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J. Vansteenkiste



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    MO23 - Radiotherapy II: Lung Toxicity, Target Definition and Quality Assurance (ID 107)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 2
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      MO23.02 - Quantification of radiation-induced lung damage with CT scans: The possible benefit for radiogenomics (ID 254)

      10:35 - 10:40  |  Author(s): J. Vansteenkiste

      • Abstract
      • Presentation
      • Slides

      Background
      Radiation-induced lung damage (RILD) is an important problem. Although physical parameters such as the mean lung dose are used in clinical practice, they are not suited for individualised radiotherapy. As radiosensitivity varies between patients, genetic correlations have been investigated, which appear to be difficult to repeat in validation studies. This may be due, in part, to differences in methods for measuring RILD across studies. Objective, quantitative measurements of RILD on a continuous instead of on an ordinal, semi-quantitative, semi-subjective scale, are needed.

      Methods
      Hounsfield Unit (HU) changes before vs. 3 months post-radiotherapy were correlated per voxel with the radiotherapy dose. Deformable registration was used to register pre and post CT scans and the density increase was quantified for various dose bins. The dose-response curve for increased HU was quantified using the slope of a linear regression (HU/Gy). The end-point for the toxicity analysis was dyspnoea ≥ grade 2.

      Results
      95 lung cancer patients were studied. Radiation dose was linearly correlated with the change in HU (mean R[2]=0.74 ± 0.28). No differences in HU/Gy between groups treated with stereotactic radiotherapy, conventional radiotherapy alone, sequential or concurrent chemo-radiotherapy were observed. In the whole patient group, 33/95 (34.7 %) had dyspnoea ≥ G2. Of the 48 patients with a HU/Gy below the median, 16 (33.3 %) developed dyspnoea ≥ G2, while in the 47 patients with a HU/Gy above the median, 17 (36.1 %) had dyspnoea ≥ G2 (not significant). Individual patients showed a nearly 21-fold difference in radiosensitivity, with HU/Gy ranging from 0 to 10 HU/Gy. Figure 1

      Conclusion
      HU changes identify objectively the whole range of individual radiosensitivity on a continuous, quantitative scale. CT density changes may allow more robust and accurate radiogenomics studies.

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      MO23.10 - Addition of EBUS-mapping of the mediastinum to PET/CT based selective nodal irradiation in NSCLC decreases geographical miss and nodal GTV volume (ID 2841)

      11:25 - 11:30  |  Author(s): J. Vansteenkiste

      • Abstract
      • Presentation
      • Slides

      Background
      FDG-PET/CT based selective lymph node (LN) irradiation is the standard when using 3D-conformal techniques (3D-CRT) for locally advanced NSCLC. With 3D-CRT, adjacent LN not included in the target volume still receive a substantial radiation dose. With current new techniques (IMRT/VMAT), the radiation dose to non-involved LN decreases, which raises the question whether selective nodal irradiation based on PET/CT is still safe. We therefore evaluated the impact of adding EBUS-TBNA (endobronchial ultrasound guided transbronchial needle aspiration)-mapping of the mediastinal LN to PET/CT in avoiding geographical miss, and on the size of nodal GTV (gross tumor volume).

      Methods
      Consecutive NSCLC-patients referred for radiotherapy (RT) in 2012 who underwent EBUS-TBNA were included. False negative (FN) LN for different constellations of PET, CT and EBUS-TBNA based on literature data were calculated, to evaluate the safety of excluding LNs based on CT, PET and EBUS findings. A practical algorithm when to include LN in the GTV was made, and tested on our patients. Results are expressed as mean +/- SD and range.

      Results
      Twenty-five consecutive patients with a full EBUS-TBNA mapping before RT were included: 11 women, 14 men; 17 adenocarcinoma, 8 squamous cell carcinoma; 14 right-sided and 11 left-sided tumors. Mean age: 62.5 +/- 9.7 years. All patients had stage III-disease based on PET-CT. LN stations 1,2R,2L,3,4R,4L,5,6,7,8,9,10-11L,10-11R were analyzed on CT- and PET-scan (=325 LN). Sixty-seven were enlarged (≥10mm), of which 63 were PET-positive. Twelve normal-sized LNs were PET-positive. Fifty LNs were investigated with EBUS-TBNA (mean: 2/patient +/-0.96;1-5): 28 were malignant, 22 normal. EBUS-TBNA detected 1 cancer-containing normal-sized LN without FDG-uptake, thus 1/25 geographical miss (4%). The cancer prevalence, taking into account the FN rate of EBUS of 20%, was calculated (Fig.1). With addition of EBUS, in PET-negative patients FN decreases with 10% for enlarged LN, and with 5% for normal-sized LN. An algorithm when to include a LN in the GTV is proposed (Fig.1). According to this algorithm, in our population 3/79 (4%) enlarged or PET-positive LN would be excluded from the GTV. At patient level, this was a GTV decrease in 3 (12%) patients.

      Conclusion
      When incidental nodal irradiation is low such as in IMRT or VMAT, EBUS-TBNA should be added to FDG-PET/CT for mediastinal staging. This avoids geographical miss in 4% of patients, and decreases the radiation volume in 12% of patients. A practical algorithm is proposed.

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    O04 - Molecular Pathology I (ID 126)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Pathology
    • Presentations: 1
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      O04.05 - Epidemiology of PI3K pathway alterations in patients with metastatic non-small cell lung cancer (NSCLC): findings from the international BASALT-1 study (ID 1810)

      11:15 - 11:25  |  Author(s): J. Vansteenkiste

      • Abstract
      • Presentation
      • Slides

      Background
      Buparlisib (BKM120) is an oral PI3K inhibitor that inhibits all four isoforms of class I PI3K (α, β, γ, δ) and has demonstrated antiproliferative, proapoptotic, and antiangiogenic activity in multiple preclinical cancer models. NSCLC cell lines with PIK3CA mutations (muts) have demonstrated increased sensitivity to buparlisib in vitro. BASALT-1 – an ongoing, multicenter, open-label, two-stage Phase ll study (NCT01297491) – evaluates the safety and efficacy of single-agent buparlisib in patients (pts) with NSCLC and an activated PI3K pathway. Here we report data on the prevalence of PI3K pathway alterations in pts with squamous (sq) or non-squamous (non-sq) NSCLC prescreened for entry into BASALT-1.

      Methods
      Pts prescreened for BASALT-1 were ≥18 years of age with previously treated metastatic NSCLC of sq or non-sq histology. PI3K pathway activation (defined as PIK3CA mut and/or PTEN mut and/or PTEN negative [neg; <10% protein expression at 1+ by immunohistochemistry]) was measured in archival or newly acquired tumor tissue collected at prescreening. PIK3CA (exons 1, 5, 7, 9, and 20) and PTEN (exons 1–9) muts were detected primarily using Sanger sequencing in a centralized fashion. Local analysis was permitted at selected sites where a SnapShot approach was most commonly used.

      Results
      As of April 10, 2013, 1183 pts had submitted tumor samples to be assayed (1179 tumors had known histology). PI3K pathway activation was detected in 16.0% of sq and 11.3% of non-sq tumors. In sq tumors (N=612), loss of PTEN protein expression (8.2%) was the most common single alteration observed, followed by PIK3CA mut only (3.1%) and PTEN mut only (2.9%). In non-sq tumors (N=567), PTEN mut only was the most common alteration (4.9%), followed by PIK3CA mut only (2.6%) and PTEN neg only (2.1%). Frequencies of co-existing genetic alterations were: PTEN mut + PTEN neg only (1.0% sq vs 0.4% non-sq), PIK3CA mut + PTEN neg only (0.7% sq vs 0.4% non-sq), PIK3CA mut + PTEN mut only (0% sq vs 0.9% non-sq), and PIK3CA mut + PTEN mut + PTEN neg (0.2% sq vs 0% non-sq). No clear gender, age or ethnicity effects were observed (Table). Figure 1

      Conclusion
      The findings from our large dataset indicate that genetic alterations in the PI3K pathway occur in a clinically significant proportion of pts with sq and non-sq relapsed NSCLC. An accurate characterization of PI3K pathway alteration frequencies in NSCLC will help guide the design of future clinical trials of PI3K inhibitors.

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    O26 - Support and Palliation II (ID 140)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Nurses
    • Presentations: 1
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      O26.06 - Impact of geriatric assessment on treatment decisions in older lung cancer patients. (ID 1419)

      17:10 - 17:20  |  Author(s): J. Vansteenkiste

      • Abstract
      • Presentation
      • Slides

      Background
      This study aims to investigate the influence of a geriatric assessment (GA) on cancer treatment decisions in older lung cancer patients (pts). We also studied the changes in functionality during treatment and the occurrence of severe chemotherapy-related toxicity.

      Methods
      For this analysis, we selected the lung cancer cohort that was part of a larger study on GA in older cancer pts in 6 tumor types in two Belgian university hospitals[1]. Between July 2009 and September 2011, pts aged 70 years or older with a newly diagnosed or progressive lung cancer were evaluated at baseline using a uniform GA including geriatric screening with G8 and the Flemish Triage Risk Screening Tool (fTRST), pain, social data, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), fall history, Mobility-Tiredness Test (MOB-T), Mini Mental State Examination (MMSE), Geriatric Depression Scale (GDS-15), Mini Nutritional Assessment (MNA), ECOG-Performance Status (ECOG-PS), Charlson Comorbidity Index (CCI) and poly-pharmacy assessment. GA results were communicated to the treating physician and, after the treatment decision, the physician was interviewed using a predefined questionnaire focusing on unknown geriatric problems revealed by GA and impact on cancer treatment decisions. Between two and three months of follow-up, functionality was reassessed and severe toxicity in pts receiving chemotherapy was recorded.

      Results
      Seventy three lung cancer pts were included with a median age of 76 years; 82.2% were non-small cell lung cancer (NSCLC) and 74% were stage IV. Treatment was modified from standard according to standard clinical assessment (including age) in 56.1%. GA revealed unknown geriatric problems in 25.8% of cases, leading to a geriatric intervention in 10.6%. 30% of physicians consulted the GA before final treatment decision and in three pts (4%) only this led to a modification of the proposed treatment: dose reduction, no chemotherapy or no radiotherapy. At follow up (n=50), functional decline was observed in 24% and 54% of pts for ADL and IADL, respectively. Grade III-IV toxicity occurred in 14/42 pts treated with chemotherapy (33%), mainly non-haematological (64%).

      Conclusion
      This analysis indicates that the treatment of older lung cancer pts is often influenced (deviated from standard) by standard clinical assessment and age. Although GA revealed previously unknown information in 25.8% of pts, only a minority of physicians consulted these results before the final cancer treatment decision. There was little impact on geriatric intervention and even less on cancer treatment decision. This discrepancy reveals the need to get physicians treating lung cancer acquainted with GA and geriatric interventions in an attempt to decrease chemotherapy related toxicity and improve quality of care. Further evaluation of GA and geriatric interventions in larger pt groups as well as their implementation in clinical practice is warranted.

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    O27 - Clinical Trials and Practice (ID 142)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Other Topics
    • Presentations: 1
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      O27.05 - Is primary tumor standardized uptake value (SUV) an independent prognostic factor for non-small cell lung cancer (NSCLC)? A meta-analysis based on individual patients data. (ID 3888)

      17:00 - 17:10  |  Author(s): J. Vansteenkiste

      • Abstract
      • Presentation
      • Slides

      Background
      [18]F-fluoro-2-deoxy-D-glucose positron emission tomography complements conventional imaging for staging lung cancer although its ability to predict outcome is less well established. Two literature-based meta-analyses suggest a prognostic value in univariate analysis. To assess FDG-PET value in predicting survival adjusted for some known prognostic factors, we carried out a meta-analysis based on individual patients data from multiple independent studies.

      Methods
      Following literature search, and after writing of a protocol for the meta-analysis, we contacted the authors of identified studies and requested individual patients data; we also tried to collect some unpublished data. Data analysis used Cox regression models stratified for the study with overall survival as primary outcome. SUV max was used as a binary covariate (median value for each study).

      Results
      Data were collected for 1526 patients (57% of the identified patients) from 11 publications and 1 unpublished series (median age : 64 years, 60% male patients, squamous cell in 34%, adenocarcinoma in 47%, stages I-II in 58%). Combined univariate hazard ratio (HR) was 1.43 (95% CI : 1.22-1.66); no statistically significant interaction between SUV and one of six additional freatures (age, gender, histology,stage, tumors size –in stages I-III patients- and surgical treatment), was found except for stage (p=0.05) with a decreased prognostic value of SUV for stage IV patients. Without considering SUV, multivariate analysis identified, in stage I-III patients, age, stage, tumor size and surgical treatment as independent prognostic factors. The addition of SUV improved that model : HR estimate for SUV effect was 1.58, statistically significant (95% CI : 1.27-1.96), p<0.0001. No interaction was found with SUV. When tumor size was not included in the tested covariates, we found SUV of additional value (adjustment for age, stage, surgical treatment) with a HR of 1.35 (95% CI : 1.15-158). Interaction between SUV and stage was detected, restricting the significant impact of SUV on survival to stage I-III patients.

      Conclusion
      Conclusions : Although suffering from selection bias and lack of homogeneous SUV assessment, these data suggest that SUV at the time of diagnosis is an independent prognostic marker for patients with stage I-III NSCLC. The utility of SUV in predicting survival in stage IV patients requires further studies.

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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-009 - Preliminary Safety and Treatment Delivery Data During Concurrent Phase of Chemoradiation Therapy of the PROCLAIM Trial: A Phase 3 Trial of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Stage III Nonsquamous Cell Lung Cancer. (ID 1196)

      09:30 - 09:30  |  Author(s): J. Vansteenkiste

      • Abstract

      Background
      Pemetrexed platinum regimens, unlike other regimens, can be given at full systemic doses with thoracic radiation therapy (TRT) in locally advanced stage III nonsquamous non–small cell lung cancer (NSCLC). Study JMIG was initiated to determine if this finding would translate into a survival advantage versus contemporary standard of care.

      Methods
      Study JMIG randomized patients with stage III unresectable nonsquamous NSCLC to experimental Pem+Cis (pemetrexed plus cisplatin and concurrent TRT for three 21-day cycles, followed by consolidation pemetrexed) or to control Etop+Cis (etoposide plus cisplatin and concurrent TRT for two 28-day cycles, followed by consolidation chemotherapy regimen of choice [excluding pemetrexed]). The primary objective was overall survival of Pem+Cis compared with Etop+Cis with safety as a secondary objective using Common Terminology Criteria for Adverse Events (CTCAE). Adverse event incidences were analyzed using Fisher’s exact test (2-sided α=0.05).

      Results
      Of 598 randomized patients, 555 received treatment: 283 Pem+Cis and 272 Etop+Cis. Baseline characteristics were similar (Pem+Cis/Etop+Cis); age (mean±SD) 59.2±9.5/58.7±9.3 years; women, n=114 (40.3%) / n=105 (38.6%); stage IIIB, n=153 (54.1%)/n=138 (50.7%); Eastern Cooperative Oncology Group performance standard of 1, n=138 (48.8%)/n=137 (50.4%); and planned target volume (mean±SD) 628.9 ±463.3/581.2±417.0 ml. Pem+Cis mean weekly dose intensities were 95.9% for both pemetrexed and cisplatin; Etop+Cis dose intensities were 96.4% and 94.1% for etoposide and cisplatin. TRT therapies were similar (Pem+Cis/Etop+Cis); TRT median (range) of 66.0 (2.0–66.3) gray (Gy)/66.0 (2.0–66.0) Gy, mean (SD) number of fractions 31.4 (4.3)/31.1 (5.2), V20 of 27.5% (6.5%)/26.7% (7.3%). Table 1 summarizes AEs during the concurrent phase by treatment. Few patients (n≤4) had grade 3 or 4 CTCAE of mucositis/stomatitis or rash. Pem+Cis had fewer SAEs of febrile neutropenia and pneumonia but increased vomiting compared with Etop+Cis. Nine patients died during the concurrent phase (not included in this safety analysis by treatment to preserve the integrity of final efficacy analysis).

      Table 1. Summary of Common Terminology Criteria for Adverse Events Grade 3 Plus 4 Occurring in ≥2% of Patients Randomized and Treated
      CTCAE (Grades 3 and 4) Pem+Cis N=283 n (%) Etop+Cis N=272 n (%) p-value
      Patients with ≥1 CTCAE* 170 (60.1) 186 (68.4) 0.042
      Neutrophils/granulocytes* 52 (18.4) 78 (28.7) 0.005
      Leukocytes* 44 (15.5) 65 (23.9) 0.014
      Esophagitis 42 (14.8) 47 (17.3) 0.488
      Lymphopenia 48 (17.0) 37 (13.6) 0.290
      Hemoglobin 14 (4.9) 20 (7.4) 0.289
      Febrile neutropenia 9 (3.2) 18 (6.6) 0.075
      Dysphagia 18 (6.4) 16 (5.9) 0.861
      Platelets 15 (5.3) 16 (5.9) 0.854
      Vomiting 12 (4.2) 13 (4.8) 0.839
      Hypokalemia 6 (2.1) 12 (4.4) 0.153
      Infection—lung (pneumonia)*[a] 1 (0.4) 9 (3.3) 0.010
      Dehydration 11 (3.9) 8 (2.9) 0.643
      Nausea 13 (4.6) 8 (2.9) 0.376
      Anorexia 10 (3.5) 7 (2.6) 0.625
      Fatigue 9 (3.2) 6 (2.2) 0.603
      Hyponatremia 5 (1.8) 6 (2.2) 0.768
      Thrombosis/thrombus/embolism 7 (2.5) 5 (1.8) 0.772
      Abbreviations: Cis = cisplatin; CTCAE = Common Terminology Criteria for Adverse Events, Version 3.0; Etop = etoposide; N = number of patients dosed; n = number of patients with at least one CTCAE; Pem = pemetrexed.
      * Statistically significant; p<.05 based on Fisher’s exact test.
      [a] CTCAE was defined as Infection (clinical/microbio)—Gr3/4 neutrophils—Pulmonary/upper respiratory—Lung (pneumonia).

      Conclusion
      During the concurrent treatment phase, patients with stage III locally advanced nonsquamous NSCLC in either treatment arm received comparable systemic therapy; however Pem+Cis had significantly lower incidences of some toxicities. Further toxicity differences may emerge with longer follow-up.

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    P2.04 - Poster Session 2 - Tumor Immunology (ID 154)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.04-002 - Differential expression of PD-L1, PD1 and CTLA4 receptor according to histology and tumour vs. surrounding non-malignant lung tissue in non-small cell lung cancer: RNA sequencing data (ID 2427)

      10:30 - 11:30  |  Author(s): J. Vansteenkiste

      • Abstract

      Background
      Immune modulatory strategies directed against CTLA4 (Cytotoxic T-Lymphocyte Antigen 4), PD1(Programmed cell Death 1) and PD-L1 (Programmed cell Death 1 Ligand 1) either in monotherapy or in combination with chemotherapy and radiotherapy offer great promise as novel treatments against lung cancer. Its outcome and therapeutic ratio may depend on the expression of the target molecules in tumours and the surrounding non-malignant lung tissue. We here report the expression of CTLA4, PD1 and PD-L1 in primary resected NSCLC and in the surrounding non-malignant lung.

      Methods
      RNA sequencing was performed on tumor tissue and normal lung tissue from resection specimens of NSCLC patients. The association between CTLA4, PD1 and PD-L1 expression levels and histology, gender, age, smoking status (current smoker vs. smoking cessation of at least one year), COPD and CRP blood levels was calculated both in the primary tumour and the normal lung. Results are expressed as mean +/- SD and range. Means were compared using Wilcoxon’s signed rank test for the distributions were non-parametrical. P-values <0.05 were considered significant.

      Results
      Fourteen patients were studied, 11 males and 3 females, with a mean age of 64.6 +/- 10.0 years (41-79). All patients had a smoking history: 6 were current smokers, 8 former smokers. COPD status: 8 no COPD, 1 GOLD class I, 3 GOLD class II, 2 GOLD class III. Pre-operative CRP (mg/dL): 15.0 +/- 2.9 (0.20-54.7). Seven patients had squamous cell cancer, 7 adenocarcinoma. PD-L1 expression in the lung was 3833 +/- 787 (372-5072), PD-L1 in the tumour 2595 +/- 1657 (788-6689), with a tumour/lung ratio of 0.67 +/- 0.37 (0.21-1.32). PD-L1 squamous vs. adenocarcinoma was 1840 +/- 1012 vs. 3350 +/- 1896, p<0.001. PD-L1 in the lung of ex-smokers vs. current smokers: 4136 +/- 811 vs. 3430 ± 591, p<0.001. These associations were not found for CTLA4 and PD1 receptor: CTLA4 tumour squamous vs. adenocarcinoma: 100.9 +/- 46.3 vs. 95.3 +/- 73.6, p=0.86; CTLA4 lung smokers vs. ex-smokers: 78.4 +/- 41.3 vs. 107.0 +/- 75.1, p=0.75. PD1 receptor tumour squamous vs. adenocarcinoma: 591 +/- 244 vs. 689 +/- 263, p=0.31 PD1 receptor in the lung of smokers vs. ex-smokers: 599 +/- 278 vs. 695 +/-216, p=0.46. No associations between CTLA4, PD1 and PD-L1 in the tumour or the lung and gender, age, COPD and CRP blood levels were found.

      Conclusion
      RNA sequencing is a useful method to dissect relevant molecules in the tumour and the lungs. Our results show more PD-L1 expression in adenocarcinoma than in squamous cell cancer, more PD-L1 expression in the non-malignant lung of ex-smokers than in current smokers and reduced PD-L1 in tumours compared to adjacent lung tissue.

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    P2.08 - Poster Session 2 - Radiotherapy (ID 198)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P2.08-002 - Modern post-operative radiotherapy for stage III non-small cell lung cancer may improve local control and survival: A publication-based meta-analysis (ID 89)

      09:30 - 09:30  |  Author(s): J. Vansteenkiste

      • Abstract

      Background
      We hypothesized that modern postoperative radiotherapy (PORT) could decrease local recurrence (LR) and improve overall survival (OS) in patients with stage IIIA-N2 non-small-cell lung cancer (NSCLC).

      Methods
      To investigate the effect of modern PORT on LR and OS, we identified published phase III trials for PORT and stratified them according to use or non-use of linear accelerators. We modelled the potential benefit of modern PORT in stage IIIA-N2 NSCLC treated with induction chemotherapy and resection.

      Results
      Of the PORT phase III studies, eleven trials (2387 patients) were included for OS analysis and eight (1677 patients) for LR. PORT decreased LR, whether given with cobalt, cobalt and linear accelerators, or with linear accelerators only. An increase in OS was only seen when PORT was given with linear accelerators, along with the most significant effect on LR (relative risk for LR and OS 0.31 (p=0.01) and 0.76 (p=0.02) for PORT vs. controls, respectively). Four trials (357 patients) were suitable to assess LR rates after surgery and/or induction chemotherapy in stage III NSCLC. LR as first relapse was 30 % (105/357) after 5 years. In the modelling part, PORT with linear accelerators was estimated to reduce LR rates to 10 % as first relapse and to increase the absolute 5-year OS by 13 %.

      Conclusion
      This modelling study generates the hypothesis that modern PORT may increase both LR and OS in stage IIIA-N2 NSCLC even in patients being treated with induction chemotherapy and surgery.

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    P2.19 - Poster Session 2 - Imaging (ID 180)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Imaging, Staging & Screening
    • Presentations: 1
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      P2.19-004 - Characterization of solitary pulmonary lesions combining visual perfusion and quantitative diffusion MR imaging (ID 1000)

      09:30 - 09:30  |  Author(s): J. Vansteenkiste

      • Abstract

      Background
      To evaluate the diagnostic accuracy of dynamic contrast enhanced (DCE)magnetic resonance (MR) and diffusion weighted imaging (DWI) sequences for defining benign or malignant character of solitary pulmonary lesion (SPL) in a preoperative setting.

      Methods
      This study was approved by the local ethics committee; all patients provided written informed consent. First, 54 consecutive patients with SPL, clinically staged (CT and PET or integrated PET-CT) as N0M0, were included in this prospective study. An additional MR examination including DCE and DWI was performed one day before the surgical procedure. Histopathology of the surgical specimen served as standard of reference. Subsequently, this functional method for SPL characterization was validated with a second cohort of 54 patients.

      Results
      In the feasibility group, 11 benign and 43 malignant SPL were included with a maximal diameter that varied from 3 to 71 mm (mean 23.2 mm). Using the conventional MR sequences with visual interpretation of DCE-MR curves sensitivity, specificity, accuracy were respectively 100%, 55% and 91%. By additional interpretation of quantitative apparent diffusion coefficient (ADC) values (with a cutoff value of 1.52x10-3 mm2/sec for ADC calculated from high b-values (ADChigh) these results improved to 98%, 82% and 94% respectively. In the validation group, with 14 benign and 40 malignant SPL (diameter ranged between 7 mm and 10 cm - mean 26.5 mm), these results were confirmed with a sensitivity, specificity and accuracy of 95%, 79%, and 91%, respectively.

      Conclusion
      Visual DCE-MR-based curve interpretation can be used for initial differentiation of benign from malignant SPL, while additional quantitative DWI-based interpretation can further improve the specificity.