ASH Clinical News July 2017 Bonus Issue | Page 10

You Make the Call : Readers ’ Response
Dose-adjusted EPOCH-R plus radiation therapy . Carmelo Carlo-Stella , MD Humanitas Cancer Center
Milan , Italy
R-CHOP x6 .
Martha Arellano , MD
Winship Cancer Institute Atlanta , GA
R-EPOCH x6 . Robert K . Stuart , MD
Medical University of South Carolina Charleston , SC
I would give dose-adjusted EPOCH-R to this patient . Amir Steinberg , MD Mount Sinai Hospital
New York , NY
R-CHOP x3-4 then radiation .
R-CHOP x6 .
Juan M . Alcantar , MD UCLA Health
Los Angeles , CA
Cesar M . Campo , MD Santa Fe , Argentina
Dose-adjusted EPOCH-R .
Indu Sabnani , MD Maplewood , NJ
I would be sure this is not double-hit lymphoma . If not , R-CHOP will do .
Achiel Van Hoof , MD General Hospital St-Jan
Brugge , Belgium
the full prescribing information ]. PROMACTA was administered to
330 patients for at least 6 months and 218 patients for at least 1 year .
Table 4 presents the most common adverse drug reactions ( experienced
by greater than or equal to 3 % of patients receiving PROMACTA ) from
the three placebo-controlled trials , with a higher incidence in PROMACTA
versus placebo .
Table 4 . Adverse Reactions ( ≥3 %) from Three Placebo-controlled Trials
in Adults with Chronic Immune ( Idiopathic ) Thrombocytopenia
PROMACTA 50 mg
Placebo
n = 241
n = 128
Adverse Reaction
(%)
(%)
Nausea
9
3
Diarrhea
9
7
Upper respiratory tract infection
7
6
Vomiting
6
< 1
Increased ALT
5
3
Myalgia
5
2
Urinary tract infection
5
3
Oropharyngeal pain
4
3
Increased AST
4
2
Pharyngitis
4
2
Back pain
3
2
Influenza
3
2
Paresthesia
3
2
Rash
3
2
In the three controlled clinical chronic ITP trials , alopecia , musculoskeletal pain , blood alkaline phosphatase increased , and dry mouth were the adverse reactions reported in 2 % of patients treated with PROMACTA and in no patients who received placebo .
Among 302 patients with chronic ITP who received PROMACTA in the single-arm extension trial , the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled trials . Table 5 presents the most common treatment-related adverse reactions ( experienced by greater than or equal to 3 % of patients receiving PROMACTA ) from the extension trial .
Table 5 . Treatment-related Adverse Reactions ( ≥3 %) from Extension Trial in Adults with Chronic Immune ( Idiopathic ) Thrombocytopenia
PROMACTA 50 mg n = 302
Adverse Reaction (%)
Headache 10 ALT increased 5 AST increased 5 Cataract 5 Fatigue 5 Blood bilirubin increased 4 Nausea 4 Hyperbilirubinemia 3 Diarrhea 3
In the three controlled chronic ITP trials , serum liver test abnormalities ( predominantly Grade 2 or less in severity ) were reported in 11 % and 7 % of patients for PROMACTA and placebo , respectively . Four patients ( 1 %) treated with PROMACTA and three patients in the placebo group ( 2 %) discontinued treatment due to hepatobiliary laboratory abnormalities . Seventeen of the patients treated with PROMACTA in the controlled trials with hepatobiliary laboratory abnormalities were re-exposed to PROMACTA in the extension trial . Eight of these patients again experienced liver test abnormalities ( less than or equal to Grade 3 ) resulting in discontinuation of PROMACTA in one patient . In the extension chronic ITP trial , six additional patients had PROMACTA discontinued due to liver test abnormalities ( less than or equal to Grade 3 ).
In clinical trials in patients with chronic ITP , one patient treated with PROMACTA (< 1 %) experienced drug-induced liver injury [ see Warnings and Precautions ( 5.2 )].
In a placebo-controlled trial of PROMACTA in patients with chronic liver disease and thrombocytopenia not related to ITP , six patients treated with PROMACTA and one patient in the placebo group developed portal vein thromboses [ see Warnings and Precautions ( 5.3 )].
Pediatric Patients : The data described below reflect median exposure to
PROMACTA of 91 days for 107 pediatric patients ( aged 1 to 17 years )
with chronic ITP , of whom 53 % were female , across the randomized
phase of two placebo-controlled trials .
Table 6 presents the most common adverse drug reactions ( experienced
by greater than or equal to 3 % of pediatric patients 1 year and older
receiving PROMACTA ) across the two placebo-controlled trials , with a
higher incidence for PROMACTA versus placebo .
Table 6 . Adverse Reactions ( ≥3 %) with a Higher Incidence for PROMACTA
versus Placebo from Two Placebo-controlled Trials in Pediatric Patients
1 Year and Older with Chronic Immune ( Idiopathic ) Thrombocytopenia
PROMACTA
Placebo
n = 107
n = 50
Adverse Reaction
(%)
(%)
Upper respiratory tract infection
17
6
Nasopharyngitis
12
4
Cough
9
0
Diarrhea
9
2
Pyrexia
9
8
Rhinitis
9
6
Abdominal pain
8
4
Oropharyngeal pain
8
2
Toothache
6
0
ALT increased a
6
0
Rash
5
2
AST increased
4
0
Rhinorrhea
4
0
a Includes adverse reactions or laboratory abnormalities > 3 x ULN .
Chronic Hepatitis C-associated Thrombocytopenia : In the two placebocontrolled
trials , 955 patients with chronic hepatitis C-associated thrombo -
cytopenia received PROMACTA . Table 7 presents the most common
adverse drug reactions ( experienced by greater than or equal to 10 % of
patients receiving PROMACTA compared with placebo ).
Table 7 . Adverse Reactions ( ≥10 % and Greater than Placebo ) from Two
Placebo-controlled Trials in Adults with Chronic Hepatitis C
PROMACTA
Placebo
+ Peginterferon / Ribavirin
+ Peginterferon / Ribavirin
n = 955
n = 484
Adverse Reaction
(%)
(%)
Anemia
40
35
Pyrexia
30
24
Fatigue
28
23
Headache
21
20
Nausea
19
14
Diarrhea
19
11
Decreased appetite
18
14
Influenza-like illness
18
16
Asthenia
16
13
Insomnia
16
15
Cough
15
12
Pruritus
15
13
Chills
14
9
Myalgia
12
10
Alopecia
10
6
Peripheral edema
10
5
Rash was reported in 9 % and 7 % of patients receiving PROMACTA and placebo , respectively .
In the two controlled clinical trials in patients with chronic hepatitis C , hyperbilirubinemia was reported in 8 % of patients receiving PROMACTA compared with 3 % for placebo . Total bilirubin greater than or equal to 1.5 x ULN was reported in 76 % and 50 % of patients receiving PROMACTA and placebo , respectively . ALT or AST greater than or equal to 3 x ULN was reported in 34 % and 38 % of patients for PROMACTA and placebo , respectively .