Paclitaxel plus platinum-based chemotherapy vs. conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. For more detailed information on the cookies we use, please check our Privacy Policy. 8600 Rockville Pike 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. 'Allergy' is a hypersensitivity reaction (HSR) initiated by specic immunolo- gical mechanisms. A history of drug or food allergy, the presence of malignant ascites, and the cumulative carboplatin dose are three independent predictive factors of carboplatin hypersensitivity in this survey. (2003) reported that paclitaxel with platinum improves overall survival compared to conventional platinum-based chemotherapy among patients with relapsed platinum-sensitive ovarian cancer. 53, 121122. (2009) reported the successful re-treatment of the majority of patients with previous carboplatin-related hypersensitivity reactions. The histological type was serous in 381 patients (51.8%) and clear cell in 148 patients (20.1%). The characteristics of the 735 patients are presented in Table 2. Vaccines (Basel). A total of 735 eligible women who underwent treatment for ovarian, fallopian tube, or primary peritoneal cancer were recruited this the study; 75 (10.2%) experienced a total of 215 carboplatin-related hypersensitivity reaction events. Int. Ann Oncol. 21, 31943200. Int. We also recorded the procedures applied to treat the hypersensitivity reactions and efforts to manage the side effects of carboplatin administration. (Bruchim et al., 2014) demonstrated safe re-treatment with carboplatin using a desensitization protocol to reduce repeated hypersensitivity reactions, and Koshiba et al. ESMO Call to Action on COVID-19 Vaccinations and Patients with Cancer: Vaccinate. The most commonly exhibited symptom/sign was hypotension (10.7%), followed by anaphylaxis (8.0%) and desaturation (6.7%). (2009) reported a 3.54% rate of severe carboplatin-related hypersensitivity reactions, which is similar to our rate of 2.2%. Monitor. Analysis of the pattern of hypersensitivity reactions in patients receiving carboplatin retreatment for recurrent ovarian cancer. Clipboard, Search History, and several other advanced features are temporarily unavailable. Management of uncommon chemotherapy-induced emergencies. Careers. Whether desensitization modulates drug allergic and anaphylactic responses facilitating tolerance is currently being investigated. doi: 10.1002/cncr.21168, Dizon, D. S., Sabbatini, P. J., Aghajanian, C., Hensley, M. L., and Spriggs, D. R. (2002). -, Sakaeda T, Kadoyama K, Yabuuchi H, Niijima S, Seki K, Shiraishi Y, et al. Desensitization Protocol to Carboplatin: A Technical Report. government site. Abstracts, slide sets and webcasts from ESMO 2017 Congress are now available. J. Gynecol. The cumulative incidence of carboplatin-related hypersensitivity was 2% after 8 cycles, 6% after 14 cycles, 8% after 19 cycles, and 10% after 33 cycles, with a plateau beyond this cycle number (Figure 1A). Accessibility 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). It didn't disappoint. van de Loosdrecht, Arjan A. and transmitted securely. Hypersensitivity to antineoplastic agents. doi: 10.1200/JCO.2006.06.0913, Polyzos, A., Tsavaris, N., Kosmas, C., Arnaouti, T., Kalahanis, N., Tsigris, C., et al. Cancer. Drug Interactions in the Treatment of Malignancy in HIV-Infected Patients. Though the characteristics of carboplatin-related hypersensitivity reactions are widely reported, limited data are available regarding such reactions in different types of patients. hypersensitivity and pneumonitis not otherwise specified. Authors: S. Rosell, I. Blasco, L. Garca Fabregat, A. Cervantes and K. Jordan Patients without ovarian cancer were excluded from retrospective analysis of details of hypersensitivity reactions recorded contemperaneously between April 2019 - January 2020 on excel and chemocare (CIS Oncology, Belfast, UK) by the treating practitioner. http://downloads.hindawi.com/journals/mbd/2010/207084.pdf, Kadoyama K, Kuwahara A, Yamamori M, Brown JB, Sakaeda T, Okuno Y. Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS. TABLE 3 Table 3. Optimal debulking surgery was performed in 491 patients (66.8%). 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. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. HHS Vulnerability Disclosure, Help MINIMAL Requirements:Google Chrome 24+,Mozilla Firefox 20+,Internet Explorer 11,Opera 1518,Apple Safari 7,SeaMonkey 2.15-2.23, Published in 2017 Ann Oncol (2017) 28 (suppl 4): iv100iv118.Authors: S. Rosell, I. Blasco, L. Garca Fabregat, A. Cervantes and K. Jordan. 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. Invest. (2017). Incidence of carboplatin-related hypersensitivity reactions in Japanese patients with gynecologic malignancies. doi: 10.1111/j.1048-891x.2005.14401.x, Takase, N., Matsumoto, K., Onoe, T., Kitao, A., Tanioka, M., Kikukawa, Y., et al. We retrospectively recruited all women with pathologically documented ovarian, fallopian tube, or primary peritoneal cancer treated with single-agent carboplatin or a carboplatin-based combination chemotherapy regimen at National Taiwan University Hospital from January 2006 to December 2013. These patients were provided with intravenous fluid infusion and medications, including corticosteroids, antihistamines, and oxygen application. Desensitization is a high risk procedure in which a drug is administrated to a patient who has already presented an allergic reaction, almost always severe. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. The ESMO Clinical Practice Guidelines (CPGs) are intended to provide the user with a set of recommendations for the best standards of cancer care, based on the findings of evidence-based medicine. Nitipir C, Parosanu A, Popa AM, Cotan H, Olaru M, Iaciu C, Orlov Slavu C. Cureus. Cancer 109, 10721078. Analysis and interpretation of data: Y-HT, Y-JT, H-CH, Y-YC, and W-FC. 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). Symptoms and signs of 75 patients with hypersensitivity reactions to carboplatin. doi: 10.1093/annonc/mdx216. Via Ginevra 4, 6900 Lugano - CH Copyright 2023 European Society for Medical Oncology All rights reserved worldwide. *Correspondence: Wen-Fang Cheng, wenfangcheng@yahoo.com, Creative Commons Attribution License (CC BY). Markman, M. (2007). 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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). 2008;14(27):2892-901. doi: 10.2174/138161208786369803. We analyzed the incidence, characteristics, risk factors, management, and outcomes of carboplatin-related hypersensitivity reactions among these patients. These scores have been defined by the guideline authors and validated by the ESMO Translational Research and Precision Medicine Working Group.17 g Selpercatinib is EMA approved for treating adults with advanced or metastatic RET fusion-positive TC who had already received lenvatinib or sorafenib. Oncol. (2009). Table 1. Compared to those without hypersensitivity reactions, women who experienced hypersensitivity reactions had a significantly higher median number of cycles (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, Table 3). Cancer 63, 2126. Characteristics of the 735 women receiving carboplatin-based chemotherapy. The PAGA project aims to adapt the ESMO Clinical Practice Guidelines by integrating Asian ethnic, scientific, socioeconomic, and local practice characteristics. 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We further evaluated the median carboplatin cycle and dose administered to women with and without carboplatin-related hypersensitivity. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. 2022 Oct 18;12:994155. doi: 10.3389/fonc.2022.994155. View the photographic highlights from ESMO 2017 here! doi: 10.1038/bjc.2013.389, Navo, M., Kunthur, A., Badell, M. L., Coffer, L. W. Read guidelines by topic Latest Guidelines News ESMO is a Swiss-registered not-for-profit organisation. Type II hypersensitivity is an IgG or IgM antibody-dependent cytotoxicity in which an antigen attached to cell membranes of red blood cells or platelets binds to an antibody, leading to cell or tissue damage such as haemolytic anaemia or thrombocytopenia. 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). PH IV/PH FDC SC is standard of care for HER2-positive BC and usually given with chemotherapy, all of which can trigger anaphylaxis/hypersensitivity. Although infusion reactions can be allergic or non-immune-mediated, the clinical manifestations are the same and require prompt assessment and appropriate intervention. Chan. 18, 615620. S.M. Platinum desensitization in patients with carboplatin hypersensitivity: a single-institution retrospective study. doi: 10.1111/IGC.0b013e3181a418ff, Greene, D. P., Ferriss, J. S., and Jazaeri, A. The ESMO guideline recommends patients receive surveillance by colonoscopy every 3 years beginning at age 25 for MLH1 and MSH2 mutation carriers and age 35 for MSH6 and PMS2 mutation carriers, or . Carboplatin hypersensitivity: evaluation and successful desensitization protocol. 24, 46994707. The imaging findings follow the American Thoracic Society and European Respiratory Society classification of interstitial pneumonia. (2010) described the use of cisplatin as an alternative to carboplatin. 2011 Aug;12(8):806-14. doi: 10.1016/S1470-2045(10)70208-4. Therefore, disease severity, histological type, malignant ascites, past drug allergies, and cumulative carboplatin dose are risk factors for carboplatin-related hypersensitivity reactions. The incidence of severe carboplatin-related hypersensitivity reactions ranges from 2 to 6%, with the lowest incidence occurring in our study. Women are more affected by drug allergy and up to 27% of women with ovarian and breast cancer develop carboplatin allergy after multiple cycles of treatment. National Library of Medicine All women with pathologically documented ovarian, fallopian tube, or primary peritoneal cancer treated with carboplatin alone or a carboplatin-based combination chemotherapy regimen at a single hospital between January 2006 and December 2013 were retrospectively recruited. 2018 Oct 1;29(Suppl 4):iv260. doi: 10.1200/JOP.18.00761. Oncol Res Treat. In addition, the development of a new generation of platinum cytotoxic drugs to avoid hypersensitivity reactions is warranted. Anticancer. Classical and new chemotherapy drugs, monoclonal antibodies (MoAbs), and small molecules to treat cancer and chronic inflammatory diseases are aimed at improving quality of life and life expectancy of patients, but an increasing number of reactions including anaphylaxis precludes their use in targeted populations. Markman et al. LUGANO-MADRID, 09 September, 2017 -The preliminary results of a study to be presented at the ESMO 2017 Congress in Madrid (1) show that socio-psychological factors have become more significant for . Epub 2019 Mar 8. The yearly incidence of carboplatin-related hypersensitivity gradually increased from 0.88 in 2006 to 5.42% in 2013 (Table 1), in association with increased use of carboplatin. Unable to load your collection due to an error, Unable to load your delegates due to an error. The symptoms and signs of the 75 women with carboplatin-related hypersensitivity reactions are given in Table 4. Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. Login to your ESMO account to sign up for ESMO newsletters and receive information about ESMO's scientific and educational resources, events, member benefits. The tests were analyzed at an accredited lab according to protocol. Zhi. Shah et al. A sincere thanks to the almost 24,000 participants who attended this year's annual congress! Careers. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. Necessary cookies enable core functionality. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. 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. 105, 14721479. 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. The incidence of carboplatin hypersensitivity ranges from 8 to 11% (Libra et al., 2003; Confino-Cohen et al., 2005; Schwartz et al., 2007; Koshiba et al., 2009). The ESMO 2017 Congress, in partnership with the European Association for Cancer Research (EACR), created an environment where cancer researchers and clinicians came together to collaborate and exchange ideas. Severe reactions are less frequent and may be fatal without appropriate intervention. The essential content of the guidelinesin condensed slide format in PDF or PowerPoint. (2005) reported that all carboplatin-associated hypersensitivity reactions occur in patients with prior carboplatin exposure, and Tamiya et al. PMC Via Ginevra 4, 6900 Lugano - CH Copyright 2023 European Society for Medical Oncology All rights reserved worldwide. In the US, PH FDC SC can be administered by healthcare professionals in patients (pts) homes. Request PDF | On Jul 13, 2017, Susana Rosell Kernen published Management of infusion reactions to systemic anticancer therapy: ESMO Clinical Practice Guidelines | Find, read and cite all the . The annual ESMO Congress is the most prestigious and influential oncology platform in Europe and is the ideal place to learn about the latest science, network with colleagues and keep pace with today's rapid developments in cancer research. Federal government websites often end in .gov or .mil. 2022 Apr 26;14(4):e24515. desensitization; drug allergy; monoclonal antibodies in cancer; platins; taxanes. The annual incidence of carboplatin-related hypersensitivity reactions in 735 women with ovarian, fallopian tube, or primary peritoneal cancers. All of these reported symptoms and signs occurred within an hour of initiating carboplatin administration. Immunotherapy 6, 905912. Cancer. 57, 163167. Login to your ESMO account to sign up for ESMO newsletters and receive information about ESMO's scientific and educational resources, events, member benefits. 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. (2013). It would be worthwhile to design a perspective trial that could randomize patients with carboplatin hypersensitivity to receive an alternative regimen without carboplatin. Ann. 2017 Nov 8;8:1472. doi: 10.3389/fimmu.2017.01472. Drafting of manuscript: Y-HT and W-FC. Univariate analysis for potential risk factors of carboplatin-related hypersensitivity reactions were assessed by the chi-square or Kruskal-Wallis test for categorical variables. 103, 608613. Curr Allergy Asthma Rep. 2023 Jan;23(1):1-11. doi: 10.1007/s11882-022-01052-z. All the statistical tests were two-tailed, and statistical significant level was defined as p-value < 0.05. 2022 May 20;12:879391. doi: 10.3389/fonc.2022.879391. Would you like email updates of new search results? Disclaimer. Timetrend analyses showed that most events were reported during the first 68 cycles with concurrent chemotherapy, with a decrease in later cycles (except MetaPHER). doi: 10.1007/s10147-014-0731-1. eCollection 2022. ESMO Call to Action on COVID-19 Vaccinations and Patients with Cancer: Vaccinate. B., Phillips, P. C., Kang, T. I., et al. (2010). All funding for this site is provided directly by ESMO. Cumulative incidence of carboplatin-related hypersensitivity reactions according to the carboplatin administration cycle number (A) and carboplatin dose (B). As shown in Table 6, drug or food history (odd ratios [OR] 2.340, 95% confidence interval [CI] 1.374-3.984, P = 0.0018), malignant ascites (OR 1.895, 95% CI 1.1083.241, P = 0.0196), and cumulative carboplatin dose (4,0004,999 mg: OR 5.507, 95% CI 1.79616.887, P = 0.0028; 5,0009,999 mg: OR 7.244, 95% CI 2.74019.149, P < 0.0001; 10,000 mg: OR 8.461, 95% CI 3.00723.806, P < 0.0001; P for trend < 0.0001) significantly positively correlated with carboplatin hypersensitivity. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences. J. Gynecol. The .gov means its official. Have a look to the ESMO 2017 Programme online! Similarly, Kandel et al. In 74 of the 75 patients, the hypersensitivity reactions subsided within several minutes to several hours after onset, and the patients recovered without any sequelae. doi: 10.1016/j.ygyno.2006.10.047, Shah, A. C., Minturn, J. E., Li, Y., Belasco, J. Necessary cookies enable core functionality. Efficacy and Adverse Events of Carboplatin Desensitisation Therapy for Gynaecological Cancer: A Retrospective Study. The cumulative incidence of carboplatin-related hypersensitivity reactions dramatically increased with >8 cycles or dose >3,500 mg. ESMO 2017 was held in partnership with the European Association for Cancer Research (EACR) in Madrid . government site. Galateanu B, Pucau AI, Tircol SA, Tanase BC, Hudita A, Negrei C, Burcea-Dragomiroiu GT, Negreanu L, Vacaroiu IA, Ginghin O. Int J Mol Sci. The cumulative incidence of carboplatin-related hypersensitivity reactions increased with the number of carboplatin cycles (Figure 1A) and increasing dose (Figure 1B), especially at >8 cycles or a dose >3,500 mg. Here, we retrospectively evaluated carboplatin-related hypersensitivity reactions among patients with gynecological cancer (ovarian, fallopian tube, or primary peritoneal cancer) who received carboplatin-containing regimens at a single medical institute in Taiwan. 84, 378382. (2001). A cumulative search for anaphylaxis/hypersensitivity (Roche Standard Adverse Event Group Terms) across all pivotal trials cited in the current EMA P IV/PH FDC SC SmPCs. doi: 10.1016/j.ygyno.2016.09.027, Bruchim, I., Goldberg, A., Fishman, A., and Confino-Cohen, R. (2014). 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Chem Immunol Allergy. S M S, Naveen NR, Rao GK, Gopan G, Chopra H, Park MN, Alshahrani MM, Jose J, Emran TB, Kim B. Epub 2019 Jul 3. Study conception and design: Y-HT and W-FC. are hypersensitivity reactions that are systemic and can be life-threatening (Olsen et al., 2019; Rosell et al., 2017). ESMO Clinical Practice . Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly. The left side, Putative mechanism of protection against, Putative mechanism of protection against anaphylaxis during human desensitizations. These ESMO Clinical Practice Guidelines provide recommendations on the prevention/management of dermatological toxicities. Most IRs are mild with symptoms such as chills, fever, nausea, headache, skin rash, pruritus, etc. This study was approved by the Research Ethics Committee at the National Taiwan University Hospital (201706023RINC). Table 5 reports the incidences of carboplatin hypersensitivity and patient characteristics reported in various investigations, including the present study. Libra, M., Sorio, R., Buonadonna, A., Berretta, M., Stefanovski, P., Toffoli, G., et al. Gerber, C. van den Hurk, P. Fernndez-Peas, D. Santini, F. Jahn, K. Jordan on behalf of the ESMO Guidelines Committee These ESMO Clinical Practice Guidelines provide recommendations on the . Via Ginevra 4, 6900 Lugano - CH Copyright 2023 European Society for Medical Oncology All rights reserved worldwide. 107, 163165. doi: 10.1093/annonc/mdx225. Here's a summary of the new ESMO guidelines in 5 key areas: . For salvage chemotherapy in the case of recurrent disease, we administered chemotherapeutic regimens including carboplatin with paclitaxel, gemcitabine, or liposomal doxorubicin. Reducing the carboplatin infusion rate and employing desensitization protocols with anti-allergy medications are especially important for patients at high risk of carboplatin hypersensitivity to detect the hypersensitivity early and avoid severe hypersensitivity without compromising the efficacy of the antineoplastic regimen. doi: 10.1111/cas.12538, Kandel, M. J., Loehr, A., Harter, P., Traut, A., Gnauert, K., and du Bois, A. Virtually all chemotherapeutic agents have the potential to initiate infusion reactions, defined in this review as unexpected reactions that cannot be explained by the known toxicity profile of the drug. We invite ESMO members and event attendees to view the 2017 webcasts and presentations using the link below. doi: 10.1200/JCO.2009.25.7519, Schwartz, J. R., Bandera, C., Bradley, A., Brard, L., Legare, R., Granai, C. O., et al. (2009). The overall safety profile was similar between subgroups. A., Colombo, N., du Bois, A., Delaloye, J. F., Kristensen, G. B., et al. Allergic and non-allergic ovarian cancer patients treated with carboplatin or carboplatin desensitization presented a similar life expectancy with a non significant advantage for the allergy desensitized patients. All funding for this site is provided directly by ESMO. In conclusion, in our present population of women with gynecological malignancies treated with platinum-based chemotherapy, 1 in 10 developed carboplatin-related hypersensitivity reactions. 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. (2015). We also provide recommendations for the continuation of treatment in ovarian cancer patients. The .gov means its official. One-fifth of these patients never attempt carboplatin reinfusion, even after only mild hypersensitivity reactions (Gadducci et al., 2008). In the late 1980s, more than a dozen phase I studies analyzed the efficacy of paclitaxel as a single agent. 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. These risk factors can help identify patients at greater risk of developing hypersensitivity.
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