2.Clinical Observation of Venetoclax Combined with Demethylating Agents on the Treatment of Relapsed/Refractory Acute Myeloid Leukemia.
Yao WANG ; Sai-Lan HUANG ; Xing-Xia ZHANG ; Mei-Ru BIAN ; Guo-Qiang LIN ; Ye-Jun SI ; Bing ZHANG ; Yan WAN ; Li WANG ; Yan-Ming ZHANG
Journal of Experimental Hematology 2023;31(2):327-332
OBJECTIVE:
To investigate the efficacy and safety of venetoclax (VEN) combined with demethylating agents (HMA) in the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
METHODS:
The clinical data of 26 adult R/R AML patients who received the combination of VEN with azacitidine (AZA) or decitabine (DAC) in Huai'an Second People's Hospital from February 2019 to November 2021 were retrospectively analyzed. The treatment response, adverse events as well as survival were observed, and the factors of influencing the efficacy and survival were explored.
RESULTS:
The overall response rate (ORR) of 26 patients was 57.7% (15 cases), including 13 cases of complete response (CR) and CR with incomplete count recovery (CRi) and 2 cases of partial response (PR). Among the 13 patients who got CR/CRi, 7 cases achieved CRm (minimal residual disease negative CR) and 6 cases did not, with statistically significant differences in overall survival (OS) and event-free survival (EFS) between the two groups (P=0.044, 0.036). The median OS of all the patients was 6.6 (0.5-15.6) months, and median EFS was 3.4 (0.5-9.9) months. There were 13 patients in the relapse group and refractory group, respectively, with response rate of 84.6% and 30.8% (P=0.015). The survival analysis showed that the relapse group had a better OS than the refractory group (P=0.026), but there was no significant difference in EFS (P=0.069). Sixteen patients who treated for 1-2 cycles and 10 patients who treated for more than 3 cycles achieved response rates of 37.5% and 90.0%, respectively (P=0.014), and patients treated for more cycles had superior OS and EFS (both P<0.01). Adverse effects were mainly bone marrow suppression, complicated by various degrees of infection, bleeding, and gastrointestinal discomfort was common, but these could be all tolerated by patients.
CONCLUSION
VEN combined with HMA is an effective salvage therapy for patients with R/R AML and is well tolerated by patients. Achieving minimal residual disease negativity is able to improve long-term survival of patients.
Adult
;
Humans
;
Retrospective Studies
;
Neoplasm, Residual/drug therapy*
;
Bridged Bicyclo Compounds, Heterocyclic/adverse effects*
;
Recurrence
;
Leukemia, Myeloid, Acute/drug therapy*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
3.Efficacy and Survival of Venetoclax Based Regimen in the Treatment of Acute Myeloid Leukemia.
Fan-Cong KONG ; Ling QI ; Wen-Feng HUANG ; Min YU ; Yu-Lan ZHOU ; De-Xiang JI ; Fei LI
Journal of Experimental Hematology 2023;31(6):1676-1683
OBJECTIVE:
To explore the efficacy and survival of venetoclax based (VEN-based) regimen in the treatment of acute myeloid leukemia(AML).
METHODS:
A retrospective study was conducted in patients who received VEN-based regimen and completed at least 1 course of efficacy evaluation at the The First Affiliated Hospital of Nanchang University from July 2019 to July 2022. The incidence of complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate, objective remission rate(ORR) and survival of patients with different risk strati- fication and gene subtypes were analyzed.
RESULTS:
A total of 79 patients were enrolled, including 43 patients with newly diagnosed unfit AML (unfit AML) and 36 relapsed/refractory AML (R/R AML). The median age of the patients was 62(14-83) years old. 36 out of 79 patients achieved CR/CRi and the ORR of the whole cohort was 64.6%. The CR/CRi rate of unfit AML patients was significantly higher than that of R/R AML patients (60.5% vs 27.8%, P=0.004). In unfit AML cohort, the patients with NPM1 and IDH1/2 mutations were benefited, 8 out of 9 patients ahcieved CR/CRi, 7/8 and 5/8 patients achieved minimal residual disease (MRD) negativity, respectively. Six out of 9 patients with TET2 mutation achieved CR/CRi, 3/6 patients achieved MRD negativity. In R/R AML cohort, 2 out of 3 patients with RUNX1 mutation achieved CR/CRi, without MRD negative, while the CR/CRi rate of patients with other gene mutations was lower than 40%. The median follow-up time was 10.1(95%CI: 8.6-11.6) months. In whole cohort, the median overall survival (mOS) time was 9.1 months and the relapse free survival (RFS) time was not reached. The mOS and RFS of unfit AML patients were significantly longer than those of R/R AML patients (14.1 vs 6.8 months, P=0.013; not reached vs 3.3 months, P=0.000). In unfit AML cohort, the mOS of patients with NPM1 or IDH1/2 mutations was not reached, while that of patients without NPM1 or IDH1/2 mutations was 8.0 months (P=0.009; P=0.022). Furthermore, the mOS of patients with TP53 mutaion was significantly shorter than that of patients without TP53 mutation (5.2 vs 14.1 months, P=0.049). In R/R AML cohort, there was no significant difference in mOS between patients with mutation in each gene subtype and those without gene mutation (P>0.05). All patients had hematology adverse reactions, 91.1% patients had AE grade≥3. The most common non-hematology adverse reactions was infection, with an incidence of 91.1%. VEN-based regimen was tolerable for AML patients.
CONCLUSION
VEN-based regimen can achieve a high response rate, especially in unfit AML with acceptable safety, and some patients can achieve MRD negative. It is also effective in NPM1-, IDH1/2-positive patients with long survival time.
Humans
;
Middle Aged
;
Aged
;
Aged, 80 and over
;
Retrospective Studies
;
Nucleophosmin
;
Bridged Bicyclo Compounds, Heterocyclic/adverse effects*
;
Leukemia, Myeloid, Acute/genetics*
;
Recurrence
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
4.Application of patient-controlled intravenous analgesia of dezocine combined with sufentanil in burn patients after surgery.
Shangkun LI ; Su MIN ; Bin WU ; Wanbi TANG
Chinese Journal of Burns 2015;31(1):48-51
OBJECTIVETo evaluate the efficacy and safety of patient-controlled intravenous analgesia (PCIA) of dezocine combined with sufentanil in burn patients after escharectomy or tangential excision followed by autologous skin grafting.
METHODSSixty burn patients hospitalized in Department of Burns and Plastic Surgery of our hospital from February 2011 to December 2013, conforming to the study criteria and going to have escharectomy or tangential excision followed by autologous skin grafting, were divided into sufentanil group (S, n = 30) and dezocine+sufentanil group (DS, n = 30) according to the random number table. Patients in group S were given 150 mL normal saline containing 2.5 µg/kg sufentanil citrate and 6 mg tropisetron after skin grafting for 48 hours. Patients in group DS were given 150 mL normal saline containing 0.25 mg/kg dezocine, 1.5 µg/kg sufentanil citrate, and 6 mg tropisetron for 48 hours. Visual Analog Scale (VAS), Bruggrmann Comfort Scale (BCS), and Ramsay Sedation Scale were used to evaluate the sedative effect or analgesic effect, and their scores were recorded at administration hour (AH) 2, 6, 12, 24, and 48. The times of efficient injection and incidence of adverse effect within the 48 AH were recorded. Data were processed with analysis of variance for repeated measurement, t test, chi-square test, and Fisher's exact test.
RESULTSThere were no obvious differences in the scores of VAS and BCS between two groups at each time point (with t values from -0.426 to 0.864, P values above 0.05). The scores of Ramsay Sedation Scale in group S at AH 2, 6, 12, 24, and 48 were respectively (3.2 ± 0.6), (3.2 ± 0.5), (3.3 ± 0.7), (3.2 ± 0.4), and (3.3 ± 0.4) points, which were higher than those in group DS [(2.4 ± 0.6), (2.5 ± 0.5), (2.4 ± 0.6), (2.4 ± 0.4), and (2.4 ± 0.5) points, with t values from 5.302 to 8.391, P values below 0.001]. The times of efficient injection within the 48 AH was 6.8 ± 0.7 in group S and 6.5 ± 0.9 in group DS, showing no significantly statistical difference (t = 1.260, P > 0.05). Respiratory depression was not observed in both groups; the incidence of pruritus was the same, and that of urine retention was similar between the 2 groups within the 48 AH (with P values above 0.05). Within the 48 AH, the incidence of nausea and vomiting in group S was 26.7% (8/30), which was obviously higher than that in group DS (6.7%, 2/30, P < 0.05); the incidence of drowsiness in group S was 20.0% (6/30), which was significantly higher than that in group DS (no patient, P < 0.05).
CONCLUSIONSDezocine combined with sufentanil can provide effective postoperative analgesia with little adverse effect for PCIA in burn patients after escharectomy or tangential excision followed by autologous skin grafting, therefore it can be widely used.
Analgesia, Patient-Controlled ; adverse effects ; Analgesics, Opioid ; administration & dosage ; Bridged Bicyclo Compounds, Heterocyclic ; administration & dosage ; adverse effects ; Burns ; surgery ; Female ; Humans ; Hypnotics and Sedatives ; administration & dosage ; Infusions, Intravenous ; Male ; Pain, Postoperative ; drug therapy ; Reconstructive Surgical Procedures ; Skin Transplantation ; Sufentanil ; administration & dosage ; adverse effects ; Tetrahydronaphthalenes ; administration & dosage ; adverse effects ; Treatment Outcome
5.Clinical efficacy of Bannaitong Mdicinal Tea combined with azasetron in preventing and treating chemotherapy induced gastrointestinal reaction.
Chinese Journal of Integrated Traditional and Western Medicine 2007;27(10):934-936
OBJECTIVETo observe the effects of Biannaitong Medicinal Tea (BNT) combined with Azasetron in preventing and treating the gastrointestinal reaction induced by chemotherapy.
METHODSSixty-four patients underwent chemotherapy with DP regimen (docetaxol + DDP) were randomly assigned to two groups, the treated group and the control group. All patients were given 10 mg Azasetron intravenously 30 min before starting chemotherapy once a day for two successive days, but to patients in the treated group, 300 mL BNT was given orally additionally in the evenings before chemotherapy. The occurrence of adverse reactions, such as antiemetic efficacy constipation, abdominal distention, etc. was observed.
RESULTSThe vomiting control rates in the two groups were insignificantly different (87.5% vs 84.4%, P > 0.05), but difference in the complete control rates between them were significant (53.1% vs 43.8% , P < 0.05). And the occurrences of constipation (3.1% vs 59.4%) and abdominal distention (15.6% vs 59.4%) in the two groups were also significantly different (both P <0.05).
CONCLUSIONBNT used in coordination with Azasetron for alleviating vomiting could enhance the antiemetic effect, reduce the adverse effects of chemotherapy, such as constipation, abdominal distension and anorexia, and thus to increase the compliance of patients.
Adult ; Aged ; Anorexia ; chemically induced ; prevention & control ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Bridged Bicyclo Compounds, Heterocyclic ; therapeutic use ; Constipation ; chemically induced ; prevention & control ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Neoplasms ; drug therapy ; Oxazines ; therapeutic use ; Phytotherapy ; Serotonin Antagonists ; therapeutic use ; Treatment Outcome