Difficulties on the access to innovative targeted therapies for lung cancer in Spain.

PURPOSE: Spanish Lung Cancer Group (SLCG) conducted a review to analyze the barriers to access to innovative targeted therapies for non-small cell lung cancer (NSCLC) in clinical practice in Spain. METHODS: Review all relevant content published on websites of European Commission, European Medicines Agency, and Spanish Agency of Medicines and Medical Products regarding the authorization and access to oncology treatments. RESULTS: More than 20 targeted therapies are available to treat different molecular alterations in patients with NSCLC. European Commission has approved treatments for genomic alterations involving the following genes: ALK, RET, ROS1, EGFR, BRAF, NTRK, KRAS, MET. However, the availability of these therapies in Spain is not complete, as innovative treatments are not reimbursed or funded late, with only five of these alterations currently covered by National Health System. CONCLUSION: SLCG considers imperative to improve the access in Spain to innovative treatments for NSCLC to reduce inequity across European countries.

The Use of Fissios App© as a Complement to a Face-to-Face Respiratory Physiotherapy Program versus an Attendance-Only Face-to-Face Physiotherapy Program in Patients Scheduled for Thoracic Surgical Procedures Reduces the Risk of Developing Postoperative Pulmonary Complications-A Quasi-Experimental Study.

Postoperative pulmonary complications (PPCs) increase the hospital length of stay (LOS) and the cost of healthcare associated with surgical procedures. Strategies to reduce PPCs begin before surgery and continue in the postoperative period. Fissios App© is a smartphone application that contains perioperative medical advice and a structured respiratory physiotherapy program. The objective was to implement the use of this app in a group of patients scheduled for a thoracic surgical procedure and determine its efficacy in reducing PPCs. This was a quasi-experimental study in which all patients attended a face-to-face respiratory physiotherapy program, and the intervention group used Fissios App© as a complement. We prospectively recorded the postoperative evolution of both groups, analyzed the categorical differences and quantitative variables, and created a binary logistic regression model. We recruited 393 patients (131 intervention and 262 control). The intervention group had a lower incidence of PPCs (12.2% versus 24% in the control group, p = 0.006), a shorter LOS (a median of 3 days (IQR = 2-5) versus 4 days (IQR = 3-6, p = 0.001) in the control group), and a reduction in the risk of developing PPCs by 63.5% (OR: 0.365, 95% CI: 0.17-0.78). The use of Fissios App© improved the clinical outcomes after surgery and reduced the probability of developing PPCs.

Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer.

BACKGROUND: Approximately 20% of patients with non-small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients. METHODS: In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery. Patients in the experimental group who had R0 resections received adjuvant treatment with nivolumab for 6 months. The primary end point was a pathological complete response (0% viable tumor in resected lung and lymph nodes). Secondary end points included progression-free survival and overall survival at 24 months and safety. RESULTS: A total of 86 patients underwent randomization; 57 were assigned to the experimental group and 29 were assigned to the control group. A pathological complete response occurred in 37% of the patients in the experimental group and in 7% in the control group (relative risk, 5.34; 95% confidence interval [CI], 1.34 to 21.23; P = 0.02). Surgery was performed in 93% of the patients in the experimental group and in 69% in the control group (relative risk, 1.35; 95% CI, 1.05 to 1.74). Kaplan-Meier estimates of progression-free survival at 24 months were 67.2% in the experimental group and 40.9% in the control group (hazard ratio for disease progression, disease recurrence, or death, 0.47; 95% CI, 0.25 to 0.88). Kaplan-Meier estimates of overall survival at 24 months were 85.0% in the experimental group and 63.6% in the control group (hazard ratio for death, 0.43; 95% CI, 0.19 to 0.98). Grade 3 or 4 adverse events occurred in 11 patients in the experimental group (19%; some patients had events of both grades) and 3 patients in the control group (10%). CONCLUSIONS: In patients with resectable stage IIIA or IIIB NSCLC, perioperative treatment with nivolumab plus chemotherapy resulted in a higher percentage of patients with a pathological complete response and longer survival than chemotherapy alone. (Funded by Bristol Myers Squibb and others; NADIM II ClinicalTrials.gov number, NCT03838159; EudraCT number, 2018-004515-45.).

Implementation of a perioperative care App in elective thoracic surgery.

INTRODUCTION: The design and implementation inconsistency of perioperative care programs limits their universalization, and it is where e-Health can standardize these processes. The objective of the study is to create a Smartphone App with a perioperative care program, implement it in a group of patients scheduled for a thoracic surgical procedure, and evaluates its use. METHODS: A prospective and descriptive study. We created a Smartphone app (Fissios App) which contains 40 perioperative recommendations and 10 chest physical exercises. Patients were recommended to use it before and after surgery; to measure its use, we created and applied a questionnaire. A descriptive analysis of patient variables and questionnaire responses was performed and their association evaluated. RESULTS: One hundred four patients were included, 60.3% were men with a median age of 62 years (51-71), and 26.72% had completed high school. The 89.3% of patients highlighted the ease of downloading and setting up the app. More than 90% of patients positively assessed clarity in explaining chest physical exercises and perioperative recommendations. One hundred four (79.4%) patients highlighted the contribution of the use of the app during the preoperative period to face the postoperative period. CONCLUSIONS: We created a Smartphone app (Fissios App) with a perioperative care program and it was successfully implemented regardless of the age or educational level of patients. The tool clearly explains the information contained and the patients reported that its use before surgery helped them to face the postoperative period, with an appropriate level of physical demand and time of use.

Preoperative detection and evaluation of the need for psychological intervention in cancer and non-cancer patients referred to thoracic surgery.

OBJECTIVES: (a) to evaluate and compare the psychological treatment needs of patients with cancer and non-cancer, who are going to undergo scheduled thoracic surgery, and (b) evaluate and compare the diagnostic accuracy of the screening tests of psychological treatment needs for cancer and non-cancer patients. METHOD: The need for psychological treatment was evaluated in a total of 169 patients prior to thoracic surgery, through a clinical interview. The screening tests used were: the physician's judgment (yes/no), the Hospital Anxiety and Depression Scale (HADS) and, the single-item interview to assess depression "Do you feel depressed?" (DEPQ). RESULTS: The number of patients who needed psychological treatment in the total sample was 47 (27.81%), in non-cancer-patients: 22 (30.99%) and in cancer patients: 25 (25.51%). The participants with treatment needs were more often young women with primary education levels, with more fears and concerns regarding their disease. With respect to the screening tests, the HADS-T (cut-off point ≥13) obtained a sensitivity (SE) of 0.75 and Specificity (SP) of 0.81 in the total sample. In patients with cancer, the HADS total score (cut-off point ≥10) obtained an SE=0.84 and SP=0.80, and, in non-cancer patients, the HADS total score (cut-off point ≥13) showed an SE=0.59 and SP=0.84. The DEPQ and the physician's judgment did not achieve adequate levels of precision. CONCLUSIONS: A high percentage of patients have psychological treatment needs before performing thoracic surgery, which are similar for cancer and non-cancer patients. Preoperative detection of patients who need psychological intervention is feasible with a simple screening test: HADS, which achieves greater precision in cancer patients.

Impact of neoadjuvant therapy on postoperative complications in non-small-cell lung cancer patients subjected to anatomic lung resection.

OBJECTIVE: To study the impact of neoadjuvant therapies on postoperative complications and mortality among non-small-cell lung cancer (NSCLC) patients subjected to anatomic lung resection and included in the Spanish cohort of the video-assisted thoracic surgery (GE-VATS) multicenter database. METHODS: The study included a total of 3085 patients from 33 centers between December 2016 and March 2018. We performed a comparative analysis of the complications and mortality in patients who received neoadjuvant therapies (n = 263) versus those who did not (n = 2822). A propensity score-matched analysis was used to adjust for potential confounders. Association between exposure in two groups and outcomes were estimated by logistic regression weighted by inverse of probability of receiving the treatment that actually received. RESULTS: In the unadjusted analysis, the chemotherapy (CT) and chemoradiotherapy (CRT) group presented a higher frequency of ICU readmissions, reinterventions, empyema, cardiovascular complications, a greater frequency of atrial fibrillation, and an increased need for blood product transfusions. In the adjusted group, CT and CRT patients had a higher rate of cardiovascular complications (CT p = 0.002; OR 2.29; 95% CI 1.34-3.94 and CRT p = 0.001; OR 2.90; 95% CI 1.52-5-52), arrhythmias (CT p = 0.013; OR 2.23; 95% CI 1.18-4.20 and CRT p = 0.046; OR 2.22; 95% CI 1.01-4.90) and transfussions (CT p = 0.042; OR 2.95; 95% CI 1.04-8.35 and CRT p < 0.001; OR 7.74; 95% CI 3.01-19-92). CONCLUSIONS: Based on our series, neoadjuvant CT and CRT were associated with a higher rate of cardiovascular complications, arrhythmias and transfussions in patients with NSCLC subjected to anatomic lung resection.

Thoracic surgery in Spain.

In this manuscript, we briefly report on the Spanish health care system and the current situation of Thoracic Surgery in the country. Our surgical speciality is approached in terms of national spread of thoracic units, education, technological development, and other relevant aspects. Thoracic Surgery national workforce is also reviewed and compared to sister specialities. Prospects and authors' recommendations for development are included. Total cost of public health care expenditure in Spain represents 9% of the gross domestic product (GDP) and the National Health System is included in the top ten more efficient systems in the World. Thoracic Surgery in Spain is an independent medical speciality. The access to training in accredited hospitals is uniformly regulated all around the country and represents the official and only route to certified medical specialization. 0.5 certified specialists in Thoracic Surgery per 100,000 habitants are working in the country, half of them being female in the age subset of 30-39. Currently, more than half of all anatomical resection in the country are performed via VATS. Seven centres are currently accredited by the Ministry of Health for lung transplantation, and the current rate of lung transplants is 7.1 per million of population. To note is the success of the non-heart-beating donors program developed in recent years. Three national professional and scientific societies are gathering most Spanish thoracic surgeons and promoting cooperative multidisciplinary studies on lung cancer and surgical techniques such are video-assisted and robotic lung resection. Implementing a national database of thoracic surgical procedures would be advisable to promote continuous clinical quality improvements.

Targeted therapy moves to earlier stages of non-small-cell lung cancer: emerging evidence, controversies and future challenges.

Lung cancer continues to be the leading cause of cancer mortality and a serious health problem despite the numerous advances made in the last decade and the rapid advance of research in this field. In recent years, there has been a decrease in mortality from lung cancer coinciding with the approval times of targeted therapy. To date, targeted therapy has been used in the context of advanced disease in clinical practice, with great benefits in survival and quality of life. The next step will be to incorporate targeted therapy into the treatment of earlier stages of non-small-cell lung cancer, and there is already a randomized trial showing a disease-free survival benefit. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of targeted therapies in nonmetastatic disease.

Lay abstract Despite major therapeutic advances over the last decade, lung cancer continues to present the highest mortality rate of all cancers. Precision and personalized therapy directed at specific alterations in the genetic material of the tumor as well as immunotherapy has significantly improved survival in metastatic non-small-cell lung cancer. The next step will be to incorporate precision medicine into the treatment of earlier stages of non-small-cell lung cancer. The recent publication of the results of the ADAURA phase III trial showing a significant improvement in disease-free survival in patients with resected EGFR-mutated non-small-cell lung cancer who received an adjuvant EGFR-directed tyrosine kinase inhibitor called osimertinib has opened the doors to the incorporation of this novel agent into routine clinical practice. However, there are many questions that need to be resolved first. In the present review, the authors discuss the findings of published reports and ongoing clinical trials assessing the role of precision medicine in nonmetastatic disease.

Effect of COVID-19 on Thoracic Oncology Surgery in Spain: A Spanish Thoracic Surgery Society (SECT) Survey.

After the first wave of COVID-19, the Spanish Society of Thoracic Surgeons (SECT) surveyed its members to assess the impact of the pandemic on thoracic oncology surgery in Spain. In May 2020, all SECT members were invited to complete an online, 40-item, multiple choice questionnaire. The questionnaire was developed by the SECT Scientific Committee and sent via email. The overall response rate was 19.2%. The respondents answered at least 91.5% of the items, with only one exception (a question about residents). Most respondents (89.3%) worked in public hospitals. The reported impact of the pandemic on routine clinical activity was considered extreme or severe by 75.5% of respondents (25.5% and 50%, respectively). Multidisciplinary tumour boards were held either with fewer members attending or through electronic platforms (44.6% and 35.9%, respectively). Surgical activity decreased by 95.7%, with 41.5% of centers performing surgery only on oncological patients and 11.7% only in emergencies. Nearly 60% of respondents reported modifying standard protocols for early-stage cancer and in the preoperative workup. Most centers (≈80%) reported using full personal protective equipment when operating on COVID-19 positive patients. The COVID-19 pandemic severely affected thoracic oncology surgery in Spain. The lack of common protocols led to a variable care delivery to lung cancer patients.

Spanish Lung Cancer Group SCAT trial: surgical audit to lymph node assessment based on IASLC recommendations.

BACKGROUND: The Spanish Customized Adjuvant Therapy (SCAT) trial assessed the role of individualized adjuvant therapy in clinical N0 incidental pN1 and/or N2 non-small cell lung cancer (NSCLC) completely resected. We assessed surgical topics with an in-depth analysis of quality of lymphadenectomy based on International Association for the Study of Lung Cancer (IASLC) recommendations. METHODS: Patients with information about lymphadenectomy available were included (N=451). Prospectively collected data about tumor, type of resection, and postoperative morbidity and quality of lymph node dissection (LND) were retrospectively evaluated. Role of lymph node assessment on survival was analyzed using Kaplan-Meier curves, using regression models to identify prognostic factors. RESULTS: In 33.7%, 17.7% and 49.9% of cases, regions 7, 10 and 11 respectively were not assessed. In 21.1% of patients, less than three lymph node regions were biopsied, while in 19.6% of patients less than six lymph nodes were assessed. In 53,4% of patients only one N1 region was evaluated. From patients with positive N2, 8.9% had no N1 regions biopsied. Twenty-nine percent of patients with at least one N2 lymph node resected shown the highest region involved. Thirty-day postoperative mortality was unknown. Five-year overall survival (OS) was 61.7% (95% CI: 55.4-67.4%), 51.5% (95% CI: 39.2-62.4%) and 42.3% (95% CI: 32.1-52.2%) for patients with N1, N2 and N1+N2 disease, respectively (P<0.01). Both number of lymph nodes resected and number of lymph nodes involved by tumor were significantly related to prognosis. CONCLUSIONS: IASLC recommendations for surgical resections were not followed in a high proportion of surgical procedures. Hilar and mediastinal lymph node assessment and involvement showed to impact prognosis. Surgical issues such as postoperative mortality could not be evaluated owing to trial design.

Preoperative detection and evaluation of the need for psychological intervention in cancer and non-cancer patients referred to thoracic surgery.

OBJECTIVES: (a) to evaluate and compare the psychological treatment needs of patients with cancer and non-cancer, who are going to undergo scheduled thoracic surgery, and (b) evaluate and compare the diagnostic accuracy of the screening tests of psychological treatment needs for cancer and non-cancer patients. METHOD: The need for psychological treatment was evaluated in a total of 169 patients prior to thoracic surgery, through a clinical interview. The screening tests used were: the physician's judgment (yes/no), the Hospital Anxiety and Depression Scale (HADS) and, the single-item interview to assess depression "Do you feel depressed?" (DEPQ). RESULTS: The number of patients who needed psychological treatment in the total sample was 47 (27.81%), in non-cancer-patients: 22 (30.99%) and in cancer patients: 25 (25.51%). The participants with treatment needs were more often young women with primary education levels, with more fears and concerns regarding their disease. With respect to the screening tests, the HADS-T (cut-off point ≥13) obtained a sensitivity (SE) of 0.75 and Specificity (SP) of 0.81 in the total sample. In patients with cancer, the HADS total score (cut-off point ≥10) obtained an SE=0.84 and SP=0.80, and, in non-cancer patients, the HADS total score (cut-off point ≥13) showed an SE=0.59 and SP=0.84. The DEPQ and the physician's judgment did not achieve adequate levels of precision. CONCLUSIONS: A high percentage of patients have psychological treatment needs before performing thoracic surgery, which are similar for cancer and non-cancer patients. Preoperative detection of patients who need psychological intervention is feasible with a simple screening test: HADS, which achieves greater precision in cancer patients.

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers.

Despite numerous advances in targeted therapy and immunotherapy in the last decade, lung cancer continues to present the highest mortality rate of all cancers. Targeted therapy based on specific genomic alterations, together with PD-1 and CTLA-4 axis blocking-based immunotherapy, have significantly improved survival in advanced non-small cell lung cancer (NSCLC) and both therapies are now well-established in this clinical setting. However, it is time for immunotherapy to be applied in patients with early-stage disease, which would be an important qualitative leap in the treatment of lung cancer patients with curative intent. Preliminary data from a multitude of studies are highly promising, but therapeutic decision-making should be guided by an understanding of the molecular features of the tumour and host. In the present review, we discuss the most recently published studies and ongoing clinical trials, controversies, future challenges and the role of biomarkers in the selection of best therapeutic options.

Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections.

INTRODUCTION: Our study sought to know the current implementation of video-assisted thoracoscopic surgery (VATS) for anatomical lung resections in Spain. We present our initial results and describe the auditing systems developed by the Spanish VATS Group (GEVATS). METHODS: We conducted a prospective multicentre cohort study that included patients receiving anatomical lung resections between 12/20/2016 and 03/20/2018. The main quality controls consisted of determining the recruitment rate of each centre and the accuracy of the perioperative data collected based on six key variables. The implications of a low recruitment rate were analysed for "90-day mortality" and "Grade IIIb-V complications". RESULTS: The series was composed of 3533 cases (1917 VATS; 54.3%) across 33 departments. The centres' median recruitment rate was 99% (25-75th:76-100%), with an overall recruitment rate of 83% and a data accuracy of 98%. We were unable to demonstrate a significant association between the recruitment rate and the risk of morbidity/mortality, but a trend was found in the unadjusted analysis for those centres with recruitment rates lower than 80% (centres with 95-100% rates as reference): grade IIIb-V OR=0.61 (p=0.081), 90-day mortality OR=0.46 (p=0.051). CONCLUSIONS: More than half of the anatomical lung resections in Spain are performed via VATS. According to our results, the centre's recruitment rate and its potential implications due to selection bias, should deserve further attention by the main voluntary multicentre studies of our speciality. The high representativeness as well as the reliability of the GEVATS data constitute a fundamental point of departure for this nationwide cohort.

Implementing a distress screening program in a thoracic surgery service. / Implementación de un programa de cribado del malestar emocional en un servicio de cirugía torácica.

INTRODUCTION: The aim of the present study was to examine the diagnostic accuracy of screening tests in detecting cases requiring psychological intervention among patients referred for thoracic surgery. METHODS: Emotional distress was evaluated in 105 patients referred for thoracic surgery by means of a diagnostic psychological interview (criterion variable). The screening ability of the following methods was analyzed: the physician's opinion (Yes/No), Hospital Anxiety and Depression Scale (HADS), single-item interview: «Are you depressed?¼ (Depression Question, ADEP) (1-5) and the single-item interview: «Are you anxious?¼ (Anxiety Question, ANXQ) (1-5). RESULTS: According to the clinical interview, 34% of the patients were clinical cases requiring psychological intervention. The total HADS (cut-off point of 10) showed a sensitivity=0.89, specificity=0.75 and AUC=0.883; the ADEP scale (>1) showed a sensitivity=0.79, specificity=0.74 and AUC=0.795; the ANXQ scale (>1) showed a sensitivity=0.78, specificity=0.41 and AUC=0.690; and the physician's opinion showed a sensitivity=0.47 and specificity=0.86. CONCLUSIONS: A high percentage of patients referred for thoracic surgery required psychological intervention. The best instrument to identify those patients requiring psychological care, taking a psychological interview as the criterion variable, was the total HADS score. This test is brief, simple and well accepted by patients; it is easy to implement within a thoracic surgery service and has a good diagnostic accuracy.

Benchmarking in Thoracic Surgery. Third Edition.

INTRODUCTION: Benchmarking entails continuous comparison of efficacy and quality among products and activities, with the primary objective of achieving excellence. OBJECTIVE: To analyze the results of benchmarking performed in 2013 on clinical practices undertaken in 2012 in 17 Spanish thoracic surgery units. METHODS: Study data were obtained from the basic minimum data set for hospitalization, registered in 2012. Data from hospital discharge reports were submitted by the participating groups, but staff from the corresponding departments did not intervene in data collection. Study cases all involved hospital discharges recorded in the participating sites. Episodes included were respiratory surgery (Major Diagnostic Category 04, Surgery), and those of the thoracic surgery unit. Cases were labelled using codes from the International Classification of Diseases, 9th revision, Clinical Modification. The refined diagnosis-related groups classification was used to evaluate differences in severity and complexity of cases. RESULTS: General parameters (number of cases, mean stay, complications, readmissions, mortality, and activity) varied widely among the participating groups. Specific interventions (lobectomy, pneumonectomy, atypical resections, and treatment of pneumothorax) also varied widely. CONCLUSIONS: As in previous editions, practices among participating groups varied considerably. Some areas for improvement emerge: admission processes need to be standardized to avoid urgent admissions and to improve pre-operative care; hospital discharges should be streamlined and discharge reports improved by including all procedures and complications. Some units have parameters which deviate excessively from the norm, and these sites need to review their processes in depth. Coding of diagnoses and comorbidities is another area where improvement is needed.

Are we ready to use biomarkers for staging, prognosis and treatment selection in early-stage non-small-cell lung cancer?

Lung cancer accounts for the majority of cancer-related deaths worldwide. At present, platinum-based therapy represents the standard of care in fit stage II and IIIA non-small cell lung cancer (NSCLC) patients following surgical resection. In advanced disease, personalized chemotherapy and targeted biologic therapy based on histological and molecular tumor profiling have already shown promise in terms of optimizing treatment efficacy. While disease stage is associated with outcome and is commonly used to determine adjuvant treatment eligibility, it is known that a subset of patients with early stage disease experience shorter survival than others with the same clinicopathological characteristics. Improved methods for identifying these individuals, at or near the time of initial diagnosis, may inform the decision to pursue adjuvant therapy options. Among the numerous candidate molecular biomarkers, only few gene-expression profiling signatures provide clinically relevant information, while real-time quantitative polymerase-chain reaction (RT-qPCR) strategy involving relatively small numbers of genes offers a practical alternative with high cross-platform performance. mRNA and/or protein expression levels of excision repair cross-complementation group 1 (ERCC1), ribonucleotide reductase M subunit 1 (RRM1) and breast cancer susceptibility gene 1 (BRCA1) are among the most promising potential biomarkers for early disease and their clinical utility is currently being evaluated in randomized phase II and III clinical trials. This review describes the most promising clinicopathological and molecular biomarkers with predictive and prognostic significance in lung cancer that have been identified through advanced research and which could influence adjuvant and neoadjuvant chemotherapy decisions for operable NSCLC in routine clinical practice.

Adjuvant chemotherapy for early-stage non-small-cell lung cancer. Single-centre experience and literature review.

BACKGROUND: In recent years platinum-based chemotherapy has become the standard of care for patients with good performance status after complete resection in stages IB-IIIA non-small-cell lung cancer (NSCLC), although the benefit is mainly in stages II and IIIA. PATIENTS AND METHODS: In a retrospective trial we evaluate the clinical efficacy and toxicity profile of a platinum- and taxanes-based adjuvant chemotherapy in completely resected IB-IIIA NSCLC. The primary end point was relapse- free survival (RFS); principal secondary end points were overall survival (OS) and safety of the regimen. Potential predictive factors of efficacy and clinical patterns of relapse were also analysed. RESULTS: From January 2003 to December 2006, 41 patients met the inclusion criteria and were evaluable. Median age at diagnosis was 68.1 years (CI 95% 54-72; range 45-78). Most patients were males (87.7%) and had an Eastern Cooperative Oncology Group performance status score (PS) of 0-1 (87.8%), and 53.6% had adenocarcinomas. Pathological stages were as follow: 48.7% stage IB, 24.3% stage II and 26.8% stage IIIA. 75.6% of patients underwent a lobectomy and mediastinal lymphadenectomy and were treated with a combination of carboplatin AUC6 and paclitaxel 200 mg/m2 (85.36%) for 3 or 4 cycles. With a median follow-up of 18.2 months (range 5.1-46.5), 26 patients (63%) were free of disease and 32 of them were alive (78%). Median RFS was 12.1 months (CI 95% 9.8-14.9) and median OS had not been reached at the time of analysis. Patients with PS< or =1 at diagnosis had a higher RFS [p=0.051 (CI 95% 0.90-0.96)]. Toxicity was generally mild and haematologic events were the most frequent. Non-haematologic toxic effects of chemotherapy were asthenia/ anorexia (12.2%), nausea/vomiting (12.2%) and peripheral neuropathy (17%), but severe toxic effects (grade 3 or greater) were uncommon (<10%). We did not observe treatment-related deaths. CONCLUSIONS: Platinum-taxane-based adjuvant chemotherapy in IB-IIIA NSCLC following complete resection is feasible, well tolerated and can be delivered in most patients in the adjuvant setting. Ongoing molecular studies may have value in determining which patients will benefit from adjuvant chemotherapy.

Long-term survival associated with complete resection after induction chemotherapy in stage IIIA (N2) and IIIB (T4N0-1) non small-cell lung cancer patients: the Spanish Lung Cancer Group Trial 9901.

PURPOSE: To assess the activity of induction chemotherapy followed by surgery in stage IIIA and selected stage IIIB non-small-cell lung cancer patients. PATIENTS AND METHODS: Mediastinoscopy proof of either positive N2 (IIIA) or T4N0-1 (IIIB) disease was required. Induction therapy was three cycles of cisplatin/gemcitabine/docetaxel, followed by surgery. RESULTS: From December 1999 to March 2003, 136 patients were entered onto the study; the clinical response rate in 129 assessable patients was 56%. The overall complete resection rate was 68.9% of patients eligible for surgery (72% of stage IIIA patients and 66% of stage IIIB patients) and 48% of all assessable patients. Eight (12.9%) of 62 completely resected patients had a pathologic complete response. Seven patients (7.8%) died during the postoperative period. The median overall survival time was 15.9 months, 3-year survival rate was 36.8%, and 5-year survival rate was 21.1%, with no significant differences in survival between stage IIIA and stage IIIB patients. Median survival time was 48.5 months for 62 completely resected patients, 12.9 months for 13 incompletely resected patients, and 16.8 months for 15 nonresected patients (P = .005). Three- and 5-year survival rates were 60.1% and 41.4% for completely resected patients, 23.1% and 11.5% for incompletely resected patients, and 31.1% and 0% for nonresected patients, respectively. In the multivariate analysis, complete resection (hazard ratio [HR] = 0.35; P < .0001), clinical response (HR = 0.32; P < .0001), and age younger than 60 years (HR = 0.64; P = .027) were the most powerful prognostic factors. CONCLUSION: Induction chemotherapy followed by surgery is effective in stage IIIA and in selected stage IIIB patients attaining complete resection.

[Pilot benchmarking study of thoracic surgery in Spain: comparison of cases of lung resection and indicators of quality]. / Experiencia piloto de benchmarking en cirugía torácica: comparación de la casuística e indicadores de calidad en resección pulmonar.

OBJECTIVE: This article describes the methods and conclusions of the first Spanish benchmarking study of thoracic surgery. The proposed aims were to describe cases of lung resection in 9 Spanish hospitals, compare indicators of quality among the 9 participating centers, and identify and propose common areas where lung-resection processes could be improved. METHODS: Information was taken from the minimum basic data set for lobectomy and pneumonectomy processes performed in 2002 and 2003. The chosen outcome indicators were in-hospital mortality, morbidity, length of hospital stay, and emergency readmissions within 30 days of discharge, adjusted according to surgical complexity. Once the results had been analyzed, the participating centers with best outcomes were identified and a variety of proposed improvements were discussed. RESULTS: A total of 1666 procedures (1276 lobectomies and 390 pneumectomies) were studied. We found differences in mean length of stay, mortality, readmission rate, and morbidity that identified centers with lower mortality or shorter hospital stay for comparable or more complex surgical procedures. However, higher morbidity and readmission rates were found in these centers. CONCLUSIONS: Measures were proposed to ensure that relevant diagnostic information is recorded on discharge. It was also proposed to reduce unnecessarily long hospital stays and to standardize the procedures. With such an approach, reliable criteria that improve the quality of lung-resection processes can be established in the future.