scholarly journals Impact of oral palonosetron in improving quality of life as compared to other oral 5-HT3 antagonists in delayed chemotherapy induced nausea and vomiting in patients of head and neck cancer

2019 ◽  
Vol 8 (3) ◽  
pp. 493
Author(s):  
Anubhuti Khare ◽  
Varsha Mandloi ◽  
Abhishek Shrivastava ◽  
Arun Kumar Shrivastava ◽  
Prashant Wadagbalkar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Receptor Antagonists ◽  
Medical College ◽  
Delayed Cinv ◽  
Gandhi Medical College ◽  
Oral Ondansetron

Background: Chemotherapy induced nausea and vomiting (CINV) remains one of the most common and debilitating complications of highly emetogenic chemotherapy (HEC). This study was undertaken to evaluate palanosetron against other 5-HT3 receptor antagonists in preventing delayed CINV with the aim of achieving complete response (CR) and improving quality of life (QoL).Methods: This was a prospective, observational study conducted on 75 histopathologically proven patients of squamous cell carcinoma of Head and Neck (H&N), who came to the Department of Radiation Oncology, Gandhi Medical College and Hamidia Hospital, Bhopal from January to December 2015. Standard protocol based chemotherapy containing highly emetogenic cisplatin based chemotherapy was administered to all the patients. For prevention of delayed chemotherapy induced nausea and vomiting all patients were prescribed oral 5-HT3 antagonists. Oral Ondansetron 4mg TDS was given to cohort 1, oral Granisetron 1 mg BD to cohort2 and oral Palanosetron 0.5mg OD was given to cohort 3. They were graded as complete response when they did not have complains of nausea and vomiting.Results: In Ondansetron, Granisetron and in Palanosetron cohort 29%, 53% and 98% patients had complete response.Conclusions: Palanosetron appears superior. Our study was conducted on handfull of patients and compared palanosetron against only two 5-HT3 receptor antagonists, so a larger study is suggested to establish the efficacy and better response of palanosetron.

A unique schedule of palonosetron, ondansetron, and dexamethasone for the prevention of delayed nausea and vomiting in patients receiving myeloablative chemotherapy

2018 ◽  
Vol 25 (6) ◽  
pp. 1336-1342
Author(s):  
J LaPorte ◽  
K Leone ◽  
X Zhang ◽  
K Holland ◽  
L Morris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Phase Ii Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Myeloablative Chemotherapy ◽  
Delayed Nausea ◽  
Delayed Cinv ◽  
The Mean ◽  
Nausea Severity

Myeloablative chemotherapy administered prior to autologous stem cell transplantation (auto-SCT) is associated with a significant amount of chemotherapy-induced nausea and vomiting (CINV). We conducted a phase II trial to assess the safety, efficacy, and impact on quality of life when palonosetron (PAL) 0.25 mg combined with dexamethasone were given on the final or only day of myeloablative chemotherapy for auto-SCT. The primary end point of this study was the incidence of achieving a delayed CINV complete response defined as no emetic episode and no use of rescue medications during the 24–120 h period post chemotherapy. Eighty-five patients were enrolled in the study and received PAL. A delayed CINV complete response was achieved in 15% of patients. A multivariate analysis demonstrated no associated differences between age, gender, diagnosis, or regimen. By day 5 after PAL, the mean nausea severity was 0.91 ± 2.45 vs. 0.09 ± 1.58 at baseline (p = 0.012). Quality of life measurements demonstrated similar quality of life between baseline and day 3. By day 6 however, nausea alone had a statistically significant impact on quality of life. In our study, PAL controlled nausea severity and sustained quality of life, but further strategies are needed to control delayed CINV associated with the auto-SCT process.

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)

2017 ◽  
Vol 35 (31) ◽  
pp. 3558-3565 ◽  
Author(s):  
Lingyun Zhang ◽  
Xiujuan Qu ◽  
Yuee Teng ◽  
Jing Shi ◽  
Ping Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Delayed Nausea

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

Palonosetron compared to ondansetron in the prevention of chemotherapy-induced nausea and vomiting: Activity, safety, and cost-effectiveness evaluation

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20573-e20573 ◽  
Author(s):  
G. Bernardo ◽  
R. Palumbo ◽  
M. Frascaroli ◽  
A. Bernardo ◽  
A. Losurdo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Positive Impact ◽  
Cost Effective ◽  
Complete Response ◽  
Pharmacoeconomic Evaluation ◽  
Nausea And Vomiting ◽  
Group A ◽  
Group B

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.

scholarly journals Effectiveness of Fosaprepitant in Combination with 5-HT3 Receptor Antagonist and Dexamethasone in Management of Chemotherapy Induced Nausea and Vomiting

2018 ◽  
Vol 2 (1) ◽  
pp. 43-47
Author(s):  
Guru Sharan Sah ◽  
Ashok Sapkota ◽  
Amog Dwadi ◽  
Sagar Tiwari ◽  
Yogesh Regmi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Receptor Antagonist ◽  
Chemotherapy Regimen ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
The Common ◽  
Chemotherapy Patients ◽  
Triplet Regimen

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is one of the common side effects of cancer chemotherapy, that affects patient’s physical and psychological aspects, decreasing patients quality of life and compliance with therapy. CINV can be acute, delayed or anticipatory. This study assessed effectiveness of fosaprepitant (NK-1 receptor antagonist) in combination with 5-hydroxytryptamine-3 receptor antagonist (5-HT3 RA) plus dexamethasone in prevention and management of nausea and vomiting in patients receiving broad range of chemotherapy regimens. Materials and methods: The current study is prospective study conducted on randomly selected 72 patients during first and second cycle of standard chemotherapeutic regimens. During 144 cycles of chemotherapy patients were randomly assigned in two different anti emetic regimen; triplet regimen (aprepitant, 5-HT3 RA, dexamethasone) and duplet regimen (5-HT3 RA, dexamethasone). All the patients were interviewed using MASCC antiemesis tool (MAT) for incidence of nausea and vomiting. Nausea and vomiting was assessed for 5 days following 1st day of each chemotherapy cycle. Results: During the period of study, duplet regimen was administered in 68 cycles and triplet regimen was administered in 76 cycles of chemotherapy. Most of the chemotherapy regimen were platinum based compounds (61%). In duplet regimen 76.6 % (52/68) and 72.1% (49/68) patients had acute and delayed vomiting respectively whereas in triplet regimen 7.9% (6/76) and 5.3% (4/76) patients had acute and delayed vomiting respectively. Complete response in triplet regimen were achieved in 89 % of chemotherapy cycles which were significantly low in duplet regimen 10 % only. Conclusions: This study concludes that addition of fosaprepitant in combination with 5-HT3 RA and dexamethasone prevents CIMV in cancer patients receiving chemotherapy.

scholarly journals An Observational Study to Evaluate the Efficacy and Quality of Life Provided by Netupitant and Palonosetron Regimen against Ondansetron in Management and Prevention of CINV

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Meghana Dutta ◽  
Rooha K
Keyword(s):  
Quality Of Life ◽  
Treatment Plan ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Health Concern ◽  
Patient Reported ◽  
Group A ◽  
Group B ◽  
The Impact

Cancer is a public health concern amongst millions of humans and claims hundreds of lives every year. The maximum worry-inducing side effect of cancer treatment is nausea and vomiting. Therefore, stopping and managing chemotherapy-induced nausea and vomiting is an important part of a cancer patient’s treatment plan. In this study, we evaluated the efficacy and quality of life provided by two commonly used antiemetic regimens in the management and prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients. We assessed patient-reported nausea, vomiting, use of rescue medication, and Functional Living IndexEmesis (FLIE) questionnaire results, and used them as parameters to make comparisons. We also examined the percentage of patients showing complete response (CR; no emesis and non-use of rescue antiemetics), and the impact of CINV on patient’s daily life during the acute and delayed phases. The results show that the complete response is achieved by 26 patients in group-B and 18 patients in group-A, from the total 60 patients, while the FLIE scores indicated better quality of life is maintained in group-B (76.6%). In the study, the predominance of Netupitant and Palonosetron regimen to Ondansetron was demonstrated.

Delayed Nausea and Vomiting Continue to Reduce Patients' Quality of Life After Highly and Moderately Emetogenic Chemotherapy Despite Antiemetic Treatment

2006 ◽  
Vol 24 (27) ◽  
pp. 4472-4478 ◽  
Author(s):  
Brigitte Bloechl-Daum ◽  
Robert R. Deuson ◽  
Panagiotis Mavros ◽  
Mogens Hansen ◽  
Jørn Herrstedt
Keyword(s):  
Quality Of Life ◽  
Negative Impact ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Daily Lives ◽  
Delayed Nausea ◽  
Delayed Cinv ◽  
The Impact

PurposeChemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. We compared the impact of acute (during the first 24 hours postchemotherapy) and delayed (days 2 through 5 postchemotherapy) CINV on patients' quality of life (QoL) after highly or moderately emetogenic chemotherapy (HEC and MEC, respectively).Patients and MethodsThis prospective, multicenter, multinational study was conducted in 14 medical practices on cancer patients undergoing either HEC or MEC treatment. Patients recorded episodes of nausea and vomiting in a diary. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire at baseline and on day 6.ResultsA total of 298 patients were assessable (67 HEC patients, 231 MEC patients). Emesis was reported by 36.4% of patients (13.2% acute, 32.5% delayed) and nausea by 59.7% (36.2% acute, 54.3% delayed). HEC patients reported significantly lower mean FLIE total score than MEC patients (95.5 v 107.8 respectively; P = .0049). Among all patients, the nausea score was significantly lower than the vomiting score (50.0 and 55.3, respectively; P = .0097). Of the 173 patients who experienced neither vomiting nor nausea during the first 24 hours postchemotherapy, 22.9% reported an impact of CINV on daily life caused by delayed CINV.ConclusionCINV continues to adversely affect patients' QoL despite antiemetic therapy even after treatment with only moderately emetogenic chemotherapy regimens, and even in the subgroup of patients who do not experience nausea and vomiting during the first 24 hours. On the basis of the FLIE results in this study, nausea had a stronger negative impact on patients' daily lives than vomiting.

Outcomes and health status of patients undergoing usual care for highly emetogenic chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18591-18591
Author(s):  
C. R. Lewis ◽  
I. N. Olver ◽  
E. Walpole ◽  
C. Shannon ◽  
N. Pavlakis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
High Risk ◽  
Complete Response ◽  
Antiemetic Guidelines ◽  
Delayed Nausea ◽  
Delayed Cinv ◽  
Combination Regimens ◽  
Specific Health

18591 Background: Chemotherapy-induced nausea and vomiting (CINV) remains a significant issue for patients, especially management of delayed symptoms. The Perugia 2004 antiemetic guidelines recommended that anthracycline/cyclophosphamide (A/C) combination regimens be considered as high risk emetogenic potential. The aim of our study was to determine the extent of CINV, and effect on quality of life for chemotherapy-naïve patients in a practice-based environment. Methods: Eligible patients were receiving their 1st cycle of high risk emetogenic or carboplatin chemotherapy, administered with “standard care” (5HT3 antagonist + dexamethasone) antiemetics (use of NK1 antagonists excluded). Patients completed a daily diary for 5 days post chemotherapy, capturing data on CINV activity and rescue medications usage. Emesis and nausea-specific health status was measured by the Functional Living Index - Emesis (FLIE); general health status was assessed using a 100mm VAS (EQVAS). Results: Of 74 patients, 42 received an A/C regimen, 16 cisplatin and 16 carboplatin. Overall complete response (no vomiting, no use of rescue antiemetics during the study period) was 60% in patients receiving carboplatin, 24% A/C and 21% cisplatin. During the delayed phase, mean total emesis episodes for carboplatin was 0.6, A/C 2.21 and cisplatin 4.08. Patients receiving carboplatin reported less delayed nausea, and better outcomes for FLIE and EQVAS scores. Treatment with either A/C or cisplatin was associated with similar deterioration in nausea control across the study period, and similar impact on FLIE scores (see table ). Conclusions: Our results are consistent with the recommendation that A/C regimens be considered highly emetogenic, with similar impact on patient symptoms and quality of life compared with cisplatin. Delayed CINV remains a target for antiemetic intervention. Similar studies need to be repeated in patients receiving additional NK1 antagonists to assess their impact on CINV outside clinical trials. [Table: see text] [Table: see text]

scholarly journals Dosimetric factors associated with long-term patient-reported outcomes after definitive radiotherapy of patients with head and neck cancer

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Toyokazu Hayakawa ◽  
Shogo Kawakami ◽  
Itaru Soda ◽  
Takuro Kainuma ◽  
Marika Nozawa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Parotid Gland ◽  
Head And Neck ◽  
Neck Cancer ◽  
Patient Reported Outcomes ◽  
Nausea And Vomiting ◽  
Patient Reported ◽  
Severe Deterioration

Abstract Background The aim of this study was to explore the relationships between dosimetric parameters of organs at risk and patient-reported outcomes (PRO) after radiotherapy of patients with head and neck cancer. Methods PRO data of 53 patients with head and neck cancer treated with radiotherapy were prospectively collected. These data concerned health-related quality of life (HRQOL) and were collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and head and neck cancer module (QLQ-H&N35). Patients were divided into “severe-deterioration” and “mild-deterioration” groups on the basis of degree of deterioration HRQOL > 6 months after completing treatment. The relationships between HRQOL deteriorations and patient-related or dosimetry-related factors were evaluated. P < 0.0013 according to Bonferroni correction was considered to denote statistical significance. Results Regarding “trouble with social eating (HNSO)” and “coughing (HNCO),” there were significant differences between the severe-deterioration and mild-deterioration groups in mean dosages to the superior pharyngeal constrictor muscle (SPC) (HNSO: 62.5 Gy vs 54.2 Gy; p = 0.00029, and HNCO: 61.5 Gy vs 54.1 Gy; p = 0.0012) and parotid gland (HNSO: 24.1 Gy vs 20.5 Gy; p = 0.000056, and HNCO: 24.2 Gy vs 20.3 Gy; p = 0.00043). Regarding “nausea and vomiting,” there was a significant difference between the two groups in the mean dosage to the middle pharyngeal constrictor muscle (MPC: 61.9 Gy vs. 58.4Gy; P = 0.00059). Conclusions We found that dosages to the SPC and parotid gland were associated with severe deterioration in HRQOL attributable to difficulty in HNSO and HNCO, whereas dosage to the MPC was associated with severe deterioration attributable to nausea and vomiting.

scholarly journals A prospective observational analysis: Poor quality of life in cancer patient population of South Indian Territory Hospital, MGM Hospital, Warangal

2016 ◽  
Author(s):  
A. Yedukondala Rao
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Cancer Patients ◽  
Nausea And Vomiting ◽  
Future Perspective ◽  
Breast Cancer Patients ◽  
Role Function ◽  
Physical Role ◽  
South Indian

Over the ten years, Quality of Life (QOL) investigations of cancer patients have become an important evaluation parameter in the cancer clinical research and treatment evaluation programs. This study was carried out in tertiary hospital located at Warangal, Andhra Pradesh, India. We assessed the overall QOL of patients affected by cervical, breast, head and neck, and stomach cancers by using EORTC QLQ C-30, QLQ-BR23, QLQ-H&N35, QLQ-CX24, and QLQSTO22 on ≤2 cycles as Review-I and ≥5 cycles as Review-II. The data were analyzed for 104 individuals with mean age of 46.1} 11.2 years. In In head and neck cancer patients, physical, role, social function, pain, insomnia, diarrhoea, speech problems, swallowing, dry mouth were significant (P < 0.05). Breast cancer patients, physical, role function, future perspective, fatigue, pain, arm symptoms and upset by hair loss were significant (P < 0.05). In stomach cancer patients, physical, role function, nausea and vomiting, pain, financial problems, Dysphagia, reflux symptoms and eating restrictions were significant (P < 0.05). In cervical cancer patients, physical, emotional function, fatigue, nausea and vomiting, pain, insomnia, symptom experience scale, menopausal symptoms were significant (P < 0.05). Most of the findings are similar to earlier studies, which shows that, QOL was predominantly influenced by the above mentioned factors in this study population and they also have some interesting implications for.

scholarly journals Quality of Life Effects of an Oral Fixed Combination of Netupitant and Palonosetron in Chemotherapy-Induced Nausea and Vomiting Prevention: Real-World Evidence in Patients with Breast Cancer Receiving Anthracycline-Cyclophosphamide-Based Chemotherapy

Breast Care ◽  
2021 ◽  
pp. 1-7
Author(s):  
Jörg Schilling ◽  
Christian M. Kurbacher ◽  
Claus Hanusch ◽  
Steffi Busch ◽  
Martin Holländer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Real World ◽  
Fixed Combination ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Interventional Study ◽  
Beneficial Effects ◽  
Real World Evidence

<b><i>Introduction:</i></b> In a prospective non-interventional study involving 2,173 patients, we showed that use of the oral fixed combination of netupitant 300 mg and palonosetron 0.5 mg (NEPA) for prevention of chemotherapy (Ctx)-induced nausea and vomiting has beneficial effects on the quality of life (QoL) of patients with various types of cancers receiving highly or moderately emetogenic Ctx. Here, we report on the effects on QoL, effectiveness, and tolerability of NEPA in patients with breast cancer exposed to anthracycline-cyclophosphamide (AC)-based Ctx. <b><i>Methods:</i></b> This is a post hoc subanalysis of a prospective non-interventional study in 1,197 patients with breast cancer receiving up to 3 cycles of doxorubicin or epirubicin plus cyclophosphamide and NEPA. NEPA administration was per the summary of product characteristics. <b><i>Results:</i></b> In cycle 1 of Ctx, a large proportion of patients (84%) reported “no impact on daily life” (NIDL) due to vomiting; 53% of patients reported NIDL due to nausea. The complete response rate was 86/88/81% in the acute/delayed/overall phase in cycle 1, and NEPA was well tolerated throughout the study. <b><i>Conclusion:</i></b> The real-world beneficial effects of NEPA prophylaxis on QoL were confirmed for patients with breast cancer receiving AC. NEPA was effective with a good safety profile in this patient population in clinical practice.

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