palonosetron and Colorectal-Neoplasms

Delayed chemotherapy-induced nausea and vomiting (CINV) is not well controlled in colorectal cancer (CRC) patients undergoing oxaliplatin (L-OHP)-based chemotherapy. Whether neurokinin-1 receptor antagonist addition to a first-generation 5HT

Topics: Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Aprepitant; Colorectal Neoplasms; Dexamethasone; Female; Humans; Incidence; Male; Middle Aged; Nausea; Oxaliplatin; Palonosetron; Serotonin 5-HT3 Receptor Antagonists; Vomiting

The 5-hydroxytryptamine-3 receptor antagonist palonosetron (PALO) is approved (United States/Europe) as an oral formulation for prevention of chemotherapy-induced nausea and vomiting in adult cancer patients undergoing moderately emetogenic chemotherapy (MEC) for the acute phase only, in the United States, or as intravenous (IV) formulation in patients undergoing MEC or highly emetogenic chemotherapy. This phase III study compares the efficacy/safety of oral versus IV PALO in Chinese patients.. Chemotherapy-naive patients with solid tumours scheduled for MEC received oral PALO 0.50 mg or IV PALO 0.25 mg. The primary objective was to demonstrate non-inferiority in terms of patients with complete response in the acute phase (0-24 hr post-chemotherapy).. Complete response rates (acute phase), evaluated in 318/320 randomised patients, were 84.6% and 85.9% for oral and IV PALO respectively. Non-inferiority was demonstrated; the two formulations showed similar efficacy/safety.. Non-inferiority of oral versus IV PALO in the acute phase was demonstrated in Chinese patients.. CTR20140711.

Topics: Administration, Intravenous; Administration, Oral; Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Agents; Breast Neoplasms; Carcinoma; China; Colorectal Neoplasms; Dexamethasone; Double-Blind Method; Female; Humans; Lung Neoplasms; Male; Middle Aged; Nausea; Neoplasms; Palonosetron; Stomach Neoplasms; Vomiting; Young Adult

Chemotherapy-induced nausea and vomiting (CINV) causes significant morbidity among colorectal cancer patients, receiving fluorouracil, oxaliplatin, and leucovorin (FOLFOX) chemotherapy even with standard antiemetic prophylaxis. The purpose of this study is to determine if the addition of aprepitant to standard antiemetic therapy improves CINV in these patients.. Patients receiving FOLFOX for colorectal cancer were given antiemetic prophylaxis with aprepitant 125 mg orally on day 1 and 80 mg on days 2 and 3. Palonosetron 0.25 mg was given IV push on day 1 only. Dexamethasone 12 mg was administered orally on day 1 and 8 mg each morning on days 2 through 4. Assessments including emetic events, rescue doses, nutritional intake, and appetite were recorded in a patient diary which was returned to study personnel in the following cycle.. Of the 53 patients screened, 50 were evaluable and had a complete dataset for cycle 1. For the first cycle, 74% of patients achieved a complete response (CR), 22% achieved a major response and 4% experienced treatment failure. The percentage of patients achieving a CR remained high throughout each cycle at 83, 83, and 86% for cycles 2, 3, and 4, respectively. Appetite and nutritional status remained largely unchanged throughout treatment. Adverse events occurring in more than 10% of patients included diarrhea (13.6%), fatigue (12.6%), and neutropenia (11%).. Aprepitant added to standard antiemetic therapy appears to be an effective and safe regimen for prevention of CINV in patients receiving FOLFOX.

Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Aprepitant; Colorectal Neoplasms; Dexamethasone; Female; Fluorouracil; Humans; Induction Chemotherapy; Leucovorin; Male; Middle Aged; Morpholines; Nausea; Organoplatinum Compounds; Palonosetron; Pilot Projects; Vomiting

The outbreak of coronavirus disease 2019 (COVID-19) has affected the treatment of cancer patients, with particular regard to the management of both chemotherapy and side effects. Chemotherapy-induced nausea and vomiting (CINV) are amongst the most troublesome side effects that impair patients' adherence to treatments and their quality of life (QoL). NEPA (Akynzeo®), is an oral fixed-dose combination of netupitant [a neurokinin-1 receptor antagonist (NK1RA), 300 mg] and palonosetron [(5-hydroxytryptamine (serotonin or 5HT) type3 receptor antagonist (5HT3RA), 0.5 mg] which has been shown to be effective in preventing CINV.. This prospective study started before the outbreak of COVID-19 and was carried out during the pandemic period. The aim was to evaluate the efficacy and safety of a single oral dose NEPA plus 12 mg of dexamethasone (DEX) in patients treated with Folfoxiri plus Bevacizumab and Folfirinox. The patients were diagnosed with advanced colorectal cancer (CRC) or advanced pancreatic ductal adenocarcinoma (PDAC). They were divided into two groups: naïve patients and patients previously treated with serotonin receptor antagonists (5HT3-RA) and neurokin-1 receptor antagonists (NK1-RA).. During the overall phase, the complete response (CR) rate was 96.8% in naïve patients treated with Folfoxiri plus Bevacizumab, and 94.6% in patients treated with Folfirinox. During the acute and delayed phases, the CR rate was 92.8% and 94.2%, with Folfoxiri and Bevacizumab, as well as 96.2% and 94.6%, with Folfirinox. There was no adequate control of CINV events in patients on antiemetic prophylaxis with 5HT3-RA or NK1-RA associated with cortisone. During the overall phase, the CR rate was 74.6% with Folfoxiri plus Bevacizumab and 75.8% with Folfirinox. During the acute and delayed phases, the CR rate was 72.5% and 74.8% with Folfoxiri plus Bevacizumab, as well as 75.2% and 74.6% with Folfirinox.. This study has shown the therapeutic benefits of NEPA in the management and prophylaxis of CINV events, both in naive patients and patients previously treated with 5HT3-RA and NK1-RA. In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic.

Topics: Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Colorectal Neoplasms; COVID-19; Female; Fluorouracil; Humans; Irinotecan; Leucovorin; Male; Middle Aged; Nausea; Oxaliplatin; Palonosetron; Pandemics; Prospective Studies; Pyridines; Vomiting

Controlling chemotherapy-induced nausea and vomiting(CINV)is very important for the continuation of chemotherapy. CINV can significantly affect a patient's quality of life, leading to poor compliance with further chemotherapy treatment. In this retrospective study, we assessed the efficacy of palonosetron versus granisetron for the incidence of CINV induced by mFOLFOX6 and FOLFIRI in patients with advanced colorectal cancer. Eighty-eight patients were included in the efficacy analyses: 39 patients in the palonosetron group and 49 patients in the granisetron group. The incidence of nausea in the granisetron group(Grade 1: 40. 8%, Grade 2: 10. 2% and Grade 3: 4. 1%)was significantly higher than in the palonosetron group (Grade 1: 25. 6% and Grade 2: 7. 7%, p=0. 0422). The incidence of vomiting and appetite loss in the granisetron group was not significantly higher than in the palonosetron group(p=0. 2419, p=0. 2648, respectively). This suggests that palonosetron exerts better efficacy against chemotherapy-induced nausea than granisetron in patients receiving mFOLFOX6 and FOLFIRI. Information on such analyses is useful to promote the effectiveness of cancer chemotherapy.

Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Colorectal Neoplasms; Female; Fluorouracil; Humans; Isoquinolines; Leucovorin; Male; Middle Aged; Nausea; Organoplatinum Compounds; Palonosetron; Quinuclidines; Retrospective Studies; Vomiting