Radiotherapy and Oncology

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1 Radiotherapy and Oncology xxx (2013) xxxxxx Contents lists available at SciVerse ScienceDirect Radiotherapy and Oncology journal homepage: Original article Outcomes of stereotactic ablative radiotherapy for central lung tumours: A systematic review Sashendra Senthi, Cornelis J.A. Haasbeek, Ben J. Slotman, Suresh Senan Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands article info abstract Article history: Received 2 November 2012 Received in revised form 9 January 2013 Accepted 14 January 2013 Available online xxxx Keywords: Lung cancer Stereotactic Inoperable Central Toxicity Mortality Background and purpose: Stereotactic ablative radiotherapy (SABR) has improved the survival for medically inoperable patients with peripheral early-stage non-small cell lung cancer (NSCLC). We performed a systematic review of outcomes for central lung tumours. Material and methods: The systematic review was performed following PRISMA guidelines. Survival outcomes were evaluated for central early-stage NSCLC. Local control and toxicity outcomes were evaluated for any centrally-located lung tumour. Results: Twenty publications met the inclusion criteria, reporting outcomes for 563 central lung tumours, including 315 patients with early-stage NSCLC. There was heterogeneity in the planning, prescribing and delivery of SABR and the common toxicity criteria used to define toxicities (versions ). Tumour location (central versus peripheral) did not impact overall survival. Local control rates were P85% when the prescribed biologically equivalent tumour dose was P100 Gy. Treatment-related mortality was 2.7% overall, and 1.0% when the biologically equivalent normal tissue dose was 6210 Gy. Grade 3 or 4 toxicities may be more common following SABR for central tumours, but occurred in less than 9% of patients. Conclusions: Post-SABR survival for early-stage NSCLC is not affected by tumour location. SABR achieves high local control with limited toxicity when appropriate fractionation schedules are used for central tumours. Ó 2013 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology xxx (2013) xxxxxx Anatomic surgical resection is the treatment of choice for patients diagnosed with early-stage non-small cell lung cancer (NSCLC) [1,2]. For tumours that are centrally located, more extensive surgical procedures are required due to tumour invasion into the major bronchi and/or vessels [3,4], which is associated with a higher mortality and morbidity [5]. Thus, the treatment of central tumours represents a high-risk clinical scenario in which the risks associated with surgery have been deemed acceptable. As the global population ages, the proportion of elderly lung cancer patients and those with comorbidities will also increase [69]. For the unfit elderly with peripheral early-stage NSCLC, stereotactic ablative radiotherapy (SABR) is considered the preferred treatment [2], offering improved survival and quality of life over conventional radiotherapy [10,11]. In an early SABR trial, fractions of 2022 Gy, delivering total doses of 6066 Gy to central tumours were associated with a greater than 10-fold increased risk of highgrade toxicity or death [12]. This led to an ongoing Radiation Therapy Oncology Group (RTOG) phase I/II trial (0813) specifically for central tumours, to determine the maximum tolerated dose which Corresponding author. Address: Department of Radiation Oncology, VU University Medical Center, De Boelelaan 1118, 1081 HV Amsterdam, The Netherlands. address: s.senthi@vumc.nl (S. Senthi). can be delivered in five fractions [13]. Similarly, it has lead others to suggest that the risks associated with SABR for central tumours may be prohibitive and high-dose accelerated radiotherapy be the subject of further research [14]. As reports from Japanese and Dutch investigators have reported favourable outcomes in early-stage tumours using daily fractions of Gy to total doses of 4860 Gy [15,16], many centres have continued to use SABR for central tumours. We performed a systematic review of published literature on the clinical outcomes of SABR for central lung tumours. Methods A systematic review was performed according to the PRISMA guidelines [17]. We searched for English-language papers published from January 2000 to August The inclusion criteria were: 1. Studies reporting clinical outcomes following SABR for primary NSCLC or metastatic lung tumours and, 2. Studies specifically reporting clinical outcomes for centrally located tumours /$ - see front matter Ó 2013 Elsevier Ireland Ltd. All rights reserved.

2 2 SABR for central lung tumours Studies were excluded if: 1. They were review articles or case reports, 2. They were not the most recently published outcomes, in instances of multiple publications from the same study cohort. Using PubMed, the search was completed in August The search strategy was (sabr[tw] OR sbrt[tw] OR srt[tw] OR stereotactic[tw]) AND lung[tw] AND (central[tw] or centrally[tw]), which identified 86 studies. Two clinicians reviewed these and the reference lists of selected articles to determine which were suitable for inclusion. Survival outcomes were restricted to patients with central early-stage NSCLC [18]. Local control and toxicity outcomes included those reported for any central tumour receiving SABR. Toxicity outcomes were included when graded using the Common Toxicity Criteria (CTC) protocol version in place at the time. The prescribed tumour doses were converted into a biologically equivalent dose (BED) to enable comparison between studies, acknowledging the limitations of this approach [19,20]. The BED was calculated using the assumption that tumour and normal tissue alpha/beta ratios were 10 Gy (BED 10 ) and 3 Gy (BED 3 ), respectively [21]. BED 10 calculations were made using the dose delivered to at least 95% of the planning target volume (). BED 3 calculations were made using the prescribed dose schedules and the maximum organ at risk doses received when studies provided this detail. BED calculations did not take into account tumour doubling time or the length of treatment. Results A total of 20 studies were found suitable for inclusion. Four of these were prospective [2225], including two Phase II studies [23,24]. Seven studies reported clinical outcomes for NSCLC together with metastatic tumours [2632] and one reported outcomes restricted to central early-stage NSCLC alone [32]. From these 20 studies, a total of 563 central tumours (including 315 early-stage NSCLC patients) received SABR. The radiotherapy details of these studies are summarized in Table 1. In these studies toxicities were described using CTC versions 2.0, 3.0 and 4.0. Survival The only prospective survival outcomes (n = 22) specific to central early-stage NSCLC were reported by Fakiris et al. [24], updating the initial report from Timmerman et al. [12]. The median overall survival was 24 months (95% CI 1842), which was not statistically different (p = 0.697) from that of peripheral tumours. Haasbeek et al. reporting outcomes from the largest retrospective cohort, found the 3-year overall survival for central (n = 63) and peripheral (n = 445) early-stage NSCLC was statistically no different, 64% vs. 51% (p = 0.09) respectively [32]. Bradley et al. reported a 2-year overall survival of 75% for all early stage NSCLC and found central (vs. peripheral) location did not impact survival on both univariate (p = 0.429) and multivariate analyses [33]. Similarly, Janssen et al. found fractionation schedule, which depended on tumour location alone, did not impact survival on both univariate and multivariate analyses [31], while Andratschke et al. found tumour location did not impact survival on univariate analysis for histologically proven early-stage NSCLC (p = 0.653) [34]. Cause-specific survivals for central early-stage NSCLC have been reported to be greater than 80% at 23 years [30,33,35]. Table 2 details all reported survival outcomes. Local control After a median follow-up of 16 months, a prospective trial by Bral et al. found that tumour location did not impact recurrence, with the crude local control for central tumours being 94% (1/17) [23]. Retrospective studies have reported similar local control outcomes, with 2 and 3-year rates typically exceeding 85% [23,26,31 33,3638], as shown in Table 2. However, six studies have reported poorer local control, of between 6076% [27,29,30,34,35]. In two of these, SABR was prescribed to the isocentre, leading to a significantly lower peripheral tumour doses being delivered [29,35]. In the third study, 23% (12/53) of patients had stage II, III or recurrent stage III disease and 10% (6/63) of lesions had SABR delivered as a radiotherapy boost following conventional radiotherapy [27]. Although stage-specific local control outcomes were not reported, in the latter study the 2-year survival for non-stage I patients was 12%. In the fourth study reporting poorer local control, only 64% (37/58) of tumours had planning target volume coverage above 95% as under-dosage was permitted to meet normal organ constraints [30]. Additionally, in this study multiple fractionation schedules were utilized, and local control was 85% when the BED 10 was P100 Gy and 60% when the BED 10 was <100 Gy. In the last two studies, the modal prescribed doses were 35 Gy [34] and 40 Gy [27] in five fractions, resulting in a respective BED 10 of 60 and 72 Gy. The importance of maintaining a BED 10 of at least 100 Gy to the tumour periphery was evident from a number of studies. Using a schedule of five fractions, Olsen et al. reported a 100% 2-year local control using a total dose of 50 Gy (BED Gy) and 50% using 45 Gy (BED Gy) [38]. Here, fractionation schedule was the only factor found to impact local control on multivariate analysis (p = 0.019). Similarly, Rowe et al. reported a 2-year local control of 94% with a BED 10 P100 Gy and 80% when <100 Gy, (p = 0.02) [37]. Using a SABR schedule of four fractions, Chang et al. reported a crude local control of 100% with a total dose of 50 Gy (BED ) vs. 57% using 40 Gy (BED Gy) [26]. Two additional studies in which central and peripheral tumours were analysed together, also found that a BED 10 above 100 Gy improved local control [15,25]. The post-sabr regional and distant control rates specifically for central early-stage NSCLC have been infrequently reported. Haasbeek et al. reported 2-year regional and distant control rates of 91% and 73%, respectively, which were no different from peripheral tumours treated by the authors using SABR over the same period, 86% (p = 0.47) and 75% (p = 0.72), respectively [32]. Two additional studies reported a crude distant recurrence rate of approximately 15%, which was the predominant pattern of recurrence [26,36]. Treatment-related mortality In a prospective study utilizing a SABR fractionation with a BED 3 of 460 Gy, Fakiris et al. reported 18% (4/22) of patients with central tumours had potential treatment-related deaths [24]. Although an independent committee defined these, they included infective pneumonia and haemoptysis in the setting of local recurrence. Bral et al. reported the only other prospectively defined treatment-related death, a case of fatal haemoptysis after stent insertion for bronchial stricture [23]. Milano et al. reported 8.7% (4/46) mortality rate using SABR for central non-stage I NSCLC and no mortalities treating central stage I tumours [27]. It must be noted that in three (75%) of these cases, the authors could not exclude respiratory infection as the cause of death. Onimura et al. and Unger et al. each reported one treatment-related death, which were caused by an oesophageal ulcer (BED Gy) and bronchial fistula (BED Gy) respectively [15,28]. The latter two cases are the only cases of treatment-related death observed when the prescribed BED 3 was 6210 Gy. Table 3 details all treatment-related mortality reported for centrally located tumours. The overall treatment-related mortality rate from central tumours receiving SABR was 2.8% (16/563). For

3 Table 1 Baseline radiotherapy details. Author (year) Simulation Target volumes Image guidance Prescription Heterogeneity correction Total dose gray/ fractions Onimura [15] (2003) Inspiration, expiration, standard ITV + PBM = Orthogonal x-rays Isocentre, got 80% No 48/8 CT Xia [22] (2006) Slow CT and fluoroscopy GTV + 10 mm = Not reported 50% Isodose covering 95% No 50/10 Chang [26] (2008) 4-Dimentional CT ITV + 8 mm = CTV + 3 mm = CT-on-rails and orthogonal X-ray 7590% Isodose covering Yes 50/4 Song [36] Standard CT with fluoroscopy GTV + PBM = Conebeam CT 85% Isodose covering 95% No 48/4 a Milano [27] Expiratory breath hold CT GTV + PBM = Stereoscopic X-ray Isocentre, got 80% No 50/5 a Fakiris [24] Standard CT GTV = CTV + PBM = No reported 80% Isodose covering 95% No 60/3 Guckenberger [40] 4-Dimentional CT ITV + 5 mm = Conebeam CT 65% Isodose covering Yes 48/8 Unger [28] Inhalation breath hold. fiducials GTV = Respiratory tracking fiducial 7080% Isodose covering 95% Yes 40/5 markers Oshiro [29] Expiratory breath hold CT GTV + PBM = Gated X-ray Not reported, likely to isocentre No 50/5 a Baba [35] Inspiration, expiration, standard ITV + PBM = Not reported Isocentre, 95% of got 80% Yes 50/4 CT Bradley [33] 4-Dimentional CT ITV + PBM = Not reported 7585% Isodose covering 95% Yes b 45/5 Andratschke [34] Multiple standard and slow CT ITV + PBM = Orthogonal x-rays 60% Isodose covering 100% Yes 35/5 a Haasbeek [32] 4-Dimentional CT ITV + 3 mm = Orthogonal X-ray 80% Isodose covering 99% No 60/8 Bral [23] Planning PET CT and fluoroscopy ITV + 5 mm = Stereoscopic X-ray 95% Isodose covering 95% No 60/4 Olsen [38] 4-Dimentional CT ITV + PBM = Conebeam CT 6090% Isodose covering 95% Yes 50/5 a Stauder [39] 4-Dimentional CT ITV + PBM = Conebeam CT 100% Isodose covering 95% Yes b 48/4 Rowe [37] 4-Dimentional CT ITV + 7 mm = Conebeam CT 100% Isodose covering 95% Yes 50/4 a Nuyttens [30] Standard CT GTV + 5 mm = Respiratory tracking fiducial 7590% Isodose covering 95% Yes 60/5 a markers Taremi [25] 4-Dimentional CT ITV + 5 mm = Conebeam CT 100% Covered 95% of Yes b 60/8 Janssen [31] 4-Dimentional CT ITV + 3 mm = CTV + PBM = Conebeam CT 80% Isodose covering No 48/8 Population based margins (PBM) utilized to account for tumour motion were typically 5 mm radially and 810 mm longitudinally. a Modal dose fractionation schedule shown when multiple schedules were utilized. b Heterogeneity correction not utilized in all treatments. S. Senthi et al. / Radiotherapy and Oncology xxx (2013) xxxxxx 3

4 4 SABR for central lung tumours Table 2 Survival and local control. Author (year) BED 10 Overall survival Cause-specific survival Local control Chang [26] (2008) 113 Crude rate 89% Song [36] % at 2 years 89% at 2 years Milano [27] % at 2 years 73% at 2 years Fakiris [24] 180 Median 24 months Unger [28] 72 63% at 1 year Oshiro [29] 80 60% at 2 years Baba [35] 90 72% at 3 years 82% at 3 years 66% at 3 years Bradley [32] 86 75% at 2 years a,b 90% at 2 years a,b 86% at 2 years Andratschke [34] 60 29% at 3 years 64% at 3 years Haasbeek [32] % at 3 years 93% at 3 years Bral [23] 150 Crude rate 94% Olsen [38] % at 2 years c Rowe [37] % at 2 years Nuyttens [30] % at 3 years b 3 years 80% 76% at 2 years Janssen [31] 77 87% at 1 year a Biologically equivalent tumour dose (BED 10 ). Survival outcomes for central early-stage NSCLC. Local control for all central lung tumours receiving SABR. a Includes central and peripheral tumours with multivariate analysis showing location had no impact on outcome. b Outcome not reported specifically but estimated from KaplanMeier curve. c Local control at 2-years using 45 and 50 Gy in five fractions was 50% and 100%, respectively (p = 0.006). tumours receiving a BED 3 P210 Gy the rate of treatment-related death was 3.6% (13/359), while it was 1.0% (2/204) when the SABR schedule had a BED 3 <210 Gy. The median duration of follow-up in all 20 studies was 19 months (range 1050). Of the studies reporting treatment-related death, the median time to death following SABR was 7.5 months (range 512.5) [15,24,27,37,39]. Grade 3 or 4 toxicity Bral et al. reported a 2-year grade 3 or higher lung toxicity free survival of 60% for central tumours in a prospective trial, with a trend towards statistical significance compared to peripheral lesions (80%, p = 0.06) [23]. Baba et al. observed a similar trend of higher pulmonary toxicity treating central tumours, with the rate of grade 23 pneumonitis being 25% vs. 11% for peripheral tumours (p = 0.11) [35]. A detailed description of all grade 3 or 4 toxicities, and the CTC protocol version used to define them are shown in Table 3. Amongst the toxicities observed, respiratory toxicity including pneumonitis, pneumonia, dyspnoea (typically increased oxygen requirement in patients already using oxygen) and bronchial stricture were the most prevalent. There was one reported case of grade 3 esophagitis, rib fracture and pericarditis each [27,32,40]. Using a wide range of fractionation schemes, Song et al. reported that 33% (3/9) of patients with central tumours developed high-grade bronchial stricture post-sabr and that 89% (8/9) developed any stricture [36]. Patients who developed high-grade strictures in their report were prescribed 4048 Gy delivered in four fractions (BED Gy). Bral et al. and Nuyttens et al. observed high-grade toxicity in 23.5% (4/17) and 17.2% (10/58), respectively [23,30]. These studies utilized SABR fractionation schemes with a BED 3 of 360 Gy and 300 Gy (modal). However, all ten high-grade toxicities seen by Nuyttens et al. were grade 3 pneumonitis, with the authors reporting that seven of these had probable co-existing infections. Three studies, treating 47 central tumours, reported no grade 3 or 4 toxicity when using a BED 3 ranging between Gy [15,22,31]. After excluding studies in which toxicity outcomes for both central and peripheral tumours or grade 2 and 3 toxicity were not reported separately, grade 3 or 4 toxicity occurred in 8.6% (36/418) of central tumours treated with SABR. Discussion Although surgery offers the best chance of survival for earlystage NSCLC, patients with a clinical diagnosis of stage I NSCLC have a 5-year survival of only 4350% [1,2]. Surgery is less likely to be recommended for the elderly and those with comorbidities [9,41]. For these patients, increasing access to SABR has improved population-based survival [4144]. Due to concerns about the safety of SABR for central tumours, we performed a systematic review, which identified 20 studies reporting clinical outcomes for 563 central tumours receiving SABR. Our main findings were that the overall survival reported following SABR for both central and peripheral early-stage NSCLC was similar, and the risk of highgrade toxicity post-sabr for central lung tumours was less than 9%. Moreover, when utilizing appropriate fractionation schedules in which the BED 10 P100 Gy and BED Gy, local control exceeded 85% and the risk of treatment-related mortality was less than 1%. Although pneumonectomy was traditionally performed for central lung tumours, the use of broncho-angioplastic procedures has reduced pneumonectomy rates for stage I NSCLC to between 5% and 11% [4547]. However, irrespective of the type of surgery performed for central stage I NSCLC, perioperative mortality and surgical complication rates are approximately 4.5% and 25%, respectively, as shown in Table 4 [5]. In addition, patients undergoing broncho-angioplasty have an 8% risk of stump/anastamotic complication, which includes bronchial necrosis, dehiscence, stricture and fistula formation [5]. These findings indicate that the risk of mortality and morbidity in treating central tumours can be considerable, even when patients are fit enough to undergo surgery. Despite this, surgery is still recommended whenever possible for early stage NSCLC [1,2]. A randomized trial comparing sublobar resection, with or without brachytherapy, for high-risk operable patients reported 33% of patients in either trial arm had grade 3 or worse toxicity [48]. This suggests that our findings of a 9% risk of high-grade toxicity, and less than 1% risk of treatment-related mortality following SABR for central tumours in elderly patients with comorbidities, should not preclude the continued evaluation of SABR in this patient group. Despite the potential inaccuracies inherent to the linearquadratic model to estimate the biologic tumour and normal tissue effects with SABR fractionation schedules [19,20], multiple studies have found a correlation between clinical outcomes and the BED

5 Table 3 Treatment-related mortality and severe toxicity. Author (year published) Onimura [15] (2003) Xia [22] (2006) Chang [26] (2008) Song [34] Milano [27] Fakiris [24] Guckenberger [40] Unger [28] Oshiro [29] Baba [35] Bradley [33] Andratschke [34] Haasbeek [32] Bral [23] Olsen [38] Stauder [39] Rowe [37] Nuyttens [30] Taremi [25] Janssen [31] Followup (months) Central tumours (n) Central early-stage NSCLC (n) Central tumours eligible for RTOG 0813 BED 3 (Gy) GTV size Grade 5 toxicity (clinical details if provided) Grade 34 toxicity (clinical details if provided) Grading (range) e system 18 9 a,b Not specified No f 144 Max < 60 mm 1 Oesophageal ulcer (5 months. Max dose BED3 154 Gy) None Unclear 133 Max < 100 mm None None c No f 258 Max < 40 mm None Yes 240 d Median 23 mm (12 45) a 7 Yes 217 d Median 10 cc (0.5277) 1 Bronchial stricture (max dose 48 BED Gy) 2 Bronchial stricture (Max dose 40/4 both, BED Gy) 1 Haemoptysis, 3 dyspnoea (at median 6.3 months. All patients with stage II-III NSCLC and received multiple courses of SABR) Yes 460 Max < 70 mm 3 Pneumonia, 1 haemoptysis, 1 dyspnoea (median 12.5 months, 4 in central tumours) Unclear 144 Max < 256 cc None CTC (v2) 1 Pneumonia, 1 pericarditis CTC (v3) 1 Apnoea, 1 pneumonia, 2 pleural effusion, 1 anxiety (At median 7.6 months, 2 in central tumours) Yes 147 Median 73 cc (23324) 1 Bronchial fistula (max dose 49 Gy BED Gy) 1 pneumonitis CTC (v3) Yes 217 d Median 1 Haemoptysis (second course BED Gy) 1 Bronchial stricture (BED Gy), 1 dyspnoea CTC (v3) 28 mm (10 (BED Gy) 40) Unclear 258 Max < 55 mm None No f 180 Max < 51 mm None Yes 117 Max < 203 cc None c No f 210 Median 36 mm (15 74) None Acute 1 chest wall pain. Late 2 dyspnoea, 1 rib fracture, 1 chest wall pain (occurred in 5 patients) Yes 360 Max < 60 mm 1 Bronchial stenosis/haemoptysis Acute 2 pneumonitis, 2 cough, 1 pneumonia. Late 3 pneumonitis, 1 pneumonia (occurred in 4 patients) c No f 217 Not specified None a,b Not specified Yes 240 Max < 60 mm 1 Bronchial stricture (7.5 months) 1 dyspnoea CTC (v3) a,c 30 No f 258 d Median 31 mm (11 57) a 39 No f 300 d Median 41 mm (12 105) 1 Haemoptysis (10.5 months. Max dose 54 Gy BED3 297 Gy) None Unclear 210 Max < 57 mm None CTC (v2) CTC (v3) CTC (v3) 3 Dyspnoea, 1 pneumonitis CTC (v4) Acute 4 pneumonitis. Late 6 pneumonitis. (3 were clearly SABR-related, 7 were more likely felt to be COPD exacerbation) b Not specified Unclear 144 Max < 142 cc None None - Biologically equivalent normal tissue dose (BED 3 ). a Study outcomes reported with respect to number of central tumours not patients. b Study did not specify number of early-stage non-small cell lung cancer patients although these were included in the study cohort. c Includes early-stage cases with tumours in the lung apex or adjacent to other non-hilar central structures. d Modal BED 3 shown if multiple fractionation schedules were utilized. Grade 34 toxicity specific to central tumours was not reported separately (includes reports in which central and peripheral or grade 2 and 3 outcomes were reported together). These studies were therefore excluded when calculating the overall rate of grade 3 or 4 toxicity. e Max gross tumour volume (GTV) of all tumours treated is shown when central tumour sizes are unavailable. f Include tumours within 2 cm of the mediastinum or brachial plexus, rather than only those in direct contact with the mediastinal or pericardial pleura as specified in radiation therapy oncology group (RTOG) CTC (v3) - S. Senthi et al. / Radiotherapy and Oncology xxx (2013) xxxxxx 5

6 6 SABR for central lung tumours Table 4 Clinical outcomes of stage I lung cancer by surgical technique. Surgical technique Patients (n) 5-year Survival (%) Loco-regional recurrence (%) Any recurrence (%) 30-day mortality a (%) Bronchoplasty [5] Bronchoplasty and angioplasty [4] Pneumonectomy [5] a Outcomes not restricted to stage I tumours. Operative complications a (%) [40,4952]. Onishi et al. describing a cohort of 245 patients from multiple Japanese institutions, found using a BED 10 P100 Gy significantly improved both local control (92% vs. 74%, p < 0.05), and 3-year overall survival (88% vs. 69%, p < 0.05) [50]. In addition, local control was not improved further when patients received a BED 10 P120 or P140 Gy. More recently, an analysis of a cohort of 505 patients treated across five counties found that a BED 10 P105 Gy was associated with higher local control, 96% vs. 85% (p < 0.001) [52]. Our analysis found that central tumours had the same doseresponse relationship for local control, with four studies reporting improved outcomes with a BED 10 P100 Gy compared to lower doses [26,30,37,38]. Interestingly, we observed a similar doseresponse relationship for treatment-related mortality, with a BED Gy reducing the risk of death by approximately 75%. Multiple fractionation schedules may or may closely achieve a BED 10 P100 Gy and BED Gy. These include schedules of: 50 Gy in 5 fractions, 54 Gy in 6 fractions, 56 Gy in 7 fractions and 60 Gy in 8 fractions. 50 Gy in 5 fractions was the modal fractionation schedule used in three studies [27,29,38]. Of these, Milano et al. reported the only treatment-related deaths (n = 2) when utilizing 50 Gy in 5 fractions, both of which occurred in patients receiving SABR for node-positive NSCLC [27]. In two studies, 83 central early-stage NSCLC patients were treated using 60 Gy in 8 fractions and none died as a result of their treatment [25,32]. As the aforementioned studies ensured the received at least 95% of the prescribed dose without deliberate under-dosing to reduce organ at risk toxicity, it is likely that these schedules enable the safe treatment of central lung tumours. Of the 20 studies included in this review, deliberate under-dosing of the was described in only one study which may, in part, have accounted for a lower local control rate of 76% at 2 years [30]. A number of limitations in this analysis must be recognized. Follow-up amongst the included publications was generally limited, with the median being 19 months (range 1050). However, this may be sufficiently long as a study of post-sabr patterns of recurrence in 676 patients with early-stage NSCLC found the median times to local, regional and distant recurrences were 14.9, 13.1 and 9.6 months, respectively [53]. There was significant heterogeneity within the included studies with respect to the planning, prescribing and delivery of SABR (Table 1). We found variations in the way SABR doses were prescribed [29,35] and how normal organs were contoured [15] which may have impacted local control and toxicity, respectively. In addition, there was heterogeneity in the definition of central, with little additional details on location to enable assessment of the toxicity risk for given clinical scenarios. The majority of the publications in this review did not use 4- dimentional CT based planning, instead used techniques which could have led to larger target volumes and an increased risk of toxicity [54,55]. When considering the treatment of central tumours, careful contouring of organs at risk [56] and strict quality assurance of all aspects of treatment planning and delivery are required [57,58]. Additionally, current treatments must account for the fact that dose calculation algorithms in use today are more accurate than those used historically, even if the impact of this may be less with central lung tumours [59,60]. In summary, this systemic review suggests SABR offers a safe and effective curative treatment for patients with central tumours who unfit for surgery. Data from the ongoing RTOG 0813 trial will provide prospective data to determine more reliable normal organ constraints with respect to the SABR fractionation schedules being assessed. Conflict of interest The VU University Medical Center has a research collaboration with Varian Medical Systems. SUS and BJS have received honoraria and travel support from Varian Medical Systems. BJS has received honoraria and travel support from BrainLAB AG. SAS and CJH declare no conflicts of interest. Role of funding source No external funding supported this research. 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