Local Progression-free Interval Research Articles

A randomized phase-II study of reirradiation and hyperthermia versus reirradiation and hyperthermia plus chemotherapy for locally recurrent breast cancer in previously irradiated area

Background In patients with inoperable local regional recurrences of breast cancer in previously irradiated areas, local control is difficult to maintain and treatment options are limited. The Dutch standard treatment for such recurrences is reirradiation combined with hyperthermia. Apart from enhancing the effect of reirradiation, hyperthermia is also known to improve local effects of chemotherapy like cisplatin. This randomized phase-II trial compares reirradiation and hyperthermia versus the same treatment combined with cisplatin. Patients and methods From December 2010 up to January 2019, 49 patients were randomized, 27 in the standard arm and 22 in the combined arm. A total of 32 Gy was given in eight fractions of 4 Gy in 4 weeks, at two fractions per week. After January 2015, the radiation schedule was changed to 46 Gy in 23 fractions of 2 Gy, at five fractions per week. Hyperthermia was added once a week after radiotherapy. The combined arm was treated with four cycles of weekly cisplatin 40 mg/m2. Results Complete response rate was 60.9% in the standard arm and 61.1% in the combined arm (p = 0.87). Partial response rate was 30.4% in the standard arm and 33.3% in the combined arm (p = 0.79). One-year overall survival was 63.4% in the standard arm and 57.4% in the combined arm. One-year local progression-free interval was 81.5% in the standard arm and 88.1% in the combined arm (p = 0.95). Twenty-five percentage of patients in the standard arm experienced grade 3 or 4 acute toxicity and 29% of patients in the combined arm (p = 0.79). Conclusion No potential benefit could be detected of adding cisplatin to reirradiation and hyperthermia in patients with recurrent breast cancer in a previously irradiated area. With or without cisplatin, most patients had subsequent local control until last follow-up or death.

Loco-Regional Control and Survival Outcomes After Combined Stereotactic Radiation Therapy and Immune Checkpoint Inhibitors for Brain Metastases From Non-Small Cell Lung Cancer

Over the past decade, improvements in the management of advanced non-small-cell lung cancer (NSCLC) through immunotherapy (IT) with PD-1 pathway inhibitors have been significant, with a major improvement in progression-free survival (PFS) and overall survival (OS). Nevertheless, brain metastases (BM) remain frequent at the time of diagnosis (10%) or during the disease (40%). Stereotactic radiation therapy (SRT) has demonstrated its interest in patients with BM from NSCLC, allowing a clear decrease in neurological toxicity compared to that induced by whole brain RT, without loss of OS. The purpose of this study was to analyze locoregional control (LRC), OS, and neurological toxicity in patients with BM from NSCLC treated with IT and SRT and propose the best possible therapeutic sequence between these two treatments.We retrospectively analyzed NSCLC patients' data with BM treated with IT and SRT within six months between 2015 and 2019. The treated lesions were categorized into the following three groups: "SRT before IT,'' "concurrent SRT and IT," and "SRT after IT.'' "Concurrent" was defined as IT within one month of SRT. Regional progression was defined as the progression or apparition of a BM outside an irradiated area. Regional progression-free interval (R-PFI), OS, and local progression-free interval (L-PFI) were estimated using Kaplan-Meier method and compared using the log-rank test.Fifty-one patients with 84 BM received SRT and IT. The patients were mostly men (60.8%) and WHO 1 (56.9%). For SRT, most lesions were treated with either 15 to 21 Gy in a single fraction (56.0%); or with 18 to 27 Gy in three fractions (41.8%). For IT, patients were treated with Nivolumab (47.1%), Pembrolizumab (33.3%), Durvalumab (15.7%), or Atezolizumab (3.9%) for a median duration of 4.9 months. Among lesions, 76 (90.5%) were intact, and eight (9.5%) were previously resected. The median follow-up from SRT was 22.5 months (2.7-47.3). Six- months and 1-year R-PFI in "SRT before IT" group, "concurrent SRT and IT" group, and "SRT after IT" group were 24.1% and 24.1% vs 56.3% and 49.6% vs 41.0% and 34,2% respectively, (P = 0.094). Although no significant difference has been observed in R-PFI, there was a trend in better regional control of BM from NSCLC in the ''concurrent SRT and IT" group. One-year OS was 67.5% vs 70.2% vs 69.2%, respectively (P = 0.44). One- year L-PFI was 70.1% vs 78.9% vs 77.8%, respectively (P = 0.79). There was no difference in toxicity between the three groups regarding radionecrosis or acute neurological toxicity.Regional control of BM from NSCLC seems to be better in the ''concurrent SRT and IT" group without an increase in acute neurological toxicity or radionecrosis rate. These results may lead to prospective studies on larger cohorts.J. Porte: None. C. Saint Martin: None. T. Frederic Moreau: None. M. Massiani: None. E. Jadaud: None. J. Otz: None. P. Verrelle: None. N. Girard: None. G. Crehange: None. A. Beddok: None.

Cutaneous squamous-cell carcinoma of the head-neck area refractory to chemo-radiotherapy: benefit from anti-PD-1 immunotherapy

Objective:Radiotherapy provides excellent results in locally advanced cutaneous squamous-cell carcinoma of the head and neck area (cSCC-HN), with a 2-year local progression-free interval obtained for about 80% of patients. Overexpression of immune checkpoint co-inhibitory molecules, like PD-L1 (programmed death ligand 1), by cancer cells may define local immunosuppression, tumour escape from immune surveillance and reduced radiotherapy efficacy.Methods:A 65-year-old female, with a large exophytic cSCC-HN invading adjacent soft tissues, was treated with hypofractionated accelerated chemo-radiotherapy. The patient received four bi-weekly cycles of chemotherapy concurrently with eight fractions of 5.5 Gy (two fractions per week). Two months after the end of chemo-radiotherapy, the tumour was stable in dimensions, without any signs of symptomatic relief. The patient was, after that, treated with anti-PD-1 immunotherapy (nivolumab). The tumour gradually regressed, reaching partial response after four cycles and complete response after 16 cycles of nivolumab. No side-effects related to immunotherapy were recorded. The patient is alive and without evidence of disease 28 months after radiotherapy.Conclusions:Treatment of patients with chemo- and radio-resistant cSCC-HN with immunotherapy may optimize the efficacy of radiotherapy by stimulating immunological tumour rejection mechanisms. cSCC-HN patients who fail to respond to chemo-radiotherapy completely are expected to benefit the most from immunotherapy because of the radio-vaccination effect expected from the preceded radiotherapy.

Efficacy and safety of CyberKnife radiosurgery in elderly patients with brain metastases: a retrospective clinical evaluation

BackgroundStereotactic radiosurgery (SRS) has been increasingly applied for up to 10 brain metastases instead of whole brain radiation therapy (WBRT) to achieve local tumor control while reducing neurotoxicity. Furthermore, brain-metastasis incidence is rising due to the increasing survival of patients with cancer. Our aim was to analyze the efficacy and safety of CyberKnife (CK) radiosurgery for elderly patients.MethodsWe retrospectively identified all patients with brain metastases ≥ 65 years old treated with CK-SRS at our institution since 2011 and analyzed data of primary diseases, multimodality treatments, and local therapy effect based on imaging follow-up and treatment safety. Kaplan–Meier analysis for local progression-free interval and overall survival were performed.ResultsWe identified 97 patients (233 lesions) fulfilling the criteria at the first CK-SRS. The mean age was 73.2 ± 5.8 (range: 65.0–87.0) years. Overall, 13.4% of the patients were > 80 years old. The three most frequent primary cancers were lung (40.2%), kidney (22.7%), and malignant melanoma (15.5%). In 38.5% (47/122 treatments) multiple brain metastases were treated with the CK-SRS, with up to eight lesions in one session. The median planning target volume (PTV) was 1.05 (range: 0.01–19.80) cm3. A single fraction was applied in 92.3% of the lesions with a median prescription dose of 19 (range: 12–21) Gy. The estimated overall survivals at 3-, 6-, and 12 months after SRS were 79, 55, and 23%, respectively. The estimated local tumor progression-free intervals at 6-, 12-, 24-, 36-, and 72 months after SRS were 99.2, 89.0, 67.2, 64.6, and 64.6%, respectively. Older age and female sex were predictive factors of local progression. The Karnofsky performance score remained stable in 97.9% of the patients; only one patient developed a neurological deficit after SRS of a cerebellar lesion (ataxia, CTCAE Grade 2).ConclusionsSRS is a safe and efficient option for the treatment of elderly patients with brain metastases with good local control rates without the side effects of WBRT. Older age and female sex seem to be predictive factors of local progression. Prospective studies are warranted to clarify the role of SRS treatment for elderly patients.

Single- versus 2-session Gamma Knife surgery for symptomatic midsize brain metastases: a propensity score-matched analysis.

Two-session Gamma Knife surgery (GKS) has recently been demonstrated to be an effective and less-invasive alternative for large brain metastases not treatable by microsurgical resection. This raises the clinical question of whether the 2-session GKS strategy further improves treatment outcomes for patients with symptomatic midsize brain metastases (2-10 cm3) as compared to single-session GKS. The present study aimed to compare the local therapeutic effects and toxicities of single-session and 2-session GKS for treating these lesions. Patients with focal neurological deficits attributable to midsize brain metastases who underwent upfront GKS during the period from 2010 to 2018 were retrospectively identified from an institutional database. Patients for whom both post-GKS imaging studies and neurological evaluations from outpatient visits were available were eligible. Using propensity score-matching (PSM) analysis, unique matched pairs which had a similar likelihood of receiving 2-session GKS were generated. The main outcome measure was a composite of imaging and/or neurological worsening of the lesion of interest. Functional improvement and overall survival (OS) were also compared between the 2 treatment arms. In total, 219 cancer patients with 252 symptomatic midsize brain metastases were eligible. Of these 252 tumors, 176 and 76 were treated with single- and 2-session GKS, respectively. After PSM, 68 pairs of tumors were obtained. The Gray test showed that 2-session GKS achieved a longer local progression-free interval than single-session GKS (1-year local control rate: 84% vs 53%; HR 0.31, 95% CI 0.16-0.63, p = 0.001). Two-session GKS was also associated with greater functional improvement in KPS scores (mean 18.3 ± 14.6 vs 12.8 ± 14.1, p = 0.040). The median OS did not differ significantly between single- and 2-session GKS (15.6 vs 24.7 months; HR 0.69, 95% CI 0.44-1.10, p = 0.11). Two-session GKS achieved more durable local tumor control and greater functional improvement than single-session GKS for patients with symptomatic midsize brain metastases, although there was no OS advantage.

OS4.4 Hypofractionated stereotactic radiotherapy and anti-PDL1 Durvalumab combination in recurrent glioblastoma: Results of the phase I part of the phase I/II STERIMGLI trial

Abstract BACKGROUND Glioblastoma (GBM) remains a lethal disease with inevitable local relapse and no standard treatment. Re-irradiation by hypofractionated stereotactic radiotherapy (hFSRT) is an option of treatment with tolerable safety, but needs improvement in term of efficacy. Radiotherapy (RT) causes immunogenic tumor cell death but also induces PDL1 and PD1 expression on tumors and immune cells, potentially evoking resistance to RT. Pre-clinical studies combining hFSRT with an anti-PD-1 antibody in GBM have shown increased efficacy of the combination. Clinical studies also show encouraging results when checkpoint inhibitors have been combined with high dose RT. We hypothesized that combining the anti PD-L1 Durvalumab (Durva) with hFSRT will be an effective regimen for patients with recurrent GBM. We designed a phase I/II clinical trial studying the combination of hFSRT with Durva for recurrent GBM≤35 mm diameter. Results of the phase I are presented. MATERIAL AND METHODS Patients were included from February 2017 to October 2017. A standard 3 + 3 de-escalation design was used. Patients were treated by hFSRT 24 Gy, 8 Gy/fraction at 80% isodose, every other day, combined with Durva infusion 1500mg first dose (Level 1) or 750 mg (Level -1) delivered on the last hFSRT day followed by 1500 mg Durva infusion every four weeks until relapse. The schema was defined as safe if one patient or less among 6 presents a dose limiting toxicity (DLT). Brain MRI was performed before RT and then every 8 weeks until relapse. Tumor assessment was performed according to RANO criteria. RESULTS Among the 6 patients (3 methylated MGMT, 3 unmethylated MGMT; all wild type IDH) included at the level 1, all completed the hFSRT course, only one had a DLT which was an immune related grade 3 vestibular neuritis. At the time of analysis (24/01/19), all the patients had a local tumor progression, 4 were still alive. Local progression free interval (LPFI) ranges from 2.1 to 8.1 months. Interestingly the 2 patients who presented a pseudo-progression had a prolonged LPFI (5.7 and 8.1 months) compared to the other patients. All the patients except these 2 patients had a lymphopenia at inclusion. PDL-1 expression varied from 0 to 70% in the primary tumor. CONCLUSION Combining three 8 Gy fractions of hFSRT with 1500 mg Durvalumab on the 3rd fraction hFSRT and every 4 weeks for recurrent GBM is well tolerated justifying exploration of its efficacy in the phase II which is currently in interim analysis

A randomized phase II trial of concurrent chemoradiation with two doses of radiotherapy, 60 Gy and 66 Gy, concomitant with a fixed dose of oral vinorelbine in locally advanced NSCLC

IntroductionIn order to test the best performing radiation dose with a convenient chemotherapy schedule of an oral formulation of radio-sensitizing vinorelbine in inoperable locally advanced non-small cell lung cancer (NSCLC), we performed a randomized phase II trial based on a “pick the winner” design. MethodsAfter 2 cycles of neoadjuvant chemotherapy, 117 patients with NSCLC stage IIB–IIIB in performance status 0–1 were randomized to radiotherapy 60Gy/30 fractions or 66Gy/33 fractions concurrent with a fixed dose of oral vinorelbine 50mg administered 3 times weekly. The primary endpoint was local progression free interval. A scheduled FDG-PET-CT-scan was performed 9months after randomization. The study was registered at ClinicalTrials.gov (NCT 00887783). ResultsBoth arms were well tolerated. The local progression free interval at 9months was 54% in the 60Gy arm and 59% in the 66Gy arm (log rank test p=0.55). There was no statistically significant difference in overall survival. The median survival was 23.3 and 23.7months in the 60 and 66Gy arm, respectively. No significant difference in toxicity was observed. ConclusionBoth 60 and 66Gy administered concomitant with oral vinorelbine showed similar local control and overall survival, and was well tolerated. The pick the winner design choose 66Gy as the winning arm.

Une forme rare de lymphome cutané primitif

Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab.Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m2) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m2 loading dose one week prior to radiotherapy followed by weekly 250 mg/m2). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6–8 weeks after treatment. Toxicity was reported as well.Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p = 0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p = 0.39; OS p = 0.99). Toxicity compared equally between both groups.The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.

Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: Efficacy and safety outcomes of a randomized, multi-center phase II study investigating

BackgroundModest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients and methodsPatients received high dose accelerated radiotherapy (66Gy in 24 fractions) and concurrent daily Cisplatin (6mg/m2) without (Arm A) or with (Arm B) weekly Cetuximab (400mg/m2 loading dose one week prior to radiotherapy followed by weekly 250mg/m2). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6–8weeks after treatment. Toxicity was reported as well. ResultsBetween February 2009 and May 2011, 102 patients were randomized. Median follow up was 29months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. ConclusionThe addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.

Incidence of isolated nodal failure in non-small cell lung cancer patients included in a prospective study of the value of PET–CT

PurposeElective nodal irradiation (ENI) is not recommended in PET–CT-based radiotherapy for NSCLC despite a low level of evidence to support such guidelines. The aim of this investigation is to find out whether omitting ENI is safe. Materials and methodsSixty-seven patients treated within a frame of a previously published prospective trial of the value of PET–CT were included in the analysis. Seventeen (25%) patients received ENI due to higher initial nodal involvement and in the remaining 50 patients (75%) with N0-N1 or single N2 disease ENI was omitted. Isolated nodal failure (INF) was recorded if relapse occurred in the initially uninvolved regional lymph node without previous or simultaneous local recurrence regardless of the status of distant metastases. ResultsWith a median follow-up of 32months, the estimated 3-year overall survival was 42%, local progression-free interval was 55%, and distant metastases-free interval was 62%. Three patients developed INF; all had ENI omitted from treatment, giving a final result of three INFs in 50 (6%) patients treated without ENI. In this group of patients, the 3-year cause-specific cumulative incidence of INF was 6.4% (95% confidence interval: 0–17%). ConclusionsThe omission of ENI appears to be not as safe as suggested by current recommendations.

Percutaneous Cryoablation of Pulmonary Metastases from Colorectal Cancer

ObjectiveTo evaluate the safety and efficacy of cryoablation for metastatic lung tumors from colorectal cancer.MethodsThe procedures were performed on 24 patients (36–82 years of age, with a median age of 62; 17 male patients, 7 female patients) for 55 metastatic tumors in the lung, during 30 sessions. The procedural safety, local progression free interval, and overall survival were assessed by follow-up computed tomographic scanning performed every 3–4 months.ResultsThe major complications were pneumothorax, 19 sessions (63%), pleural effusion, 21 sessions (70%), transient and self-limiting hemoptysis, 13 sessions (43%) and tract seeding, 1 session (3%). The 1- and 3-year local progression free intervals were 90.8% and 59%, respectively. The 3-years local progression free intervals of tumors ≤15 mm in diameter was 79.8% and that of tumors >15 mm was 28.6% (p = 0.001; log-rank test). The 1- and 3-year overall survival rates were 91% and 59.6%, respectively.ConclusionThe results indicated that percutaneous cryoablation is a feasible treatment option. The local progression free interval was satisfactory at least for tumors that were ≤15 mm in diameter.

20 Years Experience of TNF-Based Isolated Limb Perfusion for In-Transit Melanoma Metastases: TNF Dose Matters

BackgroundApproximately 5–8% of melanoma patients will develop in-transit metastases (IT-mets). Tumor necrosis factor-α (TNF) and melphalan-based isolated limb perfusion (TM-ILP) is an attractive treatment modality in melanoma patients with multiple IT-mets. This study reports on a 20 years experience and outlines the evolution and major changes since the introduction of TNF in ILP.MethodsA total of 167 TM-ILPs were performed in 148 patients, between 1991 and 2009. TM-ILPs were performed at high doses of TNF (3–4 mg) from 1991 to 2004 (n = 99) and at low doses of TNF (1–2 mg) from 2004 to 2009 (n = 68) under mild hyperthermic conditions (38°C–39.5°C.). Melphalan doses were unchanged at 10–13 mg/l (leg and arm, respectively). Characteristics for the 167 ILPs were: 81 stage IIIB, 65 stage IIIC, and 21 stage IV disease.ResultsThe overall response rate was 89% (n = 148). (Complete response [CR] = 61%; partial response [PR] = 28%). CR rates correlated with stage (P = .001) and with high-dose vs. low-dose TNF (70% vs. 49%; P < .006). High-dose TNF prolonged local control (median 16 months vs. 11 months; P = .076). Survival was not influenced by TNF dose. CR after ILP and number of lesions also correlated with local progression-free interval. Overall survival did correlate with stage of disease (P < .001), size of the lesions (P = .001), and a CR (P < .001).ConclusionsThis 2-decade single-center experience demonstrates that TM-ILP is a safe and effective treatment modality for melanoma patients with multiple IT-mets. Higher dose of TNF was associated with significantly higher CR rates and prolonged local control without an effect on overall survival.

MRI-Guided Percutaneous Cryotherapy for Soft-Tissue and Bone Metastases: Initial Experience

We sought to determine the safety and feasibility of percutaneous MRI-guided cryotherapy in the care of patients with refractory or painful metastatic lesions of soft tissue and bone adjacent to critical structures. Twenty-seven biopsy-proven metastatic lesions of soft tissue (n = 17) and bone (n = 10) in 22 patients (15 men, seven women; age range, 24-85 years) were managed with MRI-guided percutaneous cryotherapy. The mean lesion diameter was 5.2 cm. Each lesion was adjacent to or encasing one or more critical structures, including bowel, bladder, and major blood vessels. A 0.5-T open interventional MRI system was used for cryoprobe placement and ice-ball monitoring. Complications were assessed for all treatments. CT or MRI was used to determine local control of 21 tumors. Pain palliation was assessed clinically in 19 cases. The mean follow-up period was 19.5 weeks. Twenty-two (81%) of 27 tumors were managed without injury to adjacent critical structures. Two patients had transient lower extremity numbness, and two had both urinary retention and transient lower extremity paresthesia. One patient had chronic serous vaginal discharge, and one sustained a femoral neck fracture at the ablation site 6 weeks after treatment. Thirteen (62%) of the 21 tumors for which follow-up information was available either remained the same size as before treatment or regressed. Eight tumors progressed (mean local progression-free interval, 5.6 months; range, 3-18 months). Pain was palliated in 17 of 19 patients; six of the 17 experienced complete relief, and 11 had partial relief. MRI-guided percutaneous cryotherapy for metastatic lesions of soft tissue and bone adjacent to critical structures is safe and can provide local tumor control and pain relief in most patients.

SO15P PERCUTANEOUS RADIOFREQUENCY ABLATION OF LUNG TUMOURS: PROGNOSTIC RISK FACTORS FOR LOCAL PROGRESSION

Purpose The purpose of this series was to evaluate the prognostic features for local progression in non‐surgical candidates after undergoing percutaneous RFA of lung tumours.Methodology From Nov 2000, a total of 233 lung neoplasms (9 primary) in 95 patients (56 males, mean age of 66 years) with a mininum follow‐up of 6 months were included in this study. The primary end point was local progression free interval defined from the time of RFA intervention. Local progression was defined as tumour recurrence of previously RFA treated site/s. Univariate and multivariate analysis were performed to identify significant prognostic parameters for post‐ablative tumour recurrence.Results The mean number of tumours ablated per patient was 2.5 while the mean diametre of tumours was 2.2 cm. After a median follow up period of 24 months (range: 6–54 months), 32% of ablated tumours recurred. The overall median local progression free interval was 20 months (range 3–54 months) with 1, 2 and 3 year local progression free survival of 82%, 74% and 68% respectively. Univariate analysis of lesion characteristics identified size (p = 0.0002), hilar location (p = 0.0141), proximity to bronchus (p = 0.009) and vessel (p = 0.001), number of ablations required per lesion (p = 0.0052) and post‐ablation and tumour volume ratio (p = 0.0002) as statistically significant prognostic factors for tumour recurrence. Multivariate analysis identified size of lung tumours &gt;3 cm (p = 0.07) as an independent risk factor for local progression.Conclusion Percutaneous lung RFA may play a useful role as a local therapy in non‐surgical candidates with pulmonary neoplasms. However, the efficacy of local control may be restricted to lesions smaller than 3 cm.

Percutaneous radiofrequency ablation of lung tumours: results in the mid-term☆

Radiofrequency ablation (RFA) of lung tumours has recently received much attention for the promising results achieved. Herein, we report the 5 years experience of a single referral centre in Europe, with particular reference to the mid-term results. Between October 2001 and June 2005, we performed 88 RFAs of lung tumours, 9 of which were followed by surgical resection. The remaining 79 RFAs, the object of this paper, were performed to treat 64 lesions in 54 patients: 39 males and 15 females with a mean age of 71.7 years (range of 51-89). All patients had clinical or pathological evidence of the neoplastic lesion, which was non-small cell lung cancer (NSCLC) in 40 cases and a metastasis in 24 cases. The mean size of the lesions was 2.4 cm (range of 1-5). Ten lesions were re-treated from one to as many as four times. The procedure was always performed under local anaesthesia and conscious sedation. A generator of RF with max power output of 200W was utilised together with a needle with nine deployable electrodes, to achieve a target temperature of 90 degrees C that was maintained for 15-27 min according to the size of the lesions. In all cases, except two, the procedure was technically successful. Morbidity consisted in 10 cases (12.7%) of partial pneumothorax, 1 haematoma of the chest wall and 1 pleural effusion. At a mean follow-up of 23.7 months (range of 6-50) we recorded a 61.9% of complete responses, with a higher rate in the metastatic lesions (70.8%) and in those smaller than 3 cm (69.7%). Mean (median) overall survival and local progression-free interval were 17.3 (28.9) months and 12.9 (24.1) months, respectively. Efficacy of RFA in the mid-term seems to settle at a promising level, with better results for metastatic lesions and, above all, for lesions smaller than 3 cm. Notwithstanding these encouraging results, RFA remains an alternative local therapy only when surgery cannot be performed, especially in NSCLC.