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ADCETRIS® (brentuximab vedotin) is indicated for the treatment of pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.
Event-free survival: HR: 0.41 (95% CI: 0.25, 0.67); P = 0.0002; median follow-up: 42.1 months.1,2
AHOD1331 Trial Design: A randomized, open-label trial assessing the efficacy and safety of ADCETRIS+AVEPC vs ABVE-PC in 600 pediatric patients (2 to <22 years of age) with previously untreated high-risk cHL. High risk was defined as Ann Arbor Stage IIB with bulk disease, Stage IIIB, Stage IVA, and Stage IVB. Primary endpoint was event-free survival, defined as the time from randomization to the earliest of disease progression or relapse, second malignancy, or death due to any cause.1
*ADCETRIS will not work for everyone.
ABVE-PC = doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide; AVEPC =
doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide; cHL = classical Hodgkin lymphoma; CI = confidence interval; HR = hazard ratio.
*Does not apply to C86.2, C86.5, or C86.6.
ALCL = anaplastic large cell lymphoma; ALK = anaplastic lymphoma kinase; ATLL = adult T-cell leukemia/lymphoma; CPT = Current Procedural Terminology; CTCL = cutaneous T-cell lymphoma; HCPCS = Healthcare Common Procedure Coding System; HL = Hodgkin lymphoma; ICD-10-CM = International Classification of Diseases, Tenth Revision, Clinical Modification; MF = mycosis fungoides; NDC = National Drug Code; PTCL = peripheral T-cell lymphoma; PTCL-NOS = peripheral T-cell lymphoma, not otherwise specified.
References: 1. CMS.gov. ICD-10-CM tabular list of diseases and injuries. Centers for Medicare and Medicaid Services; 2019. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2019-ICD-10-CM-Tables-and-Index.zip. File name: icd10cm_tabular_2019.pdf. Accessed January 5, 2020. 2. ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc. October 2019. 3. CMS.gov. HCPCS codes. Centers for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2020-Alpha-Numeric-HCPCS-File. File name: HCPC2020_ANWEB_w_disclaimer.xls. Accessed February 20, 2020. 4. American Medical Association. CPT 2019 Professional. Chicago, IL: American Medical Association; 2020.
G-CSF was given as support for both arms.2
Primary endpoint: Event-free survival1
Selected baseline characteristics1
*Bulk tumor was defined as large mediastinal adenopathy (transverse tumor diameter more than one third the thoracic diameter at the dome of the diaphragm on a 1.83-meter posterior–anterior upright chest radiograph) or extramediastinal bulk (a continuous aggregate of nodal tissue outside the mediastinum that measured >6 cm in the transverse dimension on axial CT or the longest dimension on coronal or sagittal reformatted CT).2
†Dosage in AHOD1331: ADCETRIS+AVEPC arm: ADCETRIS 1.8 mg/kg over 30 minutes (day 1), doxorubicin 25 mg/m2 (days 1 and 2), vincristine 1.4 mg/m2 (day 8), etoposide 125 mg/m2 (days 1-3), prednisone 20 mg/m2 BID (days 1-7), cyclophosphamide 600 mg/m2 (days 1 and 2). ABVE-PC arm: doxorubicin 25 mg/m2 (days 1 and 2), bleomycin 5 units/m2 (day 1) and 10 units/m2 (day 8), vincristine 1.4 mg/m2 (days 1 and 8), etoposide 125 mg/m2 (days 1-3), prednisone 20 mg/m2 BID (days 1-7), cyclophosphamide 600 mg/m2 (days 1 and 2). Both arms received G-CSF. Each cycle was 21 days.1,2
‡ISRT (21 Gy) was prescribed after 5 cycles of systemic therapy for patients with LMA and to SRL with a 5PS of >3 at iPET; boost dose of 9 Gy was given to sites with incomplete metabolic response (5PS 3-5) at end of cycle 5.2
5PS = 5-point scale; BID = twice per day; CT = computed tomography; G-CSF = granulocyte colony–stimulating factor;
Gy = Gray; IMR = incomplete metabolic response; iPET = interim positron emission tomography;
ISRT = involved site radiation therapy; LMA = large mediastinal adenopathy; SRL = slowly responding lesion.
G-CSF was given as support for both arms.2
Primary endpoint: Event-free survival1
Selected baseline characteristics1
*Bulk tumor was defined as large mediastinal adenopathy (transverse tumor diameter more than one third the thoracic diameter at the dome of the diaphragm on a 1.83-meter posterior–anterior upright chest radiograph) or extramediastinal bulk (a continuous aggregate of nodal tissue outside the mediastinum that measured >6 cm in the transverse dimension on axial CT or the longest dimension on coronal or sagittal reformatted CT).2
†Dosage in AHOD1331: ADCETRIS+AVEPC arm: ADCETRIS 1.8 mg/kg over 30 minutes (day 1), doxorubicin 25 mg/m2 (days 1 and 2), vincristine 1.4 mg/m2 (day 8), etoposide 125 mg/m2 (days 1-3), prednisone 20 mg/m2 BID (days 1-7), cyclophosphamide 600 mg/m2 (days 1 and 2). ABVE-PC arm: doxorubicin 25 mg/m2 (days 1 and 2), bleomycin 5 units/m2 (day 1) and 10 units/m2 (day 8), vincristine 1.4 mg/m2 (days 1 and 8), etoposide 125 mg/m2 (days 1-3), prednisone 20 mg/m2 BID (days 1-7), cyclophosphamide 600 mg/m2 (days 1 and 2). Both arms received G-CSF. Each cycle was 21 days.1,2
‡ISRT (21 Gy) was prescribed after 5 cycles of systemic therapy for patients with LMA and to SRL with a 5PS of >3 at iPET; boost dose of 9 Gy was given to sites with incomplete metabolic response (5PS 3-5) at end of cycle 5.2
5PS = 5-point scale; BID = twice per day; CT = computed tomography; G-CSF = granulocyte colony–stimulating factor;
Gy = Gray; IMR = incomplete metabolic response; iPET = interim positron emission tomography;
ISRT = involved site radiation therapy; LMA = large mediastinal adenopathy; SRL = slowly responding lesion.
A+AVEPC = ADCETRIS + doxorubicin, vincristine, etoposide, prednisone, cyclophosphamide.
ADCETRIS+AVEPC (n = 296), % of patients |
ABVE-PC (n = 297), % of patients |
|||||
System Organ Class Preferred Term |
Grade 3 | Grade 4 | Grade 3 | Grade 4 | ||
Blood and lymphatic system disorders | ||||||
Anemia | 35 | 1.7 | 28 | 2 | ||
Febrile neutropenia | 28 | 3.4 | 31 | 1.7 | ||
Lymphopenia | 13 | 11 | 8 | 18 | ||
Thrombocytopenia* | 10 | 22 | 11 | 16 | ||
Neutropenia | 8 | 43 | 4.4 | 36 | ||
Gastrointestinal disorders | ||||||
Stomatitis | 10 | - | 7 | - | ||
Nausea | 3.7 | - | 2 | - | ||
Vomiting | 3.7 | - | 1.3 | - | ||
Diarrhea | 2.4 | - | 0.3 | - | ||
Colitis | 2 | 0.3 | 1 | - | ||
Infections and infestations | ||||||
Infections† | 9 | 2.7 | 7 | 3.4 | ||
Nervous system disorders | ||||||
Peripheral sensory neuropathy | 6 | - | 4.4 | - | ||
Metabolism and nutrition disorders | ||||||
Hypokalemia | 5 | 0.7 | 6 | 1 | ||
Hyponatremia | 3.4 | - | 3 | - | ||
Decreased appetite | 2.7 | - | 1.7 | - | ||
Dehydration | 2.7 | - | 1 | - | ||
Hepatobiliary disorders | ||||||
Alanine aminotransferase increased | 3.7 | 0.3 | 2.7 | 0.3 | ||
General disorders and administration site conditions | ||||||
Infusion-related reactions‡ | 3 | 1 | 5 | 1 |
Serious adverse reactions occurred in 22% of patients who received ADCETRIS+AVEPC chemotherapy. Serious adverse reactions in >2% of patients included hypotension (3%) and febrile neutropenia (3%).1
*Includes thrombocytopenia and platelet count decreased.
†Includes sepsis, device related infection, skin infection, enterocolitis infectious, pneumonia, appendicitis, cellulitis, urinary tract infection, candida infection, mucosal infection, vaginal infection, wound infection, anorectal infection, arteritis infective, bacteremia, catheter site infection, clostridium difficile colitis, gastroenteritis norovirus, gingivitis, H1N1 influenza, herpes simplex reactivation, infective myositis, klebsiella bacteremia, klebsiella sepsis, meningitis, esophageal infection, oral candidiasis, osteomyelitis, otitis media, septic shock, serratia infection, sinusitis, soft tissue infection, staphylococcal infection, vulvitis.
‡Includes anaphylactic reaction, hypersensitivity, drug hypersensitivity, infusion related reaction, and bronchospasm.
Administer as an
intravenous infusion
over 30 minutes
Every 3 weeks
Administer G-CSF primary
prophylaxis beginning with
Cycle 1 of A+AVEPC
*The dose for patients weighing greater than 100
kg should be calculated based on a weight of 100 kg.1
Recommended dosage in patients with renal impairment: No dosage adjustment is required for mild renal impairment (CrCL >50-80 mL/min) and moderate renal impairment (CrCL 30-50 mL/min). Avoid use in patients with severe (CrCL <30 mL/min) renal impairment.1
Recommended dosage in patients with hepatic impairment: Reduce the dosage of ADCETRIS to 1.2 mg/kg up to a maximum of 120 mg every 3 weeks for patients with mild hepatic impairment (Child-Pugh A). Avoid use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.1
Severity† |
Dose Modifications
|
Grade 2
|
|
Grade 3
|
|
Grade 4 |
|
Severity |
Dose Modifications
|
Grade 3 or 4 |
|
†Peripheral neuropathy was assessed using the Balis
Scale.1
G-CSF = granulocyte colony–stimulating factor.
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of:
Previously untreated Stage III/IV cHL
Previously untreated high risk cHL
cHL post-auto-HSCT consolidation
Relapsed cHL
Previously untreated sALCL or other CD30-expressing PTCL
Relapsed sALCL
Relapsed pcALCL or CD30-expressing MF
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
CONTRAINDICATION
Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.
DRUG INTERACTIONS
Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.
USE IN SPECIAL POPULATIONS
Lactation: Breastfeeding is not recommended during ADCETRIS treatment.
Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of:
Previously untreated Stage III/IV cHL
Previously untreated high risk cHL
cHL post-auto-HSCT consolidation
Relapsed cHL
Previously untreated sALCL or other CD30-expressing PTCL
Relapsed sALCL
Relapsed pcALCL or CD30-expressing MF
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
CONTRAINDICATION
Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.
DRUG INTERACTIONS
Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.
USE IN SPECIAL POPULATIONS
Lactation: Breastfeeding is not recommended during ADCETRIS treatment.
Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.
References: 1. ADCETRIS [Prescribing Information]. Bothell, WA: Seagen Inc. November 2022. 2. Castellino SM, Pei Q, Parsons SK, et al. Brentuximab vedotin with chemotherapy in pediatric high-risk Hodgkin's lymphoma. N Engl J Med. 2022;387:1649-1660.