A prospective multicenter observational study for chemotherapy-induced nausea and vomiting in gastric cancer in Japan.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 155-155
Author(s):  
Shiro Iwagami ◽  
Hideo Baba ◽  
Naoki Hirabayashi ◽  
Yoichi Sugiyama ◽  
Go Nakajima ◽  
...  

155 Background: There has been no nationwide survey on CINV or validation of the guideline in Japan. The aim of the study was to investigate the occurrence of CINV in gastric cancer patientstreated with chemotherapy for the first time. Methods: A nationwide survey on CINV was conducted by the CINV study group of Japan. 108 institutions participated in the study. A 7-day diary for CINV was provided to the patients prior to chemotherapy to record the daily occurrence and severity of CINV and the amount of food intake. Acute and delayed CINV was defined as nausea and vomiting which developed within or later than 24 hours after the start of chemotherapy, respectively. We evaluated the frequency and the risk factors of CINV. The medical staff also filled out questionnaires about their patients’ CINV. Results: A total of 154 patients were registered during the period from April 2011 to December 2012. There were 109 males and 45 females with a median age of 65 (range: 25-82). HEC was given to 152 and MEC was administered to 2 patients. CDDPwas included in all of HEC regimens. For preventing CINV, a three-drug regimen of aprepitant, 5-TH3 receptor antagonist (5- TH3 RA ), and dexamethasone was applied in 131 cases and a two-regimen of 5- TH3 RA and dexamethasone in 23. Acute nausea (AN) was ovserved in 19 patients (12.3%), while delayed nausea (DN) was experienced by 74 patients (48%). Acute vomiting (AV) occurred in 1 case (0.6%), while delayed vomiting (DV) was observed 15 cases (9.7%). The risk factors of CINV in gastric cancer were female and motion sickness. The age, pregnancy or morning sickness didn’t show any correlation with an occurrence of CINV. The staff predicted an occurrence of AN and DN in 96 patients (62.3%) and 132 (85.7%). However only experienced 19 (12.3%) and 74 (48.1%) patients showed symptoms of AN and DV, respectively. Conclusions: CINV in patients with gastric cancer seems to be under control with a management according to the guideline, however delayed CINV remains to be high and needs to be targeted by further investigation. Clinical trial information: UMIN000005971.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 24-24
Author(s):  
Keisuke Aiba ◽  
Kazuo Tamura ◽  
Toshiaki Saeki ◽  
Hideo Baba ◽  
Yuko Kitagawa ◽  
...  

24 Background: Chemotherapy-induced nausea and vomiting (CINV) is well controlled recently thanks to novel antiemetic therapy, but the incidence of nausea remained high in patients receiving either HEC or MEC. The aim of the study is to investigate patterns and severity of CIN in cancer patients who are to receive chemotherapy for the first time. Methods: A nationwide survey on CINV was conducted by the CINV study group of Japan. A 7-day diary for CINV was provided to the patient prior to chemotherapy to record daily occurrence and severity of CINV. CIN was measured using visual analog scales(VAS) of 10cm length scales. Acute and delayed CINV were defined as nausea and vomiting which developed within or after 24 hours after the start of chemotherapy, respectively. Results: A total of 2,068 patients were registered and 1,910 patients were analyzed. A mean age was 62 (range:19-87) and there were 873 males and 1,037 females. MEC was given to 715 as was HEC to 1,195 patients. Underlying diseases were esophageal (192 patients), gastric (152), colorectal (90), hepato-biliary-pancreatic (100), lung (426) and breast cancer (429), and gynecological (214) and hematological malignancy (197). Comparing patients with various cancers treated with similar emetogenic agents or regimens, we easily could find that there are several patterns of CIN severity. Firstly, temporal profiles of CIN severity of esophageal, gastric and lung cancers were similar, having daily increased delayed nausea up to Day 7. The reason of this phenomenon seems due to a single high dose of CDDP. Colorectal and hepato-biliary-pancreatic cancer had a similar mild CIN pattern over 7days, probably due to mild emetogenic nature of oxaliplatin and moderate dose of CDDP. Conclusions: Temporal profile and severity of CIN patterns seem to be divided into several groups and delayed CIN remained to be high and needs further investigation.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mototsugu Shimokawa ◽  
Toshinobu Hayashi ◽  
Junichi Nishimura ◽  
Taroh Satoh ◽  
Mutsumi Fukunaga ◽  
...  

Abstract Background Among patients with colorectal cancer (CRC) treated with oxaliplatin (L-OHP)-based chemotherapy, delayed chemotherapy-induced nausea and vomiting (CINV) have not been well controlled. Methods We pooled data from two prospective observational studies in Japan and one phase III clinical trial to assess whether delayed CINV could be controlled with a combination of three antiemetics adding a neurokinin-1 receptor antagonist and identified individual risk factors, using an inverse probability treatment-weighted analysis. Results A total of 661 patients were evaluable in this study (median age: 64 years; 391 male, and 270 female). 3 antiemetics controlled delayed nausea (33.18% vs. 42.25%; p = 0.0510) and vomiting (4.15% vs. 16.08%; p < 0.0001) better than with 2 antiemetics. Female and 2 antiemetics were risk factors for both delayed nausea (female—odds ratio [OR]: 1.918; 95% confidence interval [CI]: 1.292–2.848; p = 0.0012; 2 antiemetics—OR: 1.485; 95% CI: 1.000–2.204; p = 0.0498) and delayed vomiting (female—OR: 2.735; 95% CI: 1.410–5.304; p = 0.0029; 2 antiemetics—OR: 4.551; 95% CI: 2.116–9.785; p = 0.0001). Conclusions Identifying individual risk factors can facilitate personalized treatments for delayed CINV. We recommend a 3-antiemetic combination prophylaxis for CRC patients treated with L-OHP-based chemotherapy, especially for female patients.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 341-341
Author(s):  
Junji Furuse ◽  
Hideo Baba ◽  
Shinichi Ohkawa ◽  
Kazuya Sugimori ◽  
Kazuhide Yamamoto ◽  
...  

341 Background: There has been no nationwide survey on CINV or validation of the guideline in Japan. The aim of the study is to investigate occurrence of CINV in hepatobiliary and pancreatic (HBP) cancer patients who are to receive chemotherapy including high and moderate emetic risk for the first time. In addition, primary care medical staffs' perception on CINV for their patients is also studied. Methods: A nationwide survey on CINV was conducted by the CINV study group of Japan. 21 institutions participated in the study. A 7-day diary for CINV was provided to the patient prior to chemotherapy to record daily occurrence and severity of CINV and an amount of food intake. Acute and delayed CINV was defined as nausea and vomiting which developed within or after 24 hours after the start of chemotherapy, respectively. The medical staffs also filled out questionnaires about their patient’s CINV. Results: A total 103 HBP cancer patients of 1,952 patients registered in this study during the period from April 2011 to December 2012 were analyzed. These patients’ diary and their medical staffs' report were sent to the central office. Underlying diseases were biliary tract cancer (70 patients), hepatocellular carcinoma (23) and pancreatic cancer (10). There were 62 males with a median age of 69 (range: 37-83) and 41 females with a median age of 63 (range: 41-80). MEC was given to 4 as was HEC to 99 patients. Acute nausea was experienced in 6 (5.8%), while was noted delayed nausea in 25 (24.3%). Acute vomiting was noted in 2 (1.9%) patients, while delayed vomiting was experienced in 6 (5.8%). The predictive factors for delayed nausea were female and motion sickness. The predictive factor for delayed vomiting was morning sickness. Medical staffs overestimated the incidence of acute and delayed nausea/vomiting. Conclusions: CINV seems to be under control with management by the guideline, but delayed nausea remained to be high and needs further investigation.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Toshinobu Hayashi ◽  
Mototsugu Shimokawa ◽  
Koichi Matsuo ◽  
Hirotoshi Iihara ◽  
Kei Kawada ◽  
...  

Abstract Background Patients with lung cancer who are treated with carboplatin-based chemotherapy regimens often experience chemotherapy-induced nausea and vomiting (CINV). However, knowledge on the effect of regimen and cofactors on the risk of CINV is limited. This study aimed to analyze and compare the incidence of CINV between lung cancer patients undergoing carboplatin plus pemetrexed (CBDCA+PEM) and those undergoing carboplatin plus paclitaxel (CBDCA+PTX) chemotherapy. Methods Pooled data of 240 patients from two prospective observational studies were compared using propensity score matching. Separate multivariate logistic regression analyses were used to identify risk factors for nausea and vomiting following chemotherapy. Results Delayed nausea was significantly more common in patients treated with CBDCA+PEM than in those treated with CBDCA+PTX (51.1% vs. 36.2%, P = 0.04), but the incidence of vomiting did not significantly differ between the two groups (23.4% vs. 14.9%, P = 0.14). The occurrence of CINV peaked on day 4 in the CBDCA+PTX group and on day 5 in the CBDCA+PEM group. Multivariate analysis showed that female sex, younger age, and CBDCA+PEM regimen were independent risk factors for delayed nausea, while female sex was an independent risk factor for delayed vomiting. Conclusions The CBDCA + PEM regimen has a higher risk of causing delayed nausea than the CBDCA + PTX regimen, and aggressive antiemetic prophylaxis should be offered to patients treated with CBDCA + PEM.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 344-344
Author(s):  
Akira Shinohara ◽  
Masafumi Ikeda ◽  
Ai Irisawa ◽  
Misaki Kobayashi ◽  
Ryoko Udagawa ◽  
...  

344 Background: Modified FOLFIRINOX (mFFX) has been reported to be a high incidence of chemotherapy-induced nausea and vomiting (CINV). However, CINV is difficult to adequately control in patients receiving treatment with mFFX. The aim of this study is to evaluate the incidence of delayed CINV and to identify as risk factors for CINV in patients receiving treatment with mFFX. Methods: The study subjects were patients with advanced pancreatic cancer treated with mFFX from December 2013 to June 2015 at National Cancer Center Hospital East. The mFFX regimen consisted of oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, l-leucovorin 200 mg/m2 and a 46-h continuous infusion of fluorouracil 2400 mg/m2. The antiemetic prophylaxis consisted of aprepitant (125 mg on day1 and 80 mg on day 2-3), palonosetron (0.75 mg on day1) and dexamethasone (12 mg on day1 and 8 mg on day 2-3). All adverse events, including nausea and vomiting were graded according to the Common Toxicity Criteria for Adverse Events (CTCAE version 4.0). Results: A total of 115 patients were enrolled in this study. The incidence rates of nausea and vomiting of any grade during the first treatment cycle were 45.2% and 5.2%, respectively. Grade 2-3 of nausea and vomiting were observed in 13.9% and 0.9% of the patients, respectively. Any grade of CINV occurred frequently during days 4 to 7 for the first treatment cycle. Univariate and multivariate analyses identified female and younger age ( < 50 years) as significant independent factors associated with the incidence of any grade of CINV on days 4 to 7 for the first treatment cycle (Odds ratio [OR], 7.44; 95%CI, 2.21 to 25.1; p = 0.001; OR, 4.57; 95% CI, 1.04 to 20.1; p = 0.044). Conclusions: The risk factors of delayed CINV for the first treatment cycle were identified as female and younger age in patients treated with mFFX. Therefore, in patients with these risk factors, additional dexamethasone should be considered as an antiemetic treatment on day 4-5.


2018 ◽  
Vol 25 (6) ◽  
pp. 1336-1342
Author(s):  
J LaPorte ◽  
K Leone ◽  
X Zhang ◽  
K Holland ◽  
L Morris ◽  
...  

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.


Author(s):  
Xin-Juan Huang ◽  
Xu-Ying Li ◽  
Lu Luo

Aims: To assess the occurrence of Chemotherapy-induced nausea and vomiting (CINV) after standard antiemetic therapy in the acute (24 h post-chemotherapy) and delayed (2&ndash;5 days post-chemotherapy) phases, as well as to identify risk factors for CINV in the acute and delayed phases. Methods: This prospective longitudinal and observational study analyzed the data of 400 breast cancer patients scheduled for chemotherapy over two cycles in two hospitals. The self-report survey was developed to assess the occurrence of CINV and their associated factors. CINV was evaluated with a Multinational Association of Supportive Care in Cancer Antiemetic Tool (MAT) on days 2 and 6 of chemotherapy. The incidence of acute and delayed CINV were presented by frequency and percentage. Generalized equation estimates (GEE) was used to identify risk factors of acute and delayed CINV. Results: There were 400 evaluable patients with complete Round 1 data, 334 for Round 2 data. Among 400 patients, 29.8% and 23.5% experienced acute and delayed CINV, respectively. Risk factors associated with for acute CINV were pain/insomnia, history of CINV, history of motion sickness (MS), and highly emetogenic chemotherapy regimen, while history of MS, CINV history, number of completed chemotherapy cycle number &lt; 3, and the incidence of acute CINV were risk factors of delayed CINV (all p &lt; 0.05). Conclusions: The findings may help nurses working for Chinese population in identifying patients at risk for CINV and in planning effective program to reduce the occurrence of CINV.


2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Lichan Chen ◽  
Xiaohong Wu ◽  
Xisui Chen ◽  
Chunjiao Zhou

Background. More than 40% of patients with cancer have reported that chemotherapy-induced nausea and vomiting (CINV) remained the most debilitating side effects of treatment even in the era of new antiemetics. Objective. The purpose of this review was to systematically evaluate the clinical effect of auricular acupressure (AA) in prevention and treatment of chemotherapy-induced nausea and vomiting. Methods. The following databases were searched: PubMed, Cochrane Library, EMBASE, the Web of Science, Chinese Biological Medicine (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang, and VIP (from database inception to April 2020). Eligible randomized controlled trials of auricular acupressure in treating CINV were collected, including crossover randomized design study. The meta-analysis was carried out by RevMan software (5.3). Results. Totally 19 RCTs with 1449 patients met the inclusion criteria. Compared with control groups, the relief efficiency of overall CINV was enhanced by AA combined with antiemetics (RR = 1.31, CI 1.22 to 1.41, p  ≤ 0.001). Although the therapeutic effect on acute nausea and vomiting was not obvious, AA still played an important role in reducing delayed nausea and vomiting (delayed nausea frequency: RR = 0.68, CI −1.01 to −1.35, p  ≤ 0.001; delayed vomiting frequency: RR = 0.91, CI −1.22 to −0.61, p  ≤ 0.001). The likelihood of adverse reactions related to antiemetics was reduced by AA combined with antiemetics (RR = 0.62, CI 0.53 to 0.74, p  ≤ 0.001). Statistically significant association was found between AA and incidence of constipation, diarrhea, and tiredness, while there was no statistically significant association between AA and abdominal distension or headache. Conclusion. Auricular acupressure supplementation benefited delayed chemotherapy-induced nausea and vomiting as well as constipation, diarrhea, and tiredness. AA alone or AA supplementation has little effect on acute nausea and acute vomiting. There is no conclusion on whether AA alone is superior to antiemetics in the management of delayed CINV. Further studies are needed to confirm the efficacy of auricular acupressure alone in delayed CINV and anticipatory CINV. The results of this review provided the basis for further research with more rigorous study designs, adequate sample sizes, and standardized implementation to confirm the efficacy of auricular acupressure.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20660-e20660
Author(s):  
I. Martin ◽  
V. Montheil ◽  
S. Ropert ◽  
J. Alexandre ◽  
F. Goldwasser ◽  
...  

e20660 Background: The authors determined the incidence of acute and delayed chemotherapy-induced nausea and vomiting (CINV) among new patients (pts) receiving chemotherapy with modern antiemetic prophylaxis in 2008. Methods: A prospective observational study of adult cancer pts receiving, for the first time, moderately or highly emetogenic chemotherapy (MEC or HEC) was performed. Study participants were called on day 2 and day 8, after first and second cycle, to evaluate acute and delayed emesis according a 10-item questionnaire. All patients received, before and after their chemotherapy, the optimal antiemetic prophylaxis according to the 2006 Update of ASCO Guideline for Antiemetics. Results: 131 consecutive pts were enrolled between January and June 2008. At cycle 1, on 124 assessable pts for acute emesis: 68 pts received MEC and 18, HEC. 5.6% developed acute vomiting (5.9% for MEC and 5.6% for HEC) and 33.1%, acute nausea (39.7% for MEC and 44.4% for HEC). At cycle 1, on 101 assessable pts for delayed emesis: 5% experienced delayed vomiting (5.1% for MEC and 6.3% for HEC) and 17.8%, delayed nausea (18.6% for MEC and 31.3% for HEC). At cycle 2, on 121 assessable pts for acute emesis: 62 pts received MEC and 18, HEC. 8.3% developed acute vomiting (6.5% for MEC and 16.3% for HEC) and 31.4%, acute nausea (35.5% for MEC and 44.4% for HEC). At cycle 2, on 96 assessable pts for delayed emesis: 5.2% experienced delayed vomiting (3.3% for MEC and 9.1% for HEC) and 19.8%, delayed nausea (23% for MEC and 27.3% for HEC). Conclusions: Though the application of the last antiemetic recommendations, CINV, especially nausea, remained a substantial toxicity for patients receiving chemotherapy, pointing out the need for improved therapeutic intervention. [Table: see text]


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