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NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.

2017 – Update Meeting – 06/27/16 and 06/28/16

Follicular Lymphoma (FOLL)


Guideline Page Institution Vote
Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
FOLL-B
Internal request Based on the discussion regarding the data in the noted references
Panel discussion to reassess the for lenalidomide + rituximab as a first-line therapy for FL, the panel 12 9 3 3
category designation for consensus vote resulted in a category change from a category 3 to a
lenalidomide + rituximab as a first- category 2B recommendation.
line therapy for FL.  Martin P, Jung S-H, Johnson JL, et al. CALGB 50803 (Alliance):
A phase II trial of lenalidomide plus rituximab in patients with
previously untreated follicular lymphoma [abstract]. J Clin Oncol
2014;32:Abstract 8521.
 Fowler N, Davis R, Rawal S, et al. Safety and activity of
lenalidomide and rituximab in untreated indolent lymphoma: an
open-label, phase 2 trial. The Lancet Oncology 2014;15:1311-
1318.
FOLL-B
Internal request Based on the panel discussion regarding the long-term toxicity
Panel discussion to reassess the associated with radioimmunotherapy and superiority of maintenance 18 5 3 1
inclusion of radioimmunotherapy rituximab for the treatment of FL, the panel consensus vote resulted
as first-line consolidation or in the radioimmunotherapy category changing from a category 2A to
extended dosing for FL. a category 2B recommendation.

FOLL-B
Internal request Based on the on the discussion of data from the multicenter phase II
Panel discussion to add a qualifier trial (noted in the reference below) that evaluated idelalisib in patients 11 7 8 1
statement for the use of idelalisib with patients with indolent NHL who had received extensive prior
as second-line and subsequent treatment, the panel consensus was to include the qualifier statement
therapy for FL. “refractory to both alkylator and rituximab” for the use of idelalisib as
second-line and subsequent therapy for FL, to be consistent with the
eligibility criteria that were used in the aforementioned trial.
 Gopal A, Kahl B, De Vos S, et al. PI3Kδ inhibition by idelalisib in
patients with relapsed indolent lymphoma. N Engl J Med
2014;370:1008-1018.
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16

FOLL-B
External request Based on the submitted references and discussion, the panel
Submission from Genentech, inc consensus was to include bendamustine + obinutuzumab as an 22 1 3 1
to consider the overall survival option for second-line and subsequent therapy for FL. This was
results for the follicular lymphoma added as a category 2A recommendation.
patient population from the  See submission for references.
GADOLIN study and the following
new FDA-approved indication for
obinutuzumab: obinutuzumab is
indicated in combination with
bendamustine followed by
obinutuzumab monotherapy, for
the treatment of patients with
follicular lymphoma who relapsed
after, or are refractory to, a
rituximab containing regimen.

FOLL-B
Internal request In the aforementioned GADOLIN study, patients with indolent NHL 9 14 2 2
Panel discussion to determine if refractory to rituximab were randomized to bendamustine plus
the data to support bendamustine obinutuzumab or bendamustine monotherapy. Non-progressing
+ obinutuzumab is category 1 patients in the bendamustine plus obinutuzumab group received
level evidence for second-line and obinutuzumab maintenance. Although bendamustine plus
subsequent therapy for FL. obinutuzumab followed by obinutuzumab maintenance had improved
efficacy over bendamustine monotherapy, based on the study design
(noted above), the panel consensus was that the available evidence
does not support the inclusion of bendamustine + obinutuzumab with
a category 1 recommendation.

 Sehn LH, Chua NS, Mayer J, et al. GADOLIN: Primary results


from a phase III study of obinutuzumab plus bendamustine
compared with bendamustine alone in patients with rituximab-
refractory indolent non-Hodgkin lymphoma [abstract]. J Clin
Oncol 2015;33(15_ suppl):Abstract LBA8502.

FOLL-B
Internal request Based on the discussion for obinutuzumab maintenance for
Panel discussion to reassess the rituximab-refractory disease for second-line consolidation of FL, the 18 3 5 1
category designation for panel consensus vote resulted in a category change from a category
obinutuzumab maintenance for 2B to a category 2A recommendation.
rituximab-refractory disease for
second-line consolidation of FL.
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16

Mantle Cell Lymphoma (MANT)


Guideline Page Institution Vote
Panel Discussion/References
and Request YES NO ABSTAIN ABSENT

MANT-A
Internal request Based on the noted reference and discussion, the panel consensus
Institutional review comment to was to include lenalidomide + rituximab as a less aggressive induction 22 0 3 2
consider the inclusion of therapy option. This was added as a category 2A recommendation.
lenalidomide + rituximab as a  Ruan J, Martin P, Shah B, et al. Lenalidomide plus rituximab as
less aggressive induction initial treatment for mantle-cell lymphoma. N Engl J Med
therapy option. 2015;373:1835-44.

MANT-A
Internal request Based on the noted reference and discussion, the panel consensus
Institutional review comment to was to include bendamustine, bortezomib and rituximab as a second- 13 5 7 2
consider the inclusion of line treatment option for patients with MCL. This was added as a
bendamustine, bortezomib and category 2B recommendation.
rituximab as a second-line  Friedberg JW, Vose JM, Kelly JL, et al. The combination of
treatment option for patients with bendamustine, bortezomib, and rituximab for patients with
MCL. relapsed/refractory indolent and mantle cell non-Hodgkin
lymphoma. Blood 2011;117:2807-2812.

MANT-A
Internal request Based on the panel discussion regarding the limited data and activity 7 13 5 2
Institutional review comment to for fludarabine, cyclophosphamide ± rituximab for the second-line
reassess the inclusion of treatment of FL, the panel consensus vote resulted in the category
fludarabine, cyclophosphamide ± changing from a category 2A to a category 3 recommendation.
rituximab as a second-line
treatment option for patients with
MCL.

MANT-A The panel discussion and consensus was that fludarabine,


Internal request cyclophosphamide, mitoxantrone, and rituximab should be removed as 0 19 3 5
Institutional review comment to a second-line treatment option for MCL due to limited clinical use and
reassess the inclusion of activity.
fludarabine, cyclophosphamide,
mitoxantrone, and rituximab as a
second-line treatment option for
patients with MCL.
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16

MANT-A The panel discussion and consensus was that fludarabine,


Internal request mitoxantrone and rituximab should be removed as a second-line 0 21 0 6
Institutional review comment to treatment option for MCL due to limited clinical use and activity.
reassess the inclusion of
fludarabine, mitoxantrone and
rituximab as a second-line
treatment option for patients with
MCL.

MANT-A Based on the panel discussion regarding the limited data and activity
Internal request for pentostatin, cyclophosphamide and rituximab for the second-line 3 15 5 4
Institutional review comment to treatment of FL, the panel consensus vote resulted in the category
reassess the inclusion of changing from a category 2A to a category 3 recommendation.
pentostatin, cyclophosphamide
and rituximab as a second-line
treatment option for patients with
MCL.

MANT-A Based on the panel discussion regarding the limited data and activity
Internal request for prednisone, etoposide, procarbazine, cyclophosphamide ± 6 12 4 5
Institutional review comment to rituximab for the second-line treatment of FL, the panel consensus
reassess the inclusion of vote resulted in the category changing from a category 2A to a
prednisone, etoposide, category 3 recommendation.
procarbazine, cyclophosphamide
± rituximab as a second-line
treatment option for patients with
MCL.

MANT-A Based on the noted reference and discussion, the panel consensus
Internal request was to include venetoclax as a second-line treatment option for 23 0 2 4
Discussion comment to consider patients with MCL. This was added as a category 2A recommendation.
the inclusion of venetoclax as a  Gerecitano JF et al. A Phase 1 study of venetoclax (ABT-199 /
second-line treatment option for GDC-0199) monotherapy in patients with relapsed/refractory Non-
patients with MCL. Hodgkin Lymphoma. Blood 2015;126:Abstract 254
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16

Diffuse Large B-cell Lymphoma (BCEL)


Guideline Page Institution Vote
Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
BCEL-C
Internal request Based on the panel discussion, the consensus was to include gemcitabine, 4 15 4 4
Institutional review vinorelbine ± rituximab as a second-line and subsequent therapy option for
comment to include patients with DLBCL who are not candidates for high-dose therapy. This was
gemcitabine, added with a category 3 designation.
vinorelbine, rituximab  Papageorgiou ES, Tsirigotis P, Dimopoulos M, et al. Combination
as a second-line and chemotherapy with gemcitabine and vinorelbine in the treatment of relapsed
subsequent therapy or refractory diffuse large B-cell lymphoma: a phase-II trial by the Hellenic
option for patients with Cooperative Oncology Group. Eur J Hematol 2005;75:124-129.
DLBCL who are not  Xiros N, Economopoulos T, Valsami S, et al. Rituximab in combination with
candidates for high- vinorelbine/gemcitabine chemotherapy in patients with primary refractory or
dose therapy. early relapsed T cell rich B cell lymphoma. A pilot study. Leuk Res
2003;27:1097-1099.
 Müller-Beissenhirtz H, Kasper C, Nückel H, Dührsen U. Gemcitabine,
vinorelbine and prednisone for refractory or relapsed aggressive lymphoma,
results of a phase II single center study. Ann Hematol 2005;84:796-801.

Supportive Care
Guideline Page Institution Vote
Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
NHODG-B
External request 17 2 1 7
Submission request from Based on the of current data, the panel consensus was that the dose of
Sanofi to: rasburicase as listed in the guidelines is safe and effective. Therefore,
 Under the “First-line and at the panel voted that the information regarding rasburicase dose should
retreatment for remain the same.
hyperuricemia” bullet,
change wording to “For
inpatient treatment, one
dose of rasburicase is
frequently adequate.
Doses of 3-6 mg are
usually effective. Redosing
should be individualized.”
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16

 Add additional bullet:


“Currently the available
data evaluating the use of
fixed dose rasburicase are
limited to use in the
inpatient setting only along
with careful and frequent
monitoring. For outpatient
use, where monitoring is
limited or insufficient, the
labeled weight-based dose
of 0.2 mg/kg of
rasburicase may be more
appropriate, as well as the
use of multiple rasburicase
doses.”

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