Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis
Purpose : Radiation-induced emesis is one of the most disturbing side effects of total body irradiation (TBI). To evaluate the efficacy and to determine the best schedule of granisetron (a selective 5-hydroxytryptamine 3serotonin receptor antagonist) administration in the prevention of radiation-ind...
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| Veröffentlicht in: | International journal of radiation oncology, biology, physics biology, physics, 1996-08, Vol.36 (1), p.77-82 |
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| container_title | International journal of radiation oncology, biology, physics |
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| creator | Belkacémi, Yazid Ozsahin, Mahmut Pène, Françoise Rio, Bernard Sutton, Laurent Laporte, Jean-Philippe Touboul, Emmanuel Gorin, Norbert-Claude Laugier, Alain |
| description | Purpose
: Radiation-induced emesis is one of the most disturbing side effects of total body irradiation (TBI). To evaluate the efficacy and to determine the best schedule of granisetron (a selective 5-hydroxytryptamine
3serotonin receptor antagonist) administration in the prevention of radiation-induced nausea and vomiting, we conducted a trial involving patients receiving single-dose TBI before bone marrow transplantation (BMT).
Methods and Materials:
Thirty-six patients with non-Hodgkin's lymphoma (
n = 12, multiple myeloma (
n = 8), acute lymphoblastic leukemia (
n = 7), acute nonlymphoblastic leukemia (
n = 6, and chronic myeloid leukemia (
n = 3), referred to our department between March 1992 and February 1994 were enrolled in this study to assess the efficacy of granisetron during single-dose TBI before autologous BMT (
n = 26), allogeneic BMT (
n = 8), or syngeneic BMT (
n = 2). The male-to-female ratio was 22:14 (1.57), and the mean age was 41 ± 11 years (range 16–58). Before TBI, conditioning chemotherapy consisted of cyclophosphamide (CY) alone (60 mg/kg per day on 2 successive days) in 24 patients, CY combined with other drugs in 6, and combinations without CY in 6. All patients received single-dose TBI (10 Gy administered to the midplane at L4, and 8 Gy to the lungs). The mean instantaneous and average does rates were 0.039 ± 0.012 Gy/min (range 0.031–0.058), and 0.025-0.006 Gy/min (range 2.08–3.96), respectively. Granisetron was administered 30–45 min before TBI according to two different modalities: a total dose of 3 mg as a 5-min intravenous (i.v.) infusion (Treatment A,
n = 15; 42%) or the same treatment plus 3 mg of granisetron as a 24-h continuous i.v. infusion (total dose: 6 mg, Treatment,
n = 21; 58%). Depending on the BMT teams, hyperdiuresis was continued (
n = 19. 53%) or suspended (
n = 17, 47%) during TBI. Nausea and vomiting were assessed during the TBI session and the following 12 h, and were scored as follows: S1 = no nausea or vomiting; S2 = moderate nausea; S3 = severe nausea and/or single episode of vomiting; and S4 = multiple episodes of vomiting.
Results
: During TBI, 18 (50%) patients were scored as complete responders (S1), 1 (3%) as a major responder (S2), 9 (25%) as minor responders (S3), and 8 (22%) as nonresponders (S4). During the following 12 h, 28 (78%) patients were free of severe nausea and vomiting (S1 or S2), whereas 8 (22%) vomited (S3 or S4). In univariate analyses, the 12-h probability of emesis was signific |
| doi_str_mv | 10.1016/S0360-3016(96)00284-2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_15859789</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0360301696002842</els_id><sourcerecordid>15859789</sourcerecordid><originalsourceid>FETCH-LOGICAL-c420t-e3b0c76a8a5c2f6853d4af06e077fca46f74ce01d4d65e6be1690a28e9c666863</originalsourceid><addsrcrecordid>eNqFkU9rFDEYxoModVv9CIUcROxhNMnMZDJeipRWhYIHK3gL7yZvbGQ2WZNs7XyVflqzf9irpwSe3_vveQg55-w9Z1x--M5ayZq2ft-N8oIxobpGPCMLroaxafv-53OyOCIvyWnOvxljnA_dCTlRSrRC8gV5uosFJrqMdqY-JbAeio-BrpOPiZZYlYB0BSnFv7QkCHk9QSg76CO9ds4bMDOFYGkGh2Wm0dFflfMZS6qNfKDlHmu_uL6fJ3j0eQebGKo8benj0MYHuzFoKa4w-_yKvHAwZXx9eM_Ij5vru6svze23z1-vPt02phOsNNgumRkkKOiNcFL1re3AMYlsGJyBTrqhM8i47azsUS6Ry5GBUDgaKaWS7Rl5u-9bd_yzwVz0ymeDU70T4yZr3qt-HNRYwX4PmhRzTuh0dalaM2vO9DYTvctEbw3Xo9S7TLSodeeHAZvlCu2x6hBC1d8cdMgGJlfdMz4fMdGpgcntnpd7DKsZDx6TzsZjqIb5hKZoG_1_FvkHFL6sUw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>15859789</pqid></control><display><type>article</type><title>Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Belkacémi, Yazid ; Ozsahin, Mahmut ; Pène, Françoise ; Rio, Bernard ; Sutton, Laurent ; Laporte, Jean-Philippe ; Touboul, Emmanuel ; Gorin, Norbert-Claude ; Laugier, Alain</creator><creatorcontrib>Belkacémi, Yazid ; Ozsahin, Mahmut ; Pène, Françoise ; Rio, Bernard ; Sutton, Laurent ; Laporte, Jean-Philippe ; Touboul, Emmanuel ; Gorin, Norbert-Claude ; Laugier, Alain</creatorcontrib><description>Purpose
: Radiation-induced emesis is one of the most disturbing side effects of total body irradiation (TBI). To evaluate the efficacy and to determine the best schedule of granisetron (a selective 5-hydroxytryptamine
3serotonin receptor antagonist) administration in the prevention of radiation-induced nausea and vomiting, we conducted a trial involving patients receiving single-dose TBI before bone marrow transplantation (BMT).
Methods and Materials:
Thirty-six patients with non-Hodgkin's lymphoma (
n = 12, multiple myeloma (
n = 8), acute lymphoblastic leukemia (
n = 7), acute nonlymphoblastic leukemia (
n = 6, and chronic myeloid leukemia (
n = 3), referred to our department between March 1992 and February 1994 were enrolled in this study to assess the efficacy of granisetron during single-dose TBI before autologous BMT (
n = 26), allogeneic BMT (
n = 8), or syngeneic BMT (
n = 2). The male-to-female ratio was 22:14 (1.57), and the mean age was 41 ± 11 years (range 16–58). Before TBI, conditioning chemotherapy consisted of cyclophosphamide (CY) alone (60 mg/kg per day on 2 successive days) in 24 patients, CY combined with other drugs in 6, and combinations without CY in 6. All patients received single-dose TBI (10 Gy administered to the midplane at L4, and 8 Gy to the lungs). The mean instantaneous and average does rates were 0.039 ± 0.012 Gy/min (range 0.031–0.058), and 0.025-0.006 Gy/min (range 2.08–3.96), respectively. Granisetron was administered 30–45 min before TBI according to two different modalities: a total dose of 3 mg as a 5-min intravenous (i.v.) infusion (Treatment A,
n = 15; 42%) or the same treatment plus 3 mg of granisetron as a 24-h continuous i.v. infusion (total dose: 6 mg, Treatment,
n = 21; 58%). Depending on the BMT teams, hyperdiuresis was continued (
n = 19. 53%) or suspended (
n = 17, 47%) during TBI. Nausea and vomiting were assessed during the TBI session and the following 12 h, and were scored as follows: S1 = no nausea or vomiting; S2 = moderate nausea; S3 = severe nausea and/or single episode of vomiting; and S4 = multiple episodes of vomiting.
Results
: During TBI, 18 (50%) patients were scored as complete responders (S1), 1 (3%) as a major responder (S2), 9 (25%) as minor responders (S3), and 8 (22%) as nonresponders (S4). During the following 12 h, 28 (78%) patients were free of severe nausea and vomiting (S1 or S2), whereas 8 (22%) vomited (S3 or S4). In univariate analyses, the 12-h probability of emesis was significantly higher in patients undergoing hyperdiuresis (63% vs. 30%;
p = 0.05), and in patients older than 45 years (65% for age >45 vs. 33% for age ≤45;
p = 0.05). The probability of S3 and S4 emesis was 50% with Treatment A and 47% with Treatment B (
p = 0.86). Sex, body weight, and type of conditioning chemotherapy did not influence the 12-h probability of emesis. Multivariate analysis revealed that hyperdiuresis (
p = 0.02) and Treatment A (
p = 0.04) were independently associated with radiation-induced emesis, whereas sex (
p = 0.85), body weight (
p = 0.13), age (
p = 0.12), and type of conditioning chemotherapy (
p = 0.92) were not. No early toxicity related to granisetron was observed.
Conclusion
: Granisetron is a well-tolerated and effective antiemetic agent that can be used as monotherapy during single-dose TBI. Good control of nausea and vomiting is obtained with this antiemetic drug, and its effect is increased when hyperdiuresis is suspended during TBI.</description><identifier>ISSN: 0360-3016</identifier><identifier>EISSN: 1879-355X</identifier><identifier>DOI: 10.1016/S0360-3016(96)00284-2</identifier><identifier>PMID: 8823261</identifier><identifier>CODEN: IOBPD3</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Age Factors ; Antiemetics - therapeutic use ; Biological and medical sciences ; body irradiation ; Body Weight ; Bone Marrow Transplantation - adverse effects ; Diuresis - drug effects ; Dose-Response Relationship, Drug ; Female ; Granisetron ; Granisetron - administration & dosage ; Granisetron - therapeutic use ; Humans ; Hyperdiuresis ; Leukemia - therapy ; Lymphoma, Non-Hodgkin - therapy ; Male ; Medical sciences ; Middle Aged ; Multiple Myeloma - therapy ; Multivariate Analysis ; Nausea ; Orthopedic surgery ; Sex Factors ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Vomiting ; Whole-Body Irradiation - adverse effects</subject><ispartof>International journal of radiation oncology, biology, physics, 1996-08, Vol.36 (1), p.77-82</ispartof><rights>1996</rights><rights>1997 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c420t-e3b0c76a8a5c2f6853d4af06e077fca46f74ce01d4d65e6be1690a28e9c666863</citedby><cites>FETCH-LOGICAL-c420t-e3b0c76a8a5c2f6853d4af06e077fca46f74ce01d4d65e6be1690a28e9c666863</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0360301696002842$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2487066$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/8823261$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Belkacémi, Yazid</creatorcontrib><creatorcontrib>Ozsahin, Mahmut</creatorcontrib><creatorcontrib>Pène, Françoise</creatorcontrib><creatorcontrib>Rio, Bernard</creatorcontrib><creatorcontrib>Sutton, Laurent</creatorcontrib><creatorcontrib>Laporte, Jean-Philippe</creatorcontrib><creatorcontrib>Touboul, Emmanuel</creatorcontrib><creatorcontrib>Gorin, Norbert-Claude</creatorcontrib><creatorcontrib>Laugier, Alain</creatorcontrib><title>Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis</title><title>International journal of radiation oncology, biology, physics</title><addtitle>Int J Radiat Oncol Biol Phys</addtitle><description>Purpose
: Radiation-induced emesis is one of the most disturbing side effects of total body irradiation (TBI). To evaluate the efficacy and to determine the best schedule of granisetron (a selective 5-hydroxytryptamine
3serotonin receptor antagonist) administration in the prevention of radiation-induced nausea and vomiting, we conducted a trial involving patients receiving single-dose TBI before bone marrow transplantation (BMT).
Methods and Materials:
Thirty-six patients with non-Hodgkin's lymphoma (
n = 12, multiple myeloma (
n = 8), acute lymphoblastic leukemia (
n = 7), acute nonlymphoblastic leukemia (
n = 6, and chronic myeloid leukemia (
n = 3), referred to our department between March 1992 and February 1994 were enrolled in this study to assess the efficacy of granisetron during single-dose TBI before autologous BMT (
n = 26), allogeneic BMT (
n = 8), or syngeneic BMT (
n = 2). The male-to-female ratio was 22:14 (1.57), and the mean age was 41 ± 11 years (range 16–58). Before TBI, conditioning chemotherapy consisted of cyclophosphamide (CY) alone (60 mg/kg per day on 2 successive days) in 24 patients, CY combined with other drugs in 6, and combinations without CY in 6. All patients received single-dose TBI (10 Gy administered to the midplane at L4, and 8 Gy to the lungs). The mean instantaneous and average does rates were 0.039 ± 0.012 Gy/min (range 0.031–0.058), and 0.025-0.006 Gy/min (range 2.08–3.96), respectively. Granisetron was administered 30–45 min before TBI according to two different modalities: a total dose of 3 mg as a 5-min intravenous (i.v.) infusion (Treatment A,
n = 15; 42%) or the same treatment plus 3 mg of granisetron as a 24-h continuous i.v. infusion (total dose: 6 mg, Treatment,
n = 21; 58%). Depending on the BMT teams, hyperdiuresis was continued (
n = 19. 53%) or suspended (
n = 17, 47%) during TBI. Nausea and vomiting were assessed during the TBI session and the following 12 h, and were scored as follows: S1 = no nausea or vomiting; S2 = moderate nausea; S3 = severe nausea and/or single episode of vomiting; and S4 = multiple episodes of vomiting.
Results
: During TBI, 18 (50%) patients were scored as complete responders (S1), 1 (3%) as a major responder (S2), 9 (25%) as minor responders (S3), and 8 (22%) as nonresponders (S4). During the following 12 h, 28 (78%) patients were free of severe nausea and vomiting (S1 or S2), whereas 8 (22%) vomited (S3 or S4). In univariate analyses, the 12-h probability of emesis was significantly higher in patients undergoing hyperdiuresis (63% vs. 30%;
p = 0.05), and in patients older than 45 years (65% for age >45 vs. 33% for age ≤45;
p = 0.05). The probability of S3 and S4 emesis was 50% with Treatment A and 47% with Treatment B (
p = 0.86). Sex, body weight, and type of conditioning chemotherapy did not influence the 12-h probability of emesis. Multivariate analysis revealed that hyperdiuresis (
p = 0.02) and Treatment A (
p = 0.04) were independently associated with radiation-induced emesis, whereas sex (
p = 0.85), body weight (
p = 0.13), age (
p = 0.12), and type of conditioning chemotherapy (
p = 0.92) were not. No early toxicity related to granisetron was observed.
Conclusion
: Granisetron is a well-tolerated and effective antiemetic agent that can be used as monotherapy during single-dose TBI. Good control of nausea and vomiting is obtained with this antiemetic drug, and its effect is increased when hyperdiuresis is suspended during TBI.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Age Factors</subject><subject>Antiemetics - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>body irradiation</subject><subject>Body Weight</subject><subject>Bone Marrow Transplantation - adverse effects</subject><subject>Diuresis - drug effects</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Granisetron</subject><subject>Granisetron - administration & dosage</subject><subject>Granisetron - therapeutic use</subject><subject>Humans</subject><subject>Hyperdiuresis</subject><subject>Leukemia - therapy</subject><subject>Lymphoma, Non-Hodgkin - therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple Myeloma - therapy</subject><subject>Multivariate Analysis</subject><subject>Nausea</subject><subject>Orthopedic surgery</subject><subject>Sex Factors</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Vomiting</subject><subject>Whole-Body Irradiation - adverse effects</subject><issn>0360-3016</issn><issn>1879-355X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU9rFDEYxoModVv9CIUcROxhNMnMZDJeipRWhYIHK3gL7yZvbGQ2WZNs7XyVflqzf9irpwSe3_vveQg55-w9Z1x--M5ayZq2ft-N8oIxobpGPCMLroaxafv-53OyOCIvyWnOvxljnA_dCTlRSrRC8gV5uosFJrqMdqY-JbAeio-BrpOPiZZYlYB0BSnFv7QkCHk9QSg76CO9ds4bMDOFYGkGh2Wm0dFflfMZS6qNfKDlHmu_uL6fJ3j0eQebGKo8benj0MYHuzFoKa4w-_yKvHAwZXx9eM_Ij5vru6svze23z1-vPt02phOsNNgumRkkKOiNcFL1re3AMYlsGJyBTrqhM8i47azsUS6Ry5GBUDgaKaWS7Rl5u-9bd_yzwVz0ymeDU70T4yZr3qt-HNRYwX4PmhRzTuh0dalaM2vO9DYTvctEbw3Xo9S7TLSodeeHAZvlCu2x6hBC1d8cdMgGJlfdMz4fMdGpgcntnpd7DKsZDx6TzsZjqIb5hKZoG_1_FvkHFL6sUw</recordid><startdate>19960801</startdate><enddate>19960801</enddate><creator>Belkacémi, Yazid</creator><creator>Ozsahin, Mahmut</creator><creator>Pène, Françoise</creator><creator>Rio, Bernard</creator><creator>Sutton, Laurent</creator><creator>Laporte, Jean-Philippe</creator><creator>Touboul, Emmanuel</creator><creator>Gorin, Norbert-Claude</creator><creator>Laugier, Alain</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>19960801</creationdate><title>Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis</title><author>Belkacémi, Yazid ; Ozsahin, Mahmut ; Pène, Françoise ; Rio, Bernard ; Sutton, Laurent ; Laporte, Jean-Philippe ; Touboul, Emmanuel ; Gorin, Norbert-Claude ; Laugier, Alain</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c420t-e3b0c76a8a5c2f6853d4af06e077fca46f74ce01d4d65e6be1690a28e9c666863</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1996</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Age Factors</topic><topic>Antiemetics - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>body irradiation</topic><topic>Body Weight</topic><topic>Bone Marrow Transplantation - adverse effects</topic><topic>Diuresis - drug effects</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Granisetron</topic><topic>Granisetron - administration & dosage</topic><topic>Granisetron - therapeutic use</topic><topic>Humans</topic><topic>Hyperdiuresis</topic><topic>Leukemia - therapy</topic><topic>Lymphoma, Non-Hodgkin - therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple Myeloma - therapy</topic><topic>Multivariate Analysis</topic><topic>Nausea</topic><topic>Orthopedic surgery</topic><topic>Sex Factors</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Vomiting</topic><topic>Whole-Body Irradiation - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Belkacémi, Yazid</creatorcontrib><creatorcontrib>Ozsahin, Mahmut</creatorcontrib><creatorcontrib>Pène, Françoise</creatorcontrib><creatorcontrib>Rio, Bernard</creatorcontrib><creatorcontrib>Sutton, Laurent</creatorcontrib><creatorcontrib>Laporte, Jean-Philippe</creatorcontrib><creatorcontrib>Touboul, Emmanuel</creatorcontrib><creatorcontrib>Gorin, Norbert-Claude</creatorcontrib><creatorcontrib>Laugier, Alain</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>International journal of radiation oncology, biology, physics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Belkacémi, Yazid</au><au>Ozsahin, Mahmut</au><au>Pène, Françoise</au><au>Rio, Bernard</au><au>Sutton, Laurent</au><au>Laporte, Jean-Philippe</au><au>Touboul, Emmanuel</au><au>Gorin, Norbert-Claude</au><au>Laugier, Alain</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis</atitle><jtitle>International journal of radiation oncology, biology, physics</jtitle><addtitle>Int J Radiat Oncol Biol Phys</addtitle><date>1996-08-01</date><risdate>1996</risdate><volume>36</volume><issue>1</issue><spage>77</spage><epage>82</epage><pages>77-82</pages><issn>0360-3016</issn><eissn>1879-355X</eissn><coden>IOBPD3</coden><abstract>Purpose
: Radiation-induced emesis is one of the most disturbing side effects of total body irradiation (TBI). To evaluate the efficacy and to determine the best schedule of granisetron (a selective 5-hydroxytryptamine
3serotonin receptor antagonist) administration in the prevention of radiation-induced nausea and vomiting, we conducted a trial involving patients receiving single-dose TBI before bone marrow transplantation (BMT).
Methods and Materials:
Thirty-six patients with non-Hodgkin's lymphoma (
n = 12, multiple myeloma (
n = 8), acute lymphoblastic leukemia (
n = 7), acute nonlymphoblastic leukemia (
n = 6, and chronic myeloid leukemia (
n = 3), referred to our department between March 1992 and February 1994 were enrolled in this study to assess the efficacy of granisetron during single-dose TBI before autologous BMT (
n = 26), allogeneic BMT (
n = 8), or syngeneic BMT (
n = 2). The male-to-female ratio was 22:14 (1.57), and the mean age was 41 ± 11 years (range 16–58). Before TBI, conditioning chemotherapy consisted of cyclophosphamide (CY) alone (60 mg/kg per day on 2 successive days) in 24 patients, CY combined with other drugs in 6, and combinations without CY in 6. All patients received single-dose TBI (10 Gy administered to the midplane at L4, and 8 Gy to the lungs). The mean instantaneous and average does rates were 0.039 ± 0.012 Gy/min (range 0.031–0.058), and 0.025-0.006 Gy/min (range 2.08–3.96), respectively. Granisetron was administered 30–45 min before TBI according to two different modalities: a total dose of 3 mg as a 5-min intravenous (i.v.) infusion (Treatment A,
n = 15; 42%) or the same treatment plus 3 mg of granisetron as a 24-h continuous i.v. infusion (total dose: 6 mg, Treatment,
n = 21; 58%). Depending on the BMT teams, hyperdiuresis was continued (
n = 19. 53%) or suspended (
n = 17, 47%) during TBI. Nausea and vomiting were assessed during the TBI session and the following 12 h, and were scored as follows: S1 = no nausea or vomiting; S2 = moderate nausea; S3 = severe nausea and/or single episode of vomiting; and S4 = multiple episodes of vomiting.
Results
: During TBI, 18 (50%) patients were scored as complete responders (S1), 1 (3%) as a major responder (S2), 9 (25%) as minor responders (S3), and 8 (22%) as nonresponders (S4). During the following 12 h, 28 (78%) patients were free of severe nausea and vomiting (S1 or S2), whereas 8 (22%) vomited (S3 or S4). In univariate analyses, the 12-h probability of emesis was significantly higher in patients undergoing hyperdiuresis (63% vs. 30%;
p = 0.05), and in patients older than 45 years (65% for age >45 vs. 33% for age ≤45;
p = 0.05). The probability of S3 and S4 emesis was 50% with Treatment A and 47% with Treatment B (
p = 0.86). Sex, body weight, and type of conditioning chemotherapy did not influence the 12-h probability of emesis. Multivariate analysis revealed that hyperdiuresis (
p = 0.02) and Treatment A (
p = 0.04) were independently associated with radiation-induced emesis, whereas sex (
p = 0.85), body weight (
p = 0.13), age (
p = 0.12), and type of conditioning chemotherapy (
p = 0.92) were not. No early toxicity related to granisetron was observed.
Conclusion
: Granisetron is a well-tolerated and effective antiemetic agent that can be used as monotherapy during single-dose TBI. Good control of nausea and vomiting is obtained with this antiemetic drug, and its effect is increased when hyperdiuresis is suspended during TBI.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>8823261</pmid><doi>10.1016/S0360-3016(96)00284-2</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0360-3016 |
| ispartof | International journal of radiation oncology, biology, physics, 1996-08, Vol.36 (1), p.77-82 |
| issn | 0360-3016 1879-355X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_15859789 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Adult Age Factors Antiemetics - therapeutic use Biological and medical sciences body irradiation Body Weight Bone Marrow Transplantation - adverse effects Diuresis - drug effects Dose-Response Relationship, Drug Female Granisetron Granisetron - administration & dosage Granisetron - therapeutic use Humans Hyperdiuresis Leukemia - therapy Lymphoma, Non-Hodgkin - therapy Male Medical sciences Middle Aged Multiple Myeloma - therapy Multivariate Analysis Nausea Orthopedic surgery Sex Factors Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Vomiting Whole-Body Irradiation - adverse effects |
| title | Total body irradiation prior to bone marrow transplantation: Efficacy and safety of granisetron in the prophylaxis and control of radiation-induced emesis |
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