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Professor Marie José Kersten and others have carried out a phase II clinical study to evaluate the combination of verbutuximab (BV) and DHAP (dexamethasone, cisplatin, and cytarabine) regimens in relapsed or refractory classics Efficacy and safety in patients with type Hodgkin’s lymphoma (R/R cHL).
Research background and purpose In the past ten years, the standard treatment of R/R cHL patients suitable for hematopoietic stem cell transplantation has been salvage chemotherapy to achieve a partial remission (PR) effect, followed by high-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT) for consolidation treatment .
The above-mentioned standard treatment strategies can cure 40%-60% of R/R cHL patients.
Patients with R/R cHL who have achieved complete metabolic remission (mCR) assessed by PET/CT before ASCT treatment have a better prognosis after ASCT.
Therefore, increasing the mCR rate of R/R cHL patients before ASCT is of great significance to improve the overall cure rate of such patients.
The traditional DHAP salvage chemotherapy regimen can make the mCR rate of R/R cHL patients reach 50%-60%.
BV is an antibody-drug conjugate (ADC) targeting CD30.
The results of several previous phase II studies have shown that BV single-agent or combined chemotherapy has good clinical activity in R/R cHL patients.
Adverse events (AE) in the application of BV mainly include infusion-related reactions (IRR), bone marrow suppression, and peripheral neuropathy.
Peripheral neuropathy in most patients is reversible.
Previously published Phase I studies of the BV combined with DHAP regimen in the treatment of 12 R/R cHL patients confirmed the clinical feasibility of the BV-DHAP combined regimen and its controllable toxicity.
Based on this, the researchers carried out a phase II clinical study of BV-DHAP in the treatment of R/R cHL patients.
Research methods This multi-center, single-arm phase II clinical study included patients with primary refractory or relapsed cHL who were aged ≥18 years and had pathological immunohistochemistry CD30 positive.
All patients received the BV-DHAP regimen, in which the dose of BV was 1.
8 mg/kg intravenously on the first day, the dose of DHAP was dexamethasone 40 mg orally on the first 1-4 days, and the cisplatin 100 mg/m2 was continuously infused for 24 hours on the first day.
On day 1, cytarabine 2g/mA2 q12h was injected intravenously for 3 hours on the second day; day 21 was a treatment cycle.
Patients were treated with BV-DHAP regimen for 3 cycles after PET/CT examination to evaluate the efficacy.
Patients whose efficacy reached metabolic partial remission (mPR) and mCR received BEMA (carmustine, etoposide, cytarabine and melphalan) ASCT consolidation treatment for the pretreatment regimen.
The main endpoints of the study were the proportion of patients who achieved mCR on PET/CT examination after 3 cycles of BV-DHAP treatment, and the incidence of grade 3/4 non-hematological adverse events (AEs), including those during BV-DHAP treatment Neurotoxicity.
Results of the study The phase II study recruited 55 patients with R/R cHL from May 2014 to July 2017; the median age of the patients was 29 years old, of which 43% were refractory to the original, first-line treatment 29% of patients relapsed within 1 year.
89% of patients completed 3 cycles of BV-DHAP treatment, and 85% of patients received ASCT consolidation therapy.
After 3 cycles of BV-DHAP treatment, the patient’s mCR rate was 81% (95%CI: 67%-90%), the mPR rate was 10%, and the overall effective rate (ORR) was 90% (95%CI: 79%- 97%); another 10% of patients did not receive ASCT because of disease progression (PD).
Among the 5 patients whose efficacy was mPR after 3 cycles of combined salvage treatment, 4 patients achieved mCR after ASCT consolidation treatment; the other patient achieved mCR after ASCT after receiving additional local lesion radiotherapy, and is still maintaining mCR.
. The 2-year progression-free survival (PFS) rate of all patients was 74% (95%CI: 63%-86%), and the 2-year OS rate was 95% (95%CI: 90%-100%).
There was no significant difference between the baseline characteristics of patients with mCR and mPR after salvage chemotherapy.
Compared with patients with advanced relapse, patients with primary refractory disease had a lower mCR rate trend (73% vs 86%), but there was no statistical difference (P=0.
29).
Therefore, patients receiving ASCT were collected peripheral blood stem cells after the second cycle of salvage treatment, and the median absolute value of the collected stem cells CD34+ was 5.
3×106/kg (range: 1.
8×106/kg-22.
7×106/kg) .
During the patient's BV-DHAP treatment, the most common grade 3-4 non-hematological AEs were neutropenic fever (FN) (N=14), followed by elevated liver enzymes (N=10) and electrolyte disturbances (N=6); The proportions of patients with newly developed grade 1 and grade 2 peripheral neuropathy were 27% and 5%, respectively, but all recovered spontaneously.
One patient developed fatal hepatic vein occlusion syndrome (VOD) after ASCT.
Research conclusions The research results show that 3 cycles of BV-DHAP is an effective rescue treatment plan for R/R cHL patients, but it is necessary to pay close attention to the side effects of patients during treatment.
References: Marie José Kersten, Julia Driessen, Josée M Zijlstra, et al.
Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HaVONaVE/LL.
PC .
2021 Apr 1;106(4):1129-1137.
Stamp "read the original text" and we will make progress together
Research background and purpose In the past ten years, the standard treatment of R/R cHL patients suitable for hematopoietic stem cell transplantation has been salvage chemotherapy to achieve a partial remission (PR) effect, followed by high-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT) for consolidation treatment .
The above-mentioned standard treatment strategies can cure 40%-60% of R/R cHL patients.
Patients with R/R cHL who have achieved complete metabolic remission (mCR) assessed by PET/CT before ASCT treatment have a better prognosis after ASCT.
Therefore, increasing the mCR rate of R/R cHL patients before ASCT is of great significance to improve the overall cure rate of such patients.
The traditional DHAP salvage chemotherapy regimen can make the mCR rate of R/R cHL patients reach 50%-60%.
BV is an antibody-drug conjugate (ADC) targeting CD30.
The results of several previous phase II studies have shown that BV single-agent or combined chemotherapy has good clinical activity in R/R cHL patients.
Adverse events (AE) in the application of BV mainly include infusion-related reactions (IRR), bone marrow suppression, and peripheral neuropathy.
Peripheral neuropathy in most patients is reversible.
Previously published Phase I studies of the BV combined with DHAP regimen in the treatment of 12 R/R cHL patients confirmed the clinical feasibility of the BV-DHAP combined regimen and its controllable toxicity.
Based on this, the researchers carried out a phase II clinical study of BV-DHAP in the treatment of R/R cHL patients.
Research methods This multi-center, single-arm phase II clinical study included patients with primary refractory or relapsed cHL who were aged ≥18 years and had pathological immunohistochemistry CD30 positive.
All patients received the BV-DHAP regimen, in which the dose of BV was 1.
8 mg/kg intravenously on the first day, the dose of DHAP was dexamethasone 40 mg orally on the first 1-4 days, and the cisplatin 100 mg/m2 was continuously infused for 24 hours on the first day.
On day 1, cytarabine 2g/mA2 q12h was injected intravenously for 3 hours on the second day; day 21 was a treatment cycle.
Patients were treated with BV-DHAP regimen for 3 cycles after PET/CT examination to evaluate the efficacy.
Patients whose efficacy reached metabolic partial remission (mPR) and mCR received BEMA (carmustine, etoposide, cytarabine and melphalan) ASCT consolidation treatment for the pretreatment regimen.
The main endpoints of the study were the proportion of patients who achieved mCR on PET/CT examination after 3 cycles of BV-DHAP treatment, and the incidence of grade 3/4 non-hematological adverse events (AEs), including those during BV-DHAP treatment Neurotoxicity.
Results of the study The phase II study recruited 55 patients with R/R cHL from May 2014 to July 2017; the median age of the patients was 29 years old, of which 43% were refractory to the original, first-line treatment 29% of patients relapsed within 1 year.
89% of patients completed 3 cycles of BV-DHAP treatment, and 85% of patients received ASCT consolidation therapy.
After 3 cycles of BV-DHAP treatment, the patient’s mCR rate was 81% (95%CI: 67%-90%), the mPR rate was 10%, and the overall effective rate (ORR) was 90% (95%CI: 79%- 97%); another 10% of patients did not receive ASCT because of disease progression (PD).
Among the 5 patients whose efficacy was mPR after 3 cycles of combined salvage treatment, 4 patients achieved mCR after ASCT consolidation treatment; the other patient achieved mCR after ASCT after receiving additional local lesion radiotherapy, and is still maintaining mCR.
. The 2-year progression-free survival (PFS) rate of all patients was 74% (95%CI: 63%-86%), and the 2-year OS rate was 95% (95%CI: 90%-100%).
There was no significant difference between the baseline characteristics of patients with mCR and mPR after salvage chemotherapy.
Compared with patients with advanced relapse, patients with primary refractory disease had a lower mCR rate trend (73% vs 86%), but there was no statistical difference (P=0.
29).
Therefore, patients receiving ASCT were collected peripheral blood stem cells after the second cycle of salvage treatment, and the median absolute value of the collected stem cells CD34+ was 5.
3×106/kg (range: 1.
8×106/kg-22.
7×106/kg) .
During the patient's BV-DHAP treatment, the most common grade 3-4 non-hematological AEs were neutropenic fever (FN) (N=14), followed by elevated liver enzymes (N=10) and electrolyte disturbances (N=6); The proportions of patients with newly developed grade 1 and grade 2 peripheral neuropathy were 27% and 5%, respectively, but all recovered spontaneously.
One patient developed fatal hepatic vein occlusion syndrome (VOD) after ASCT.
Research conclusions The research results show that 3 cycles of BV-DHAP is an effective rescue treatment plan for R/R cHL patients, but it is necessary to pay close attention to the side effects of patients during treatment.
References: Marie José Kersten, Julia Driessen, Josée M Zijlstra, et al.
Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HaVONaVE/LL.
PC .
2021 Apr 1;106(4):1129-1137.
Stamp "read the original text" and we will make progress together
