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 ◽  
...  

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.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 131-131
Author(s):  
Shinya Kajiura ◽  
Ayumu Hosokawa ◽  
Sohachi Nanjyo ◽  
Hiroki Yoshita ◽  
Nobuhiro Suzuki ◽  
...  

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.


Author(s):  
Yoshinori Wakasugi ◽  
Satoshi Noda ◽  
Yoshihiro Ikuno ◽  
Miya Horie ◽  
Katsuyuki Kito ◽  
...  

Abstract Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) regimen includes a high dose of prednisolone (100 mg/body), which exhibits an anticancer and antiemetic effect. However, its optimal use for antiemetic therapy has not been established yet. We assessed the efficacy of granisetron plus aprepitant versus granisetron for CHOP or rituximab-CHOP (R-CHOP) regimen-induced nausea and vomiting in malignant lymphoma. Methods This retrospective and observational clinical study included patients who received CHOP or R-CHOP regimen as initiating chemotherapy between July 2010 and March 2016 (N = 39). Patients were assigned to an aprepitant [aprepitant (125 mg on day 1, 80 mg on days 2–3) plus granisetron (3 mg); n = 15] or control regimen group [granisetron (3 mg); n = 24]. Complete response (CR), defined as no vomiting and no use of rescue therapy during overall phase (0–120 h), was the primary endpoint. Secondary endpoints included the time to first vomiting and using rescue medication and complete protection (CP) defined as no vomiting and no retching and/or no nausea and no rescue therapy. The patient records were investigated, and data were retrospectively analyzed. Results CR rate CP rates did not significantly differ between the groups during the observation period (80.0% versus 83.3%, p = 1.000; and 80.0% versus 79.2%, p = 1.000, respectively). Additionally, the time to first vomiting and using rescue medication in did not significantly differ between the groups (p = 0.909). Conclusions This study suggests that granisetron alone could be one treatment option in the management of CINV in patients with non-Hodgkin lymphoma receiving CHOP or R-CHOP regimen.


2018 ◽  
Vol 07 (01) ◽  
pp. 27-30 ◽  
Author(s):  
Navin Nayan ◽  
M. Bhattacharyya ◽  
Vikas K. Jagtap ◽  
A. K. Kalita ◽  
R. Sunku ◽  
...  

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.


2020 ◽  
Author(s):  
Rudolph M Navari ◽  
Eric J Roeland

Breakthrough chemotherapy-induced nausea and vomiting (CINV) is nausea and/or vomiting occurring within 5 days of chemotherapy administration despite using guideline-directed prophylactic antiemetic agents. It is highly prevalent (30–40%), usually requiring immediate treatment or “rescue” medication. If breakthrough CINV occurs, antiemetic guidelines recommend using an antiemetic agent from a different class not used in prophylaxis, along with intravenous hydration and/or dexamethasone. Data supporting these guideline recommendations are limited. Importantly, costs associated with breakthrough CINV can be substantial (i.e., unscheduled hydrations). Two retrospective analyses evaluating guideline-adherent CINV prophylaxis suggest that the initial antiemetic selection may decrease breakthrough CINV. Here we review optimal CINV prophylactic strategies and introduce unscheduled hydration as a potential important surrogate for breakthrough CINV aligning with cost-effective cancer care.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  

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.


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 624-624
Author(s):  
Sosuke Kato ◽  
Hiraku Fukushima ◽  
Kanji Kato ◽  
Satoshi Yuki ◽  
Kazuaki Harada ◽  
...  

624 Background: Indisetron is a 5-HT3 receptor antagonist that also antagonizes 5-HT4receptors. Indisetron tablets showed the non-inferiority to ondansetron tablets in terms of efficacy for preventing CINV. Moreover, preclinical data administered with irinotecan showed indisetron significantly reduced stool frequency in mice and inhibited the colonic peristalsis in dogs. We designed a pilot study compared with granisetron in the efficacy and tolerability of indisetron for irinotecan-induced nausea, vomiting and especially in diarrhea. Methods: Advanced colorectal cancer patients treated with FOLFIRI or IRIS (Irinotecan + S-1) with or without bevacizumab were enrolled in this study. Treatment: Arm A: indisetron tablets 8mg po day1. Arm B: granisetron 3mg iv day 1. The primary endpoints were the incidence of acute-onset diarrhea and complete protection from vomiting. Secondary endpoints were tolerability, complete protection from nausea and rate of no rescue medication. Results: Between May 2008 and July 2012, 33 patients (pts) were randomized. The study was closed prematurely due to poor accrual. Arm A: 16 pts, arm B 17 pts. Median age A: 68 y.o., B: 66 y.o.: ECOG PS 0/1: A: 12/4, B: 14/3pts. There was no significant difference of the incidence of acute-onset diarrhea between both groups (18.8% in A vs. 35.3% in B, p = 0.438). The proportion of complete protection from vomiting was 87.5% in A and 88.2% in B (p = 1.000). Similarly, complete protection from nausea, rate of no rescue medication, proportion of patients with a complete response (defined as no emetic episodes and no rescue medication) did not have a significant difference. Severity of nausea/vomiting and AE induced by 5-HT3 receptor antagonist were also similar between two groups. Conclusions: Compared with granisetron, indisetron showed effective and feasible results for preventing CINV induced by FOLFIRI or IRIS. Indisetron had also not improved the incidence of acute-onset diarrhea induced by irinotecan. Clinical trial information: UMIN000010162.


2021 ◽  
Author(s):  
Yosuke Takakusagi ◽  
Kio Kano ◽  
Satoshi Shima ◽  
Keisuke Tsuchida ◽  
Nobutaka Mizoguchi ◽  
...  

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.


2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo

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.


2020 ◽  
Vol 7 (8) ◽  
Author(s):  
Ma’koseh M ◽  
◽  
Sa’deh S ◽  
Halahleh K ◽  
Abu-Jazar H ◽  
...  

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.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9626-9626
Author(s):  
J. A. Boice ◽  
H. Schmoll ◽  
C. Brown ◽  
A. Taylor

9626 Background: Aprepitant (A) has been shown in a previous trial to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving cyclophosphamide and anthracycline. This study assessed A in patients with a variety of tumors receiving a broad range of MEC regimens. Methods: This Phase III, randomized, gender-stratified, double-blind, trial enrolled female and male patients ≥18 years old with confirmed malignancies naïve to MEC or highly emetogenic chemotherapy and scheduled to receive a single dose of 1 or more MEC agent. Patients received A triple-therapy regimen (A 125 mg, ondansetron [O] 8 mg b.i.d., and dexamethasone [D] 12 mg on Day 1 of chemotherapy, A 80 mg q.d. on Days 2–3) or a control regimen (O 8 mg b.i.d. and D 20 mg on Day 1, and O 8 mg q12h on Days 2–3) all administered orally. Episodes of vomiting, nausea, and rescue medication use were recorded in a patient diary. Tolerability was assessed by physical and lab examinations, and adverse event (AE) reporting. Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting and no rescue medication use), respectively, during the 120 hours postchemotherapy. Results: Among 848 randomized patients, 77% were female while 52, 20, 13, and 5% of patients had breast, colorectal, lung, or ovarian cancer, respectively. Significantly more patients in the A group achieved No Vomiting and Complete Response (a difference of 14.1 &12.4 percentage points vs. control, respectively). The incidences of AEs were generally similar in the aprepitant (61.9%) and control groups (66.5%). Conclusions: The aprepitant regimen provided superior efficacy over the control regimen in the treatment of CINV in a broad range of patients receiving MEC in both No Vomiting and Complete Response endpoints. Aprepitant was generally well tolerated. [Table: see text] [Table: see text]


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