Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 226-226
Author(s):  
Toshimichi Miya ◽  
Kunihiko Kobayashi ◽  
Mitsunori Hino ◽  
Masahiro Ando ◽  
Susumu Takeuchi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Phase ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Antiemetic Therapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Treatment ◽  
Severe Adverse Events ◽  
Delayed Phase

226 Background: Chemotherapy-induced nausea and vomiting (CINV) is a major adverse toxicity of cancer chemotherapy. Recommended treatments for prevention of CINV vary among guidelines, and optimal care for CINV caused by moderately emetogenic chemotherapy has not been established. This study assess efficacy and safety of triple antiemetic therapy consist palonosetron, dexamethasone and aprepitant for carboplatin-based chemotherapy. Methods: Chemotherapy-naïve patients with lung cancer scheduled for a first course of a carboplatin-containing regimen formed the study cohort. Patients were pretreated with antiemetic therapy consist palonosetron (0.75 mg, i.v.) and dexamethasone (9.9 mg, i.v.) on day 1, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. Primary endpoint was the proportion of patients who did not experience vomiting and did not require rescue medication (complete response (CR)) in the acute phase (0-24 h), late phase (24-168 h) and overall. Secondary endpoint was the proportion of patients who experienced no vomiting episodes and no more than mild nausea without the need for rescue medication (complete control (CC)). Results: Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Conclusions: Triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant shows excellent effects in preventing CINV in patients receiving a carboplatin-containing regimen. Clinical trial information: UMIN000017877.

Efficacy of a 1-day 3-drug antiemetic regimen for prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9111-9111 ◽  
Author(s):  
S. M. Grunberg ◽  
M. Dugan ◽  
H. B. Muss ◽  
M. Wood ◽  
S. Burdette-Radoux ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Regimen ◽  
Delayed Nausea ◽  
Pre Treatment ◽  
Significant Nausea

9111 Background: Serotonin antagonists, NK-1 antagonists (NKA) and corticosteroids (C) have all shown efficacy against chemotherapy-induced nausea and vomiting. However these agents are commonly used in cumbersome and inconvenient multiple day regimens that can also raise questions of compliance. Palonosetron is a serotonin antagonist with a 40 hour half-life, requiring only one dose for several days of exposure. Single high doses of NKA and C can also be used to simulate drug exposures achieved with a multiple day regimen. We have therefore evaluated a 1-day 3-drug antiemetic regimen for 5 day efficacy against moderately emetogenic chemotherapy. Methods: Patients with solid tumors receiving their first cycle of cyclophosphamide and/or doxorubicin were eligible to receive a single pre-treatment dose of palonosetron 0.25 mg IV/dexamethasone 20 mg PO/aprepitant 285 mg PO. Nausea and vomiting were evaluated over the following 5 days with a patient diary including vomiting episodes, use of rescue medication, and daily nausea visual analogue scale (VAS). Patients were urged to begin rescue medication for nausea, vomiting, or related discomfort. Endpoints included Complete Response (CR) (no emesis or rescue), No Emesis (NE), and No Significant Nausea (NSN) (VAS<25) during the acute period (A) (Day 1), the delayed period (D) (Days 2–5), and the overall period (O) (Days 1–5). Adverse events were recorded and tabulated for at least 14 days. Results: 32 of 40 planned patients have been entered on study. 31 women and 1 man with breast cancer receiving adjuvant chemotherapy with median age 52 years (range 34–74) have been treated and all are evaluable. CR for A/D/O was 78%/59%/50%. However NE for A/D/O was 100%/97%/97%, and NSN for A/D/O was 75%/62%/56%. Only 8 patients had more than one day of Significant Nausea. The most common treatment-related adverse events were fatigue and mild headache. Conclusions: A 1-day 3-drug antiemetic regimen is feasible and effective, and should be tested against a multiple day standard antiemetic regimen. [Table: see text]

scholarly journals Comparative study of fosaprepitant and aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients

2021 ◽  
Author(s):  
Li Ting Yu ◽  
zhuo wang ◽  
fen zhou ◽  
Shuangshuang Shen ◽  
Shunguo Zhang ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Acute Phase ◽  
Pediatric Cancer ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Phase 0 ◽  
Pediatric Cancer Patients ◽  
To Receive ◽  
Delayed Phase

Abstract Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant). Children recruited to arm-A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with aprepitant. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy. Results: One hundred and eight patients were analyzed (55 in the fosaprepitant arm and 53 in the aprepitant arm). CR rates were higher in the fosaprepitant arm compared with the aprepitant arm during the acute phase (95 % vs 79 %, P =0.01< 0.05), delayed phase (71 % vs 66 %, P =0.89 ), and overall phase (69 % vs 57 %, P =0.18). Furthermore, the demand of rescue anti-emetics observed in fosaprepitant arm (7 %) has no difference with aprepitant arm (11 %). Conclusion: Addition of fosaprepitant to ondansetron and dexamethasone is more effective than aprepitant for the prevention of acute vomiting.

Nausea and vomiting during high-dose interleukin-2 (HD IL-2) therapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20661-e20661
Author(s):  
Mark Fesler ◽  
Melinda Bernabe Chu ◽  
Eric Armbrecht ◽  
Scott Fosko ◽  
Eddy C. Hsueh ◽  
...  
Keyword(s):  
Acute Phase ◽  
Drug Targets ◽  
Rescue Medication ◽  
Rescue Therapy ◽  
Interleukin 2 ◽  
Retrospective Chart Review ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Saint Louis ◽  
Delayed Phase

e20661 Background: Nausea and vomiting (N/V) are two common side effects during HD IL-2 therapy. They may be severe enough to cause electrolyte imbalances or lead to missed doses, which may compromise response. Our aim was to describe the incidence of N/V during HD IL-2 therapy at our institution. Methods: A retrospective chart review of patients treated with HD IL-2 therapy (720,000 IU/kg per dose intravenously; 14 doses, 2 cycles per course, maximum 2 courses) from January 1999 to June 2011 at Saint Louis University was performed. Patients received scheduled PO ondansetron 24 mg daily and prochlorperazine 10 mg IV or PO every 4 hours as needed per standard protocol. Additional antiemetics were ordered at the clinician’s discretion. Data regarding incidence of N/V and use and type of rescue medication for N/V were recorded. Results: 104 patients were identified (68 melanoma and 36 renal cell carcinoma). Median age was 53.7 years (17.7-77.7 years) and there were 66 men and 38 women. Only 3.8% of patients (4 out of 104) were able to complete HD IL-2 therapy without rescue medication. All patients (n = 100) who needed rescue therapy received prochlorperazine on day 1 of treatment (acute phase) and at least 1 additional day during days 2-6 of each admission (delayed phase). Metoclopramide (n = 23) was the most common supplemental antiemetic ordered followed by promethazine (n = 16), meclizine (n = 5), and palonsetron (n = 3). Conclusions: Almost all patients who underwent HD IL-2 therapy had N/V that necessitated rescue therapy during both the acute phase and the delayed phase. Decreasing the incidence and severity of N/V may increase patients’ quality of life during this demanding regimen. Current protocols are single-institution based, but generally include daily 5HT-3 antagonists and prochlorperazine as needed. Our data suggests that this regimen is inadequate. One challenge to management is that steroids, which are commonly used as adjuncts, are contraindicated during immunotherapy. Additional therapeutic options are still needed. Recently new drug targets, including neurokinin-1 receptor (NK1R) inhibitors, have been approved to treat N/V during chemotherapy. NK1R inhibitors may be of assistance during immunotherapy with HD IL-2 in the future.

Efficacy and Safety of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 5196-5196
Author(s):  
Brian Choi ◽  
Gabriela Borsaru ◽  
Daniel Voisin ◽  
Gianluca Ballinari ◽  
Nicola Di Renzo
Keyword(s):  
Adverse Events ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Negative Consequences ◽  
Efficacy And Safety ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Prophylaxis ◽  
Secondary Endpoints ◽  
Hodgkin's Lymphomas

Abstract Abstract 5196 Background: Patients undergoing chemotherapy (CT) commonly receive repeated cycles of treatment. While chemotherapy-induced nausea and vomiting (CINV) can be a disruptive, unwanted side effect with negative consequences on patient quality of life, possible discontinuation of therapy, and associated increased health care resources, prevention of CINV in cycle 1 diminishes its potential in subsequent cycles. Therefore, optimizing antiemetic prophylaxis at initiation of CT is critical. Palonosetron (PALO), a potent 5-HT3 receptor antagonist (RA) with a distinctly different pharmacokinetic and receptor binding profile, has demonstrated improved CINV protection compared to older 5-HT3 RAs in multiple phase 3 and 4 single-CT-cycle clinical trials; however, few studies have evaluated PALO over multiple cycles of CT. Methods: This was a prospective, multicenter, single-arm study designed to assess the efficacy and safety of single IV doses of PALO 0.25 mg in preventing CINV in chemotherapy-naïve patients with Non-Hodgkin's Lymphomas (NHL) scheduled to receive at least 2 repeated, consecutive cycles of moderately emetogenic chemotherapy (CHOP, R-CHOP or ProMACE-CytaBOM). Corticosteroids were part of the CT regimen but not administered as an antiemetic. The primary efficacy endpoint was complete response (CR: defined as no emesis and no use of rescue medication) during the overall phase (0–120 h) following CT during each cycle. Secondary endpoints included CR during the acute (0–24 h) and delayed (24–120 h) time periods, as well as evaluation of proportion of emesis-free patients and nausea severity (according to a 100 mm VAS) during all 3 time intervals. The safety profile and adverse events were also assessed. Results: A total of 88 patients with either B-cell (91%) or T-cell (9%) NHL received PALO for a total of 317 CT cycles (mean 3.6; median 4). The majority of patients were white (99%) males (60%) with a mean age of 59.7 yrs who received either CHOP (47%) or R-CHOP (52%). CR rates during the acute, delayed and overall phases were sustained across the 4 CT cycles (Table). High proportions of patients remained emesis-free and experienced less than significant nausea (0 to <25 mm VAS) during the 5 days post-CT throughout repeated CT cycles (Table). PALO was well tolerated over repeated cycles, with few adverse events considered possibly/probably/definitely related (TRAEs: treatment related adverse events) (8% of patients; none serious). The incidence of the typically frequent TRAEs of headache and constipation was low (1% and 2%) and there were no unexpected or relevant differences in TRAEs between cycles or in later cycles (6%, 3%, 0%, 4% cycles 1–4, respectively). Conclusion: A single, fixed IV dose of palonosetron was shown to be safe and effective in preventing CINV over repeated chemotherapy cycles in patients with NHL. Disclosures: Voisin: Helsinn Healthcare: Employment. Ballinari:Helsinn Healthcare: Employment.

scholarly journals Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens

2015 ◽  
Vol 04 (01) ◽  
pp. 007-010 ◽  
Author(s):  
Sachin Hingmire ◽  
Nirmal Raut
Keyword(s):  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Moderately Emetogenic Chemotherapy ◽  
Open Label ◽  
Highly Emetogenic Chemotherapy ◽  
Serious Adverse Events ◽  
Complete Control

Abstract Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens. Aims: The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens. Settings and Design: Investigator initiated, multicentric, open-label, prospective, noncomparative, observational trial. Subjects and Methods: Triple drug regimen with aprepitant, palonosetron, and dexamethasaone administration was assessed for the prevention of CINV during acute, delayed, and the overall phase (OP) for HEC/MEC Regimens. The primary endpoint was complete response (CR; no emesis and no use of rescue medication) and the key secondary endpoint was the complete control (CC; no emesis, no rescue medication and no more than mild nausea) during the OP. Statistical Analysis Used: Perprotocol efficacy was analyzed for the first cycle with results represented in terms of CR/CC rates using descriptive statistics. Results: Seventy-five patients were included in the study with median age of 49.7 years and 89.7% being females. The CR rate (OP) for patients administered HEC or MEC regimens during the first cycle were 92% and 90.9%, respectively. Similarly, the CC rates (OP) were 75% and 90% for these regimens, respectively. 7 (9.2%) patients reported adverse drug reactions that were mild and transient with no reports of any serious adverse events. Conclusions: Use of aprepitant containing regimen for patients receiving HEC/MEC regimen resulted in significantly high CR and CC response rates, which further consolidate its potential role to improve patient quality of life and compliance to disease management.

scholarly journals Phase II Multicenter, Not Comparative, Study of Multiple Doses of NEPA (netupitant + palonosetron) in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Non-Hodgkin Lymphoma Patients Eligible for Autologous Hematopoietic Stem Cell Transplantation Receiving Multiple Days / High Dose Chemotherapy Regimens

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1974-1974
Author(s):  
Nicola Di Renzo ◽  
Maurizio Musso ◽  
Rosanna Scimè ◽  
Giuseppe Milone ◽  
Tommasina Perrone ◽  
...  
Keyword(s):  
Stem Cell ◽  
Adverse Events ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Acute Phase ◽  
Primary Endpoint ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Antiemetic Prophylaxis ◽  
Delayed Phase

Cancer chemotherapy may be associated with a high incidence of nausea and vomiting (CINV), which may occur acutely within 24 hours after the start of chemotherapy (acute phase) or in the following days (delayed phase). Despite the availability of several antiemetics, clinical findings show that control of nausea and vomiting continue to be a serious concern for hematological patients, mainly for those receiving multiple-day (MD) and high-dose (HD) chemotherapy (CT), for which no specific international recommendations have been formulated, due to the lack of a unanimous consensus between the main international guidelines. NEPA is the first antiemetic developed as an oral fixed dose combination of two drugs that are antagonists of two receptors involved in the control of nausea and vomiting: a new highly selective NK1-RA, netupitant, and a second generation 5HT3-RA, palonosetron, that simplify the antiemetic regimen allowing for a lower number of capsules and days of treatment. In clinical practice, NEPA is administered together with dexamethasone that contributes to CINV prophylaxis by its intrinsic antiemetic properties. However, dexamethasone also exhibits an important immunosuppressive activity, which could lead to several adverse events, such as increasing the risk of serious infections, especially in patients undergoing myeloablative treatment. The rational of this study was to explore the efficacy of multiple doses of NEPA given with an every-other-day regimen without dexamethasone in preventing CINV in patients with non-Hodgkin's lymphoma (NHL) eligible for autologous stem cell transplantation (ASCT) and treated with MD-HD-CT. The chemotherapy regimen (BEAM/FEAM) was administered for 6 days, NEPA was taken on day 1, 3 and 5, and nausea and vomiting were monitored up to day 15. No dexamethasone was given for antiemetic prophylaxis. The primary endpoint was the percentage of patients achieving a Complete Response (CR; no vomiting and no use of rescue medication) during the overall phase, defined as the period from day 1 (first day of chemotherapy) until 2 days after the last dose of chemotherapy. Seventy patients participated to the study. According to the adopted Fleming one-stage design, the primary endpoint of this study was achieved. Indeed, the number of complete responders for the overall phase was 60, which is greater than the predetermined cut-off of 42, representing the minimum frequency of responders for which the treatment is considered effective. In addition to the primary efficacy result, several additional endpoints were evaluated for the study period (Figure 1). The CR values were 87.1% (primary endpoint, overall phase: days 1-8), 88.6% (acute phase: days 1-6) and 98.6% (delayed phase: days 7-8), while the complete control (CR with no more than mild nausea) was 85.7% (overall phase), 88.6% (acute phase) and 95.7% (delayed phase) (Figure 1A). Moreover, the percentages of patients that did not have any emetic episodes were 88.6% (overall phase), 90% (acute phase) and 98.6% (delayed phase) and patients that did not require a rescue therapy for controlling CINV were 94.3% (overall phase), 94.3% (acute phase) and 100% (delayed phase). Daily records taken from day 1 to day 15 showed that values for all these categories were above 85% for all the days of observation (Figure 1B). Patients also documented the grade of their nausea according to the Likert scale. Moderate and severe episodes of nausea were reported by less than 10% for the overall phase and less than 5% in both acute and delayed phase and the daily values of no nausea were above 65% for each day of the treatment (Figure 1C and 1D). Indeed, the mean patient global satisfaction for the antiemetic prophylaxis for the study period was 9.13 ± 1.59 out of 10. Regarding safety, a total of 12 Treatment-Emergent Adverse Events (TEAEs) occurred in 6 (8.6%) subjects enrolled in the study. Among these, only 1 (8.3%, constipation) was evaluated as possibly related to NEPA administration. Moreover, the only two TEAEs classified as SAE (Serious Adverse Event) were two episodes of fever that have been evaluated as not-related to NEPA. Therefore, the safety profile of NEPA was confirmed also in this setting. In conclusion, our study demonstrated that multiple alternate dosing of NEPA without the addition of dexamethasone can effectively prevent nausea and vomiting in a difficult setting, such as MD/HD-CT with a good tolerability profile. Disclosures No relevant conflicts of interest to declare.

Efficacy of a Transdermal Granisetron Patch in Controlling Chemotherapy-Induced Nausea and Vomiting (CINV) in Hematologic Cancer Patients

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3045-3045
Author(s):  
Ruben Niesvizky ◽  
Ana Fernández Velasco ◽  
Doris S Wong ◽  
Deborah Braccia
Keyword(s):  
Cancer Patients ◽  
Acute Phase ◽  
Rescue Medication ◽  
Hematologic Malignancies ◽  
Emetogenic Chemotherapy ◽  
Response To Therapy ◽  
Patient Assessment ◽  
Highly Emetogenic Chemotherapy ◽  
Hematologic Cancer ◽  
Delayed Phase

Abstract Introduction: Multiday, highly emetogenic chemotherapy regimens are commonly used in the management of hematologic malignancies. Despite progress in prophylaxis, CINV, especially during the delayed phase, can remain a significant barrier to attaining planned chemotherapy dose on time for some patients. A granisetron transdermal system (GTS) has been shown to be as effective as oral granisetron in controlling CINV across multiple tumor types. This post-hoc analysis specifically examined the efficacy and safety of GTS in patients with hematologic malignancies. Methods: A randomized, phase 3 study has been published comparing GTS (7 day application) to oral granisetron (2 mg/day) in patients receiving either moderately or highly emetogenic chemotherapy for 3-5 days. Data for this analysis were limited to patients with a primary tumor diagnosis of lymphoma (n=51), leukemia (n=27), or multiple myeloma (n=5). The rates of complete control (CC; no vomiting, mild nausea, no rescue medication) and complete response (CR; no vomiting, no rescue medication) using either GTS or oral granisetron were compared during both the acute (first 24 hours) and delayed phase (days 2 to 5) following chemotherapy. Need for rescue medication and patient assessment of response to therapy with GTS were also compared. Results: 83 hematologic cancer patients (31 GTS, 52 oral granisetron) were included. The majority of patients received a non-cisplatin regimen with corticosteroids (59 patients; 71%). Patients received chemotherapy for 3 days (37; 45%) or 4 to 5 days (46 patients; 55%). During the acute phase of CINV, the CC rate of 94% and CR rate of 94% in the GTS group were similar to rates in the overall population (94% and 95%, respectively). There was no difference in CC and CR between GTS and oral granisetron in the acute phase (P=0.90 and 0.59, respectively). In the delayed phase, GTS resulted in CC in 87% and CR in 90%; compared with CC in 77% and CR in 81% of patients given oral granisetron (P=0.26 and 0.25, respectively). The use of rescue medication over the entire study period and patient assessment of overall response to therapy were not different between arms (P=0.60 and 0.92, respectively). GTS was well tolerated; the only treatment related adverse event was one case of mild constipation. Conclusion: This retrospective analysis suggests GTS may be an appropriate option for prevention of CINV in hematologic cancer patients. A trend toward improved control in the delayed phase was observed and further investigation of a benefit in delayed CINV for hematologic malignancies may be warranted. Disclosures Fernández Velasco: ProStrakan: Employment. Wong:ProStrakan: Employment. Braccia:ProStrakan: Employment.

scholarly journals Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Cindy Weinstein ◽  
Karin Jordan ◽  
Stuart Green ◽  
Saleem Khanani ◽  
Elizabeth Beckford-Brathwaite ◽  
...  
Keyword(s):  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Cancer Type ◽  
Moderately Emetogenic Chemotherapy ◽  
Post Hoc Analysis ◽  
Link Type ◽  
Control Regimen ◽  
Post Hoc ◽  
To Receive ◽  
Delayed Phase

Abstract Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Methods Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. Results CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. Conclusions This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Trial registration ClinicalTrials.govNCT01594749, registered May 9, 2012.

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