erythrodysesthesia

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The most commonly reported adverse reactions (all grades; grade 3/4) occurring in[greater than or equal to]5% of patients receiving CYRAMZA plus FOLFIRI and[greater than or equal to]2% higher than placebo plus FOLFIRI in study 4 were diarrhea (60% vs 51%; 11% vs 10%), neutropenia (59% vs 46%; 38% vs 23%), decreased appetite (37% vs 27%; 2% vs 2%), epistaxis (33% vs 15%; 0% vs 0%), stomatitis (31% vs 21%; 4% vs 2%), thrombocytopenia (28% vs 14%; 3% vs <1%), hypertension (26% vs 9%; 11% vs 3%), peripheral edema (20% vs 9%; <1% vs 0%), proteinuria (17% vs 5%; 3% vs <1%), palmar-plantar erythrodysesthesia syndrome (13% vs 5%; 1% vs <1%), gastrointestinal hemorrhage events (12% vs 7%; 2% vs 1%), hypoalbuminemia (6% vs 2%; 1% vs 0%).
The most common side effects of Lenvima were high blood pressure (hypertension), fatigue, diarrhea, joint and muscle pain (arthralgia/myalgia), decreased appetite, decreased weight, nausea, inflammation of the lining of the mouth (stomatitis), headache, vomiting, excess protein in the urine (proteinuria), swelling and pain in the palms, hands and/or the soles of the feet (palmar-plantar erythrodysesthesia syndrome), abdominal pain and changes in voice volume or quality (dysphonia).
The Swiss pharmaceutical group Helsinn and the Spanish company, Advancell, Advanced In Vitro Cell Technologies, SA, today announced a partnering agreement for the development and worldwide commercialization of ATH008, a new topical product for the prevention and/or treatment of Palmoplantar Erythrodysesthesia Syndrome, PPES (caused for example by fluoropyrimidines-based chemotherapy) and of Hand-Foot Skin Reactions, HFSR (caused for example by multitargeted kinase inhibitors, MKIs).
Palmar-Plantar Erythrodysesthesia (PPE) Syndrome occurs in patients treated with COMETRIQ.
While most commonly associated with chemotherapy agent toxicity, palmar/plantar erythrodysesthesia (PPE) or hand-foot syndrome (HFS) was initially described in association with sickle cell [beta]-thalassemia (13,14,15) and subsequently with sickle cell crisis.
The most common adverse reactions observed in LENVIMA-treated patients vs placebo-treated patients were hypertension (73% vs 16%), fatigue (67% vs 35%), diarrhea (67% vs 17%), arthralgia/myalgia (62% vs 28%), decreased appetite (54% vs 18%), weight decreased (51% vs 15%), nausea (47% vs 25%), stomatitis (41% vs 8%), headache (38% vs 11%), vomiting (36% vs 15%), proteinuria (34% vs 3%), palmar-plantar erythrodysesthesia syndrome (32% vs 1%), abdominal pain (31% vs 11%), and dysphonia (31% vs 5%).
Acral erythema: painful swelling and inflammation of the palms of the hands and soles of the feet; may result in hyperkeratosis and desquamation; should be distinguished from palmar-plantar erythrodysesthesia (hand-foot syndrome) that occurs with some chemotherapy
Advancell has announced the initiation of a clinical phase IIb study of its treatment ATH008 for palmar-plantar erythrodysesthesia syndrome, or hand-foot syndrome, a painful side effect of chemotherapy.
The most commonly reported adverse reactions (all grades; grade 3/4) occurring in >5% of patients receiving CYRAMZA plus FOLFIRI and[greater than or equal to]2% higher than placebo plus FOLFIRI in study 4 were diarrhea (60% vs 51%; 11% vs 10%), neutropenia (59% vs 46%; 38% vs 23%), decreased appetite (37% vs 27%; 2% vs 2%), epistaxis (33% vs 15%; 0% vs 0%), stomatitis (31% vs 21%; 4% vs 2%), thrombocytopenia (28% vs 14%; 3% vs <1%), hypertension (26% vs 9%; 11% vs 3%), peripheral edema (20% vs 9%; <1% vs 0%), proteinuria (17% vs 5%; 3% vs <1%), palmar-plantar erythrodysesthesia syndrome (13% vs 5%; 1% vs <1%), gastrointestinal hemorrhage events (12% vs 7%; 2% vs 1%), hypoalbuminemia (6% vs 2%; 1% vs 0%).
The most frequent adverse events (AEs) of grade 3 with greater than 2% incidence in the cabozantinib arm were: diarrhea (16%), palmar-plantar erythrodysesthesia (13%), fatigue (9%), hypertension (8%), decreased weight (5%), decreased appetite (5%), and stomatitis (2%).
The only dose limiting toxicity (DLT) seen to date was grade 3 Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) in one patient at the 80 mg dose.