A Prospective Observational Study on Effect of Short-Term Periodic Steroid Premedication on Bone Metabolism in Gastrointestinal Cancer (ESPRESSO-01)

Nakamura, Michio; Ishiguro, Atsushi; Muranaka, Toshiya; Fukushima, H.; Yuki, Satoshi; Ono, Kota; Murai, Taichi; Matsuda, Chika; Oba, Ayane; Itaya, Kazufumi; Sone, Takayuki; Yagisawa, Masataka; Koike, Yuta; Endo, Ayana; Tsukuda, Yoko; Ono, Yuji; Kudo, Takahiko; Nagasaka, Atsushi; Nishikawa, Shuji; Komatsu, Yoshito

doi:10.1634/theoncologist.2016-0308

Cited by 36 publications

(20 citation statements)

References 54 publications

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“…Effective approaches to reduce patients’ exposure to steroids remain among the hot topics in clinical research on CINV. Recent evidences from prospective studies highlighted a potentially detrimental impact of short‐term prophylactic dexamethasone in patients undergoing consecutive courses of emetogenic chemotherapy . Aapro et al compared the efficacy of palonosetron when administered alone or in combination with 1‐day dexamethasone, in post hoc analyses of two studies on CINV in patients undergoing MEC; they reported that the proportion of nausea was lower in patients treated with the 1‐day dexamethasone regimen over a 5‐day period .…”

Section: Discussionmentioning

confidence: 99%

One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis

et al. 2019

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Background. A dexamethasone-sparing regimen consisting of palonosetron plus 1-day dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) has been studied previously. Here, we evaluate the noninferiority of the dexamethasone-sparing regimen in overall antiemetic control using a meta-analysis based on individual patient data (IPD). Materials and Methods. We conducted a systematic review for randomized trials reporting CINV outcomes for the comparison of palonosetron plus 1-day dexamethasone (d1 arm) versus the same regimen followed by dexamethasone on days 2-3 after chemotherapy (d3 arm) in chemotherapynaïve adult patients undergoing either moderately emetogenic chemotherapy (MEC) or anthracycline plus cyclophosphamide (AC)-containing chemotherapy. PubMed and MEDLINE were searched electronically. A manual search was also conducted. The primary endpoint was complete response (CR; no emesis and no rescue medication) in the overall 5-day study period. The noninferiority margin was set at −8.0% (d1 arm−d3 arm). Results. Five studies (n = 1,194) were eligible for analysis and all IPD was collected. In the overall study period, the d1 arm showed noninferiority to the d3 arm for CR as well as complete control (pooled risk difference in CR rate − 1.5%, 95% confidence interval [CI] −7.1 to 4.0%, I 2 = 0%; in complete control rate − 2.4%, 95% CI −7.7 to 2.9%, I 2 = 0%). There was no significant interaction between dexamethasone regimen and risk factors (type of chemotherapy, sex, age, and alcohol consumption). Conclusion. This IPD meta-analysis indicates that the dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic control in patients undergoing MEC or AC-containing chemotherapy, irrespective of known risk factors for CINV. The Oncologist 2019;24:1593-1600 Implications for Practice: Although dexamethasone in combination with other antiemetic agents has been used to prevent chemotherapy-induced nausea and vomiting (CINV), it is of clinical importance to minimize total dose of dexamethasone in patients undergoing multiple cycles of emetogenic chemotherapy. This individual-patient-data meta-analysis from five Symptom Management and Supportive Care randomized controlled trials (1,194 patients) demonstrated a noninferiority of the dexamethasone-sparing regimen for complete response and complete control of CINV. The outcomes were comparable across patients with different characteristics. These findings thus help physicians minimize use of the steroid and further reduce the burden of dexamethasone-related side effects in patients undergoing multiple consecutive courses of emetogenic chemotherapy.Okada, Oba, Furukawa et al. 1597 b d3 arm: palonosetron plus 3-day dexamethasone.

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Section: Discussionmentioning

confidence: 99%

One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis

et al. 2019

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“… 23 Thus, in patients who develop acute CINV, dexamethasone may be useful in preventing nausea and anorexia in the delayed phase. However, because dexamethasone has several side effects, including insomnia, indigestion/epigastric discomfort, agitation, and increased appetite, 24 , 25 we need to be mindful of these side effects when using dexamethasone for delayed antiemetic prophylaxis.…”

Section: Discussionmentioning

confidence: 99%

Risk factors for delayed chemotherapy-induced nausea and vomiting with low-emetic-risk chemotherapy: a prospective, observational, multicenter study

Hayashi

Shimokawa²,

Matsuo

et al. 2018

CMAR

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PurposeImprovement in the control of delayed chemotherapy-induced nausea and vomiting (CINV) is needed. There is limited information on antiemetic prophylaxis for patients undergoing low-emetic-risk chemotherapy (LEC), and the optimal antiemetic treatment is not well understood. Therefore, we analyzed the risk factors for delayed CINV to aid in the development of individualized treatments.Patients and methodsThis prospective multicenter study was conducted in 13 hospitals and included patients with solid cancers undergoing LEC. A total of 222 patients were enrolled between September 2013 and November 2014. The participants completed a daily diary for 5 days after the commencement of the first cycle of LEC to describe the daily incidence of CINV (yes/no). Furthermore, the participants described the severity of nausea and the amount of food intake with the help of VAS.ResultsTwo hundred and ten patients provided their data that were analyzed using multivariate logistic regression to examine the risk factors for delayed CINV. History of CINV, Eastern Cooperative Oncology Group performance status score ≥1, acute CINV, and single-day antiemetic prophylaxis were identified as independent risk factors for delayed CINV.ConclusionThe current use of antiemetic prophylaxis according to the recommended guideline appears to effectively control delayed CINV in patients undergoing LEC. Therefore, patients with the abovementioned risk factors should be carefully observed, and their treatment should be adjusted according to their symptoms. The use of multiple-day dexamethasone may be beneficial for those patients who develop acute CINV, especially when it is accompanied by anorexia.

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“…Bone metabolism in women differs from that in men because of differences in endocrinological factors, physical activity, and diet. Furthermore, the previous study demonstrated anticancer agents influenced bone metabolism [13]. The only previous prospective study that reported on changes in BMD after gastric cancer surgery enrolled not only men, but also women, and some patients received adjuvant chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Changes in bone metabolism after gastric cancer surgery in male patients: a prospective observational study

Atsumi

Rino

Wada³

et al. 2018

Gastric Cancer

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A Prospective Observational Study on Effect of Short-Term Periodic Steroid Premedication on Bone Metabolism in Gastrointestinal Cancer (ESPRESSO-01)

Abstract: This study is an evaluation of the effect of gastrointestinal cancer chemotherapy with short‐term periodic steroid premedication on bone metabolism. Primary endpoints were changes in bone mineral densities and metabolic bone turnover 16 weeks after initiation of chemotherapy.

Cited by 36 publications

References 54 publications

One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis

One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis

Risk factors for delayed chemotherapy-induced nausea and vomiting with low-emetic-risk chemotherapy: a prospective, observational, multicenter study

Changes in bone metabolism after gastric cancer surgery in male patients: a prospective observational study

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