Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma

Felipe Samaniego; Peter McLaughlin; Sattva S. Neelapu; Lei Feng; Michelle Fanale; Loretta Nastoupil; Maria Alma Rodriguez; Barbara Pro; Erin Taylor; Fredrick B. Hagemeister; Nathan Fowler

doi:10.1080/10428194.2020.1821005

Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma

Felipe Samaniego^*, Peter McLaughlin, Sattva S. Neelapu, Lei Feng, Michelle Fanale, Loretta Nastoupil, Maria Alma Rodriguez, Barbara Pro, Erin Taylor, Fredrick B. Hagemeister, Nathan Fowler

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

R-FND (rituximab, fludarabine, mitoxantrone, and dexamethasone) can induce molecular remissions in indolent lymphoma. The addition of ⁹⁰yttrium ibritumomab tiuxetan (⁹⁰YIT) radioimmunotherapy following first-line induction treatment in patients with advanced follicular lymphoma (FL) may improve remission rates. We now report 10-year follow-up results from our sequential treatment approach with an abbreviated regimen of R-FND followed by ⁹⁰YIT consolidation and rituximab maintenance. Forty-nine patients were enrolled; 47 received treatment. Patients had high-risk (FLIPI score ≥3) FL of grade 1–3A and stage III/IV with adequate hematologic function. Following R-FND, the complete and partial response rates were 91% and 8.5%, respectively. After ⁹⁰YIT consolidation, the CR rate increased to 97%. The 10-year PFS rate was 49%. The most common non-hematologic, grade 3 or 4 adverse events were fatigue, dyspnea, and myalgia. Five developed myelodysplastic syndrome (MDS). This treatment approach is most appropriate in FLIPI-based high-risk patients whose outlook with standard therapy is inadequate.

Original language	English (US)
Pages (from-to)	58-67
Number of pages	10
Journal	Leukemia and Lymphoma
Volume	62
Issue number	1
DOIs	https://doi.org/10.1080/10428194.2020.1821005
State	Published - 2021

Funding

For their support in bringing this project to completion, we thank the staff in the Department of Lymphoma and Myeloma at MD Anderson, including Stephanie Martch and Shayda Dioun for her assistance with writing and editing the manuscript. Our clinical protocol was approved by the MD Anderson Institutional Review Board and supported by the National Institute of Health/NCI, Cancer Center Support Grant P30 CA16672 (PI: Dr. Peter Pisters). This study was originally sponsored by Genentech and IDEC Pharmaceutical. Subsequently, IDEC’s role was taken over by Cell Therapeutics, and then Spectrum. Neither sponsor played a role in the design of the study; in the collection, analysis, and interpretation of the data; or in writing the manuscript. This study was originally sponsored by Genentech and IDEC Pharmaceutical. Subsequently, IDEC’s role was taken over by Cell Therapeutics, and then Spectrum. Neither sponsor played a role in the design of the study; in the collection, analysis, and interpretation of the data; or in writing the manuscript. Our clinical protocol was approved by the MD Anderson Institutional Review Board and supported by the National Institute of Health/NCI, Cancer Center Support Grant P30 CA16672 (PI: Dr. Peter Pisters).

Keywords

B-cell lymphoma
BCL2
Fludarabine
ibritumomab tiuxetan
radioimmunotherapy

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1080/10428194.2020.1821005

Cite this

Samaniego, F., McLaughlin, P., Neelapu, S. S., Feng, L., Fanale, M., Nastoupil, L., Rodriguez, M. A., Pro, B., Taylor, E., Hagemeister, F. B., & Fowler, N. (2021). Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma. Leukemia and Lymphoma, 62(1), 58-67. https://doi.org/10.1080/10428194.2020.1821005

@article{1a79453b65ad4e3bb2bf505b634c41bc,

title = "Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma",

abstract = "R-FND (rituximab, fludarabine, mitoxantrone, and dexamethasone) can induce molecular remissions in indolent lymphoma. The addition of 90yttrium ibritumomab tiuxetan (90YIT) radioimmunotherapy following first-line induction treatment in patients with advanced follicular lymphoma (FL) may improve remission rates. We now report 10-year follow-up results from our sequential treatment approach with an abbreviated regimen of R-FND followed by 90YIT consolidation and rituximab maintenance. Forty-nine patients were enrolled; 47 received treatment. Patients had high-risk (FLIPI score ≥3) FL of grade 1–3A and stage III/IV with adequate hematologic function. Following R-FND, the complete and partial response rates were 91% and 8.5%, respectively. After 90YIT consolidation, the CR rate increased to 97%. The 10-year PFS rate was 49%. The most common non-hematologic, grade 3 or 4 adverse events were fatigue, dyspnea, and myalgia. Five developed myelodysplastic syndrome (MDS). This treatment approach is most appropriate in FLIPI-based high-risk patients whose outlook with standard therapy is inadequate.",

keywords = "B-cell lymphoma, BCL2, Fludarabine, ibritumomab tiuxetan, radioimmunotherapy",

author = "Felipe Samaniego and Peter McLaughlin and Neelapu, {Sattva S.} and Lei Feng and Michelle Fanale and Loretta Nastoupil and Rodriguez, {Maria Alma} and Barbara Pro and Erin Taylor and Hagemeister, {Fredrick B.} and Nathan Fowler",

note = "Publisher Copyright: {\textcopyright} 2020 The University of Texas MD Anderson Cancer Center.",

year = "2021",

doi = "10.1080/10428194.2020.1821005",

language = "English (US)",

volume = "62",

pages = "58--67",

journal = "Leukemia and Lymphoma",

issn = "1042-8194",

publisher = "Informa Healthcare",

number = "1",

}

Samaniego, F, McLaughlin, P, Neelapu, SS, Feng, L, Fanale, M, Nastoupil, L, Rodriguez, MA, Pro, B, Taylor, E, Hagemeister, FB & Fowler, N 2021, 'Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma', Leukemia and Lymphoma, vol. 62, no. 1, pp. 58-67. https://doi.org/10.1080/10428194.2020.1821005

Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma. / Samaniego, Felipe; McLaughlin, Peter; Neelapu, Sattva S. et al.
In: Leukemia and Lymphoma, Vol. 62, No. 1, 2021, p. 58-67.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma

AU - Samaniego, Felipe

AU - McLaughlin, Peter

AU - Neelapu, Sattva S.

AU - Feng, Lei

AU - Fanale, Michelle

AU - Nastoupil, Loretta

AU - Rodriguez, Maria Alma

AU - Pro, Barbara

AU - Taylor, Erin

AU - Hagemeister, Fredrick B.

AU - Fowler, Nathan

PY - 2021

Y1 - 2021

N2 - R-FND (rituximab, fludarabine, mitoxantrone, and dexamethasone) can induce molecular remissions in indolent lymphoma. The addition of 90yttrium ibritumomab tiuxetan (90YIT) radioimmunotherapy following first-line induction treatment in patients with advanced follicular lymphoma (FL) may improve remission rates. We now report 10-year follow-up results from our sequential treatment approach with an abbreviated regimen of R-FND followed by 90YIT consolidation and rituximab maintenance. Forty-nine patients were enrolled; 47 received treatment. Patients had high-risk (FLIPI score ≥3) FL of grade 1–3A and stage III/IV with adequate hematologic function. Following R-FND, the complete and partial response rates were 91% and 8.5%, respectively. After 90YIT consolidation, the CR rate increased to 97%. The 10-year PFS rate was 49%. The most common non-hematologic, grade 3 or 4 adverse events were fatigue, dyspnea, and myalgia. Five developed myelodysplastic syndrome (MDS). This treatment approach is most appropriate in FLIPI-based high-risk patients whose outlook with standard therapy is inadequate.

AB - R-FND (rituximab, fludarabine, mitoxantrone, and dexamethasone) can induce molecular remissions in indolent lymphoma. The addition of 90yttrium ibritumomab tiuxetan (90YIT) radioimmunotherapy following first-line induction treatment in patients with advanced follicular lymphoma (FL) may improve remission rates. We now report 10-year follow-up results from our sequential treatment approach with an abbreviated regimen of R-FND followed by 90YIT consolidation and rituximab maintenance. Forty-nine patients were enrolled; 47 received treatment. Patients had high-risk (FLIPI score ≥3) FL of grade 1–3A and stage III/IV with adequate hematologic function. Following R-FND, the complete and partial response rates were 91% and 8.5%, respectively. After 90YIT consolidation, the CR rate increased to 97%. The 10-year PFS rate was 49%. The most common non-hematologic, grade 3 or 4 adverse events were fatigue, dyspnea, and myalgia. Five developed myelodysplastic syndrome (MDS). This treatment approach is most appropriate in FLIPI-based high-risk patients whose outlook with standard therapy is inadequate.

KW - B-cell lymphoma

KW - BCL2

KW - Fludarabine

KW - ibritumomab tiuxetan

KW - radioimmunotherapy

UR - http://www.scopus.com/inward/record.url?scp=85091029291&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85091029291&partnerID=8YFLogxK

U2 - 10.1080/10428194.2020.1821005

DO - 10.1080/10428194.2020.1821005

M3 - Article

C2 - 32924687

AN - SCOPUS:85091029291

SN - 1042-8194

VL - 62

SP - 58

EP - 67

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

IS - 1

ER -

Initial report of a phase II study with R-FND followed by ibritumomab tiuxetan radioimmunotherapy and rituximab maintenance in patients with untreated high-risk follicular lymphoma

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this