Radiation-induced emesis: a prospective observational multicenter Italian trial

Maranzano, Ernesto; Latini, P; Roila, Fausto; Angelis, Valerio De; Tonato, Maurizio; Ballatori, Enzo; Favero, A. Del; Ciccarese, Giulia; Palladino, M A; Galardi, A.; Cintolesi,; Sulprizio, S; Biti, Gianpaolo; Dessi, Marina; Maxia, G; Lupattelli, Marco; Piro, F.; Bellavita, Rita; Bianchi, Pauline; Timurian, D; Fior, S. Dal; Iannone, T.; Bonanno, I (Bonanno I); Magno, L; Fillini, C.; Marchetti, G; Giudici, Stefania; Corvò, Renzo; Mignogna, Marcello; Sargenti, A; Renzis, Costantino De; Sansotta, Giuseppe; Russo, Antonio; Ricci, S.; Sciumè, F.; Liotta, P; Duca, Martina Del; Emiliani, E; Morganti, A.G.; Cellini, Numa; Mandoliti, Giovanni; Polico, C; Trippa, Fabio; Checcaglini, F; Sola, Barbara; Ab, Trotti; Ponticelli, Pietro; Lombardi, Rossana; Sarti, Enrico; Moro, G.; Iacopino, B.; Galuppi, Andrea; Palmucci, Tullio; Monica, MM La; Leggio, Massimo; Lonardi, Federico; Marzi, Matteo Jacopo; Marco, A. Di; Pergolizzi, Stefano; Pizzi, G; Cerrotta, A.; Orecchia, Roberto; Barsacchi, Lucia; Silvestro, Giustino; Scoppa, G.; Franchini, P.; Vanzo, C.; Cristallini, S.; D’Abbiero, Nunziata; Salvi, G.; Tombolini, Vincenzo; Parisi, Salvatore; Alfieri, Maria Laura; Sebaste, Lucio; Malinverni, Giuseppe; Tomio, L.; Buffoli, Alberto; Pradella, R.

doi:10.1016/s0360-3016(99)00055-3

Cited by 67 publications

(3 citation statements)

References 16 publications

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“…Risk factors for RINV are less investigated compared to those for chemotherapy-induced nausea and vomiting (CINV). Two observational studies by the Italian Group for Antiemetic Research in Radiotherapy (IGAAR) identified that irradiated site (upper abdomen), field size > 400 cm 2 , and concomitant chemotherapy are independent risk factors for development of RINV [2,24].…”

Section: Risk Factorsmentioning

confidence: 99%

2023 Updated MASCC/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting

Ruhlmann,

Jordan,

Jahn

et al. 2023

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Purpose Radiotherapy and chemoradiotherapy-induced nausea and vomiting (RINV and C-RINV) are common and distressing, and there is a need for guidance for clinicians to provide up to date optimal antiemetic prophylaxis and treatment. Through a comprehensive review of the literature concerning RINV and C-RINV, this manuscript aims to update the evidence for antiemetic prophylaxis and rescue therapy and provide a new edition of recommendations for the MASCC/ESMO antiemetic guidelines for RINV and C-RINV. Methods A systematic review of the literature including data published from May 1, 2015, to January 31, 2023, was performed. All authors assessed the literature. Results The searches yielded 343 references; 37 met criteria for full article review, and 20 were ultimately retained. Only one randomized study in chemoradiation had the impact to provide new recommendations for the antiemetic guideline. Based on expert consensus, it was decided to change the recommendation for the “low emetic risk” category from “prophylaxis or rescue” to “rescue” only, while the drugs of choice remain unchanged. Conclusion As for the previous guideline, the serotonin receptor antagonists are still the cornerstone in antiemetic prophylaxis of nausea and vomiting induced by high and moderate emetic risk radiotherapy. The guideline update provides new recommendation for the management of C-RINV for radiotherapy and concomitant weekly cisplatin. To avoid overtreatment, antiemetic prophylaxis is no longer recommended for the “low emetic risk” category.

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Section: Risk Factorsmentioning

confidence: 99%

2023 Updated MASCC/ESMO Consensus Recommendations: prevention of radiotherapy- and chemoradiotherapy-induced nausea and vomiting

Ruhlmann,

Jordan,

Jahn

et al. 2023

Support Care Cancer

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“…Nausea and vomiting are still perceived as major problems that result in substantial impairments in the patient’s functional activity and quality of life in patients receiving radiotherapy alone or with concomitant chemotherapy . Nausea and vomiting can also lengthen the overall radiotherapy time; sometimes patients even refuse further treatment, which can have serious influences on the treatment adherence and survival outcome .…”

Section: Introductionmentioning

confidence: 99%

“…Nausea and vomiting are still perceived as major problems that result in substantial impairments in the patient's functional activity and quality of life in patients receiving radiotherapy alone or with concomitant chemotherapy. [1][2][3] Nausea and vomiting can also lengthen the overall radiotherapy time; sometimes patients even refuse further treatment, which can have serious influences on the treatment adherence and survival outcome. [4][5][6] Unlike substantial evidence in the prevention of chemotherapy-induced nausea and vomiting (CINV), research in the prevention of nausea and vomiting caused by concurrent chemoradiotherapy (CCRT) is currently lacking.…”

Section: Introductionmentioning

confidence: 99%

Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy–Induced Nausea and Vomiting

et al. 2023

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ImportanceUnlike substantial evidence in the prevention of chemotherapy-induced nausea and vomiting (CINV), research in the prevention of nausea and vomiting caused by concurrent chemoradiotherapy (CCRT) is currently lacking.ObjectiveTo compare the efficacy and safety of fosaprepitant weekly vs every 3 weeks for the prevention of nausea and emesis caused by CCRT among patients with nasopharyngeal carcinoma.Design, Setting, and ParticipantsThis pilot randomized clinical trial was conducted at a single cancer center from November 24, 2020, to July 26, 2021, among patients with nasopharyngeal carcinoma who had achieved CINV control after 2 to 3 cycles of induction chemotherapy. Efficacy analyses were performed in the intention-to-treat population. Data were analyzed on November 4, 2022.InterventionsEligible patients were randomly assigned (1:1) to receive fosaprepitant either weekly or every 3 weeks.Main Outcomes and MeasuresThe primary end point was the proportion of patients with sustained complete response (defined as no emesis and no rescue therapy) during CCRT. Secondary end points were sustained no emesis, no nausea, no significant nausea, mean time to first emetic episode, quality of life, and 1-year progression-free survival (PFS).ResultsA total of 100 patients (mean [SD] age, 46.6 [10.9] years; 83 [83.0%] male) who had achieved CINV control after induction chemotherapy were randomly assigned to receive fosaprepitant weekly (50 patients) or every 3 weeks (50 patients). There was no significantly significant difference in cumulative risk of emesis or rescue therapy in the group that received weekly fosaprepitant compared with those who received fosaprepitant every 3 weeks (subhazard ratio, 0.66 [95% CI, 0.43-1.02]; P = .06). The proportion of patients with sustained no emesis (38% vs 14%; P = .003) or no significant nausea (92% vs 72%; P = .002) was significantly higher in the group that received fosaprepitant weekly vs those who received fosaprepitant every 3 weeks. Treatments were well tolerated. Patients in the weekly group had improved scores for multiple quality-of-life measures. There was no significant difference in survival outcomes between groups (91.8% vs 93.7%; P = .99). In the mean brainstem dose subgroups, a possible treatment interaction effect was observed in sustained complete response (mean brainstem dose ≥36 Gy: hazard ratio [HR], 0.32 [95% CI, 0.15-0.69]; mean brainstem dose &lt;36 Gy: HR, 0.95 [95% CI, 0.55-1.63]) and sustained no emesis (mean brainstem dose ≥36 Gy: HR, 0.21 [95% CI, 0.08-0.53]; mean brainstem dose &lt;36 Gy: HR, 0.73 [95% CI, 0.41-1.28]).Conclusions and RelevanceIn this pilot randomized clinical trial, there was no statistically significant difference in the complete response primary end point, but patients receiving weekly fosaprepitant were less likely to experience emesis compared with those who received fosaprepitant every 3 weeks, especially in the subgroup with a mean brainstem dose of 36 Gy or more. Weekly fosaprepitant was well tolerated and improved quality of life of patients without compromising survival.Trial RegistrationClinicalTrials.gov Identifier: NCT04636632

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