ALBERT

Description: Abstract 2377 Poster Board II-354 Fludarabine containing regimens has become the gold standard for first-line treatment of CLL. The prognosis for the response is usually done by mutation analysis and cytogenetics. These types of analyses are time consuming and could not be available in general practice. Staging is very easy tool for predicting the response, although it is not a matter of individual prognosis. The aim of the study was to find clinical data predicting the response. As a model, we have evaluated the response after 3 fludarabine containing regimens. Patients and methods 75 patients treated by fludarabin containing regimens (FC and FCR) were included (2002-2008). Staging was performed according to Binet (1977). Stage B and C patients were included. Lymph nodes were evaluated by CT and ultrasound. CD38 was done by CytoFlow (cut off 30%). Mutation analysis was studied by PCR and sequencing with cut off 98%. Early response(ER) was defined as PR and CR after 3 cycles of therapy, others were considered as nER. CR was defined according to NCI criteria. The patients were treated and followed-up by the single team of physicians, there were no losses of follow-us.SPSS - 17 statistical program was used for analysis. Results. In the whole group, median PFS was 25 mons . There were 40 ER pts(33 - PR and 7 - CR).Median PFS in ER patients was 38mons, in other patients (nER) – 17mons (p= 0.0001). After 6 cycles of therapy, the overall response was 100%; CR was 83% and 7% PR I ER pts, in nER- resp- 67%, 23% and 41% ( p 〈 0,001). Differences of median PFS according to standard prognostic factors is presented in table 1: Thus, ER patients with standard adverse prognostic factors did better than nER with similar prognostic factors. ER patients in comparison to nER had higher median PFS on both FC (28 mons vs 14 mons, p=0.001) and FCR (58 mons vs 18 mons, p=0.018) regimens. Conclusion. The early response (PR and CR) after three fluadarabine containing regimens is a good predictor for PFS. More intensive treatment should be considered for patients without early response. Disclosures: No relevant conflicts of interest to declare.

Description: Abstract 4406 We have found only one study aimed to find prognostic significance of abdominal lymph nodes in CLL (E. Montserrat et al, 2007). It was shown that Rai O CLL patients with enlarged abdominal lymph nodes had inferior survival. It merely means that CT scan could early reveal patients with enlarged lymph nodes. This cohort of patients is included in stage 0 only due to the fact of unavailability of CT scan at the times Rai and Binet staging were described (1975, 1977). The aim of the study was to evaluate prognostic significance of abdominal lymph nodes enlargement for the response to FC and FCR Patients and methods 71 untreated CLL patients were included according to the intent to treatment by fludarabine containing regimens (FC and FCR). Staging was performed according to Binet system. Stage B and C patients were included. Lymph nodes were revealed by CT and ultrasound before therapy (Lymph nodes more than 10mm in diameter were considered as abnormal and more than 100 mm in diameter were considered as bulky). CD38 was performed by CytoFlow (cut off 30%). Mutation analysis was done with PCR and sequencing (E.Nikitin, Hematological centre, Moscow), (cut off 98%). CR was defined according to NCI criteria. The patients were treated and followed-up by the single team of physicians, there were no losses of follow-us. SPSS - 17 statistical program was used for analysis. Results Overall response (OR) was 86% (61 pts), the rate of CR was 55% (39 pts), the rate of PR 31% (22 pts). In the whole group, FC: OR 81%, CR 46%, PR 35%. FCR: OR 91%, CR 67%, PR 24%), median of PFS was 26 mons (21 mons for FC and 35 for FCR, p=0.006). CD38 positivity, unmutated type and stage C had adverse prognostic significance in the whole group (p= 0,04; p=0,05; p=0,02), in FCR subgroups, mutation status and CD38 had marginal significance in FCR(p=0.9, p=0.75). Abdominal lymph nodes were enlarged in 41 pts (58%), 16 pts had bulky EAL(23%). PFS was lower in the group of patients with EAL in comparison to patients without EAL(18 and 48 mons, p 0.001). Difference in PFS has been also revealed in FC and FCR subgroups: 16 and 25 mons, p=0,003 for FC; 22 and 56 mons, p=0,01 for FCR (Fig.1) All fludarabine containing regimens resistant patients appeared to have EAL (10 pts). The duration of CR and PR were longer in patients without EAL(resp.p = 0.03 and 0.06, Fig. 2). The differences of PFS were also studied inside the groups defined by standard prognostic markers. CD38-, EAL+ patients had median PFS of 23mons, CD38-, EAL- patients-median not achieved (p= 0.01) CD 38+EAL+patients had median PFS of 12 mons, CD38+EAL- patients – 30 mons (p=0,04) Thus, CD38+ patients without EAL had even better PFS than CD38- patients with EAL. VH-mut+ EAL+ patients had median PFS of 18 mons, VH-mut+ EAL- patients – 58 mons (p=0,06) VH-mut- EAL+ patients had median PFS of 11 mons, VH-mut- EAL- patients – 18 mons (p=0,06) Thus, unmutated patients wit EAL had similar PFS with mutated patients without EAL. Stage B EAL+ patients had median PFS of 20 mons, Stage B EAL- patients – 58 mons (p=0,004) Stage C EAL+ patients had median PFS of 15 mons, Stage C EAL- patients – 21 mons (p=0,05) Thus, patients with stage B without EAL had PFS four times better, than patients with stage C, EAL+. Median PFS is similar in patients stage B EAL+ and stage C EAL-. The response equal to PR and more than PR after three cycles of chemotherapy was more frequent in patients without EAL (65% vs 18%, p 〈 0,001) Conclusion Enlarged abdominal lymph nodes(EAL) is an adverse prognostic marker for response both to FC and FCR. Differences in PFS according to EAL were also revealed inside standard prognostics subgroups (mutation status and CD38,stage). Even more, PFS of patients with standard adverse prognostic factors without EAL were similar to patients without standard adverse prognostic with EAL. CLL with EAL is a separate entity of CLL. Disclosures: No relevant conflicts of interest to declare.