2017 Nov 8;8:1472. doi: 10.3389/fimmu.2017.01472. Overall, the evidence supports that the number of carboplatin cycles and dose are the principal risk factors for carboplatin-related hypersensitivity reactions, and that caution is warranted in cases of carboplatin infusion beyond 8 cycles or 3,500 mg. 19, 460465. Via Ginevra 4, 6900 Lugano - CH Copyright 2023 European Society for Medical Oncology All rights reserved worldwide. We analyzed the incidence, characteristics, risk factors, management, and outcomes of carboplatin-related hypersensitivity reactions among these patients. Would you like email updates of new search results? The ESMO Clinical Practice Guidelines, prepared and reviewed by leading experts and based on the findings of evidence-based medicine, provide you with a set of recommendations to help patients with the best care options. Disclaimer. 24, 342351. Cisplatin may be a valid alternative approach in ovarian carcinoma with carboplatin hypersensitivity. 4-step 4-h carboplatin desensitization protocol for patients with gynecological malignancies showing platinum hypersensitivity: a retrospective study. The MASCC/ESMO guidelines recommend that patients receiving HEC are given a dose of 20 mg dexamethasone on Day 1 to prevent acute emesis; however, if the NK 1 RAs aprepitant or netupitant are also used, a reduced dose of 12 mg dexamethasone is recommended. Furthermore, patients with carboplatin hypersensitivity had a higher incidence of previous allergic history to other cytotoxic drugs, including gemcitabine, paclitaxel, and doxorubicin, compared to those without (12/75 vs. 30/660, P < 0.001, chi-squared test; Table 7). Discontinuations due to anaphylaxis/hypersensitivity were rare for PH IV (generally <1% except two TRYPHAENA arms: 1% and 3%); no discontinuations of PH FDC SC have been recorded so far. Report of three cases. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences. A., Raja, F. A., Fotopoulou, C., Gonzalez-Martin, A., Colombo, N., Sessa, C., et al. J. Gynecol. Cancer Sci. Doxorubicin/adriamycin and other chemotherapies present with sudden onset hypo or hypertension in up to 60% of patients and rituximab and other monoclonal antibodies present with cutaneous and cardiovascular symptoms in 70% of the patients. doi: 10.3802/jgo.2013.24.4.342, Confino-Cohen, R., Fishman, A., Altaras, M., and Goldberg, A. The rate of hypersensitivity to carboplatin did not differ by patient age, menopausal status, disease entity, receipt of optimal debulking, or the amount of ascites. The PAGA project aims to adapt the ESMO Clinical Practice Guidelines by integrating Asian ethnic, scientific, socioeconomic, and local practice characteristics. The ESMO Congress is the most influential annual meeting for oncology professionals in Europe. Please enable it to take advantage of the complete set of features! Res. 2022 Apr 26;14(4):e24515. Optimal debulking surgery was performed in 491 patients (66.8%). FOIA 103, 608613. However, prolonged carboplatin use is associated with an increased incidence of carboplatin-related hypersensitivity reactions (Markman et al., 1999; Wang et al., 2009). This analysis includes 4772 pts. Assess for lymphadenopathy, facial or distal extremity swelling (may be signs of drug-induced hypersensitivity syndrome/DRESS). The histological type was serous in 381 patients (51.8%) and clear cell in 148 patients (20.1%). This study was approved by the Research Ethics Committee at the National Taiwan University Hospital (201706023RINC). Multistep IgE Mast Cell Desensitization Is a Dose- and Time-Dependent Process Partially Regulated by SHIP-1. Information for media including press accreditation. Furthermore, Moon et al. doi: 10.1006/gyno.2001.6519, Gadducci, A., Tana, R., Teti, G., Zanca, G., Fanucchi, A., and Genazzani, A. R. (2008). There is a need to further characterise risk of anaphylaxis/hypersensitivity with PH IV/PH FDC SC to support safe administration outside of clinics. The https:// ensures that you are connecting to the Table 6. van de Loosdrecht, Arjan A. ESMO 2017 Congress Integrating science into oncology for a better patient outcome Start date 08 Sep 2017 End date 12 Sep 2017 Location Madrid, Spain In an era of deep understanding of the molecular biology underlying the development of cancer, it is crucial that researchers and clinicians exchange knowledge. Drug Interactions in the Treatment of Malignancy in HIV-Infected Patients. 2019 Nov;15(11):e925-e933. 2017 Jul 1;28(suppl_4):iv119-iv142. 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Curr Pharm Des. However, other studies have reported severe hypersensitivity reactions to cisplatin in patients with prior carboplatin hypersensitivity reactions (Zweizig et al., 1994; Dizon et al., 2002). MBC: CLEOPATRA (NCT00567190; PMID 22149875, 23602601, 25693012; 32171426), MetaPHER (NCT02402712; 33748921); EBC: APHINITY (NCT01358877; 28581356, 33539215), NeoSphere (NCT00545688; 22153890, 27179402), TRYPHAENA (NCT00976989; 23704196, 29223479), BERENICE (NCT02132949; 29253081, SABCS 2017 P5-20-04), FeDeriCa (NCT03493854; 33357420), PHranceSCa (NCT03674112; ESMO 2020 165MO). The essential content of the guidelinesin condensed slide format in PDF or PowerPoint. doi: 10.1111/j.1525-1438.2007.01063.x, Genc, D. B., Canpolat, C., and Berrak, S. G. (2012). (2010) described the use of cisplatin as an alternative to carboplatin. Same-Day Desensitization in Patients Who Experience Their First Reaction to a Platin Agent at the Oncology Day Unit: A Pilot Study to Safely Include This Technique Within the Multidisciplinary Pathways for the Diagnosis & Management of Hypersensitivity to Platin Agents. The rate of hypersensitivity was significantly higher among patients with advanced stage disease (IIIIV) compared to patients with early stage disease (III) (P < 0.001, Kruskal-Wallis test), and among patients with serous or mixed histological type compared to patients with other histological types (P = 0.003, Kruskal-Wallis test). Oncol. For salvage chemotherapy in the case of recurrent disease, we administered chemotherapeutic regimens including carboplatin with paclitaxel, gemcitabine, or liposomal doxorubicin. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Ann Oncol. Author Information. The ESMO Expert Consensus Statement series of publications contain recommendations on well-defined, controversial or clinically relevant topics and are produced by 20-40 key experts in the field. We assessed occurrence, incidence and severity of these events in key Roche clinical trials of PH IV/PH FDC SC, and did a timetrend analysis (by cycle) for metastatic BC (MBC) and early BC (EBC) studies. The term 'hypersensitivity' should be used to describe objectively reprodu- cible symptoms or signs initiated by exposure to a dened stimu- lus at a dose tolerated by normal persons. Copyright 2017 Tai, Tai, Hsu, Lee, Chen, Chiang, Chen, Chen and Cheng. Though the characteristics of carboplatin-related hypersensitivity reactions are widely reported, limited data are available regarding such reactions in different types of patients. doi: 10.1093/annonc/mdt333. 2012;97:217-33. doi: 10.1159/000335637. All funding for this site is provided directly by ESMO. ESMO Colloquia are innovative sessions within the Congress programme, organised by ESMO and supported by industry, Information about the exhibition and Satellite Symposia, Contact details and welcome message, plus other general information about ESMO 2017. HHS Vulnerability Disclosure, Help Evaluation of the incidence of carboplatin hypersensitivity in cancer patients. 17, 11411145. An official website of the United States government. Carboplatin-related hypersensitivity reactions were defined as symptoms and signs occurring minutes to hours after carboplatin administration. A. In the late 1980s, more than a dozen phase I studies analyzed the efficacy of paclitaxel as a single agent. Efficacy and Adverse Events of Carboplatin Desensitisation Therapy for Gynaecological Cancer: A Retrospective Study. The characteristics of the 735 patients are presented in Table 2. 3, 10 In subsequent trials, 11 - 16 patients were premedicated Analysis and interpretation of data: Y-HT, Y-JT, H-CH, Y-YC, and W-FC. Sixty-one of these patients were re-challenged with carboplatin following their initial hypersensitivity reaction. sharing sensitive information, make sure youre on a federal Timetrend analyses showed that most events were reported during the first 68 cycles with concurrent chemotherapy, with a decrease in later cycles (except MetaPHER). Monitor. Gynecol. Via Ginevra 4, 6900 Lugano - CH Copyright 2023 European Society for Medical Oncology All rights reserved worldwide. We evaluated the prevalence of and risk factors for hypersensitivity reactions related to carboplatin, which is commonly used to treat gynecological malignancies. Front. doi: 10.2217/imt.14.71, Chiang, Y. C., Chen, C. A., Chiang, C. J., Hsu, T. H., Lin, M. C., You, S. L., et al. Check the latest publications and updates here to make sure you dont miss anything. There was a striking difference in PFSmedian 16.8 versus 5.6 months, HR 0.52 (highly significant)with the difference in PFS sustained at 12- and 18-month landmarks. Cancer. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Ovarian cancer is the leading cause of death from gynecological malignancies (Chiang et al., 2013), with a 5-year survival rate of 46% in the United States (92% when localized, 73% with regional metastases, and 28% with distant metastases) (Siegel et al., 2016). Whether, BRCA 1/2 and HRD-related genes modulate Th2 gene expression and increase specific IgE to carboplatin is still unknown. J. Med. By delivering the target, Symptoms and signs of hypersensitivity reactions amendable to desensitization. A three-step method was developed to identify hypersensitivity reactions, including anaphylaxis, in a clinical trial database and could be applied to investigational drugs to improve early detection and monitoring of potential safety concerns, subsequent patient safety management strategies, and potentially programme-wide drug development (2012) demonstrated that carboplatin treatment can be continued successfully in patients whose hypersensitivity reactions are managed in a timely fashion. Department of Pharmacological and Biomolecular Sciences, Faculty of Pharmacy, University of Milan, Italy, Ospedale Oncologico Armando Businco, Italy, University of Arkansas for Medical Sciences, United States. B., Phillips, P. C., Kang, T. I., et al. Educate. European Hematology Association (EHA) and European . This patient developed hypersensitivity reactions during her 23rd cycle of carboplatin administration at a cumulative dose of approximately 14,000 mg. She experienced skin rash, tachycardia, and dyspnea 13 min after starting the infusion. In conclusion, in our present population of women with gynecological malignancies treated with platinum-based chemotherapy, 1 in 10 developed carboplatin-related hypersensitivity reactions. doi: 10.1111/j.1525-1438.2005.00136.x, Koshiba, H., Hosokawa, K., Kubo, A., Miyagi, Y., Oda, T., Miyagi, Y., et al. -. MINIMAL Requirements:Google Chrome 24+,Mozilla Firefox 20+,Internet Explorer 11,Opera 1518,Apple Safari 7,SeaMonkey 2.15-2.23, Published in 2020 Ann Oncol (2020)Authors:M.E. Up to 16% of patients with ovarian cancer who undergo treatment with carboplatin-containing regimens experience carboplatin-related hypersensitivity (Markman et al., 1999; Polyzos et al., 2001; Sliesoraitis and Chikhale, 2005). Login to your ESMO account to sign up for ESMO newsletters and receive information about ESMO's scientific and educational resources, events, member benefits. Cancer. The results of the trial could answer whether carboplatin hypersensitivity patients have similar chemo-responses in non-platinum regimens without compromising the efficacy of the antineoplastic regimens of these patients. Br. Table 2. Login to your ESMO account to sign up for ESMO newsletters and receive information about ESMO's scientific and educational resources, events, member benefits. WHIPPANY, N.J., Sept. 1, 2017 /PRNewswire/ -- Bayer will present the latest research from across its growing oncology portfolio at the European Society for Medical Oncology (ESMO) 2017 Congress . Cisplatinum rechallenge in relapsed ovarian cancer patients with platinum reinduction therapy and carboplatin hypersensitivity. 105, 14721479. Similarly, Kandel et al. Yamamoto A, Kamoi S, Matsuda S, Kawase R, Nakanishi K, Suzuki S. Medicines (Basel). Management of infusion reactions to systemic anticancer therapy: ESMO Clinical Practice Guidelines. Necessary cookies enable core functionality. (1999). Compared to women without hypersensitivity reactions, women who experienced hypersensitivity reactions had a significantly greater median cycle number (12 vs. 6, P < 0.001, independent sample t-test) and dose (6,816 vs. 3,844 mg, P < 0.001, independent sample t-test). 17 This dose reduction is due to the ability of both aprepitant and netupitant to inhibit the metabolism of dexamethasone leading to higher . Among the 651 women (88.6%) diagnosed with ovarian cancer, 474 (64.5%) had stage IIIIV disease. Hypersensitivity reactions associated with platinum-containing antineoplastic agents for thoracic malignancies. Annals of Oncology (2021) 32 (suppl_5): S407-S446. Adnan A, Acharya S, Alenazy LA, de Las Vecillas L, Giavina Bianchi P, Picard M, Calbache-Gil L, Romero-Pinedo S, Abad A-Molina AC, Kerr W, Pedicone C, Nagai J, Hollers E, Dwyer D, Castells M. J Immunol. One patient who experienced a carboplatin-related hypersensitivity reaction progressed to respiratory arrest and died. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). Blood. (2010). PMC 53, 121122. Int. All the statistical tests were two-tailed, and statistical significant level was defined as p-value < 0.05. Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS. Chemother. NCT00567190, NCT02402712, NCT01358877, NCT00545688, NCT00976989, NCT02132949, NCT03493854, NCT03674112. 2008;14(27):2892-901. doi: 10.2174/138161208786369803. Gender, age, ethnicity and race were similar between subgroups as were objective response rates (ORR) (64% CPI-treated v 62% CPI-nave). MINIMAL Requirements:Google Chrome 24+,Mozilla Firefox 20+,Internet Explorer 11,Opera 1518,Apple Safari 7,SeaMonkey 2.15-2.23. doi: 10.1002/cncr.21168, Dizon, D. S., Sabbatini, P. J., Aghajanian, C., Hensley, M. L., and Spriggs, D. R. (2002). eCollection 2022. Front Oncol. MINIMAL Requirements:Google Chrome 24+,Mozilla Firefox 20+,Internet Explorer 11,Opera 1518,Apple Safari 7,SeaMonkey 2.15-2.23. 2018 Jun;54(3):375-385. doi: 10.1007/s12016-016-8556-5. It didn't disappoint. (1994). reported that the majority (93%) of patients with a BRCA1/2 mutation develop carboplatin hypersensitivity, and that BRCA1/2 mutation is an independent risk factor for the development of carboplatin hypersensitivity. doi: 10.1016/j.ygyno.2007.06.016, Markman, M., Kennedy, A., Webster, K., Elson, P., Peterson, G., Kulp, B., et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Analysis of the pattern of hypersensitivity reactions in patients receiving carboplatin retreatment for recurrent ovarian cancer. doi: 10.1200/JCO.2003.02.153, Parmar, M. K., Ledermann, J. Monitor. The incidence of carboplatin-related hypersensitivity was higher in patients with advanced stage disease (P < 0.001, Kruskal-Wallis test), serous and mixed histological types (P = 0.003, Kruskal-Wallis test), malignant ascites (P = 0.009, chi-square test), and history of other drug allergy (P < 0.001, chi-square test). The independent sample t-test was used to evaluate how carboplatin cycle and dose correlated with the incidence of hypersensitivity and severe hypersensitivity reactions. (2011). Unable to load your collection due to an error, Unable to load your delegates due to an error. Clinical practice guidance in a modernised format that focuses on visual representation of recommendations for quick and easy reference by practicing clinicians. 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Symptoms and signs of 75 patients with hypersensitivity reactions to carboplatin. Assess for pustules or blisters or erosions in addition to areas of "dusky erythema" which may feel painful to palpation. eCollection 2022. All accepted abstracts are available in theESMO 2017 Abstract Book. Bookshelf The comparison between other countries and ours about characteristics of the patients receiving carboplatin-based chemotherapy and risk factors of carboplatin-related hypersensitivity reactions. Webcasts and presentations from ESMO 2017 can be accessed by ESMO members and event attendees. ESMO Clinical Practice Guidelines Provide your patients with the best care options Supporting your clinical decisions with ESMO's regularly updated Clinical Practice Guidelines and consensus recommendations, developed by the leading experts in our profession.