On Location
6 months post-HCT. QoL, depression, and anxiety
symptoms were assessed at the time of admission
for HCT, week 2 of hospitalization, and 6 months
post-transplant.
The mean age of patients in the study was 56.3
years. Of the 250 patients, 48.8% (n=122) were
male and 51.2% (n=128) were female. The majority
(88%) were white. Diagnoses included:
• acute leukemia: 81 patients (32.4%)
• lymphoma: 71 (28.4%)
• myeloma: 50 (20%)
• other hematologic malignancy (such as myelodysplastic
syndromes or a myeloproliferative
neoplasm): 48 (19.2%)
Nearly one-half (44%; n=110) were undergoing
autologous HCT, while 19.2% (n=48) were undergoing
myeloablative allogeneic HCT, and 36.8%
(n=92) were undergoing reduced intensity conditioning
allogeneic HCT.
Of the patients enrolled in the study, 18.9%
experienced PTSD symptoms, the most common
of which were avoidance and hypervigilance.
Patients who were married or had a long-term
partner were less likely to experience PTSD symptoms,
while those who had anxiety or depression
symptoms at baseline or an increase in anxiety
during the HCT process were more likely to develop
PTSD symptoms.
“Intervention during HCT could be beneficial
in preventing PTSD symptoms,” Ms. Griffith concluded.
“For example, we know from other work of
our research group that integrating palliative care
during the transplant hospitalization can reduce
the risk of PTSD at 6 months post-transplant.”
Limitations of this study include its homogenous
patient population from a single tertiary
hospital and inability to assess the causality of the
relationship between baseline factors and PTSD
symptoms.
The authors report no relevant conflicts of interest.
References
1. Griffith S, Fenech AL, Nelson A. Post-traumatic stress symptoms in hematopoietic
stem cell transplant (HCT) recipients. Abstract #7505. Presented as
part of the ASCO20 Virtual Scientific Program. May 29-31, 2020.
2. Griffith S, Fenech AL, Nelson A, et al. Post-traumatic stress symptoms in
hematopoietic stem cell transplant (HCT) recipients. J Clin Oncol. 38: 2020
(suppl; abstr 7505).
KEYNOTE-204: Pembrolizumab Superior to Brentuximab in Relapsed/Refractory
Classic Hodgkin Lymphoma
Treatment with anti-PD-1 antibody pembrolizumab
prolonged progression-free survival (PFS)
more than brentuximab vedotin (BV) in patients
with relapsed or refractory classic Hodgkin lymphoma
(cHL), including patients ineligible for
transplant, according to findings from the phase
III KEYNOTE-204 trial presented as part of the
ASCO20 Virtual Scientific Program.
Salvage chemotherapy and autologous hematopoietic
cell transplant (AHCT) represent the
standard of care for relapsed/refractory cHL,
explained study author John Kuruvilla, MD, of
the Princess Margaret Cancer Centre in Toronto,
ON, Canada. Unfortunately, there is no standard
of care for patients who are ineligible for
AHCT due to chemotherapy-refractory disease,
comorbidities, or advanced age. Based on the
findings from KEYNOTE-204, Dr. Kuruvilla said,
“Pembrolizumab should be considered the preferred
treatment option and new standard of
care for the treatment of relapsed/refractory cHL
in patients that have relapsed post-AHCT or are
ineligible for AHCT.”
The trial enrolled patients with relapsed/
refractory cHL who had either undergone or were
ineligible for AHCT. Patients were eligible regardless
of prior exposure to BV. All patients had an
Eastern Cooperative Oncology Group (ECOG) Performance
Status score of 0 or 1 and measurable
disease. Measurable disease was defined as ≥1
lesion that could be measured in ≥2 dimensions
with the use of a spiral computed tomography
(CT) scan or combined CT plus positron emission
tomography (PET) scan.
Patients were randomly assigned to either
intravenous pembrolizumab 200 mg every 3
weeks (n=148) or intravenous BV 1.8 mg/kg every 3
weeks (n=152). The investigators stratified patients
within treatment groups by whether they had a
prior AHCT (pembrolizumab: n=56; BV: n=56) or
had no history of AHCT (pembrolizumab: n=95;
BV: n=97).
In addition, patients were stratified by post–
firstline therapy status:
• primary refractory after end of first-line
therapy (pembrolizumab: n=61; BV: n=62)
• relapsed <12 months after end of first-line
therapy (pembrolizumab: n=42; BV: n=42)
• relapsed ≥12 months after end of first-line
therapy (pembrolizumab: n=48; BV: n=49)
The primary endpoints of the trial included
PFS and overall survival (OS). Secondary endpoints
included the objective response rate (ORR)
and safety as well as duration of response (DOR).
In the pembrolizumab and BV groups, the
median ages were 36 years (range = 18-84) and
35 years (range = 18-83), respectively. More than
half of patients had an ECOG score of 0 (58% in
the pembrolizumab and 65.3% in the BV arm).
Only 3.3% of patients randomized to pembrolizumab
and 6.5% of patients randomized to BV
had prior exposure to BV.
Prior radiation was recorded for 38.4% of
patients in the pembrolizumab group and 39.9%
of patients in the BV group. The median numbers
of prior therapies were 2 (range = 1-10) and
3 (range = 1-11), respectively.
The median time from randomization to data
cutoff was 25.7 months (range = 18.2-42.3), and
the median follow-up period was 24.7 months
(range = 0.6-42.3). The median time patients
spent on therapy was 305 days (range = 1-814) for
those receiving pembrolizumab and 146.5 days
(range = 1-794) for those on BV.
A slightly smaller proportion of patients treated
with pembrolizumab experienced grade 3 to 5
treatment-related adverse events (TRAEs) compared
with BV (19.6% vs. 25.0%). There was 1
death associated with a TRAE, grade 5 pneumonia,
recorded in the pembrolizumab arm.
In the primary PFS analysis, pembrolizumab
was associated with significantly greater improvement
in median PFS compared with BV (13.2
vs. 8.3 months, respectively; hazard ratio [HR] =
0.65; 95% CI 0.48-0.88; p=0.00271). The 12-month
PFS rate was 53.9% in the pembrolizumab group
versus 35.6% in the BV group.
Treatment with pembrolizumab was also associated
with significantly greater improvements
in PFS compared with BV in various subgroups,
including:
• patients with no AHCT (HR=0.61; 95% CI
0.42-0.89)
• patients with primary refractory disease
(HR=0.52; 95% CI 0.33-0.83)
• patients with prior BV (HR=0.34; 95% CI
0.04-3.10)
• BV-naïve patients (HR=0.67; 95% CI
0.49-0.92)
The ORRs were 65.6% for pembrolizumab and
54.2% for BV. The complete response rates were
24.5% for pembrolizumab and 24.2% for BV. A
longer median duration of response was observed
for pembrolizumab (20.7 months [range = 0.0-
33.2]) versus BV (13.8 months [range = 0.0-33.9]).
Study authors report relationships with Merck,
which sponsored this trial.
Reference
Kuruvilla J, Ramchandren R, Santoro A, et al. KEYNOTE-204: Randomized, openlabel,
phase III study of pembrolizumab (pembro) versus brentuximab vedotin
(BV) in relapsed or refractory classic Hodgkin lymphoma (R/R cHL). Abstract
8005. Presented as part of the ASCO20 Virtual Scientific Program. May 29-31,
2020.
18 ASH Clinical News July 2020 Bonus Mid-Year Edition