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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

Progression Free Survival from RIT
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Fig1: Progression Free Survival from RIT

Mentions: After 4 cycles of FCR 7 patients obtained CR and 2 PR, 2 patients in PR converted to CR after 90Y-RIT. In February 2015, with a median observation period of 95 months (range 20–114) since FCR and 88 months (range 13–104) since RIT, the median OS and the PFS have not been reached, 6/9 patients were alive in CR and current analysis has shown that either OS or PFS are 67 % at 7.5 year (Fig. 1). Grade 3 or 4 neutropenia occurred in 8/9 patients treated with FCR and in 9/9 patients assessable after 90Y-RIT. Subsequently to radioimmunotherapy the median neutrophil nadir was 0.8 × 109/ L (range 0.1-0.9 × 109/ L) at week 5, the median platelet count nadir was 49 × 109/ L (range 17–80 × 109/ L) at week 5. The median duration nadir for both neutrophils or platelets was 14 days. One patient developed herpes zoster infection after 8 months following valacyclovir discontinuation; another patient developed fungal infection. Both infections disappeared after specific treatment. One patient developed t-MDS (treatment-related myelodysplastic syndrome) at 26 months after 90Y-RIT. This patient before FCR and consolidation with 90Y-RIT had received 3 previous regimens: at diagnosis 6 courses of CHOP, at first relapse, 3 years later, 4 courses of FM/R (fludarabine, mitoxantrone plus rituximab) and after 1 year at the second relapse the patient received cyclophosphamide plus dexamethasone and rituximab, remaining in CR for 48 months. The patient died at 73 years of age of sepsis during support therapy for t-MDS. Other 2 patients died: 1 for acute renal failure and 1 for ictus cerebri.Fig. 1


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)

Progression Free Survival from RIT
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Progression Free Survival from RIT
Mentions: After 4 cycles of FCR 7 patients obtained CR and 2 PR, 2 patients in PR converted to CR after 90Y-RIT. In February 2015, with a median observation period of 95 months (range 20–114) since FCR and 88 months (range 13–104) since RIT, the median OS and the PFS have not been reached, 6/9 patients were alive in CR and current analysis has shown that either OS or PFS are 67 % at 7.5 year (Fig. 1). Grade 3 or 4 neutropenia occurred in 8/9 patients treated with FCR and in 9/9 patients assessable after 90Y-RIT. Subsequently to radioimmunotherapy the median neutrophil nadir was 0.8 × 109/ L (range 0.1-0.9 × 109/ L) at week 5, the median platelet count nadir was 49 × 109/ L (range 17–80 × 109/ L) at week 5. The median duration nadir for both neutrophils or platelets was 14 days. One patient developed herpes zoster infection after 8 months following valacyclovir discontinuation; another patient developed fungal infection. Both infections disappeared after specific treatment. One patient developed t-MDS (treatment-related myelodysplastic syndrome) at 26 months after 90Y-RIT. This patient before FCR and consolidation with 90Y-RIT had received 3 previous regimens: at diagnosis 6 courses of CHOP, at first relapse, 3 years later, 4 courses of FM/R (fludarabine, mitoxantrone plus rituximab) and after 1 year at the second relapse the patient received cyclophosphamide plus dexamethasone and rituximab, remaining in CR for 48 months. The patient died at 73 years of age of sepsis during support therapy for t-MDS. Other 2 patients died: 1 for acute renal failure and 1 for ictus cerebri.Fig. 1

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