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Long term efficacy and safety of Fludarabine, Cyclophosphamide and Rituximab regimen followed by (90)Y-ibritumomab tiuxetan consolidation for the treatment of relapsed grades 1 and 2 follicular lymphoma.

Pisani F, Sciuto R, Dessanti ML, Giannarelli D, Kayal R, Rea S, Marchesi F, Marino M - Exp Hematol Oncol (2015)

Bottom Line: The median overall (OS) and progression free survival (PFS) have not been reached, in this analysis both OS or PFS are 67 % at 7.5 year.The most common grade 3 or 4 adverse events were hematologic.These results confirm the long term efficacy and safety of 4 cycles of FCR followed by (90)Y-RIT in relapsed grades 1 and 2 FL and suggest that this regimen could be a therapeutic option for this setting of patients, specially at age of 60-75 with no unexpected toxicities.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology Regina Elena National Cancer Institute, Via Elio Chianesi, 53 - 00144 Rome, Italy.

ABSTRACT

Background: In this retrospective study, we investigated the efficacy and safety of radioimmunotherapy with (90)Yttrium- ibritumomab tiuxetan ((90)Y-RIT) in 9 patients with recurrent follicular lymphoma (FL) who were treated in a consolidation setting after having achieved complete (CR) or partial remission (PR) with Fludarabine, Cyclophosphamide and Rituximab (FCR).

Methods: The median age was 63 years (range 46-77). All patients were relapsed with histologically confirmed CD20-positive (grade 1 or 2) FL, at relapse they received FCR every 28 days: F (25 mg/m(2)x 3 days), C (1 gr/m(2) day 1) and R (375 mg/m(2) day 4) for 4 cycles. Those who achieved at least a PR with <25 % bone marrow involvement were treated with (90)Y-RIT 11.1 or 14.8 MBq/Kg, at 3 months after completing FCR. Patients underwent a further restaging at 12 weeks after (90)Y-RIT with a total body CT scan, FDG-PET/CT and bilateral bone marrow biopsy.

Results: Nine patients completed the treatment: FCR followed by (90)Y-RIT (6 patients at 14.8 MBq/Kg, 3 patients at 11.1 MBq/Kg). After FCR, 7 patients obtained CR and 2 PR; after (90)Y-RIT 2 patients in PR converted to CR 12 weeks later. With a median follow up of 95 months (range 20-114) since FCR and 88 months (range 13-104) since (90)Y-RIT 3 deaths were not related to lymphoma; all 3 deceased patients obtained CR before (90)Y-RIT and died still in CR. The median overall (OS) and progression free survival (PFS) have not been reached, in this analysis both OS or PFS are 67 % at 7.5 year. The most common grade 3 or 4 adverse events were hematologic.

Conclusions: These results confirm the long term efficacy and safety of 4 cycles of FCR followed by (90)Y-RIT in relapsed grades 1 and 2 FL and suggest that this regimen could be a therapeutic option for this setting of patients, specially at age of 60-75 with no unexpected toxicities.

No MeSH data available.


Related in: MedlinePlus

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Fig2: Treatment schema

Mentions: The patients who were included in the current retrospective analysis had CD20+ histologically confirmed relapsed grade 1 or 2 follicular lymphoma and had received at least 1 prior treatment. In this single institution study, between August 2005 and July 2010, 9 patients at relapse had received 4 cycles of FCR: fludarabine at a dose of 25 mg/m2 i.v. on days 1 to 3; cyclophosphamide at a dose of 1 gr/ m2 i.v. on day 1 and rituximab at a dose of 375 mg/ m2 was given on day 4 of each cycle every 28 days. Patients were restaged with CT scan, FDG PET/CT and bone marrow biopsies after the last course of FCR, who had achieved at least a partial remission with < 25 % bone marrow involvement received, 12 weeks since the last course of FCR, 2 infusions of rituximab 250 mg/ m2 one week apart, with the first infusion administered alone and the second infusion followed immediately by 90 Y–RIT (14.8 MBq/Kg – 11 MBq/Kg), if the platelet number was between 100 x 109/ L and 149 x 109/ L, not exceeding a total of 1.184 MBq it was administered as a slow i.v. push over 10 min (Fig. 2). The patients were age ≥ 18 years, with WHO performance status of 0 to 2 and the last chemotherapy with or without rituximab was administered at least 3 months before start of FCR; no patient under maintenance therapy with rituximab was considered. Before starting 90Y-RIT an absolute neutrophil count ≥ 1.5 × 109 L, hemoglobin levels ≥ 9 gr/dl and a platelet count ≥ 100 × 109 L were required. None of the patients had central nervous system (CNS) involvement and positive HIV. All patients provided an informed consent according to institutional guidelines.Fig. 2


Long term efficacy and safety of Fludarabine, Cyclophosphamide and Rituximab regimen followed by (90)Y-ibritumomab tiuxetan consolidation for the treatment of relapsed grades 1 and 2 follicular lymphoma.

Pisani F, Sciuto R, Dessanti ML, Giannarelli D, Kayal R, Rea S, Marchesi F, Marino M - Exp Hematol Oncol (2015)

Treatment schema
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4482187&req=5

Fig2: Treatment schema
Mentions: The patients who were included in the current retrospective analysis had CD20+ histologically confirmed relapsed grade 1 or 2 follicular lymphoma and had received at least 1 prior treatment. In this single institution study, between August 2005 and July 2010, 9 patients at relapse had received 4 cycles of FCR: fludarabine at a dose of 25 mg/m2 i.v. on days 1 to 3; cyclophosphamide at a dose of 1 gr/ m2 i.v. on day 1 and rituximab at a dose of 375 mg/ m2 was given on day 4 of each cycle every 28 days. Patients were restaged with CT scan, FDG PET/CT and bone marrow biopsies after the last course of FCR, who had achieved at least a partial remission with < 25 % bone marrow involvement received, 12 weeks since the last course of FCR, 2 infusions of rituximab 250 mg/ m2 one week apart, with the first infusion administered alone and the second infusion followed immediately by 90 Y–RIT (14.8 MBq/Kg – 11 MBq/Kg), if the platelet number was between 100 x 109/ L and 149 x 109/ L, not exceeding a total of 1.184 MBq it was administered as a slow i.v. push over 10 min (Fig. 2). The patients were age ≥ 18 years, with WHO performance status of 0 to 2 and the last chemotherapy with or without rituximab was administered at least 3 months before start of FCR; no patient under maintenance therapy with rituximab was considered. Before starting 90Y-RIT an absolute neutrophil count ≥ 1.5 × 109 L, hemoglobin levels ≥ 9 gr/dl and a platelet count ≥ 100 × 109 L were required. None of the patients had central nervous system (CNS) involvement and positive HIV. All patients provided an informed consent according to institutional guidelines.Fig. 2

Bottom Line: The median overall (OS) and progression free survival (PFS) have not been reached, in this analysis both OS or PFS are 67 % at 7.5 year.The most common grade 3 or 4 adverse events were hematologic.These results confirm the long term efficacy and safety of 4 cycles of FCR followed by (90)Y-RIT in relapsed grades 1 and 2 FL and suggest that this regimen could be a therapeutic option for this setting of patients, specially at age of 60-75 with no unexpected toxicities.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology Regina Elena National Cancer Institute, Via Elio Chianesi, 53 - 00144 Rome, Italy.

ABSTRACT

Background: In this retrospective study, we investigated the efficacy and safety of radioimmunotherapy with (90)Yttrium- ibritumomab tiuxetan ((90)Y-RIT) in 9 patients with recurrent follicular lymphoma (FL) who were treated in a consolidation setting after having achieved complete (CR) or partial remission (PR) with Fludarabine, Cyclophosphamide and Rituximab (FCR).

Methods: The median age was 63 years (range 46-77). All patients were relapsed with histologically confirmed CD20-positive (grade 1 or 2) FL, at relapse they received FCR every 28 days: F (25 mg/m(2)x 3 days), C (1 gr/m(2) day 1) and R (375 mg/m(2) day 4) for 4 cycles. Those who achieved at least a PR with <25 % bone marrow involvement were treated with (90)Y-RIT 11.1 or 14.8 MBq/Kg, at 3 months after completing FCR. Patients underwent a further restaging at 12 weeks after (90)Y-RIT with a total body CT scan, FDG-PET/CT and bilateral bone marrow biopsy.

Results: Nine patients completed the treatment: FCR followed by (90)Y-RIT (6 patients at 14.8 MBq/Kg, 3 patients at 11.1 MBq/Kg). After FCR, 7 patients obtained CR and 2 PR; after (90)Y-RIT 2 patients in PR converted to CR 12 weeks later. With a median follow up of 95 months (range 20-114) since FCR and 88 months (range 13-104) since (90)Y-RIT 3 deaths were not related to lymphoma; all 3 deceased patients obtained CR before (90)Y-RIT and died still in CR. The median overall (OS) and progression free survival (PFS) have not been reached, in this analysis both OS or PFS are 67 % at 7.5 year. The most common grade 3 or 4 adverse events were hematologic.

Conclusions: These results confirm the long term efficacy and safety of 4 cycles of FCR followed by (90)Y-RIT in relapsed grades 1 and 2 FL and suggest that this regimen could be a therapeutic option for this setting of patients, specially at age of 60-75 with no unexpected toxicities.

No MeSH data available.


Related in: MedlinePlus