Can Granisetron Injection Used as Primary Prophylaxis Improve the Control of Nausea and Vomiting with Low- Emetogenic Chemotherapy?

Background: The purpose of this study is to examine the risk of uncontrolled chemotherapy-induced nauseaand vomiting (CINV) among patients receiving low emetogenic chemotherapy (LEC) with and without granisetroninjection as the primary prophylaxis in addition to dexamethasone and metochlopramide. Materials and Methods:This was a single-centre, prospective cohort study. A total of 96 patients receiving LEC (52 with and 42 withoutgranisetron) were randomly selected from the full patient list generated using the e-Hospital Information System(e-His). The rates of complete control (no CINV from days 1 to 5) and complete response (no nausea or vomitingin both acute and delayed phases) were identified through patient diaries which were adapted from the MASCCAntiemesis Tool (MAT). Selected covariates including gender, age, active alcohol consumption, morning sicknessand previous chemotherapy history were controlled using the multiple logistic regression analyses. Results: Bothgroups showed significant difference with LEC regimens (p<0.001). No differences were found in age, gender,ethnic group and other baseline characteristics. The granisetron group indicated a higher complete response ratein acute emesis (adjusted OR: 0.1; 95%CI 0.02-0.85; p=0.034) than did the non-granisetron group. Both groupsshowed similar complete control and complete response rates for acute nausea, delayed nausea and delayedemesis. Conclusions: Granisetron injection used as the primary prophylaxis in LEC demonstrated limited rolesin CINV control. Optimization of the guideline-recommended antiemetic regimens may serve as a less costlyalternative to protect patients from uncontrolled acute emesis.     

Randomised trial for the prevention of delayed emesis in patients receiving high-dose cisplatin.

Despite recent advances in control of acute emesis following cisplatin-based chemotherapy regimens, delayed emesis remains a significant cause of treatment-related morbidity and factors associated with delayed emesis have not yet been evaluated. A prospective randomised trial was conducted to compare the efficacy and toxicity of granisetron, dexamethasone plus prochlorperazine with granisetron alone in controlling cisplatin-induced delayed emesis and to identify the important factors that influence its occurrence and severity. Seventy cisplatin-naive patients with inoperable solid tumors participated in the trial. Patients who received 80 mg m-2 or 100 mg m-2 of cisplatin were randomly assigned to receive either granisetron 40 micrograms kg-1 intravenously (i.v.) on day 1, dexamethasone 20 mg i.v. on days 2 and 3 and prochlorperazine 5 mg orally thrice daily on days 1-5 or granisetron 40 micrograms kg-1 i.v. on day 1 alone. There was no difference in their acute antiemetic efficacy. A combination regimen was more effective than granisetron alone in preventing delayed symptoms, with superior rates of complete plus major responses of 77% vs 51% (P = 0.0460). Treatment arm was the only determinant factor for the occurrence of delayed emesis (P = 0.0101).     

Acute and delayed nausea and emesis control in pediatric oncology patients

BACKGROUND: To the authors' knowledge there is little information available regarding the effectiveness of standard antiemetic therapy among cancer patients who receive emetogenic chemotherapy in clinical practice, especially in the pediatric population. The current study was undertaken to determine the effectiveness of standard antiemetic interventions among children receiving emetogenic chemotherapy. METHODS: The authors conducted a retrospective review of antiemetic surveys for children who received emetogenic chemotherapy. Patients and/or their parents were surveyed for acute and delayed nausea and emesis after each course of emetogenic chemotherapy. The survey consisted of validated measures of the severity of nausea and emesis. Complete protection (CP) rates were calculated for each chemotherapy regimen during both the acute and delayed phases and also by gender and age group (ages birth-3 yrs, 4-11 yrs, and 12-20 yrs). Antiemetic therapy consisted of intravenous ondansetron administered once daily during chemotherapy either alone (for moderately emetogenic chemotherapy) or in combination with dexamethasone (for severely emetogenic chemotherapy). RESULTS: In total, 224 different patients completed 1256 surveys. CP from both acute and delayed nausea and emesis was more likely in the children ages birth-3 years than in older children. For moderately emetogenic regimens, nausea and emesis in the acute and delayed phases were controlled well. Among severely emetogenic chemotherapy regimens, 7 of 12 different regimen types had CP rates < 50% in either the acute phase or the delayed phase. CP rates were particularly low for cisplatin-based and cyclophosphamide-based regimens. CONCLUSIONS: Nausea and emesis remain significant problems among children who receive emetogenic chemotherapy. CP rates were associated significantly with patient age, and higher rates were observed among very young children.     

Costs of treating and preventing nausea and vomiting in patients receiving chemotherapy.

PURPOSE: To evaluate the effect of ondansetron availability on the costs of managing nausea and vomiting. METHODS: We retrospectively assessed antiemetic costs (drug costs, nursing time, pharmacy time, physician's time, supplies, and facility "hotel" costs, in 1991 Canadian dollars) for all patients who received moderately or highly emetogenic chemotherapy from 6 months before to 6 months after ondansetron became commercially available in September 1991. We compared the costs for treating patients who received ondansetron versus those who received other antiemetic regimens, the costs for treating patients in the 6 months before versus the 6 months after ondansetron commercial availability, and the costs for treating patients in the first 4 months versus the last 4 months of the study period. RESULTS: We found no cost differences for patients treated with ondansetron versus other antiemetic regimens. However, there was a significant reduction in emesis management costs for patients treated after versus before the availability of ondansetron: for patients treated in the last third versus first third of the study period, there was a decrease in cost per patient per month of treatment of $374 (95% confidence interval, $243 to $505). These savings were achieved through a reduction in hospital bed days and other costs associated with the prevention and more effective management of nausea and vomiting. At the same time, the number of patients who received emetogenic chemotherapy and their average age increased, presumably because of the better control of gastrointestinal toxicity. CONCLUSION: Ondansetron availability has been associated with changes in the clinical management of cancer patients receiving chemotherapy and with overall cost savings compared with previously available antiemetic therapy.     

Cost-effectiveness analysis of cisplatin plus etoposide and carboplatin plus paclitaxel in a phase III randomized trial for non-small cell lung cancer

Aim: Carboplatin plus paclitaxel is a more costly chemotherapy regimen than cisplatin plus etoposide; however there have been reports of higher efficacy and less toxicity of this regimen. Thus, this study aimed to assess the cost‐effectiveness of these two chemotherapy regimens in advanced non‐small cell lung cancer (NSCLC). Methods: Using the perspective of Maharaj Nakorn Chiang Mai Hospital, Thailand, direct medical costs, including chemotherapy, drugs, medical service charges, costs of adverse events, concomitant medication and survival time were directly gathered from 65 patients enrolled from August 2005 to November 2008. A one‐way sensitivity analysis was performed. An incremental cost‐effectiveness ratio (ICER) was also calculated. Results: Of these 65 patients, 30 received cisplatin plus etoposide (Arm I) and 35 received carboplatin plus paclitaxel (Arm II). The median survival time was not statistically significant (8.23 months vs 8.80 months in Arm I and II, respectively; P = 0.99). The total cost per patient in Arm II was about three times that in Arm I (95,548 Baht vs 29,692 Baht) while quality‐adjusted life‐years (QALY) in Arm II were slightly above those in Arm I (0.587 vs 0.412). The ICER was equal to 375,958 Baht per QALY. Conclusion: With a cost‐effectiveness threshold of 100,000 Baht in Thailand, carboplatin plus paclitaxel was still not cost‐effective. While the selection of a suitable regimen for individual patients should not rely on drug and hospital costs alone, the overall cost, including the burden on patients, should be taken into consideration.     

三种5—羟色胺受体阻滞剂预防化疗药物所致消化道毒性的临床分析

目的探讨恩丹西酮、枢复宁、康泉预防化疗药物引起恶心呕吐的临床效果。方法采用随机对照法观察了对以顺铂为主化疗药物的止吐作用,选择病例分别为４０例、３２例及９５例。结果恩丹西酮、枢复宁、康泉对控制急性呕吐的有效率（ＣＲ＋ＰＲ）分别为：８５％、８４．４％、９６．８％,康泉与恩丹西酮、枢复宁比较均有统计学意义（Ｐ＜０．０５）,而恩丹西酮与枢复宁两者比较无统计学意义（Ｐ＞０．０５）。呕吐完全控制率（ＣＲ）三者分别为６５％、７５％及８１．１％,康泉与恩丹西酮比较有统计学意义（Ｐ＜０．０５）,而康泉与枢复宁及恩丹西酮与枢复宁比较均无统计学意义（Ｐ＞０．０５）。结论恩丹西酮与枢复宁对预防化疗药物引起的呕吐有效,而康泉的效果优于枢复宁及恩丹西酮。但是,康泉的价格昂贵,临床应用受到限制。     

Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis: Italian Group for Antiemetic Research

Background: Differences in pharmacodynamic and pharma-cokineticcharacteristics among serotonin-receptor antagonists have beenreported in preclinical studies. This prompted us to carry outa study to determine whether such differences are importantin terms of clinical efficacy or tolerability Patients and methods: 973 consecutive cancer patients scheduledto receive cisplatin for the first time (at doses > 50 mg²),entered a double-blind multicenter randomized study comparingintravenous ondansetron 8 mg versus granisetron 3 mg. Dexamethasone20 mg was added to both serotonin antagonists. On days 2 to4 after chemotherapy all patients received oral metoclopramideplus intramuscular dexamethasone as antiemetic prophylaxis fordelayed emesis. Nausea and vomiting were assessed daily untilday 6 after chemotherapy Results: We evaluated 966 patients (483 receiving ondansetronand 483 granisetron). Complete protection from acute vomiting/nauseawas obtained in 79.3%/72.0% of patients receiving ondansetronand in 79.9%/71.8% of those receiving granisetron. Completeprotection from delayed vomiting\nausea was obtained in 69.7%/52.9%and 70.0%/ 49.6% of patients receiving the ondansetron or granisetronregimens, respectively. Adverse effects were mild and not significantlydifferent between the two antiemetic regimens Conclusions: Ondansetron 8 mg and granisetron 3 mg, both combinedwith dexamethasone, showed similar efficacy and tolerabilityin the prevention of cisplatin-induced emesis. The choice betweenthe two regimens can be dictated by their respective purchaseprices antiemetics, cisplatin, dexamethasone, granisetron, ondansetron     

Use of 5-HT3 receptor antagonists to prevent nausea and emesis caused by chemotherapy for patients with breast carcinoma in community practice settings.

BACKGROUND: Although 5-HT3 receptor antagonists are clinically more effective in controlling emesis, particularly that caused by high dose cisplatin, than previously available agents, they appear to be less effective against nausea. This report focuses on the effectiveness of these agents against nausea and emesis in patients receiving two moderately emetogenic combination chemotherapy regimens as treatment for breast carcinoma in community practice settings. METHODS: Six hundred ninety-two breast carcinoma patients (688 female, 4 male; mean age, 51 years) enrolled in a nonrandomized study completed the Morrow Assessment of Nausea and Emesis (MANE) following 4 consecutive chemotherapy treatments. The frequency, duration, and severity of postchemotherapy nausea (PN) and postchemotherapy emesis (PE) were compared by type of antiemetic (5-HT3 receptor antagonist vs. other) and chemotherapy regimen (cyclophosphamide and doxorubicin with or without 5-fluorouracil [CA/CAF] vs. cyclophosphamide, methrotrexate, and 5-fluorouracil [CMF]). RESULTS: Within each regimen, the mean duration of PN was significantly longer for patients who received a 5-HT3 receptor antagonist than for those who were not given an antiemetic of that type (CA: 40.3 hours vs. 29.6 hours, P < 0.05; CMF: 37.6 hours vs. 30.2 hours, P < 0.05). There were no significant differences in the frequency or severity of nausea or in the frequency, severity, or duration of emesis by type of antiemetic for patients receiving either regimen. CONCLUSIONS: The results of this observational study suggest that 5-HT3 receptor antagonists are no more effective than other commonly used medications in controlling postchemotherapy nausea and emesis in women with breast carcinoma who are treated with moderately emetogenic chemotherapy in community practice settings. In fact, they may be associated with significant prolongation of the course of postchemotherapy nausea.     

Comparative efficacy of three 5-HT3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: a randomized crossover study

The purpose of this study was to compare the antiemetic efficacy of three 5-HT3 antagonists (granisetron, ondansetron, tropisetron) plus dexamethasone for the prevention of acute emesis induced by high-dose cisplatin chemotherapy. This was a randomized, open label, crossover study. Recruited into the study were 94 chemotherapy-naive patients of whom five were excluded because chemotherapy was not given, noncisplatin regimen was used instead, or presence of anticipatory vomiting. The remaining 89 evaluable patients were mostly (86.5%) male, and were all treated for head and neck cancers. The antiemetic regimens consisted of 1) granisetron 3 mg i.v. and dexamethasone 20 mg i.v. on day 1 (GRADEX); 2) tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. on day 1 (TRODEX); and 3) ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. to be followed by ondansetron 8 mg p.o. x 2 on day 1 (ONDEX). Patients were randomized to receive one of the three regimens in the first cycle, and treatment was crossed over to the other two regimens in subsequent cycles. Antiemetic efficacy was assessed using self-report diaries recording the number of vomiting episodes as well as duration and severity of nausea within the first 24 hours. Complete response was defined as no vomiting with or without mild nausea, and major response was defined as one vomiting episode and/or moderate to severe nausea. Major efficacy refers to either complete or major response. A total of 219 cycles was given to 89 patients: 16 received one cycle only, 16 received two cycles, and 57 received three cycles. No carryover effects were observed between cycles. Using pooled data from all cycles, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 68%, and 71%, respectively (p = 0.11); the corresponding major efficacy rates were 91%, 93%, and 86%, respectively (p = 0.36). When only the first cycle was considered, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 75%, and 74%, respectively (p = 0.58); the corresponding major efficacy rates were 92%, 94%, and 84%, respectively (p = 0.38). Analysis of the crossover data showed that the majority of patients achieved complete response or major efficacy with the different pairs of regimens, and there were no significant differences between different regimens in terms of complete response or major efficacy. The only exception was GRADEX versus TRODEX, in which 15.5% of patient achieved complete response with GRADEX as compared with 1.7% with TRODEX (p = 0.025). The majority of patients (53%) did not report any preference, whereas 14% preferred GRADEX, 15% preferred TRODEX, and 18% preferred ONDEX. The three 5-HT3 antagonists, when used in combination with steroids, had similar major efficacy for prophylaxis against cisplatin-induced acute emesis. Although GRADEX was superior to TRODEX in terms of complete response, this may not be of clinical significance. The choice of antiemetic regimens should therefore depend on patient preference and drug cost.     

High doses of methylprednisolone with or without alizapride in the prevention of cisplatin-induced emesis. A randomized, double-blind, crossover study

Fifty-two patients undergoing cisplatin-based chemotherapy were randomized to receive either methylprednisolone (1 g i.v. total dose) or methylprednisolone plus alizapride (800 mg i.v. total dose). Major control of emesis (less than or equal to 2 episodes of vomiting) was obtained in around 30% of patients, without difference between the two arms. The combined antiemetic treatment was significantly superior to the single drug in reducing overall number of vomiting episodes (median: 4 vs. 9), duration of emesis (2 vs. 4.5 h), and number of patients with more than 5 vomiting episodes (47.5 vs. 62.5%). Both antiemetic regimens had negligible toxicity and were easily given to outpatients. Though some superiority has been shown for the combined treatment over the single methylprednisolone, the low rate of major control of emesis does not warrant for further investigations of this regimen in cisplatin-treatment patients.     

Chemotherapy-induced emesis: management of early and delayed emesis in milder emetogenic regimens

 The objective of the present study was to examine the problem of the control of nausea and vomiting induced by non-cisplatin containing cyclophosphamide-based chemotherapy regimens in breast cancer patients. This was randomized, double-blind, parallel-group and placebo-controlled study comparing the efficacy of three antiemetic therapeutic regimens (ondansetron for 3 days, ondasetron plus metoclopramide, and ondansetron given in a single dose) in breast cancer patients receiving cyclophosphamide-based chemotherapy regimens on an outpatient basis. Both the primary and the secondary efficacy were measured. The primary efficacy variable was the number of emetic episodies (considering early and delayed emesis). The secondary efficacy variable measured was the quality of life. Two-by-two tables using the chi-square test and relative-risk concept were elaborated for statistical analysis. There was no difference between high-dose ondansetron and ondansetron plus metoclopramide among patients given CMF (cyclophosphamide, methotrexate, 5-fluorouracil). The single-dose ondansetron regimen showed the worst results. In patients given an FEC regimen (cyclophosphamide, epirubicin, 5-fluorouracil) the antiemetic efficacy was best for the high-dose ondansetron regimen, followed by the ondansetron plus metoclopramide regimen, and was worst for single-dose ondansetron administration. Despite the use of different antiemetic schedules, nausea and emesis are significant problems in patients receiving cyclophosphamide-based chemotherapy. Their adequate control should be the aim of any antiemetic approach. Received: 23 September 1995/Accepted: 25 January 1996     

Comparative trial of oral granisetron and intravenous ondansetron in patients receiving chemotherapy for breast cancer. Study Group of Granisetron

This multicentric randomized trial compared two strategies in the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy in patients with breast cancer. The antiemetic efficacy and side effects of oral granisetron, followed by metoclopramide, were compared to those of intravenous (IV) ondansetron followed by oral ondansetron. 198 chemonaive patients with breast cancer, treated with a moderately emetogenic chemotherapy, were randomly assigned to receive either oral granisetron 1 mg twice a day on day 1, followed by metoclopramide, 60 mg on day 2 and 3, or ondansetron, 8 mg IV on day 1, followed by ondansetron 8 mg tablet twice a day on day 2 and 3. Both treatments have shown similar control of acute emesis: complete response was achieved in 71% of granisetron group and 66% of ondansetron, and total response in respectively 49% and 53%. However, granisetron plus metoclopramide showed a trend towards better efficacy than oral ondansetron in the prevention of delayed emesis. Furthermore, during the overall study period (day 1 to 5), the percentage of complete responses in the group receiving oral granisetron followed by oral metoclopramide was significantly higher than in the group receiving ondansetron (53% versus 37%; p = 0.022). In conclusion, oral granisetron has shown similar efficacy as IV ondansetron in the prevention of acute emesis induced by moderately emetogenic chemotherapy. Oral granisetron followed by metoclopramide seems more efficient than IV plus oral ondansetron in the prevention of delayed emesis.     

阿瑞匹坦预防含顺铂的两药方案治疗Ⅳ期肺癌所致呕吐的临床研究

目的:探讨阿瑞匹坦用于含顺铂的两药方案治疗Ⅳ期肺癌所引起的恶心、呕吐（CINV）的止吐作用和安全性。方法:Ⅳ期肺癌病例42例,均采用含顺铂的两药方案化疗。第一疗程化疗采用格拉司琼、地塞米松等标准止吐方案,但止吐效果不理想,第二疗程加用阿瑞匹坦,采用自体比较方法评价阿瑞匹坦的用药效果及安全性。结果:第二疗程患者止吐效果显著好于第一疗程,两个疗程患者止吐效果间比较差异具有统计学意义（P<0.01）。第二疗程患者急性恶心、急性呕吐、延迟恶心和延迟呕吐的发生率均显著低于第一疗程,两个疗程间数据比较差异具有统计学意义（P<0.01）。第二疗程患者腹泻、头晕、头痛、便秘、腹胀、失眠和皮疹的发生率比较差异无统计学意义（P>0.05）,但疲倦和口干发生率显著高于第一疗程（P<0.05）,说明疲倦和口干可能为阿瑞匹坦最常见的不良反应。结论:对标准止吐方案治疗后无显著效果的Ⅳ期肺癌化疗患者,加用阿瑞匹坦可达到较好的止吐效果,尤其对延迟恶心、呕吐效果显著。且用药安全性好,适合于临床应用。     

Prevention of delayed emesis induced by moderately emetogenic chemotherapy in patients with acute emesis

The rates of delayed nausea and vomiting by moderately emetogenic chemotherapy in patients with previous experience of acute emesis are usually quite high. This is a pilot study aiming to evaluate the safety of a new antiemetic schedule to prevent delayed emesis in this subset of patients. During 5 consecutive cycles of moderately emetogenic chemotherapy, we evaluated 50 patients (15 males) who experienced acute emesis in the first cycle of treatment. The regimen for prevention of delayed emesis consisted of daily tropisetron (5 mg orally from d 2 to d 6 of each chemotherapeutic cycle) associated to ACTH-Depot (1 mg intramuscularly 24 and 68 h after the initiation of chemotherapy). In 77% of chemotherapy cycles, there was a total elimination of nausea and vomiting, whereas in the remaining 23% of cycles, there was a major response defined as ≤ 2 vomiting episodes per cycle or nausea grade 1 according to the WHO. The efficacy of the antiemetic regimen persisted during the entire treatment program without the appearance of toxic effects. The proposed antiemetic regimen is highly active in preventing delayed nausea and vomiting episodes in patients receiving moderately emetogenic chemotherapy. Moreover, no toxic effects were observed. These promising results require confirmation by a randomized trial.     

Oral granisetron alone and in combination with dexamethasone: A double-blind randomized comparison against high-dose metoclopramide plus dexamethasone in prevention of cisplatin-induced emesis

PATIENTS AND METHODS:: Three anti-emetic treatment regimens were compared in 357 patientsreceiving cisplatin therapy (mean dose 81 mg/m²) in this double-blindrandomized study. Regimens studied were i) granisetron 1 mgbd orally for 7 days (granisetron alone); ii) gran 1 mg bd orallyfor 7 days plus prophylactic dexamethasone (12 mg i.v.) on thefirst day only (gran/dex); iii) metoclopramide (3 mg/kg i.v.loading dose; 4 mg/kg i.v. infusion) plus dex (12 mg i.v.) onthe first day followed by met 10 mg orally tds for a further6 days (met/dex). RESULTS:: At 24 hours, gran/dex was significantly superior to met/dexin terms of total anti-emetic control, defined as no nausea,no vomiting, no rescue anti-emetic therapy, not withdrawn (54.7%gran/dex vs. 37.2/ met/dex; (P < 0.01). There was also asignificant delay in time to onset of nausea (P < 0.01) andvomiting (P < 0.01) following gran/dex compared with met/dex.Oral granisetron alone was as effective as met/dex in controlof acute emesis in all parameters examined. There were no significantdifferences between the three groups in the control of delayednausea and vomiting. The most common adverse experiences in both granisetron groupswere headache and constipation, both characteristic of 5-HT₃antagonists. Agitation, somnolence, diarrhoea and decreasedappetite were reported more frequently by the met/dex group. CONCLUSIONS:: Oral granisetron as a single agent is as effective as high dosesof i.v. met/dex in preventing cisplatin-induced emesis. Oralgranisetron in combination with a corticosteroid provides superioranti-emetic control to the met/dex regimen in patients undergoinghighly emetogenic chemotherapy. granisetron, oral, metoclopramide, dexamethasone, anti-emetic, cisplatin     

Patient statement of satisfaction with antiemetic treatment is related to quality of life

The aim of our study was to explore the possible relationship between patient satisfaction with antiemetic treatment and quality of life (QoL). The study sample consisted of 136 chemotherapy-naive patients with breast cancer, with Karnofsky index 90% to 100%, scheduled to receive their first cycle of, mainly adjuvant, 5-fluorouracil/doxorubicin/cyclophosphamide chemotherapy. Two antiemetic regimens were used for the prevention of acute emesis. No antiemetic prophylaxis was given for delayed emesis. QoL was assessed using the Rotterdam Symptom Checklist (RSCL). The RSCL was completed before chemotherapy (day 1) and on day 5. Statement of satisfaction was given on day 5. The change in RSCL scores between day 5 and day 1 was calculated and compared in three subgroups of patients: those very satisfied (n = 55), satisfied (n = 65), and unsatisfied with antiemetic treatment (n = 16). Patient statement of satisfaction was related to psychological distress (p = 0.002), physical symptom distress (p = 0.002), and activity level (p = 0.002). It was also related to the control of nausea (p < 0.01) and vomiting (p < 0.0001). We suggest that patient statement of satisfaction with antiemetic treatment could be an outcome measure for response assessment in antiemetic trials.     

Prognostic factors influencing cisplatin-induced emesis. Definition and validation of a predictive logistic model

Data obtained from 209 patients who entered different prospective randomized antiemetic trials were analyzed to establish the prognostic value of some variables on the control of cisplatin-induced emesis. The antiemetic regimens evaluated included the following: metoclopramide (M) at 1, 2, and 4 mg/kg total dose and a combination of M (4 mg/kg) with dexamethasone (D) (40 mg). Vomiting lasting more than 1 hour (no protection [NP]) was the endpoint selected for the analysis. A logistic model carried out, first on the 110 subjects receiving the M + D regimen and then on the whole sample, selected sex (P = 0.0001), Eastern Cooperative Oncology Group performance status (PS) (P = 0.006), and age (P = 0.01) among the six factors considered. Since the prognostic value of these variables is mostly related to their interaction, three major risk classes were identified. The corresponding NP rates were 26.3%, 42.4%, and 70.8% for the low-risk, intermediate-risk, and high-risk groups, respectively (P = 0.000002). Except for the lowest M level, the observed NP rates were significantly associated to the risk classes, whereas the antiemetic regimen influenced the antiemetic outcome only in the low-risk class. Regardless of the regimen employed, certain patient characteristics, such as sex, PS, and age, significantly affect cisplatin-related emesis and should be carefully considered in planning further studies.     

枢复宁防止由非顺铂化疗所致呕吐的疗效观察

本文报道用枢复宁十地塞米松与灭吐灵十地塞米松随机对照,控制非顺铂化疗诱发的呕吐。58例病人经随机分组后,28例用枢复宁加地塞米松,30例按本院常用剂量灭吐灵加地塞米松治疗。枢复宁十地塞米松对急性恶心和呕吐的完全控制率均显著高于灭吐灵十地塞米松(分别为87％比72％,P<0.05,94％比67％,P<0.001)。对延缓性呕吐的完全控制。枢复宁十地塞米松也高于灭吐灵十地塞米松,分别为85％—94％比58％—82％(P<0.05)。枢复宁十地塞米松副作用轻,主要有头痛(13％)和便秘(9％),不引起锥体外系反应。因此,枢复宁十地塞米松是一个较为有效的联合止吐方案。