The Experts below are selected from a list of 732 Experts worldwide ranked by ideXlab platform
Joel Picus - One of the best experts on this subject based on the ideXlab platform.
-
Phase II study of Fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-eads, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen. Methods GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 %. Results Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 %) patients (95 % Agresti-Coull binomial C.I. 14.5 %, 37.1 %). Conclusion The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of Fosaprepitant for aprepitant. It is unknown whether the substitution of Fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917
-
phase ii study of Fosaprepitant 5ht3 receptor antagonist dexamethasone in patients with germ cell tumors undergoing 5 day cisplatin based chemotherapy a hoosier cancer research network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Somer Caseeads, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen.
Nabil Adra - One of the best experts on this subject based on the ideXlab platform.
-
Phase II study of Fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-eads, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen. Methods GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 %. Results Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 %) patients (95 % Agresti-Coull binomial C.I. 14.5 %, 37.1 %). Conclusion The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of Fosaprepitant for aprepitant. It is unknown whether the substitution of Fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917
-
phase ii study of Fosaprepitant 5ht3 receptor antagonist dexamethasone in patients with germ cell tumors undergoing 5 day cisplatin based chemotherapy a hoosier cancer research network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Somer Caseeads, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen.
-
Phase II study of Fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-eads, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. HaukeAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen.
B L Rapoport - One of the best experts on this subject based on the ideXlab platform.
-
evaluation of factors contributing to the response to Fosaprepitant in a heterogeneous moderately emetogenic chemotherapy population an exploratory analysis of a randomized phase iii trial
Supportive Care in Cancer, 2018Co-Authors: Cindy Weinstein, Karin Jordan, Stuart A Green, Elber Camacho, S Khanani, Elizabeth Beckfordbrathwaite, Annpey Pong, S J Noga, B L RapoportAbstract:Purpose Fosaprepitant improved prevention of chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase III trial (PN031). This post hoc analysis explored factors that may have influenced response.
-
neurokinin 1 receptor antagonists in the prevention of chemotherapy induced nausea and vomiting focus on Fosaprepitant
Future Oncology, 2018Co-Authors: B L Rapoport, Karin Jordan, Cindy WeinsteinAbstract:: Chemotherapy-induced nausea and vomiting (CINV) remains a challenge in cancer care. Improved understanding of CINV pathophysiology has triggered the development of new antiemetic therapeutic options, such as selective neurokinin-1 (NK1) receptor antagonists (RAs), which effectively prevent CINV when added to a standard antiemetic regimen (serotonin-3 RA and dexamethasone). Aprepitant and its water-soluble prodrug, Fosaprepitant dimeglumine, are the most widely used NK1 RAs, with extensive clinical use worldwide. Recently, a Phase III trial prospectively evaluated Fosaprepitant-based antiemetic therapy for CINV prevention in a large, well-defined nonanthracycline- and cyclophosphamide-based moderately emetogenic chemotherapy population. Fosaprepitant demonstrated significantly improved efficacy outcomes compared with a control regimen and was generally well tolerated, indicating that NK1 RAs are a valuable therapeutic option in this setting.
-
single dose Fosaprepitant for the prevention of chemotherapy induced nausea and vomiting associated with moderately emetogenic chemotherapy results of a randomized double blind phase iii trial
Annals of Oncology, 2016Co-Authors: Cindy Weinstein, Karin Jordan, Stuart A Green, S Khanani, Elizabeth Beckfordbrathwaite, S J Noga, Elber S Camacho, Waldimir Vallejos, L Liang, B L RapoportAbstract:Background To establish the role of antiemetic therapy with neurokinin-1 (NK1) receptor antagonists (RAs) in nonanthracycline and cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) regimens, this study evaluated single-dose intravenous (i.v.) Fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with non-AC MEC.
-
aprepitant and Fosaprepitant a 10 year review of efficacy and safety
Oncologist, 2015Co-Authors: Matti Aapro, B L Rapoport, Alexandra D Carides, H J Schmoll, Li Zhang, David WarrAbstract:Chemotherapy-induced nausea and vomiting (CINV) is a commonadverseeventassociatedwithanticancer treatmentthat canhaveasignificantadverseimpactonpatienthealth-related quality of life and that can potentially undermine the effectiveness of chemotherapy. Traditional regimens to prevent CINVgenerallyinvolvedacombinationofacorticosteroidplus a5-hydroxytryptamine(5HT3)receptorantagonist(RA).Inthe past10years,antiemetictreatmenthasgreatlyadvancedwith the availability of the neurokinin-1 receptor antagonist (NK1 RA) aprepitant and its prodrug Fosaprepitant. NK1 RAs have a different mechanism of action in CINV than corticosteroids and 5HT3 RAs, thus their use can complement traditional antiemeticdrugsandcanenhancecontrolofCINV.Thisreview examined accumulated data regarding the safety and efficacy ofaprepitantandFosaprepitantoverthedecadesincethefirst regulatory approval. Data from key studies of aprepitant and Fosaprepitant in the prevention of CINV in patients receiving moderately and highly emetogenic chemotherapy were explored, as were recommendations in currently available guidelines for their use. In addition, their use as antiemetic therapy in special patient populations washighlighted. Future perspectivesonpotential usesofaprepitantandFosaprepitantforindications other than CINV are presented. The Oncologist 2015; 20:1–9 Implications for Practice: Aprepitant (and its prodrug Fosaprepitant) is a neurokinin-1 receptor antagonist approved more than a decade ago for the prevention of chemotherapy-induced nausea and vomiting (CINV). Its alternative mechanism of action complementstraditionalantiemeticdrugs,enhancingcontrolofCINV.Thisreviewexaminedsafetyandefficacydataforaprepitant and Fosaprepitantaccumulated since the first regulatory approval and explores recommendations in current guidelines for their use.The review serves as a useful reminder for the practitioner that aprepitant and Fosaprepitant are valuable additions to the therapeuticarmamentariumforthepreventionofCINV.FutureperspectivesonpotentialusesofaprepitantandFosaprepitantfor indications other than CINV are discussed.
Ralph J. Hauke - One of the best experts on this subject based on the ideXlab platform.
-
Phase II study of Fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-eads, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen. Methods GCT patients receiving a 5-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given IV on days 3 and 5. A 5HT3-RA days 1–5 (days 1, 3, and 5, if palonosetron) plus dexamethasone 20 mg days 1 and 2 and 4 mg po bid days 6, 7, and 8 was administered. Rescue antiemetics were allowed. The primary objective was to determine the CR rate—no emetic episodes or use of rescue medications. Accrual of 64 patients was planned with expected CR > 27 %. Results Sixty-five patients were enrolled of whom 54 were eligible for analysis. Median age was 33. Fifty-one patients received bleomycin, etoposide, and cisplatin (BEP) chemotherapy. CR was observed in 13 (24.1 %) patients (95 % Agresti-Coull binomial C.I. 14.5 %, 37.1 %). Conclusion The data in this phase II study, in contrast to our prior phase III study, appears to indicate a lower CR rate with the substitution of Fosaprepitant for aprepitant. It is unknown whether the substitution of Fosaprepitant for aprepitant provides the same benefit in multi-day cisplatin that was achieved with single-day cisplatin. Trial registration Clinical trial information NCT01736917
-
phase ii study of Fosaprepitant 5ht3 receptor antagonist dexamethasone in patients with germ cell tumors undergoing 5 day cisplatin based chemotherapy a hoosier cancer research network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. Hauke, Somer Caseeads, Joel PicusAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen.
-
Phase II study of Fosaprepitant + 5HT3 receptor antagonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: a Hoosier Cancer Research Network study
Supportive Care in Cancer, 2016Co-Authors: Nabil Adra, Costantine Albany, Mary J. Brames, Somer Case-eads, Cynthia S. Johnson, Christopher A. Fausel, Timothy Breen, Nasser H. Hanna, Ralph J. HaukeAbstract:Purpose A phase III study adding aprepitant to a 5HT3 receptor antagonist (5HT3-RA) plus dexamethasone in germ cell tumor (GCT) patients treated with 5-day cisplatin combination chemotherapy demonstrated a significant improvement in complete response (CR) (J Clin Onc 30:3998-4003, 2012). Fosaprepitant has demonstrated non-inferiority compared to aprepitant in single-day cisplatin chemotherapy and is approved as a single-dose alternative. This single-arm phase II study is the first clinical trial evaluating Fosaprepitant in patients receiving multi-day cisplatin regimen.
Alexis D. Leal - One of the best experts on this subject based on the ideXlab platform.
-
An analysis of Fosaprepitant-induced venous toxicity in patients receiving highly emetogenic chemotherapy
Supportive Care in Cancer, 2015Co-Authors: Livia T. Hegerova, Alexis D. Leal, Darryl C. Grendahl, Drew K. Seisler, Kristine M. Sorgatz, Kari J. Anderson, Crystal R. Hilger, Charles L. LoprinziAbstract:Purpose Fosaprepitant is an antiemetic used for chemotherapy-induced nausea and vomiting. We recently reported increased infusion site adverse events (ISAE) in a cohort of breast cancer patients receiving chemotherapy with doxorubicin and cyclophosphamide (AC). In this current study, we evaluated the venous toxicity of Fosaprepitant use with non-anthracycline platinum-based antineoplastic regimens. Methods A retrospective review was conducted of the first 81 patients initiated on Fosaprepitant among patients receiving highly emetogenic chemotherapy, on or after January 1, 2011 at Mayo Clinic Rochester. None of these regimens included an anthracycline. Data collected included baseline demographics, chemotherapy regimen, type of intravenous access and type, and severity of ISAE. Data from these patients were compared to previously collected data from patients who had received AC. Statistical analysis using χ 2 and univariate logistic regression was used to evaluate the association between treatment regimen, Fosaprepitant, and risk of ISAE. Results Among these 81 patients, the incidence of ISAE was 7.4 % in the non-anthracycline platinum group. The most commonly reported ISAE were swelling (3 %), extravasation (3 %), and phlebitis (3 %). When stratified by regimen, Fosaprepitant was associated with a statistically significant increased risk of ISAE in the anthracycline group (OR 8.1; 95 % CI 2.0–31.9) compared to the platinum group. Conclusions Fosaprepitant antiemetic therapy causes significant ISAE that are appreciably higher than previous reports. Patients receiving platinum-based chemotherapy appear to have less significant ISAE than do patients who receive anthracycline-based regimens.
-
an analysis of Fosaprepitant induced venous toxicity in patients receiving highly emetogenic chemotherapy
Supportive Care in Cancer, 2015Co-Authors: Livia T. Hegerova, Alexis D. Leal, Darryl C. Grendahl, Drew K. Seisler, Kristine M. Sorgatz, Kari J. Anderson, Crystal R. Hilger, Charles L. LoprinziAbstract:Purpose Fosaprepitant is an antiemetic used for chemotherapy-induced nausea and vomiting. We recently reported increased infusion site adverse events (ISAE) in a cohort of breast cancer patients receiving chemotherapy with doxorubicin and cyclophosphamide (AC). In this current study, we evaluated the venous toxicity of Fosaprepitant use with non-anthracycline platinum-based antineoplastic regimens.
-
Fosaprepitant induced phlebitis a focus on patients receiving doxorubicin cyclophosphamide therapy
Supportive Care in Cancer, 2014Co-Authors: Alexis D. Leal, Darryl C. Grendahl, Drew K. Seisler, Kari J. Anderson, Crystal R. Hilger, Kunal C Kadakia, Sherry A Looker, Kristine Sorgatz, Alison Jacobson, Timothy J HobdayAbstract:Purpose The purpose of this study was to investigate the incidence of Fosaprepitant-associated infusion site adverse events (ISAEs) among a cohort of breast cancer patients receiving doxorubicin/cyclophosphamide (AC) chemotherapy.
-
Fosaprepitant-induced phlebitis: a focus on patients receiving doxorubicin/cyclophosphamide therapy
Supportive Care in Cancer, 2014Co-Authors: Alexis D. Leal, Darryl C. Grendahl, Drew K. Seisler, Kari J. Anderson, Crystal R. Hilger, Kunal C Kadakia, Sherry A Looker, Kristine Sorgatz, Alison Jacobson, Timothy J HobdayAbstract:Purpose The purpose of this study was to investigate the incidence of Fosaprepitant-associated infusion site adverse events (ISAEs) among a cohort of breast cancer patients receiving doxorubicin/cyclophosphamide (AC) chemotherapy.
-
Fosaprepitant induced phlebitis a focus on patients receiving doxorubicin cyclophosphamide therapy
Journal of Clinical Oncology, 2013Co-Authors: Alexis D. Leal, Darryl C. Grendahl, Drew K. Seisler, Kari J. Anderson, Crystal R. Hilger, Kunal C Kadakia, Sherry A Looker, Kristine Sorgatz, Alison Jacobson, Timothy J HobdayAbstract:e20605 Background: Intravenous (IV) Fosaprepitant is a potent antiemetic, commonly used in patients receiving chemotherapy. The purpose of this study was to investigate the incidence of IV fosaprep...