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 |
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 |