2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients

Roila, Fausto; Molassiotis, Alex; Herrstedt, Jørn; Aapro, Matti; Gralla, Richard J.; Bruera, Éduardo; Clark‐Snow, Rebecca; Dupuis, L. Lee; Einhorn, Lawrence H.; Feyer, Petra; Hesketh, Paul J.; Jordan, Karin; Olver, Ian; Rapoport, Bernardo; Roscoe, Joseph A.; Ruhlmann, Christina H; Walsh, Declan; Warr, David; Wetering, M. van der

doi:10.1093/annonc/mdw270

Cited by 504 publications

(607 citation statements)

References 65 publications

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“…The 2016 Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology guideline for the prevention of chemotherapy-induced nausea and vomiting classifies cisplatin as a highly emetogenic chemotherapy and recommend the prophylactic use of antiemetic regimens (25). In this trial, we did not require the prophylactic use of antiemetic agents but a majority of patients received prophylaxis based on standard treatment center protocols.…”

Section: Discussionmentioning

confidence: 99%

Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors

Subbiah

Grilley‐Olson

Combest

et al. 2018

Clinical Cancer Research

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Purpose: NC-6004, a novel cisplatin nanoparticle developed using micellar technology exhibits sustained release of cisplatin and selective distribution to tumors. Preclinical data demonstrated a favorable tolerability profile and preserved or improved antitumor activity compared with cisplatin across animal models. We evaluated the safety and tolerability of NC-6004 and gemcitabine using a Bayesian continual reassessment model (N-CRM) to determine the optimal dose.Experimental Design: Patients with advanced solid tumors received NC-6004 at 60 to 180 mg/m 2 on day 1 and gemcitabine at 1,250 mg/m 2 on days 1 and 8 every 3 weeks. Dose escalation of NC-6004 began with a single patient run-in until a dose-limiting toxicity occurred at 180 mg/m 2 . Cohorts of four patients were enrolled at doses predicted by the N-CRM. The maximum tolerated dose (MTD) was defined as having the greatest probability of target toxicity <25%. Quality of life was assessed using EORTC-QLQ-C30.Results: Among 22 patients, the most common grade III/IV hematologic adverse events were leukopenia (68%) and thrombocytopenia (59%). Of 20 pretreated patients evaluable for response, half were previously exposed to a platinum agent. The MTD was 135 mg/m 2 . Nine patients were treated at the MTD with median treatment duration of 15 weeks (range, 3-50). Tumor shrinkage occurred in 11 (55%), partial responses in 3 (15%), and stable disease in 14 (70%). Most patients reported stable or improved EORTC QLQ-C30 scores.Conclusions: Greater cisplatin equivalent doses were achieved with no clinically significant neuro-, oto-, or nephrotoxicity. These data demonstrate tolerability and promising activity of NC-6004 in combination with gemcitabine.

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Section: Discussionmentioning

confidence: 99%

Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors

Subbiah

Grilley‐Olson

Combest

et al. 2018

Clinical Cancer Research

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“…The MASCC/ESMO guidelines updated in 2016 state that addition of an NK-1 inhibitor to a 5-HT3 receptor antagonist and dexamethasone is recommended to prevent carboplatin-induced acute nausea and vomiting (Roila et al 2016). Ito et al (2014) reported a randomized phase-2 trial that compared standard antiemetic therapy with a 5-HT3 receptor antagonist and dexamethasone with aprepitant add-on triple antiemetic therapy in patients with NSCLC who received carboplatin-based first-line chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, the Multinational Association of Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO) updated the guidelines for prevention of chemotherapy-and radiotherapyinduced nausea and vomiting (Roila et al 2016). Previous MASCC/ESMO guidelines recommended the 5-HT3 receptor antagonist palonosetron plus dexamethasone for prophylaxis of acute nausea and vomiting; also, dexamethasone (p.o.)…”

Section: Introductionmentioning

confidence: 99%

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

Miya

Kobayashi

Hino

et al. 2016

JCO

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Background: Chemotherapy-induced nausea and vomiting (CINV) is a major adverse toxicity of cancer chemotherapy. Recommended treatments for prevention of CINV vary among published guidelines, and optimal care for CINV caused by moderately emetogenic chemotherapy has not been established. This study assessed the efficacy and safety of triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant for carboplatin-based chemotherapy. Chemotherapy-naïve patients with lung cancer scheduled for a first course of a carboplatin-containing regimen formed the study cohort. Patients were pretreated with antiemetic therapy comprising palonosetron (0.75 mg, i.v.) and dexamethasone (9.9 mg, i.v.) on day 1, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. Primary endpoint was the proportion of patients who did not experience vomiting and did not require rescue medication [complete response (CR)] in the acute phase (0-24 h), late phase (24-168 h) and overall. Secondary endpoint was the proportion of patients who experienced no vomiting episodes and no more than mild nausea without the need for rescue medication [complete control (CC)].Results: Prevalence of a CR during the acute phase, delayed phase, and overall was 100, 91.9 and 91.9%, whereas that of CC was 100, 84.4 and 84.4%, respectively. The most common adverse event was mild constipation; severe adverse events related to antiemetic treatment were not observed. Conclusion: Triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant shows excellent effects in the prevention of CINV in patients receiving a carboplatin-containing regimen.

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“…8,9 Several clinical guidelines have addressed the importance of the prophylactic administration of antiemetic drugs for preventing CINV, including the American Society of Clinical Oncology (ASCO), Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology (MASCC/ESMO) and National Comprehensive Cancer Network (NCCN). 10,11,12 There is constancy among these guidelines on key principles with only minor differences. 5,13 Although these guidelines are widely available and regularly updated, adherence is often low.…”

Section: Introductionmentioning

confidence: 99%

Adherence to guidelines on prophylaxis of chemotherapy-induced nausea and vomiting in the National Cancer Institute, Sudan

2017

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Objective: To evaluate the adherence to American Society of Clinical Oncology (ASCO) guidelines for antiemetic prophylaxis of chemotherapy-induced nausea and vomiting and assess the outcomes of the prescribed antiemetic drugs. Methods: This prospective, observational study enrolled chemotherapy-naive cancer patients who were admitted to the National Cancer Institute between May and July 2015 for intravenous chemotherapy. Patient’s demographic data, chemotherapy protocols and types of antiemetic drugs were collected by reviewing patients’ files, chemotherapy prescription forms and interviewing the patients. Results: The data revealed that 90% of pre-chemotherapy antiemetic prescriptions did not adhere to antiemetic guidelines. The trends of non-adherence included an overuse of ondansetron (14%), under-prescribing of dexamethasone (16%) and corticosteroid duplication (14%). Regarding antiemetic use for the prevention of delayed emesis, the data showed that 90% of antiemetic prescriptions were non-adherent with ASCO guidelines, with overuse of ondansetron (20%) and metoclopramide (37%) and lack of dexamethasone prescriptions (80%) on days 2 and 3 being the most frequently reported trends. The percentage of patients with complete response (no emesis or rescue therapy) over 5 days post chemotherapy was 36%. Conclusion: The study indicated an extremely low adherence rate to ASCO guidelines for antiemetic prophylaxis of chemotherapy-induced nausea and vomiting. Non-adherence included a trend of both underuse and overuse of indicated antiemetic medications.

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2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients

Cited by 504 publications

References 65 publications

Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors

Phase Ib/II Trial of NC-6004 (Nanoparticle Cisplatin) Plus Gemcitabine in Patients with Advanced Solid Tumors

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

Adherence to guidelines on prophylaxis of chemotherapy-induced nausea and vomiting in the National Cancer Institute, Sudan

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