The S-REAL study: Spanish real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy.

OBJECTIVES: The S-REAL study aimed to assess the effectiveness of durvalumab as consolidation therapy after definitive chemoradiotherapy (CRT) in a real-world cohort of patients with locally advanced, unresectable stage III non-small cell lung cancer (LA-NSCLC) included in a Spanish early access program (EAP). METHODS: In this multicentre, observational, retrospective study we analysed data from patients treated in 39 Spanish hospitals, who started intravenous durvalumab (10 mg/kg every 2 weeks) between September 2017 and December 2018. The primary endpoint was progression-free survival (PFS). Secondary endpoints included patient characterization and adverse events of special interest (AESI). RESULTS: A total of 244 patients were followed up for a median of 21.9 months [range 1.2-34.7]. Median duration of durvalumab was 45.5 weeks (11.4 months) [0-145]. Median PFS was 16.7 months (95% CI 12.2-25). No remarkable differences in PFS were observed between patients with programmed cell death-ligand 1 (PD-L1) expression ≥ 1% or < 1% (16.7 versus 15.6 months, respectively). However, PFS was higher in patients who had received prior concurrent CRT (cCRT) versus sequential CRT (sCRT) (20.6 versus 9.4 months). AESIs leading to durvalumab discontinuation were registered in 11.1% of patients. CONCLUSIONS: These results are in line with prior published evidence and confirm the benefits of durvalumab in the treatment of LA-NSCLC patients in a real-world setting. We also observed a lower incidence of important treatment-associated toxicities, such as pneumonitis, compared with the pivotal phase III PACIFIC clinical study.

The role of sex and gender in the diagnosis and treatment of lung cancer: the 6th ICAPEM Annual Symposium.

The incidence and mortality of lung cancer in women are rising, with both increasing by 124% between 2003 and 2019. The main risk factor for lung cancer is tobacco use, but indoor radon gas exposure is one of the leading causes in nonsmokers. The most recent evidence demonstrates that multiple factors can make women more susceptible to harm from these risk factors or carcinogens. For this consensus statement, the Association for Lung Cancer Research in Women (ICAPEM) invited a group of lung cancer experts to perform a detailed gender-based analysis of lung cancer. Clinically, female patients have different lung cancer profiles, and most actionable driver alterations are more prevalent in women, particularly in never-smokers. Additionally, the impact of certain therapies seems to be different. In the future, it will be necessary to carry out specific studies to improve the understanding of the role of certain biomarkers and gender in the prognosis and evolution of lung cancer.

New update to the guidelines on testing predictive biomarkers in non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.

Non-small cell lung cancer (NSCLC) presents the greatest number of identified therapeutic targets, some of which have therapeutic utility. Currently, detecting EGFR, BRAF, KRAS and MET mutations, ALK, ROS1, NTRK and RET translocations, and PD-L1 expression in these patients is considered essential. The use of next-generation sequencing facilitates precise molecular diagnosis and allows the detection of other emerging mutations, such as the HER2 mutation and predictive biomarkers for immunotherapy responses. In this consensus, a group of experts in the diagnosis and treatment of NSCLC selected by the Spanish Society of Pathology and the Spanish Society of Medical Oncology have evaluated currently available information and propose a series of recommendations to optimize the detection and use of biomarkers in daily clinical practice.

A Delphi consensus panel about clinical management of early-stage EGFR-mutated non-small cell lung cancer (NSCLC) in Spain: a Delphi consensus panel study.

PURPOSE: This Delphi panel study assessed the level of consensus between medical oncologists on the clinical management of patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC). METHODS: A modified two-round Delphi approach was used. A scientific committee comprised of medical oncologists developed an online questionnaire. Delphi panel experts rated their level of agreement with each questionnaire statement on a 9-point Likert scale. The questionnaire included 36 statements from 3 domains (clinical management of early-stage NSCLC: 15 statements; role of adjuvant therapy in early-stage NSCLC: 9 statements; and role of adjuvant therapy in early-stage NSCLC with sensitizing EGFR mutation: 12 statements). RESULTS: In round 1, consensus was reached for 24/36 statements (66.7%). Nine statements that did not achieve consensus after the first round were evaluated in round 2, and none of them reached consensus. Overall, 84.4% of the panelists agreed that EGFR mutation testing should be done after surgery. Consensus was not achieved on whether the implementation of EGFR mutation testing in resected early-stage NSCLC could limit the use of adjuvant osimertinib. The panelists recognized the rationale for the use of osimertinib in the adjuvant scenario (88%) and 72% agreed that it may change the treatment paradigm in stage IB-IIIA EGFR-mutated NSCLC. Consensus was not reached on the inconvenience of prolonged duration of osimertinib. CONCLUSIONS: This Delphi study provides valuable insights into relevant questions in the management of early-stage EGFR-mutated NSCLC. However, specific issues remain unresolved. The expert consensus emphasizes the role of adjuvant treatment with osimertinib in this scenario.

Equity, barriers and cancer disparities: study of the Spanish Society of Medical Oncology on the access to oncologic drugs in the Spanish Regions.

PURPOSE: The Spanish Society of Medical Oncology (SEOM) has conducted a study on the access to oncologic drugs across the 17 Spanish Regions with the aim of identifying potential heterogeneities and making proposals for eliminating the barriers identified at the different levels. METHODS: An Expert Panel made up of medical oncologists designed a survey on certain indications approved for 11 drugs in the approach of breast cancer, melanoma, lung cancer, prostate cancer and support treatment. This survey was sent to 144 National Health System (NHS) hospitals. RESULTS: 77 hospitals answered the survey. The information modules analysed were: scope of the Commission that establishes binding decisions related to drug access; conditions, stages and periods of drug application, approval and administration processes; barriers to accessing drugs. CONCLUSIONS: The study shows variability in drug access. The SEOM makes proposals addressed to reducing the differences identified and homogenizing drug access conditions.

Pilot study on workload estimate in breast cancer, lung cancer and colorectal cancer in a Medical Oncology Service at Valme hospital.

New advances in the diagnosis and treatment of cancer and the increased incidence and prevalence of this disease have led to an increase in the number and duration of visits in Medical Oncology in the last few years. Based on the functions of a medical oncologist and the time recommended for each work activity established by the Spanish Society of Medical Oncology (SEOM), we carried out a pilot study on the three most frequent neoplasias in our country [breast cancer (BC), lung cancer (LC) and colorectal cancer (CRC)], in order to determine the real time each patient requires from a physician and thus establish a recommendation on the number of medical oncologists necessary. Using the actual itinerary of the first 20 patients of 2009 in each of the three neoplasias seen at the Medical Oncology Service of the Virgen de Valme University Hospital, we measured the number of visits, the antineoplastic treatments received, the number of hospital admissions and average length of stay. During the years following the study, these data were estimated based on the natural history of each neoplasia. During the first year, the average time spent by the medical oncologist was 235, 390 and 265 min on each outpatient with BC, LC and CRC, respectively. In hospitalisation, the average oncologist/patient minutes were 40, 360 and 118 for BC, LC and CRC, respectively. Finally, the time spent on each visit or day of hospitalisation was that recommended by the SEOM, achieving an ultimate ratio of 1 oncologist for every 83 first visits.

Functions and workload of medical oncologists in Spain.

The functions and workload of medical oncologists are becoming increasingly relevant as cancer is a priority health issue in our country. Taking into account the specific characteristics and complexity of caring for cancer patients, the time of physicians attached to Medical Oncology could be distributed as follows: 70% for consultation (including participation in tumour committees and multidisciplinary units), 15% for research and 15% for training, teaching and clinical sessions. The time distribution for Heads of Services or Heads of Units is different, since it must also include their clinical management tasks, team coordination, and relations with other services and institutions. The average time, calculated in minutes, spent on each activity per patient is as follows: first visit and "second visit or results visit" 60-90 min; successive visits at the day hospital 15 min; successive visits of patients for follow-up or checkups 20 min; visits with family members 15-20 min; telephone or e-mail consultations 5-10 min; hospitalisation 20 min; and interconsultation 30-60 min. Also, participation in multidisciplinary committees takes up 60-120 min of an oncologist's time each week. When new technologies such as electronic medical records, e-mail and other software are used, these times increase with a correction factor that is still to be defined and which could vary according to the centre. Finally, the ratio recommended by SEOM is one medical oncologist for every 83 new patients a year.

Guidelines for biomarker testing in advanced non-small-cell lung cancer. A national consensus of the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathology (SEAP).

Patients with advanced non-small-cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) mutations can now have specific treatment based on the result of biomarker analysis and patients with rearrangements of the anaplastic lymphoma kinase (ALK) gene will probably soon be able to. This will give them better quality of life and progression-free survival than conventional chemotherapy. This consensus statement was conceived as a joint initiative of the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathology (SEAP), and makes diagnostic and treatment recommendations for advanced NSCLC patients based on the scientific evidence on biomarker use. It therefore provides an opportunity to improve healthcare efficiency and resource use, which will undoubtedly benefit these patients. Although this field is in continuous evolution, at present, with the available data, this panel of experts recommends that all patients with advanced NSCLC of non-squamous cell subtype, or non-smokers regardless of the histological subtype, should be tested for EGFR gene mutations within a maximum of 7 days from the pathological diagnosis. Involved laboratories must participate in external quality control programmes. In contrast, ALK gene rearrangements should only be tested in the context of a clinical trial, although the promising data obtained will certainly justify in the near future its routine testing in patients with no EGFR mutations. Lastly, routine testing for other molecular abnormalities is not considered necessary in the current clinical practice.

Consensus of the Spanish Society of Medical Oncology (SEOM) and Spanish Society of Pathology (SEAP) for HER2 testing in gastric carcinoma.

The identification of HER2 alterations in advanced gastric carcinomas is of critical importance in daily clinical practice as such neoplasms require specific treatment with trastuzumab. For these reasons, pathologists and oncologists with expertise in gastric carcinomas and HER2 testing from both organisations (SEAP and SEOM) have endeavoured to discuss and agree on national guidelines for HER2 testing in gastric carcinomas. These guidelines are based on the experience of those who participated in the discussions and also on experience published internationally. These agreed guidelines give the minimum requirements that a pathological anatomy laboratory must fulfil in order to guarantee adequate HER2 testing in daily practice. Any laboratories which do not meet the minimum standards set out in the guidelines must make every effort to achieve compliance.

Management of lung cancer-associated anaemia: the Spanish Lung Cancer Anaemia Survey (SLCAS).

BACKGROUND: The purpose of the Spanish Lung Cancer Anaemia Survey (SLCAS) was to thoroughly investigate lung cancer-associated anaemia management, and describe the profile of lung cancer patients in relation to anaemia incidence and tumour type in Spain. PATIENTS AND METHODS: This survey collected data from 1089 randomly recruited patients gathered by 50 Spanish physicians at 38 sites. In addition, a qualitative assay was performed through 16 one-to-one and 2 one-to-two interviews, and a discussion group of 4 cancer specialists participating in the survey. RESULTS: Lung cancer patients undergoing chemotherapy treatment had haemoglobin (Hb) levels <12.0 g/dl in 58.0% of the cases, in contrast to 39.0% of patients receiving no chemotherapy. Anaemia was treated in 53.0% of patients with Hb<12 g/dl (45.0% epoetin, 3.9% transfusion, 4.1% iron). Mean Hb level trigger was 9.7 g/dl for administration of epoetin and 8.2 g/dl for blood transfusion. CONCLUSIONS: SLCAS reveals a significant change in the management of anaemia and clinical practice pattern in the use of erythropoiesis-stimulating agents (45.0% vs. 18.0%) and much less use of blood transfusions (3.9% vs. 15.0%) since the European Cancer Anaemia Survey performed five years ago.