CLINICAL NEWS
On Location Meeting on Hematologic Malignancies
TABLE 3.
Clinical Trial Enrollment and COG Availability per Agent Class
Allows enrollment
of patients
<18 years old
Agent Class
Limited to patients
≥18 years old
COG availability
Cytotoxic T lymphocytes
9
3
10
HDAC inhibitor
3
16
12
Small molecule
7
92
51
Monoclonal antibody
5
63
24
CAR T cell
12
22
19
Immunotherapy (CLTA4, PD1, PDL1, vaccine)
1
42
28
mTOR inhibitor
3
8
8
Tyrosine kinase inhibitors
7
46
27
Donor cells
4
4
8
Antibody-drug conjugate
3
35
15
Proteasome inhibitor
3
22
17
IMiD
3
6
4
5
Radioimmunotherapy
1
13
BiTE
0
3
3
PI3K inhibitor
0
18
10
Pleomorphic pathway modifier
0
4
1
Miscellaneous
3
4
7
The majority of the meeting program focused on How I
Treat presentations. During their presentations, speakers
asked the audience how they would respond to patient
cases. Audience members voted live at the meeting via
an audience response system. ASH Clinical News selected
two of these patient scenario questions to ask readers
what they would do. Here’s how your answers matched
up to your colleagues.
COG = Children’s Oncology Group; HDAC = histone deacetylases; CAR = chimeric antigen receptor; mTOR = mammalian target of rapamycin;
IMiD = immunomodulatory drug; BiTE = bi-specific T-cell engagers
TABLE 4.
Pre-Merger Versus Post-Merger Outcomes
Pre-Merger Period
(2002-2008)
Factors studied
ALL
AML
Total
leukemia
Post-Merger Period
(2008-2014)
Percent Increase
ALL
AML
Total
leukemia
ALL
AML
Total
leukemia
108
Clinical trial enrollments
51
1
52
67
41
108
31
4,000
Therapeutic trial enrollments
19
0
19
29
13
42
52
13 vs. 0
121
Hispanic patients enrolled
9
0
9
40
4
44
773
4 vs. 0
370
AfricanAmerican patients enrolled
8
1
9
17
12
29
111
1,100
220
AYA patients enrolled*
6
0
6
32
11
43
400
11 vs. 0
610
AYA = 15-39 years old; ALL = acute lymphocytic leukemia; AML = acute myeloid leukemia; AYA = adolescents and young adults
*
“It is accepted that the dramatic
historic decrease in mortality
from ALL and AML in children
and more recently AYA patients
is directly related to improved
participation in NCI-sponsored
COG clinical trials,” Dr. Mittal,
from the Department of Pediatrics
in the Division of Pediatric Hematology Oncology at Rush University Medical Center in Chicago,
Illinois, and authors wrote. “It is
also known that [patients in these
minority populations] are underrepresented in COG clinical trials
and may benefit from targeted
attention.”
The 2008 program was a collaboration between two COG institutions (the University of Illinois
at Chicago and Rush University)
and one non-member hospital
(John H. Stroger Hospital of Cook
County); this UIC/Rush/Stroger
COG Clinical Trials program
created a unified COG program,
using one lead international review
board and one research team.
The authors compared COG enrollment data from the pre-merger
period (2002-2008) and the post-
26
ASH Clinical News
merger period (2008-2014), and
collected information about clinical
trial participants’ race/ethnicity,
age at diagnosis, gender, insurance
status, and leukemia type.
In the post-merger period,
the rates of Hispanic, AfricanAmerican, and AYA patients
enrolled in therapeutic clinical
trials all increased (TABLE 4).
Enrollment rates were very low
for patients with AML before the
merger, and these patients experienced the greatest growth in
enrollment after the clinical trials
program was implemented.
In addition to increasing the
number of patients involved with
clinical trials, the UIC/Rush/Stroger COG Clinical Trials program
also increased the number of providers across all institutions who
were engaged in COG enrollment.
In the pre-merger period, seven
providers (6 pediatric oncologists
and 1 medical oncologist) were
involved in COG enrollment; in
the post-merger period, that number increased to 18 total providers
(9 pediatric oncologists, 6 medical
oncologists, and 3 pediatric nurse
practitioners).
You Make the Call
(ASH Meeting on Hematologic
Malignancies Edition!)
“A significant increase in
COG leukemia trial enrollment,
especially for under-represented
minorities and AYAs, was a
direct result of the creation of
the novel program,” the authors
concluded. “Improving access to
these clinical trials is essential to
addressing current disparities in
leukemia survival. … The UIC/
Rush/Stroger COG Program
serves as a model for improved
collaboration between competing institutions and specialists
within institutions to increase access to current clinical trials for
minority and AYA patients with
leukemia.” ●
REFERENCES
What would you recommend for a woman with highgrade MDS and increasing PRBC transfusion needs?
Patient Case: Mrs. Holland, a 70-year-old woman with a
long-standing history of del5q MDS, now presents with
increasing PRBC transfusion requirements. She was diagnosed in 2011, when her local oncologist started her on lenalidomide 10 mg PO BID and she had about three years
of transfusion independence while on this medication.
However, now she has had increasing PRBC needs. She
has had a trial of ESA for three months and her transfusion requirements have not decreased. Today, her WBC is
3.2 (low), her HGB is 6.5, and her platelet 80. Differential
is normal, although ANC 1200 and without blasts.
A bone marrow biopsy is performed and shows a
persistent myeloid neoplasm with 30 percent cellularity
and 18 percent blasts. Karyotyping shows 46,XX,del(5)
(q13q33)[20].
Here’s how MHM attendees and ASH Clinical News
readers would treat this patient:
a. Bone marrow transplant immediately:
5% [MHM] and 6.25% [ACN]
b. Increase lenalidomide dose: 4% and 0%
ypomethylating therapy with azacitidine/
c. H
decitabine: 72% and 87.5%
d. Combination therapy with HMT plus lenalidomide:
12% and 6.25%
e. Induction chemotherapy with “7+3”: 7% and 0%
What treatment would you recommend for a young
woman diagnosed with nodular sclerosing Hodgkin
lymphoma?
Patient Case: Mary, a 23-year-old woman presents
with a left supraclavicular mass, which has been slowly
growing over three months. Over the past six months,
pruritus has been steadily worsening, but she has no
other symptoms. A biopsy is performed and pathology
comes back with nodular sclerosing Hodgkin lymphoma.
She has a normal CBC and renal and liver function. A
PET/CT scan is performed and shows left lower neck,
mediastinal, left hilar lymphadenopathy, largest 4 cm.
Here’s how MHM attendees and ASH Clinical News
readers would treat this patient:
1. Crawley MA, Stein M, Patel K, Martin MG. Clinical trial
availability in adolescent and young adult patients
with non-Hodgkin lymphoma. Abstract #89225.
Presented at the ASH Meeting on Hematologic
Malignancies, September 16-17, 2016; Chicago, IL.
a. ABVD x 6: 13% and 32%
2. Mittal N, Martinez M, Davidson J, et al. Improving
access for adolescents and young adults (AYAs)
and underrepresented minorities with leukemia to
children’s oncology group (COG) clinical trials: A
novel collaborative approach to address disparities
in leukemia. Abstract #89542. Presented at the ASH
Meeting on Hematologic Malignancies, September
16-17, 2016; Chicago, IL.
c. ABVD x 3 => PET scan: 52% and 32%
b. ABVD x 2 + IFRT: 30% and 18%
d. PET negative => stop Tx; PET positive => IFRT:
0% and 14%
e. Mantle radiotherapy: 5% and 0%
f. AVD + brentuximab vedotin x 4: 0% and 4%
October 2016