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RESULTS median time was 22.2 months for patients pre-treated with
2 or < 2 chemotherapeutic regimens and 2.7 months for the
The principal clinical characteristics of patients are shown other ones [Figure 1] [P = 0.029 in multivariate analysis;
in Table 1. All studied patients had received 2 previous Table 3]. Even IPI value was able to influence TTF: patients
chemotherapeutic programs as median (range: 1-5). All with IPI ≤ 2 had significantly more prolonged TTF than the
cases were evaluable for response. ORR was 48.8%: CR other ones [P = 0.048 in multivariate analysis; Table 3].
15/45 (33.3%); PR 7/45 (15.5%). At the time of this analysis,
after a median follow-up of 22 months (range: 5-148), 4/22 Toxicity
responsive patients relapsed with a median duration of No serious adverse event was observed. The treatment
response of 10.5 months (range: 4-15). With a median follow- was generally well-tolerated, with the majority of patients
up of 57 months, the 2-year TTF and OS rates were 43% treated on out-patient modality. Neutropenia grades 2, 3,
and 70%, respectively. No significant difference occurred and 4 were, respectively, reported in 8.9%, 4.4%, and 2.2%
with regard the OS in the 2 subsets divided according to the of cases; whereas thrombocytopenia grades 2 and 3 were
IPI value and numbers of chemotherapeutic regimens (P reported in 4.4% and 8.8% of patients, respectively. No febrile
= 0.823 and P = 0.389, respectively) [Table 2]. Response neutropenia was observed. Grade 2 neurotoxicity occurred
was influenced by the NPTs. Of 45 patients, 27 were pre- in 2.2%, but no grade 3/4 neurotoxicity was reported. In 6
treated with 2 or less than 2 chemotherapeutic regimens and patients, creatinine levels (which not overcame 176 μmol/L)
12 achieved CR, 5 PR, and 10 a stable/progressive disease increased during treatment. Hospitalization was necessary in
(SD/PD), with an ORR of 17/27 (63%). The remaining 18 1 case. As to toxicity not significant difference occurred in
patients were pre-treated with more than 2 chemotherapeutic each subset of patients and it was not affected by the number
regimens. Three cases of them obtained a CR, one a PR, and of previous treatments. In fact, among 27 patients pre-treated
the 14 remaining an SD/PD with an ORR of 4/18 (22%). with 2 or < 2 chemotherapeutic regimens, we recorded 8
Thus, patients pre-treated with 2 or < 2 chemotherapeutic cases of hematological toxicity (29%) and in the remaining 18
regimens had better ORR (P = 0.014, Fisher exact test). TTF patients treated with more than 2 chemotherapeutic regimens,
we recorded 5 hematological toxicity (28%) (P = ns).
Table 1: Principal clinical characteristics of patients
Number % DISCUSSION
Sex
Female 20 44 About 40-60% of elderly patients with DLBCL will be
Male 25 56 refractory or will experience relapse during their clinical
Age course. [11] These and other patients are not eligible for
≤ 65 years 36 80 ASCT due to old age, or important comorbidities and
> 65 years 9 20 management of this population is not yet standardized.
LDH Many current regimens, such as DHAP, ICE, ESHAP,
≤ 300 UI/L 18 40 show an ORR between 39% and 69%, but remarkable
[3,4]
> 300 UI/L 27 60 side-effects are frequent. Therefore, these regimens
Stage are not feasible for this subset of refractory/relapsed
DLBCLs. Gemcitabine is a drug classified as a
I 2 4
II 12 26
III 11 25
IV 20 45
IPI
0 2 4
1 9 20
2 16 36
3 15 34
4 1 2
5 0 0
Not available 2 4
NPT
1 9 20
2 18 40
3 13 29
4 4 9
5 1 2 Months
NPT: number of previous treatments; LDH: lactate dehydrogenase; Figure 1: Time to treatment failure curves according to the number of
IPI: international prognostic index previous chemotherapeutic regiments

Journal of Cancer Metastasis and Treatment ¦ Volume 2 ¦ Issue 2 ¦ February 29, 2016 ¦ 61