Antiemetic therapy of fosaprepitant, palonosetron, and dexamethasone combined with cisplatin-based chemotherapy for head and neck carcinomas

Tsukahara, Kiyoaki; Nakamura, Kazuhiro; Motohashi, Ray; Sato, Hiroki; Endo, Minoru; Katsube, Yukiteru; Ueda, Yoshio; Suzuki, Mamoru

doi:10.3109/00016489.2014.913314

Cited by 9 publications

(9 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As previously reported, in the cisplatin stratum (Table 2), delayed-phase CR was numerically higher in the APF530 arm versus the ondansetron arm, with a corresponding treatment difference of 10 18 This more in-depth analysis found similar trends favoring the APF530 over the ondansetron regimen across overalland acute-phase CR (Table 2).…”

Section: Resultssupporting

confidence: 80%

See 1 more Smart Citation

APF530 for nausea and vomiting prevention following cisplatin: phase 3 MAGIC trial analysis

Schwartzberg

Mosier

Geller

et al. 2017

J Community Support Oncol

View full text Add to dashboard Cite

Background APF530 is approved for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with initial and repeat moderately emetogenic chemotherapy or anthracycline plus cyclophosphamide (AC) regimens, based on phase 3 trials. Objective To evaluate APF530 for CINV among cisplatin-stratum patients in the phase 3 MAGIC trial. Methods Stratification was by planned receipt of cisplatin, with randomization to APF530 500 mg SC or ondansetron 0.15 mg/ kg IV. Patients received fosaprepitant 150 mg IV plus dexamethasone 12 mg IV (day 1) and oral dexamethasone 8 mg (once, day 2; twice daily, days 3-4). The primary endpoint was delayed-phase complete response (CR). Other endpoints included CR, complete control (CC), and total response (TR) across phases, time to first rescue medication use, proportion of patients with no rescue medication use, and nausea frequency. Adverse event (AE) assessments included injection-site reactions (ISRs). This analysis evaluated cisplatin-stratum patients. Results 264 of 942 randomized patients were included in the cisplatin stratum, 252 in the efficacy analyses (124 APF530, 128 ondansetron). Delayed-phase CR was numerically higher with APF530 than ondansetron, with a 10.6% treatment difference (APF530: 65.3% [81/124]; ondansetron: 54.7% [70/128]; P = .085). Similar trends favored APF530 for CC, TR, rescue medication use, and nausea endpoints. APF530 was well tolerated; most AEs were ISRs, generally mild or moderate. Limitations Exploratory analysis, not powered to detect significant between-arm differences. Conclusions Consistent with significant results in the overall population, APF530 showed clinical benefits in CINV control in patients scheduled for cisplatin-based regimens. Funding Heron Therapeutics Inc, maker of the study drug, APF530.

show abstract

Section: Resultssupporting

confidence: 80%

“…8,9 However, the administration of oral medication to patients experiencing CINV and those with head and neck cancer may be difficult. 10 Alternative antiemetic treatments that provide CINV control into the delayed phase and with a convenient route of administration, are needed.…”

mentioning

confidence: 99%

APF530 for nausea and vomiting prevention following cisplatin: phase 3 MAGIC trial analysis

Schwartzberg

Mosier

Geller

et al. 2017

J Community Support Oncol

View full text Add to dashboard Cite

show abstract

“…While a three-day oral regimen of aprepitant was the first approved NK 1 RA, randomized controlled trials have shown that a single IV dose of fosaprepitant is non-inferior to aprepitant and may be more convenient for patients. 4,5 According to the National Comprehensive Cancer Network antiemetic guidelines, 2 the addition of an NK 1 RA to dexamethasone and a 5HT-3 RA is an effective combination for relieving CINV due to highly and some moderately emetogenic chemotherapy. The most common adverse reactions reported for fosaprepitant are fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in the extremity.…”

Section: Discussionmentioning

confidence: 99%

Systemic hypersensitivity to fosaprepitant – A report of two cases

Baxley¹,

Lee

Medina

2016

J Oncol Pharm Pract

View full text Add to dashboard Cite

Fosaprepitant is a widely administered antiemetic used mainly for moderately to highly emetogenic chemotherapy. Local injection site reactions are the most common type of infusion reaction reported from fosaprepitant. At our institution, two separate patients have experienced systemic hypersensitivity reactions to their infusions of fosaprepitant. We report a review of the literature and the details of these reactions.

show abstract

“…It is unclear, however, whether palonosetron is more effective against delayed emesis when administered with an NK 1 RA. Several single-arm studies found that palonosetron had additional antiemetic efficacy when added to aprepitant and dexamethasone in patients with gynecological, head/neck and lung cancer [ 29 – 31 ]. Only one phase III trial, the TRIPLE study, compared granisetron and palonosetron added to basal antiemetic therapy with NK 1 RA and corticosteroid, finding that palonosetron was superior to granisetron in preventing delayed emesis and nausea [ 32 ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with gastric cancer treated with S-1 plus cisplatin

et al. 2015

View full text Add to dashboard Cite

PurposeThe purpose of our study was to evaluate the efficacy of a new combination antiemetic therapy consisting of palonosetron, aprepitant, and dexamethasone in gastric cancer patients undergoing chemotherapy with S-1 plus cisplatin.MethodsThis prospective, multi-institutional observational study assessed patient-reported nausea, vomiting, use of rescue therapy, change of dietary intake, and Functional Living Index-Emesis (FLIE) questionnaire results. The percentages of patients showing complete response (CR; no emesis and non-use of any rescue antiemetics) and complete protection (CP; no significant nausea and non-use of any rescue antiemetics), change of dietary intake, and impact of chemotherapy-induced nausea and vomiting on daily life during the overall (0–120 h after cisplatin administration), acute (0–24 h), and delayed (24–120 h) phases were examined. These findings were compared with our previous study, which used granisetron, aprepitant, and dexamethasone, to assess the relative effectiveness of palonosetron versus granisetron in combination antiemetic therapy.ResultsOf the 72 included patients, 66 (91.6 %), 70 (97.2 %), and 50 (69.1 %) achieved CR, and 48 (66.7 %), 61 (84.7 %) and 49 (68.1 %) achieved CP during in the overall, acute, and delayed phases of cisplatin administration, respectively. Approximately half of the patients had some degree of anorexia. FLIE results indicated that 78.6 % of patients maintained their quality of life. Palonosetron was not superior to granisetron in combination antiemetic therapy.ConclusionsThree-drug combination antiemetic therapy with palonosetron, aprepitant, and dexamethasone was tolerable in gastric cancer patients undergoing treatment with S-1 plus cisplatin. The predominance of palonosetron to granisetron was not demonstrated in this study.

show abstract

Antiemetic therapy of fosaprepitant, palonosetron, and dexamethasone combined with cisplatin-based chemotherapy for head and neck carcinomas

Cited by 9 publications

References 19 publications

APF530 for nausea and vomiting prevention following cisplatin: phase 3 MAGIC trial analysis

APF530 for nausea and vomiting prevention following cisplatin: phase 3 MAGIC trial analysis

Systemic hypersensitivity to fosaprepitant – A report of two cases

Evaluation of the efficacy of palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with gastric cancer treated with S-1 plus cisplatin

Contact Info

Product

Resources

About