with less ⩾grade 3 toxicities compared with R-MPL (71.1% vs 87.0%). R-MP is more feasible while still associated with similar efficacy compared with R-MPL and warrants further improvement in future studies.

No MeSH data available.


Related in: MedlinePlus