Preventive effect of rikkunshito, traditional Japanese medicine, for chemotherapy-induced nausea and vomiting.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 131-131
Author(s):  
Shinya Kajiura ◽  
Ayumu Hosokawa ◽  
Sohachi Nanjyo ◽  
Hiroki Yoshita ◽  
Nobuhiro Suzuki ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Preventive Effect ◽  
Major Toxicity ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
Anti Cancer ◽  
Cancer Anorexia

131 Background: Supportive therapies are being developed for chemotherapy-induced nausea and vomiting (CINV). Rikkunshito is a Kanpo medicine, which is a part of traditionally practiced Japanese-based ancient Chinese medicine. It has been reported to be effective against cisplatin-induced anorexia in rats. In the present study, we evaluated the preventive effect of Rikkunshito for CINV in patients receiving high-dose cisplatin. Methods: We selected subjects who received chemotherapy including cisplatin (≥60mg/m2) for gastric or esophageal cancer between April 2010 and August 2012 at our institution. We targeted 20 cases treated without a reduction in the anti-cancer medication in the second course and added 7.5g/day of Rikkunshito, orally administered for seven days, to their second course treatment regimen. All cases were treated with 5-HT3 receptor antagonist and steroid, and palonosetron for the prevention of CINV in their first and second courses. We evaluated the complete response (CR, defined as no emesis and no rescue medication) rate and other toxicity, according to CTCAE v4.0, of the first and second courses. Results: The median age of the patients was 63 years (range, 49–77 years). The chemotherapy regimens were cisplatin + 5-FU in 15 cases with esophageal cancer, cisplatin + S-1 in five cases with gastric cancer. Anorexia in the first course was grade 0/1/2 = 5/11/4, but had been mitigated in the second course to grade 0/1/2 = 12/6/2 (P = 0.042). CR rate was 75.0% in the first course (95% CI, 56.0%–94.0%) and by the second course had improved to 95.0% (95% CI, 85.4%–100%). And about the other major toxicity, there was no significant difference between first and second courses. Conclusions: These results suggest that Rikkunshito has the potential to improve CINV in patients receiving high-dose cisplatin.

Preventive effect of rikkunshito, traditional Japanese medicine, for chemotherapy-induced nausea and vomiting.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 135-135
Author(s):  
Shinya Kajiura ◽  
Ayumu Hosokawa ◽  
Hiroki Yoshita ◽  
Naokatsu Nakada ◽  
Yuko Itaya ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Rescue Medication ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Preventive Effect ◽  
Major Toxicity ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
Anti Cancer

135 Background: Supportive therapies are being developed for chemotherapy-induced nausea and vomiting (CINV). Rikkunshito is a Kanpo medicine, which is a part of traditionally practiced Japanese-based ancient Chinese medicine. It has been reported to be effective against cisplatin-induced anorexia in rats. In the present study, we evaluated the preventive effect of rikkunshito for CINV in patients receiving high-dose cisplatin. Methods: We selected subjects who received chemotherapy including cisplatin (≥60mg/m2) for gastric or esophageal cancer between April 2008 and July 2011 at our institution. We targeted 26 cases treated without a reduction in the anti-cancer medication in the second course and added 7.5g/day of rikkunshito, orally administered for seven days, to their second course treatment regimen. All cases were treated with 5-HT3 receptor antagonist and steroid, and 12 cases were treated with palonosetron for the prevention of CINV in their first and second courses. We evaluated the complete response (CR, defined as no emesis and no rescue medication) rate and other toxicity, according to CTCAE v4.0, of the first and second courses. Results: The median age of the patients was 67 years (range, 49–77 years). There were nine cases of gastric cancer and 17 cases of esophageal cancer. The chemotherapy regimens were cisplatin + irinotecan in two cases, cisplatin + 5-FU in 15 cases, cisplatin + S-1 in seven cases and cisplatin + 5-FU + docetaxel in two cases. Six cases received concomitant radiation therapy. Anorexia in the first course was grade 0/1/2 = 4/12/10, but had been mitigated in the second course to grade 0/1/2 = 11/11/4 (P = 0.020). CR rate was 69.3% in the first course (95% CI, 51.6%–87.0%) and by the second course had improved to 88.5% (95% CI, 76.2%–100%) (P = 0.089). And about the other major toxicity, there was no significant difference between first and second courses. Conclusions: These results suggest that rikkunshito has the potential to improve CINV in patients receiving high-dose cisplatin.

scholarly journals Standard-dose versus high-dose radiotherapy with concurrent chemotherapy in esophageal cancer: A prospective randomized study

2018 ◽  
Vol 07 (01) ◽  
pp. 27-30 ◽  
Author(s):  
Navin Nayan ◽  
M. Bhattacharyya ◽  
Vikas K. Jagtap ◽  
A. K. Kalita ◽  
R. Sunku ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Total Dose ◽  
Standard Dose ◽  
Randomized Study ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Prospective Randomized Study ◽  
High Dose ◽  
Large Sample Size

Abstract Objective: The objective of this study is comparision of local and distant control rates with high-dose versus standard-dose radiotherapy along with concurrent chemotherapy in esophageal cancer – a prospective randomized study. Materials and Methods: Histologically proven Stage I–III patients with carcinoma esophagus were randomized into two groups. One group has been treated with standard-dose radiotherapy, i.e., a total dose of 50.4 Gy (1.8 Gy/day, 28#, 5 days/week). The other group (study arm) has received high-dose radiotherapy, i.e. a total dose of 64.8 Gy (1.8 Gy/day, 36#, 5 days/week). Both groups have received 2 cycles of 3 weekly concurrent chemotherapy (cisplatin 75 mg/m[2] on day 1 and 5-fluorouracil 750 mg/m[2] continuous intravenous infusion over 24 h on day 1–4). Follow-up response evaluation was done by both endoscopy and computed tomography scan after 6–8 weeks and after 2 months thereafter. Results: Out of a total of 28 patients, 68% showed a complete response, 14% showed partial response, and 18% patients developed progressive disease at first and subsequent follow up (median follow-up of 21 months). Among the complete response patients, rates were higher in high-dose group compared to standard-dose radiotherapy group (71% vs. 64%, P = 0.38). Treatment-related toxicities were acceptable in both groups. Conclusion: High-dose radiotherapy with concurrent chemotherapy seems to be more effective with acceptable toxicity in our study. However, further follow-up and large sample size may be required to validate the current study conclusion.

scholarly journals Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Strabismus Surgery ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Oculocardiac Reflex ◽  
Significant Difference

Aim.Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery.Methods.A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen.Results.The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex.Conclusion.Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial wasCTRI/2009/091/001000.

scholarly journals Clinical Outcomes of Radiotherapy in Elderly and Younger Patients with T4 Esophageal Cancer: A Retrospective Single-Center Analysis

2021 ◽  
Author(s):  
Yosuke Takakusagi ◽  
Kio Kano ◽  
Satoshi Shima ◽  
Keisuke Tsuchida ◽  
Nobutaka Mizoguchi ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Clinical Outcomes ◽  
Complete Response ◽  
The Elderly ◽  
Elderly Group ◽  
Cancer Center ◽  
Esophageal Fistula ◽  
Younger Patients ◽  
Significant Difference ◽  
T4 Esophageal Cancer

Abstract Background/AimThe standard of treatment for esophageal cancer with adjacent organ invasion (T4) has not been established. Radiotherapy (RT) is a treatment option, but its efficacy and safety in elderly patients remains unclear. We retrospectively analyzed the clinical outcomes of RT in elderly and younger patients with T4 esophageal cancer.Materials and MethodsSixty-nine patients with T4 esophageal cancer who underwent RT at the Kanagawa Cancer Center between January 2014 and November 2020 were included in this study. Patients aged ≥70 years were defined as the elderly group and those aged <70 years were defined as the younger group.The total dose of RT was set at 60 Gy in 30 fractions. Chemotherapy combined with 5-fluorouracil and cisplatin was administered concurrently with RT. The overall survival (OS) rate was estimated using the Kaplan–Meier method. Adverse events were assessed using the CTCAE v4.0. Clinical outcomes were compared between the elderly and younger groups.ResultsThe median survival time (MST) of the elderly group was 21.5 months, and the OS rates at 1, 3, and 5 years were 63.7%, 31.3%, and 15.6%, respectively. The MST of the younger group was 12.5 months, and the OS rates at 1, 3, and 5 years were 52.2%, 29.4%, and 29.4%, respectively. A significant difference in OS was not observed between the two groups (p = 0.767). Themultivariate analysis revealed thatthe complete response (CR) of the primary tumor and adjuvant chemotherapy (ACTx) were significant predictors of OS (p< 0.001 and<0.001, respectively). Regarding toxicity, the frequency of thrombocytopenia was significantly higher in the elderly group, whereas the frequency of esophageal fistula was significantly higher in the younger group (p = 0.012 and 0.022, respectively). Other toxicities were not significantly different between the two groups.ConclusionsOS was not significantly different between the elderly and younger groups. ACTx and CR were predictors of OS. The frequency of thrombocytopenia was higher in the elderly group and that of esophageal fistula was higher in the younger group. However, other toxicities were not significantly differentbetween the two groups.

scholarly journals The addition of omeprazole to ondansetron for treating chemotherapy-induced nausea and vomiting in pediatric cancer patients

2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo
Keyword(s):  
Placebo Group ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Pediatric Cancer Patients

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.

scholarly journals Comparison of Two Post-Transplant Predictive Indexes: Day 100 is a Better Time-Point for Response Evaluation after Autologous Stem Cell Transplantation in Multiple Myeloma: Ass Retrospective Study

2020 ◽  
Vol 7 (8) ◽  
Author(s):  
Ma’koseh M ◽  
◽  
Sa’deh S ◽  
Halahleh K ◽  
Abu-Jazar H ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Progression Free Survival ◽  
Complete Response ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Cell Transplant ◽  
Response Evaluation ◽  
Therapeutic Implications ◽  
Significant Difference

In Multiple Myeloma (MM), response to High-Dose Chemotherapy (HDC) and Autologous Stem Cell Transplant (ASCT) has important prognostic and therapeutic implications. Best timing for response evaluation after ASCT is not well studied. Our study evaluated the correlation between response on day 30 and day 100 after ASCT with Progression Free Survival (PFS) and Overall Survival (OS) in 119 MM patients. Median follow-up was 39.8 months. Complete Response (CR) was achieved in 53.8% and 55.5% of patients on D 30 and D 100, respectively. On D30, there was no significant difference in PFS or OS in CR vs. no CR group (35.4 vs. 22.1 months, p: 0.058) and (92.6 months vs. not reached p: 0.96) respectively nor in responders (R) vs. Non-Responders (NR) group (97.8 vs. 47.1 months p: 0.08) and (30.2 vs. 18.9 months, p: 0.09) respectively. While on D100, PFS was significantly better in CR vs. no CR group (33.8 vs. 18.1 months, p: 0.0047) as well as in R vs. NR (30.6 vs. 16.9 months p: 0.015). However, OS was not better in either (92.6 vs. 52.1 months p: 0.46) and (92.6 months vs. not reached p: 0, 88) respectively. In conclusion, after HDC and ASCT for MM, we recommend doing response evaluation on D100 rather than D30 as it better correlates with PFS. Further studies are required to confirm this finding in the era of consolidation and maintenance treatment.

Patients with Immunoglobulin Light Chain Amyloidosis (AL) Undergoing High Dose Chemotherapy with Autologous Stem Cell Transplantation (ASCT) have Superior Outcomes As Compared to Patients with Multiple Myeloma (MM)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 600-600
Author(s):  
Kirupananthan Seenithamby ◽  
Angela Dispenzieri ◽  
Martha Q Lacy ◽  
Shaji K. Kumar ◽  
Francis K Buadi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Plasma Cell ◽  
Conditioning Regimen ◽  
Complete Response ◽  
High Dose ◽  
Data Set ◽  
Risk Of Death ◽  
Hematologic Response ◽  
Significant Difference ◽  
Disease Specific

Abstract Abstract 600 Background: Both MM and AL are plasma cell neoplasms. The underlying clone in both diseases appears to be different not only in terms of “tumor burden” but also in terms of their underlying biology. The overall “fitness” of patients with these two diseases is also different, with AL patients having more major organ dysfunction. Therapy for both diseases is directed at killing the underlying clone. ASCT is one method of reducing the clone size and thereby improving overall survival. Post-ASCT outcomes between the two diseases have never been formally compared. Methods: We compiled all patients with a diagnosis of AL or MM who received ASCT at the Mayo Clinic Rochester between June 1996 and January 2011 to compare outcomes. Patients were retrieved from two prospectively maintained clinical transplant data bases (M.A.G.). Differences between groups were compared using Fisher's exact and Wilcoxon tests. Survival was calculated using the method of Kaplan-Meier, and differences between survival outcomes were calculated by log rank. Cox regression modeling was done to determine how non-disease specific variables—i.e. age, time period of ASCT, number of prior regimens, time to ASCT from diagnosis and acquisition of complete response (CR)—affected outcomes. All statistical analyses were performed using JMP (SAS, NC) software. This study was approved by the Mayo IRB. Results: The data set was comprised of 454 patients with AL and 1116 patients with MM. There were significant differences between the two respective groups of patients in terms of number of prior regimens (0 vs 1, p<0.0001), time to ASCT (3.95 months vs 7.20 months, p<0.0001), intensity of conditioning regimen (non-attenuated in 69.4% vs 89.1%, p<0.0001), serum creatinine (1.1mg/dl vs 1mg/dl p<0.0001), creatinine clearance (72.5 ml/minute vs 80 ml/minute p<0.0001), albumin (2.61g/dl vs 3.50g/dl, p<0.0001) CRP (0.40mg/dl vs 0.63mg/dl p<0.0001), LDH (196 U/l vs 182U/l, p<0.0001), and bone marrow plasmacytosis at transplant (6% vs 9%, p<0.0001). Hematologic response rates were also significantly different between the groups, with higher overall hematologic response in the MM group (90.9% vs 79.5%, p<0.0001) and higher complete response (CR) rates (40.1% vs 29.4%, p<0.0001) in the AL group. With a median follow-up of surviving patients of 68 months, the respective median overall survival (OS) for the AL and MM patients was 113 and 59.5 months, p<0.0001. Notably, the 5-year OS of AL and MM patients achieving CR were 91.4% and 57.7%, respectively, p<0.0001. If only those patients who were transplanted within 1 year of their diagnosis are included in the analysis, the respective 5-year OS of AL and MM patients achieving CR were 90.4% and 61.3%, p<0.0001 (Figure 1). To correct for imbalances in non-disease specific parameters, 3 multivariate analyses were performed using: 1) all patients; 2) only those achieving CR; and 3) only those who achieved a CR and were transplanted within 12 months of their diagnosis (Table 1). Among those patients achieving CR, MM patients had nearly a 4-fold risk of death as compared to patients with AL. Conclusion: Although ASCT is not available to all patients with either AL or MM, there is a significant difference in outcomes based on the diagnosis. Patients with AL who undergo ASCT enjoy a superior survival as compared MM patients undergoing the same procedure. This difference is most notable among those patients who achieve CR suggesting very different plasma cell biology between the two diseases. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Hedgehog Pathway as a Potential Intervention Target in Esophageal Cancer

Cancers ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 821 ◽  
Author(s):  
Da Wang ◽  
Peter Nagle ◽  
Helena Wang ◽  
Justin Smit ◽  
Hette Faber ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Treatment Resistance ◽  
Complete Response ◽  
Therapy Resistance ◽  
Neoadjuvant Chemoradiation ◽  
Control Group ◽  
Cancer Stemness ◽  
Anti Cancer ◽  
Sphere Formation

Esophageal cancer (EC) is an aggressive disease with a poor prognosis. Treatment resistance is a major challenge in successful anti-cancer therapy. Pathological complete response after neoadjuvant chemoradiation (nCRT) is low, thus requiring therapy optimization. The Hedgehog (HH) pathway has been implicated in therapy resistance, as well as in cancer stemness. This article focusses on the HH pathway as a putative target in the treatment of EC. Immunohistochemistry on HH members was applied to EC patient material followed by modulation of 3D-EC cell cultures, fluorescence-activated cell sorting (FACS), and gene expression analysis after HH pathway modulation. Sonic Hedgehog (SHH) and its receptor Patched1 (PTCH1) were significantly enriched in EC resection material of patients with microresidual disease (mRD) after receiving nCRT, compared to the control group. Stimulation with SHH resulted in an up-regulation of cancer stemness in EC sphere cultures, as indicated by increased sphere formation after sorting for CD44+/CD24− EC cancer stem-like cell (CSC) population. On the contrary, inhibiting this pathway with vismodegib led to a decrease in cancer stemness and both radiation and carboplatin resistance. Our results strengthen the role of the HH pathway in chemoradiotherapy resistance. These findings suggest that targeting the HH pathway could be an attractive approach to control CSCs.

scholarly journals Comparison of the effects of radiotherapy doses of 50.4 Gy and 60 Gy on outcomes of chemoradiotherapy for thoracic esophageal cancer: subgroup analysis based on the Comprehensive Registry of Esophageal Cancer in Japan from 2009 to 2011 by the Japan Esophageal Society

Esophagus ◽  
2020 ◽  
Vol 17 (2) ◽  
pp. 122-126 ◽  
Author(s):  
Kenji Nemoto ◽  
Shohei Kawashiro ◽  
Yasushi Toh ◽  
Hodaka Numasaki ◽  
Yuji Tachimori ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Complete Response ◽  
Large Database ◽  
Definitive Chemoradiotherapy ◽  
Thoracic Esophageal Cancer ◽  
Significant Difference ◽  
Japan Esophageal Society ◽  
Using Data ◽  
First Time ◽  
Comprehensive Registry

Abstract Background In definitive chemoradiotherapy (CRTx) for esophageal cancer, a radiotherapy (RT) dose of 50.4 Gy in 28 fractions has been the standard in many countries, while 60 Gy in 30 fractions has been frequently used in Japan. To clarify the optimal RT dose in CRTx for esophageal cancer, we compared clinical outcomes with the two doses using data from the Comprehensive Registry of Esophageal Cancer in Japan by the Japan Esophageal Society (JES). Methods Of the patients enrolled in the registry for 2015–2017 surveys (patients treated between 2009 and 2011), 996 patients who received definitive CRTx with 50.4 Gy or 60 Gy for thoracic esophageal cancer were eligible for analysis. Results The complete response (CR) rates in the 50.4 Gy and 60 Gy groups were 49.1% and 46.4%, respectively (p = 0.5851). The 5-year overall survival (OS) rates in the 50.4 Gy group and 60 Gy group for stages I, II/III and IV were 64.2% and 57.2%, 35.0% and 27.0%, and 18.0% and 15.3%, respectively. Since no significant difference was found between the two groups, the 50.4 Gy group was not inferior to the 60 Gy group with regard to OS. Conclusions The analysis revealed that the 50.4 Gy group had a non-inferior outcome in comparison with the 60 Gy group for stages I, II/III and IV thoracic esophageal cancer. These results were obtained from a large database for the first time in Japan.

The Oral Neurokinin-1 Antagonist Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial in Patients Receiving High-Dose Cisplatin—The Aprepitant Protocol 052 Study Group

2003 ◽  
Vol 21 (22) ◽  
pp. 4112-4119 ◽  
Author(s):  
Paul J. Hesketh ◽  
Steven M. Grunberg ◽  
Richard J. Gralla ◽  
David G. Warr ◽  
Fausto Roila ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Therapy Group ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo

Purpose: In early clinical trials with patients receiving highly emetogenic chemotherapy, the neurokinin antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen consisting of a type-three 5-hydroxytryptamine antagonist and a corticosteroid. This multicenter, randomized, double-blind, placebo-controlled phase III study was performed to establish definitively the superiority of the aprepitant regimen versus standard therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). Patients and Methods: Patients receiving cisplatin ≥ 70 mg/m2 for the first time were given either standard therapy (ondansetron and dexamethasone on day 1; dexamethasone on days 2 to 4) or an aprepitant regimen (aprepitant plus ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2 to 3; dexamethasone on day 4). Patients recorded nausea and vomiting episodes in a diary. The primary end point was complete response (no emesis and no rescue therapy) on days 1 to 5 postcisplatin, analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments. Results: The percentage of patients with complete response on days 1 to 5 was significantly higher in the aprepitant group (72.7% [n = 260] v 52.3% in the standard therapy group [n = 260]), as were the percentages on day 1, and especially on days 2 to 5 (P < .001 for all three comparisons). Conclusion: Compared with standard dual therapy, addition of aprepitant was generally well tolerated and provided consistently superior protection against CINV in patients receiving highly emetogenic cisplatin-based chemotherapy.

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