APF530 Could Improve Nausea Control in Cancer Patients

“A phase III study showed that APF530, a delayed release formulation of granisetron, could improve control of emesis in cancer patients receiving highly emetogenic chemotherapy (HEC). The results were presented at the 2015 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium in San Francisco (abstract 68).

“Ian D. Schnadig, MD, of Compass Oncology in Portland, Oregon, presented the study, and said that with regards to supportive care, ‘we still have a ways to go to move the ball down the field in this important domain of cancer care.’ Specifically, managing delayed-phase chemotherapy-induced nausea and vomiting (CINV) is an unmet medical need, he said.

“The MAGIC trial was a phase III, prospective, randomized, placebo-controlled, double-dummy, double-blind trial including 942 patients receiving an HEC regimen. In one arm, patients received ondansetron and a placebo injection; in the other, they received an ondansetron placebo and a APF530 injection. Both groups received fosaprepitant and dexamethasone. The most common chemotherapy regimens were doxorubicin/cyclophosphamide-based and cisplatin-based.”

Data Shows Disconnect Between Healthcare Professionals and Patient Perceptions of Impact of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting

“Norgine B.V. has presented new data highlighting a perceptual gap between healthcare professionals and patients in terms of the incidence and impact on patients’ daily life of chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV).

“These data were sponsored by Norgine and presented at the joint Multinational Association of Supportive Care in Cancer (MASCC) / International Society of Oral Oncology (ISOO) 2015 Annual Meeting.

“The data demonstrate that physicians and oncology nurses overestimate the incidence of CINV/RINV, but underestimate the impact of the condition on patients’ daily lives (p1

“In addition, just 38% of patients reported full compliance with physicians’/nurses’ guidelines when self-administering anti-emetic medication, compared with 60% estimated by physicians and nurses. Leading factors given for poor patient compliance included reluctance to add to a pill burden and fear that swallowing itself would induce nausea/vomiting.”

Emesis Combo Quells CINV in Three Trials (CME/CE)

The gist: Some cancer patients who are treated with chemotherapy experience nausea and vomiting as side effects. Researchers recently conducted three clinical trials with volunteer patients to test a treatment for chemotherapy-induced nausea and vomiting (CINV). The trials compared two different dosing schedules of a treatment that combines the drugs netupitant and palonosetron (aka Aloxi). The researchers reported that a single-dose schedule solved the CINV problem for more patients than a multidose schedule.

“A single-dose antiemetic regimen provided superior control of chemotherapy-induced nausea and vomiting (CINV) as compared with a standard multidose regimen, according to results of three randomized trials.

“In each trial, the fixed-dose combination of netupitant and palonosetron (Aloxi) led to a significantly higher rate of complete response during the delayed phase of the first cycle of chemotherapy versus control regimens. Complete response rates with netupitant-palonosetron (NEPA) regimen ranged from 76% to 89%, representing absolute differences of 5% to 14% versus the control groups.

“Taken together, results of the three trials suggest a ‘winning team’ in the search for optimal management of CINV, reported Matti Aapro, MD, of the Multidisciplinary Oncology Institute in Genolier, Switzerland, and colleagues in the July issue of Annals of Oncology.

” ‘If the present registration trial results are replicated in the “real” clinical world, then the NEPA formulation appears to be an advance in terms of overall efficacy and simplicity of dosing regime with the maintenance of efficacy over multiple cycles of chemotherapy being particularly encouraging,’ Paul L.R. Andrews, PhD, of St George’s University of London, said in an accompanying editorial.”