Real-world data from the Portuguese Nivolumab Expanded Access Program (EAP) in previously treated Non Small Cell Lung Cancer (NSCLC).

OBJECTIVE: The main aim of the study was to evaluate the efficacy and safety profile of Nivolumab, an immune-checkpoint-inhibitor antibody, in advanced, previously treated, Non-Small Cell Lung Cancer (NSCLC) patients, in a real world setting. METHODS: We performed a retrospective, multicentre data analysis of patients who were included in the Portuguese Nivolumab Expanded Access Program (EAP). Eligibility criteria included histologically or citologically confirmed NSCLC, stage IIIB and IV, evaluable disease, sufficient organ function and at least one prior line of chemotherapy. The endpoints included Overall Response Rate (ORR), Disease Control Rate (DCR), Progression Free Survival (PFS) and Overall Survival (OS). Safety analysis was performed with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, and immune-related Adverse Events (irAEs) were treated according to protocol treatment guidelines. Tumour response was assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Data was analysed using SPSS, version 21.0 (IBM Statistics). RESULTS: From June 2015 to December 2016, a total of 229 patients with advanced NSCLC were enrolled at 30 Portuguese centres. Clinical data were collected up to the end of July 2018. The baseline median age was 64 years (range 37-83) and the majority of patients were males (70.3%) and former/current smokers (69.4%). Patients with non-squamous histology predominated (88.1%), and 67.6% of the patients had received 2 or more prior lines of chemotherapy. Out of 229 patients, data was available for 219 patients (3 patients did not start treatment, while data was unavailable in 7 patients); of the 219 patients, 15.5% were not evaluated for radiological tumour assessment, 1.4% had complete response (CR), 21% partial response (PR), 31% stable disease (SD) and 31.1% progressive disease (PD). Thus, the ORR was 22.4% and DCR was 53.4% in this population. At the time of survival analysis the median PFS was 4.91 months (95% CI, 3.89-6.11) and median OS was 13.21 months (95% CI, 9.89-16.53). The safety profile was in line with clinical trial data. CONCLUSIONS: Efficacy and safety results observed in this retrospective analysis were consistent with observations reported in clinical trials and from other centres.

Lung cancer in Northern Portugal: A hospital-based study.

INTRODUCTION: Lung cancer is the deadliest cancer worldwide. In Portugal, the disease remains the main cause of cancer death in males. AIM: This study aims to evaluate the demographic and clinical characteristics of lung cancer patients diagnosed and treated in northern Portugal hospitals from 2000 to 2010. PATIENTS AND METHODS: Twelve hospitals in the north of Portugal contributed to this study. The demographic and clinic characteristics of the patients registered in each hospital from 2000 to 2010 and the patterns of their occurrence were analyzed. RESULTS: During an 11-year period (2000-2010), 9767 lung cancer patients were registered in the participating hospitals. Comparing the number of the patients registered in the year 2000 to those registered during 2010, there was a significant increase in lung cancer cases. Females represent only 20% of the total registered lung cancer cases; however, during the study period, the number of female patients increased by 30%. A significant number of the patients, 3117 (48.6%), had poor performance status at presentation. The adenocarcinoma histology became more preponderant over the study period. Most of the patients were diagnosed as stages IIIB or IV: 7206 of 9267 (77.8%). Chemotherapy was the treatment of choice for 3529 (40.4%) patients, whereas surgical treatment was achieved in 1301 (14.9%) cases. CONCLUSION: A significant number of lung cancer patients have been diagnosed and treated in hospitals in northern Portugal, and the incidence of the disease among females has been increasing. The overwhelming majority of the tumors were diagnosed in advanced stage; nevertheless, surgical treatment was possible in 14.9% of the patients.

[Epidemiological study of lung cancer in Portugal (2000/2002)]. / Estudo epidemiológico do cancro do pulmão em Portugal nos anos de 2000/2002.

Lung cancer is the most common form of cancer death in the world. Five-year survival is about 15%, without any change to this picture envisaged. It is the 3rd most prevalent type of cancer in Portugal and the primary cause of cancer death. 85% of lung cancer cases are attributable to smoking. One study performed in Portugal for 3 years (2000/2002) by the Lung Oncology Work Committee of the Portuguese Society of Pulmonology in 22 Hospitals showed that of a total of 4396 patients with lung cancer, 81.8% were male and 18.2% were female, with a mean age of 64.49 +/- 11.28 years. About 70% of patients were smokers or former smokers, with 50.3% of patients presenting with performance status (Zubrod) 1. Histologically, 37.5% were adenocarcinoma, followed by squamous carcinoma in 30.5% of cases, and small cell lung cancer in 12.5%; neuroendocrine carcinoma presented in 1.4% of cases; non small cell lung cancer in 10.5%; mixed carcinoma in 0.7%; large cell carcinoma in 2.3%; and others/not specified in 4.6% of cases. Staging (known in 4097 patients), showed 113 patients in stage IA (2.8%)and 250 patients in stage IB (6.1%); only 0.8% in stage IIA and 4.5% in stage IIB; 9.1% in stage IIIA and 29.9% in stage IIIB; 46.9% were already in stage IV by the time of diagnosis. The first therapeutic option was known in 3855 patients. Surgery was performed in 8.2% and 21.8% of cases were treated with combined therapies (surgery and chemotherapy or radiotherapy, or combination of chemotherapy and radiotherapy); chemotherapy alone was first choice in 43.7% of patients and in 20.3% only best support therapy was chosen.