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WITHDRAWAL OF BIOLOGICAL TREATMENT AND SMALL MOLECULES IN IBD PATIENTS DIAGNOSED WITH CANCER: REAL WORLD EVIDENCE FROM ENEIDA REGISTRY OF GETECCU

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Introduction

While biologic agents and small molecules have revolutionized inflammatory bowel disease (IBD) treatment, concerns persist regarding their usage in patients with a history of malignancy due to potential impact on cancer development or recurrence. There remains a notable gap in understanding their utilization in this setting, especially concerning newer agents like ustekinumab, vedolizumab, and small molecules.

Aims & Methods

We aimed to study clinicians' views on using biologic therapy in IBD patients with extracolonic cancer, focusing on whether to continue or stop treatment and analysing factors influencing their decisions. We also aimed to describe clinical characteristics of this group of patients.
IBD patients under biologics or small molecules at the time of cancer diagnosis in ENEIDA registry, a prospectively maintained database from GETECCU, were included. Variables included demographic and clinical data, biologic drugs received, and start/discontinuation dates. Additional information on oncologic history and IBD treatment changes after cancer diagnosis were collected directly from investigators. Main variable was the discontinuation of biologics/small molecules due to the diagnosis of cancer. Logistic regression analysis was used to identify factors associated with biologics/small molecules discontinuation due to cancer diagnosis.

Results

1,386 patients with extra-colonic malignancies receiving biologics or small molecules were identified from ENEIDA registry. From this cohort, we identified 467 patients that were under biological treatment at the time of cancer diagnosis. Demographic and clinical characteristics revealed a median age at IBD diagnosis of 38 years, with 61% males. Crohn’s disease accounted for 71% of cases. The most common cancer types were non-melanoma skin cancer (26%) and haematological neoplasms (14%), followed by nefrourotelial cancers, breast cancer, prostate cancer and melanoma. Vedolizumab, ustekinumab and small molecules represented 15% of the patient cohort, while anti-TNF were the most prevalent biologics at cancer diagnosis. Before cancer diagnosis, 40% patients had received previous biological drugs, while 60% were receiving their first biologic therapy.
Clinical decisions post-cancer diagnosis included discontinuing biological treatment (56%) and no changes in treatment (44%) as described in table 1. Multivariate analysis showed significant differences in discontinuing biologic therapy depending on neoplasm origin and type of biologic treatment. While patients with non-melanoma skin cancer where more likely to continue with biologic therapy after having an extracolonic cancer diagnosis, other types of cancer led clinicians to discontinue treatment more frequently (Table 2). We also observed that the probability of maintaining biological treatment was significantly higher in patients receiving ustekinumab and vedolizumab compared with anti-TNF agents. No significant differences were found based on the type of IBD, number of biologic treatments received before cancer diagnosis, sex and age at cancer diagnosis.

Table 1 Biological treatment when diagnosed with cancer Anti-TNF agents Ustekinumab Vedolizumab Type of extracolonic cancer Non melanoma skin cancer Hematologic neoplasms Nefro-urologic neoplasms Breast cancer Prostate cancer Melanoma Other cancers	No changes in biological treatment 158 (39.8%) 20 (66.7%) 24 (68.6%) 105 (86.8%) 8 (12.3%) 20 (43.5%) 7 (15.9%) 9 (28.1%) 4 (23.5%) 51 (35.9%)	Discontinuation of biological treatment 239 (60.2%) 10 (33.3%) 11 (31.4%) 16 (13.2%) 57 (87.7%) 26 (56.5%) 37 (84.1%) 23 (71.9%) 13 (76.5%) 91 (56.3%)
Table 2 Probability of discontinuation biological treatment Depending on biological treatment Ustekinumab vs Anti-TNF Vedolizumab vs Anti-TNF Depending on cancer origin Hematologic neoplasms vs. non-melanoma skin cancer Breast cancer vs. non-melanoma skin cancer Melanoma vs. non-melanoma skin cancer Prostate cancer vs. non-melanoma skin cancer Other cancers vs. non-melanoma skin cancer Nefro-urologic neoplasms vs. non-melanoma skin cancer	OR (95% CI) 0.24 (0.10-0.60) 0.18 (0.08-0.41) 59.9 (23.2-154.9) 33.1 (12.4-88.2) 22.2 (6.1-80.8) 18.7 (7.1-48.9) 13.3 (7.0-25.3) 11.1 (4.9-25.2)

Conclusion

In real life, over 50% of IBD patients discontinue biologics/small molecules when extracolonic cancer is diagnosed. The likelihood of treatment discontinuation is higher with anti-TNF agents than with more recently approved drugs (such as vedolizumab or ustekinumab). The type of cancer has great impact on the decision of treatment discontinuation. Management of IBD in patients diagnosed with cancer remains a challenge.

WITHDRAWAL OF BIOLOGICAL TREATMENT AND SMALL MOLECULES IN IBD PATIENTS DIAGNOSED WITH CANCER: REAL WORLD EVIDENCE FROM ENEIDA REGISTRY OF GETECCU

Mario Calvo 1, Ingrid Ordás 2, Jordina Llaó 3, Isabel Pérez-Martínez 4, Francisco Mesonero Gismero 5, Maria Luisa De Castro Parga 6, Natalia Marcos Carrasco 7, Gloria Esther Rodríguez González 8, Carla Jerusalén Gargallo-Puyuelo 9, Luis Miguel García 10, Cristina Roig Ramos 11, María Dolores Martín-Arranz 12, CORAL RIVAS 13, Jordi Guardiola 14, Beatriz Sicilia Aladrén 15, Lorena Bernal 16, Fernando Bermejo 17, Sheila González Padilla 18, Lucía Márquez-Mosquera 19, Ainara Elorza 20, Mariana Fe García Sepulcre 21, Sandra Izquierdo 22, Alejandro Mínguez Sabater 23, Marta Quñones 24, Manuel Barreiro de Acosta 25, Carlos Taxonera Samso 26, Ángel Ponferrada-Díaz 27, Eva Iglesias-Flores 28, Marta Piqueras Cano 29, Eva Sesé 30, David Busquets Casals 31, Francesc Bas-Cutrina 32, Elena Betoré 33, Ana Zaida Gómez Moreno 34, Laura Ramos Lopez 35, Pablo Pérez-Galindo 36, Alicia López-García 37, Ana Royo 38, Jesús Castro-Poceiro 39, Alfredo J. Lucendo 40, Pilar Robledo Andrés 41, Luis Bujanda Fernández de Piérola 42, Jose Maria Huguet 43, Margarita Menacho 44, Luis Hernández Villalba 45, Manuel Van Domselar 46, Mª Teresa Diz-Lois Palomares 47, Eugeni Domenech Morral 48, Javier P. Gisbert 1, María Chaparro 1

1 Hospital Universitario de la Princesa, Madrid, Spain|||Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Madrid, Spain|||Universidad Autónoma de Madrid, Madrid, Spain|||Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Diges

2 Hospital Clinic of Barcelona, Barcelona, Spain|||IDIBAPS, Barcelona, Spain|||Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

3 Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona., Badalona, Spain

4 Hospital Universitario Central de Asturias, Oviedo, Spain

5 Hospital Ramon y Cajal, Madrid, Spain

6 Hospital Alvaro cunqueiro. CHUVI., Vigo, Spain|||Fundación biomédica Galicia Sur, Galicia, Spain

7 Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain

8 H. Universitario Ntra. Señora Candelaria, Tenerife, Spain

9 Hospital Lozano Blesa, Zaragoza, Spain

10 Hospital Universitario de la Princesa, Madrid, Spain

11 Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

12 Hospital La Paz, Madrid, Spain

13 Hospital Universitario Marqués de Valdecilla e IDIVAL, Santander, Spain

14 Hospital Universitario de Bellvitge, L'Hospitalert de LLobregat (Barcelona), Spain

15 Hospital de Burgos, Burgos, Spain

16 Hospital General Universitario Dr Balmis, Alicante, Spain

17 H Fuenlabrada, Fuenlabrada, Spain

18 Hospital Clínico Universitario, Valencia, Spain

19 Servei de Digestiu, Hospital del Mar, Barcelona.IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain

20 Hospital Universitario Galdakao-Usansolo, Galdakao, Spain|||Instituto De Investigación Sanitario Biobizkaia, Vicaya, Spain

21 Hospital General Universitario, Elche, Spain

22 Servicio de Aparato Digestivo. Hospital Clínico Universitario de Valladolid., Valladolid, Spain

23 Hospital Universitario Politécnico la Fe, Valencia, Spain

24 Hospital Universitario Fundación Alcorcón, Madrid, Spain

25 University Hospital of Santiago, Santiago de Compostela, Spain

26 Hospital Clinico, Madrid, Spain

27 Hospital Infanta Leonor, Madrid, Spain

28 Hospital Universitario Reina Sofía, Córdoba, Spain. kInstituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain

29 Hospital Consorci Terrassa, Terrassa, Spain

30 Hospital Universitario Arnau de Vilanova, Lleida, Spain

31 Hospital de Girona Dr. J. Trueta, ICO GERONA, Girona, Spain

32 Universitat de Barcelona, Barcelona, Spain|||Hospital Universitari de Bellvitge - IDIBELL, L'Hospitalet de Llobregat, Barcelona, Catalonia., Spain

33 Hospital Universitario San Jorge de Huesca, Huesca, Spain

34 Hospital General Universitario de Ciudad Real., Ciudad Real, Spain

35 Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain

36 Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain

37 Hospital Universitario Infanta Sofía, Madrid, Spain

38 Hospital Universitario Miguel Servet, Zaragoza, Spain

39 Hospital Sant Joan Despí Moisès Broggi, Barcelona, Spain

40 Hospital General de Tomelloso, Madrid, Spain

41 Hospital Universitario de Cáceres, Cáceres, Spain

42 Biogipuzkoa Health Research Institute, San Sebastián, Spain|||Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain|||Universidad del País Vasco (UPV/EHU), Bilbao, Spain

43 Hospital General Universitario de Valencia, Valencia, Spain

44 Hospital Joan XXIII de Tarragona, Tarragona, Spain

45 Hospital Santos Reyes, Aranda de Duero, Spain

46 Hospital Universitario de Torrejón, Madrid, Spain|||Universidad Francisco de Vitoria, Madrid, Spain

47 Hospital Universitario A Coruña, A Coruña, Spain

48 Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona. CIBEREHD. Universitat Autònoma de Barcelona, Barcelona, Spain|||Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain