PMID- 30578473 OWN - NLM STAT- MEDLINE DCOM- 20190603 LR - 20200225 IS - 2210-7711 (Electronic) VI - 41 IP - 1 DP - 2019 Feb TI - A multicentre observational study of the effectiveness, safety and economic impact of nivolumab on non-small-cell lung cancer in real clinical practice. PG - 272-279 LID - 10.1007/s11096-018-0772-z [doi] AB - Background Immunotherapy has become a standard treatment for lung cancer; however, the high cost makes it necessary to assess health outcomes. Objective The aim of this study was to evaluate the effectiveness, safety and economic cost of nivolumab in real-world clinical practice. Setting Fifteen regional and academic hospitals from Spain participated in this study. Methods This study was a retrospective, multicentre and observational study involving patients who experienced progression after first-line therapy for non-small-cell lung cancer and were treated with nivolumab between January 2016 and July 2017. Effectiveness and safety were evaluated by the oncologist, and the data from the electronic clinical records of the patients were collected by the research team. Economic cost was calculated using the cost of acquiring nivolumab for the public health system. Main outcome measures Effectiveness variables were overall survival (OS) and progression-free survival (PFS). The safety variable was the incidence of adverse events (AEs), and the cost per life-year gained (LYG) was the economic variable. Results A total of 221 patients were enrolled (83.7% men). The mean age was 64.5 years, and 84.6% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1. Squamous tumours accounted for 59.7% of the total, and 78.7% of the patients presented a time since platinum therapy (TPT) > 6 months. The mean nivolumab dose was 216 mg (SD 211), and the treatment duration was 7.0 months (95% CI 5.8-8.1). The median PFS was 5.3 months (95% CI 3.2-7.3), and OS was 9.7 months (95% CI 7.6-11.8). The median PFS and OS values were statistically significantly superior for patients with an ECOG score of 0-1 and for patients with a TPT > 6 months. The median OS was also statistically significantly superior for patients with non-squamous histology. Regarding safety, 71% of the patients presented AEs of any grade, and in 18.6%, the nivolumab treatment had to be delayed or discontinued. The cost of nivolumab per patient was euro19,910.00 (SD 19,369), and the cost per LYG was euro110,026.00 (euro77,557.00-euro231,171.00). Conclusions This study confirms that the efficacy and safety of nivolumab treatment in a real population are comparable to the results obtained in clinical trials. A greater clinical benefit of nivolumab therapy was observed in patients with an ECOG score of 0-1, a TPT > 6 months or non-squamous histology. Despite the benefit observed, the cost per LYG is above the threshold of efficiency established by public health institutes. FAU - Merino Almazan, Macarena AU - Merino Almazan M AD - Hospital Pharmacy Department, Complejo Hospitalario de Jaen, Jaen, Spain. FAU - Duarte Perez, Juan Manuel AU - Duarte Perez JM AD - Pharmacology Department of Faculty of Pharmacy, University of Granada, Granada, Spain. FAU - Marin Pozo, Juan Francisco AU - Marin Pozo JF AUID- ORCID: 0000-0002-6090-8905 AD - Hospital Pharmacy Department, Servicio Farmacia Hospitalaria, Complejo Hospitalario de Jaen, Avda Ejercito Espanol, 10, 23007, Jaen, Spain. jfmarinpozo@yahoo.es. FAU - Ortega Granados, Ana Laura AU - Ortega Granados AL AD - Medical Oncology Department, Complejo Hospitalario de Jaen, Jaen, Spain. FAU - Muros De Fuentes, Begona AU - Muros De Fuentes B AD - Hospital Pharmacy Department, Hospital Clinico Virgen de la Victoria, Malaga, Spain. FAU - Quesada Sanz, Paz AU - Quesada Sanz P AD - Hospital Pharmacy Department, Hospital Punta de Europa, Algeciras, Spain. FAU - Gago Sanchez, Ana Isabel AU - Gago Sanchez AI AD - Hospital Pharmacy Department, Hospital Universitario Reina Sofia, Cordoba, Spain. FAU - Rodriguez Gomez, Patricia AU - Rodriguez Gomez P AD - Hospital Pharmacy Department, Hospital Universitario San Cecilio, Granada, Spain. FAU - Jurado Garcia, Jose Miguel AU - Jurado Garcia JM AD - Medical Oncology Department, Hospital Universitario San Cecilio, Granada, Spain. FAU - Artime Rodriguez-Hermida, Fatima AU - Artime Rodriguez-Hermida F AD - Hospital Pharmacy Department, Hospital Virgen de las Nieves, Granada, Spain. FAU - Martinez Bautista, Maria Jose AU - Martinez Bautista MJ AD - Hospital Pharmacy Department, Hospital Universitario Puerta del Mar, Cadiz, Spain. FAU - Rueda Ramos, Antonio AU - Rueda Ramos A AD - Medical Oncology Department, Hospital Universitario Puerta del Mar, Cadiz, Spain. FAU - Mora Rodriguez, Beatriz AU - Mora Rodriguez B AD - Hospital Pharmacy Department, Hospital Regional Universitario Malaga, Malaga, Spain. FAU - Martinez Diaz, Maria Carmen AU - Martinez Diaz MC AD - Hospital Pharmacy Department, Hospital Puerto Real, Puerto Real, Spain. FAU - Nieto Guindo, Pablo AU - Nieto Guindo P AD - Hospital Pharmacy Department, Hospital Torrecardenas, Almeria, Spain. FAU - Garrido Siles, Margarita AU - Garrido Siles M AD - Hospital Pharmacy Department, Hospital Costa del Sol, Marbella, Spain. FAU - Villatoro Roldan, Rosa AU - Villatoro Roldan R AD - Medical Oncology Department, Hospital Costa del Sol, Marbella, Spain. FAU - Roldan Morales, Jose Carlos AU - Roldan Morales JC AD - Hospital Pharmacy Department, Hospital SAS de La Linea, La Linea, Spain. FAU - Artacho Criado, Silvia Maria AU - Artacho Criado SM AD - Hospital Pharmacy Department, Hospital Valme, Seville, Spain. FAU - Banos Roldan, Ursula AU - Banos Roldan U AD - Hospital Pharmacy Department, Hospital Virgen Macarena, Seville, Spain. FAU - Inoriza Rueda, Angel AU - Inoriza Rueda A AD - Medical Oncology Department, Hospital Juan Ramon Jimenez, Huelva, Spain. FAU - Garrido Martinez, Maria Teresa AU - Garrido Martinez MT AD - Hospital Pharmacy Department, Hospital Juan Ramon Jimenez, Huelva, Spain. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20181222 PL - Netherlands TA - Int J Clin Pharm JT - International journal of clinical pharmacy JID - 101554912 RN - 0 (Antineoplastic Agents, Immunological) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Aged MH - Antineoplastic Agents, Immunological/economics/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/diagnosis/*drug therapy/economics MH - *Cost-Benefit Analysis/trends MH - Female MH - Humans MH - Lung Neoplasms/diagnosis/*drug therapy/economics MH - Male MH - Middle Aged MH - Nivolumab/*therapeutic use MH - Retrospective Studies MH - Treatment Outcome OTO - NOTNLM OT - Immunotherapy OT - Nivolumab OT - Non-small-cell lung cancer OT - Real-world data OT - Spain EDAT- 2018/12/24 06:00 MHDA- 2019/06/04 06:00 CRDT- 2018/12/23 06:00 PHST- 2018/05/29 00:00 [received] PHST- 2018/12/14 00:00 [accepted] PHST- 2018/12/24 06:00 [pubmed] PHST- 2019/06/04 06:00 [medline] PHST- 2018/12/23 06:00 [entrez] AID - 10.1007/s11096-018-0772-z [pii] AID - 10.1007/s11096-018-0772-z [doi] PST - ppublish SO - Int J Clin Pharm. 2019 Feb;41(1):272-279. doi: 10.1007/s11096-018-0772-z. Epub 2018 Dec 22.