Stefano Meduri

Adopting integrated care pathways in non-small-cell lung cancer: from theory to practice.

Introduction: Integrated care pathways (ICPs) have been proposed as effective strategies for quality improvement. To date, limited data are available that detail the methodology to design an optimal care pathway for patients with non–small-cell lung cancer (NSCLC). The main aim of this study was to assess the quality of health care delivered to lung cancer patients referred to a hub university hospital. Methods: All professionals involved with the management of NSCLC patients, in cooperation with health care researchers, identified 11 quality indicators and associated benchmarks. These were used to estimate the quality and efficiency of health care delivered to a cohort of 175 NSCLC patients. Results: The gap between “desired” and “actual” performance has been measured by benchmarking current practice against key quality indicators. Diagnostic workup, multidisciplinary team care and medical treatment of advanced disease have emerged as areas of good performance. Conversely, the management of early-stage disease offers room for improvement, in terms of both accuracy of nodal staging and surgical timeliness. Conclusions: Analyzing the process of caring for NSCLC patients is feasible and offers room for improvement. Acquired knowledge may be shared with hospital administrators, guide the revision of ICPs, and enable the delivery of consistent, high-quality clinical standards.

A randomised phase II study of docetaxel/oxaliplatin and docetaxel in patients with previously treated non-small cell lung cancer: An Alpe-Adria Thoracic Oncology Multidisciplinary group trial (ATOM 019)

INTRODUCTION To date, no combination regimen has proven superior to single agent chemotherapy as a second-line treatment for non-small cell lung cancer (NSCLC). METHODS This multicenter, non-comparative randomised phase II trial evaluated the activity of docetaxel (75 mg/m(2) on day 1) with oxaliplatin (70 mg/m(2) on day 2) every 3 weeks in previously treated NSCLC patients; the reference arm was single-agent docetaxel (75 mg/m(2) on day 1 every 3 weeks). It was designed as a one-stage, three-outcome phase II trial; 21 evaluable patients were required in each arm. The primary end-point was response rate; secondary end-points were toxicity, progression free survival (PFS) and overall survival. RESULTS Fifty patients were enrolled. Patient characteristics included male/female, 76/24%; median age 62 years; ECOG PS 0/1, 36/64%; previous platinum-based chemotherapy, 98%. Partial response was seen in 20% and 8%, stable disease in 52% and 32%, of patients treated with docetaxel/oxaliplatin and docetaxel, respectively. Main grade 3-4 toxicities were neutropenia 56% and 64%; febrile neutropenia 4% and 8%; diarrhoea 12% and 4% for docetaxel/oxaliplatin and docetaxel, respectively. Median PFS was 5.0 and 1.7 months, median survival 11.0 and 7.1 months, and 1-year survival 44% and 32% for docetaxel/oxaliplatin and docetaxel, respectively. CONCLUSIONS The study met its pre-defined study end-point; docetaxel/oxaliplatin and more generally platinum-containing doublets warrant further evaluation as second-line therapy for patients with NSCLC.

Impact of low-dose computed tomography screening on lung cancer mortality among asbestos-exposed workers

Background We previously showed that low-dose computed tomography (LDCT) screening in asbestos-exposed workers is effective in detecting lung cancer (LC) at an early stage. Here, we evaluate whether LDCT screening could reduce mortality from LC in such a high-risk population. Methods Within a cohort of 2433 asbestos-exposed men enrolled in an Occupational Health surveillance programme, we compared mortality between the participants in the ATOM002 study (LDCT-P, N  =  926) and contemporary non-participants (LDCT-NP, N  =  1507). We estimated standardized mortality ratios for the LDCT-P and LDCT-NP populations using regional and national rates (SMR_FVG and SMR_ITA, respectively). We compared survival for all causes, all neoplasms, LC and malignant neoplasm of pleura (MNP) between LDCT-P and LDCT-NP using Cox proportional hazard models adjusted for age, smoking history, asbestos exposure level and comorbidities. Results A reduction in mortality from LC was observed in the LDCT-P group compared with regional and national figures (SMR_FVG  =  0.55, 95% confidence interval (CI) 0.24-1.09; SMR_ITA  =  0.51, 95% CI 0.22-1.01); this was not the case for the LDCT-NP group (SMR_FVG  =  2.07, 95% CI 1.53-2.73; SMR_ITA  =  1.98, 95% CI 1.47-2.61). A strong reduction in LC mortality was observed for the LDCT-P compared with the LDCT-NP [hazard ratio (HR)  =  0.41, 95% CI 0.17-0.96]. Mortality was also reduced for all causes (HR  =  0.61, 95% CI 0.44-0.84), but not for all neoplasms (HR  =  0.97, 95% CI 0.62-1.50) and MNP (HR  =  0.86, 95% CI 0.31-2.41) within the LDCT-P population. Conclusions In our cohort, participation in the LDCT screening study was associated with reduced mortality from LC. This finding supports the use of LDCT in surveillance programmes for asbestos-exposed workers.

Integrated care pathways (ICPs) for non-small cell lung cancer (NSCLC) patients (Pts): A multidisciplinary quality improvement project.

e16573 Background: ICPs are structured multidisciplinary care plans for a specific clinical condition; they describe the tasks to be carried out together with their timing and sequence and the discipline involved in completing the task. They have been proposed as quality improvement strategies of both clinical and organizational aspects of patient-oriented care. Nowadays few data are available to detail existing ICPs for NSCLC pts and the methodology for designing an optimal care plan. Aim of this project was to review current clinical pathways in the care of NSCLC pts who were referred to the University Hospital of Udine, Italy. METHODS A multidisciplinary focus group was established to: 1) map existing local care pathways for NSCLC pts; 2) review the literature and available guidelines to identify quality benchmarks and corresponding, specific indicators; 3) apply these indicators to assess the quality of existing ICPs; 4) recognize key areas for process improvement. RESULTS Eleven quality indicators were identified. They consist in intermediate outputs of the care process and may assess both clinical, organizational and economical aspects of pts care. Indicators were used to survey the ICPs of 175 NSCLC pts who were referred to our Hospital in 2008; data for 6 representative indicators are shown below (Table). CONCLUSIONS By means of a limited set of quality indicators, we were able to verify the adherence of routine clinical practice to clinical guidelines and to elicit some critical issues in the care of NSCLC pts. Results need to be shared and discussed with Hospital Managers, with the aim of guiding the redesign of ICPs and improving the clinical, organizational and economic efficiency of the care process. [Table: see text].

Lung cancer and mesothelioma screening with low-dose spiral computed tomography (LDCT) in 1,000 asbestos-exposed workers: An Alpe-Adria Thoracic Oncology Multidisciplinary group study (ATOM 002)

7048 Background: LDCT is more sensitive than chest radiography (CXR) for detection of early stage lung cancer in heavy smokers. However, little is known about LDCT screening in asbestos-exposed subjects. To address this issue, we have designed a prospective, nonrandomized trial to evaluate baseline and annual repeat screening with LDCT in 1,000 asymptomatic asbestos-exposed workers. Here, we report the results of the baseline screening. METHODS Eligibility criteria include: exposure to asbestos, age 40 to 75 yrs, no prior cancer or severe concomitant conditions, no chest CT scan in the last 2 yrs. After written informed consent, eligible subjects undergo a structured interview, CXR and LDCT. Subjects with negative baseline exams undergo annual repeat LDCT. Subjects with positive baseline exams undergo high resolution CT (HRCT) and additional diagnostic workup. RESULTS Between February 2002 and October 2003, 1007 volunteers have been enrolled. Subject characteristics: median age, 59 yrs; males, 97%; smoking history, 66%; former or current shipyard workers, 78%; median asbestos exposure time, 30 yrs. The following data refer to 943 participants. On LDCT, 619 non calcified nodules (NCN) have been identified in 41% of participants. CXR detected 43 nodules. Pleural abnormalities have been detected in 42% and 69% of participants by CXR and LDCT, respectively. So far, six cases of stage I lung cancer have been diagnosed and treated with radical surgery: 3 bronchioloalveolar carcinomas, 1 carcinosarcoma, 2 adenocarcinomas. In addition, one malignant pleural mesothelioma and one thymic carcinoid have been identified. CONCLUSIONS LDCT seems to be useful for the early detection of lung cancer also in asbestos-exposed subjects. Annual repeat LDCT screening may provide information on the natural history and evolution of asbestos-related pleural abnormalities. Study supported by Compagnia di San Paolo, Torino, and Provincia di Gorizia. No significant financial relationships to disclose.