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Corinne Faivre-Finn
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MA 09 - The Current Status of Radiation Oncology (ID 666)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:Tomoki Kimura, Yong Chan Ahn
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 316
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MA 09.11 - Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non-Small Cell Lung Cancer (NSCLC) – a Feasibility Study (ID 7978)
12:10 - 12:15 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background:
The majority of stage III patients with non-small cell lung cancer (NSCLC) are unsuitable for concurrent chemoradiotherapy. Alternative treatment options include sequential chemoradiotherapy and radiotherapy (RT) alone. As the rate of local failure is high there is a rationale for treatment intensification.
Method:
Isotoxic Intensity Modulated Radiotherapy (IMRT) is a multicentre feasibility study combining a number of intensification strategies; dose escalation, acceleration and hyperfractionation. Patients with inoperable stage III NSCLC, ECOG performance status (PS) 0-2, unsuitable for concurrent chemoradiotherapy were recruited. A minimum of 2 cycles of induction chemotherapy was mandated before RT. The dose of radiation was increased until one or more of the organs at risk (OAR) met predefined constraints or the maximum dose of 79.2Gy was reached. RT was delivered twice-daily in 1.8 Gy fractions. A RT quality assurance programme was in place. The primary end point was feasibility (>80% of patients achieving >60Gy EQD2 i.e. total biologically equivalent in 2 Gy fraction), with acute/late toxicity (CTCAE version 4.0), local control and overall survival as secondary end points.
Result:
Between June 2014 and March 2016, 37 patients were enrolled from 7 UK centres. Median age = 67 years (range 46-86). Male:female ratio = 18:19. ECOG PS=0, 5 (13.51%), PS=1, 29 (78.38%), PS=2, 3 (8.11%). Stage IIIa:IIIb ratio 23 (62.2%):14 (37.8%). Out of 37 patients, 2(5.4%) failed to achieve EQD2 >60Gy due to large tumour size and inability to meet OAR constraints, they received standard RT. This was due to large tumour size and inability to meet OAR constraints. Median prescribed tumour dose was 77.4Gy (61.2 – 79.2Gy) with the maximum dose of 79.2Gy delivered to 14 (37.8%) patients. All patients completed RT as scheduled except one due to disease progression. Grade (G)3 acute toxicities included: dysphagia 1 (2.9%), dypsnoea 2 (5.7%), lung infection 3 (5.7%) and radiation oesophagitis 2 (5.7%). There were three G5 events: radiation pneumonitis, trachea-oesophageal fistula and bronchopulmonary haemorrhage, which were probably treatment related. G3 late toxicities included: fatigue 1 (2.9%), dyspnoea 3 (8.6%) and 1 (2.9%) case of late G4 lung infection. At time of analysis median follow-up was 12.8 months for 20 survivors. Overall survival and progression-free survival at 1 year was 75% and 59% respectively.
Conclusion:
In the majority, treatment intensification using isotoxic IMRT is feasible. This regime will be tested alongside other intensified treatments against standard sequential chemoradiotherapy in the ADSCAN study (ISRCTN47674500).
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MA 17 - Locally Advanced NSCLC (ID 671)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:S. Jheon, Georgios Stamatis
- Coordinates: 10/17/2017, 15:45 - 17:30, F203 + F204 (Annex Hall)
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MA 17.14 - Phase I Trial Evaluating MEK Inhibitor Selumetinib with Concomitant Thoracic Radiotherapy in Non-Small-Cell Lung Cancer (ID 8982)
17:10 - 17:15 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background:
The RAS/RAF/MEK/ERK signalling pathway has a pivotal role in cancer proliferation and modulating response to treatment. Selumetinib, an inhibitor of MEK, has been shown to enhance the effect of radiotherapy (RT) in preclinical studies.
Method:
Single-arm, single-centre, open-label phase I trial. Patients with stage III non-small cell lung cancer (NSCLC) not suitable for concurrent chemo-radiotherapy or stage IV with dominant thoracic symptoms. Patients were recruited to a dose-finding stage (based on the Fibonacci 3+3 design; maximum number =18) followed by the recruitment of an expanded cohort (n=15). Oral Selumetinib (AZD6244, ARRY-142886) was administered at a starting dose of 50mg twice daily commencing 7 days prior to RT, then in combination with thoracic RT for 6-6.5 weeks (60-66Gy in 30-33 fractions). The primary objective was to determine the recommended Phase II dose.
Result:
From 06/10-02/15, 21patients enrolled. Median age 63 years (range 50-73). M:F ratio 12(57%):9(43%). ECOG PS 0:1, 7(33%):14(67%). Stage III 16(76%):IV 5(24%). Mean GTV 64cm[3] (range 0.8–223.7). In the dose-finding stage, 2 out of 6 patients experienced dose-limiting toxicities (DLT) but only one DLT (G3 diarrhoea) was attributable to treatment. Despite meeting criteria for escalation, trial management group elected to treat patients on the expanded cohort (n=15) at the starting dose. All 21 patients completed RT as planned and received induction chemotherapy. Compliance rate of Selumetinib was >80%. Common adverse events are listed-see table. There were 2 survivors (24 & 26months) at analysis. The median survival was 9.7 months and 2-year survival was 24%. The main cause of disease progression was distant metastases in 16/21 (76%).
Conclusion:
The combination of thoracic RT and Selumetinib is feasible and associated with an acceptable toxicity profile. However our efficacy results, based on 21 patients, suggest that this combination should not be pursued in a subsequent phase II trial.Acute Toxicity (CTCAE v4.0) (during treatment and including up to 3 months post treatment) Toxicity Grade N = 21 (%) Acneiform rash 0 1 2 3 4 (19.04%) 7 (33.33%) 9 (42.86%) 1 (4.76%) AST[1] increased 0 1 3 17 (80.95%) 3 (14.29%) 1 (4.76%)** Diarrhoea 0 1 2 3 5 (23.81%) 13 (61.90%) 2 (9.52%) 1 (4.76%)* GGT[2] increased 0 1 2 3 16 (76.19%) 2 (9.52%) 2 (9.52%) 1 (4.76%) Haemoptysis 0 1 19 (90.48%) 2 (9.52%) Maculo-papular rash 0 1 3 16 (76.19%) 4 (19.05%) 1 (4.76%) Mucositis 0 1 2 18 (85.71%) 2 (9.52%) 1 (4.76%) Nausea 0 1 2 11 (52.38%) 9 (42.86%) 1 (4.76%) Radiation dermatitis 0 1 2 3 8 (38.10%) 7 (33.33%) 5 (23.81%) 1 (4.76%) Radiation oesophagitis 0 1 2 3 3 (14.29%) 2 (9.52%) 15 (71.43%) 1 (4.76%) Radiation pneumonitis 0 1 2 15 (71.43%) 0 6 (28.57%) Late Toxicity (follow up from 3+ months onwards) Toxicity Grade N = 21 (%) Pneumonitis 0 1 2 16 2 (9.52%) 3 (14.29%) Pulmonary fibrosis 0 1 19 2 (9.52%) Radiation oesophagitis 0 2 19 (90.48%) 2 (9.52%) * patient stopped drug on day 49 **patient stopped drug on day 29 abbreviations: 1) AST, Aspartate aminotransferase 2) GGT; Gamma-glutamyltransferase
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MTE 04 - Radiotherapy for SCLC (Sign Up Required) (ID 553)
- Event: WCLC 2017
- Type: Meet the Expert
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 07:00 - 08:00, Room 311 + 312
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MTE 04.01 - Role of Radiotherapy in Multimodality Treatment for SCLC (ID 7778)
07:00 - 07:30 | Presenting Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Abstract:
Major advances in SCLC include improvements in RT techniques, the use of prophylactic cranial irradiation (PCI) for all stages of SCLC and the improved combination of chemotherapy and RT (Califano). The role of thoracic radiotherapy is well established in the management of stage I-III SCLC (Pignon). There is increasing evidence in the literature in favour of early concurrent chemo-radiotherapy, and a standard of care for patients with a good performance status is twice-daily thoracic radiotherapy (45 Gy in 3 weeks) with concurrent cisplatin and etoposide (Turrisi). Although current clinical trials are exploring the efficacy of new chemotherapeutic strategies, essential questions related to the optimisation of thoracic radiotherapy and the benefit of chemo-radiotherapy in sub-groups of patients remain unanswered, e.g. the elderly (Blackhall). The CONVERT trial (twice-daily (BD) versus once daily (OD) radiotherapy given concurrently with chemotherapy in stage I-III SCLC) was reported at ASCO 2016 (Faivre-Finn). OD RT did not result in a superior survival or worse toxicity than BD RT (two-year survival was 56% (95% CI 50-61) vs 51% (95% CI 45-57), p= 0.14). The survival for both regimens was higher than previously reported and using modern RT techniques radiation toxicities were lower than expected. In the stage IV setting the CREST trial as shown that the addition on thoracic RT to chemotherapy and PCI leads to a significant reduction in intrathoracic recurrence and, despite the lack of a significant benefit in overall survival at 1 year, there were significant improvements in overall survival at 2 years (Slotman). It is crucial that patients with SCLC are given the opportunity to participate in clinical research in order to continue to improve the survival of this disease. Molecular studies are ongoing aiming to gain improved insight into the molecular biology of SCLC, discover and/or validate candidate biomarkers for response, resistance to or toxicity of systemic treatment and radiation. It is expected that this understanding will lead to the development of targeted therapies that will not only prove efficacious but also less toxic than more conventional chemotherapy treatments. In combination with advanced RT techniques and better imaging, it is hoped that the rates of long term survivors will increase significantly in the future. We will address the following controversial questions • Should BDRT be considered standard of care in stage I-III SCLC? • Role of CTRT in stage I-II SCLC • Role of CTRT in elderly patients with LS-SCLC • Should thoracic RT be given to all patients with stage IV SCLC? References Califano R, et al. Management of small cell lung cancer: recent developments for optimal care. Drugs. 2012 5;72(4):471-90 Pignon JP, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med 1992; 327:1618-1622. Turrisi AT, et al. Twice daily compared to once-daily thoracic radiotherapy in limited-stage small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med 1999; 340: 265-271. Auperin A, et al. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med 1999;341(7):476-84. Blanchard P, et al. Prophylactic cranial irradiation in lung cancer. Curr Opin Oncol. 2010; 22(2):94-101 Blackhall F et al. Treatment of limited small cell lung cancer: an old or new challenge? Curr Opin Oncol. 2011; 23(2):158-62 Faivre-Finn C, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18(8):1116-1125 Slotman BJ, et al.Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 3;385(9962):36-42 Slotman BJ, et al. Which patients with ES-SCLC are most likely to benefit from more aggressive radiotherapy: A secondary analysis of the Phase III CREST trial. Lung Cancer. 2017; 108:150-153
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OA 01 - The New Aspect of Radiation Therapy (ID 652)
- Event: WCLC 2017
- Type: Oral
- Track: Radiotherapy
- Presentations: 1
- Moderators:M. Hiraoka, S.H. Kim
- Coordinates: 10/16/2017, 11:00 - 12:30, F201 + F202 (Annex Hall)
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OA 01.05 - Analysis of Radiotherapy Quality Assurance Data for the Convert Trial - Does Non-Compliance to Protocol Affect Survival? (ID 10117)
11:45 - 11:55 | Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background:
The CONVERT Trial is a multicentre phase III study which recruited 547 patients with limited-stage SCLC from April 2008 to November 2013. Patients were randomised to receive once daily (66Gy in 33 fractions) or twice daily (45Gy in 30 fractions) radiotherapy concurrently with chemotherapy. The primary endpoint was overall survival. This study investigates the effect of non-compliance to radiotherapy protocol on survival for the CONVERT Trial.
Method:
489/557 received chemo-radiotherapy according to protocol. As part of the CONVERT trial quality assurance (QA) programme, 94 patient datasets (19.2%) treated with concurrent chemoradiotherapy (n=489) were reviewed and deviations from protocol were categorised as acceptable, acceptable variation and unacceptable variation using the Global Harmonisation Group (GHG) variation definitions. Organ at risk outlining (heart, spinal canal and lung minus planning target volume (PTV)), target delineation and margins applied, PTV coverage, treatment planning technique and radiotherapy treatment time were reviewed and classified according to the GHG definitions. A multiplicative factor (F) was calculated for each treatment plan, based on the GHG definitions. A low factor indicates a low number of protocol deviations. Protocol deviations were correlated with survival and number of patients recruited per centre.
Result:
94/489 patients were included in this analysis (19.2% of the randomised patients). The median number of patients recruited per centre was 6 (range 1-109). Protocol deviations were categorised as acceptable (57.6%), acceptable variation (23.3%) or unacceptable variation (19.1%). Amongst the unacceptable variations the PTV coverage was the most common deviation to protocol. In these 71 patients (75.5%) the dose distribution within the PTV was greater than 7% of the prescribed dose. Patients with increasing number of organ at risk outlining protocol deviations and with an increase in the multiplicative factor (F) had a lower survival. Further details will be presented at the meeting including survival in the 3 GHG categories. Centres recruiting >25 patients were found to have a lower number of protocol deviations (median 2, range 2-3) compared with centres recruiting fewer than 25 patients (median 3, range 0-4.5), and were most likely to delineate organs at risk correctly.
Conclusion:
High recruiting centres are most likely to comply with a trial protocol. Overall survival was affected by the number and type of protocol deviations, highlighting the importance of a robust trial QA programme in prospective radiotherapy trials.
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OA 02 - Mesothelioma: Challenges For New Treatment (ID 653)
- Event: WCLC 2017
- Type: Oral
- Track: Mesothelioma
- Presentations: 1
- Moderators:S. Hasegawa, Anna Nowak
- Coordinates: 10/16/2017, 11:00 - 12:30, F205 + F206 (Annex Hall)
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OA 02.03 - Prophylactic Irradiation of Tracts (PIT) in Patients with Pleural Mesothelioma: Results of a Multicentre Phase III Trial (ID 7980)
11:20 - 11:30 | Presenting Author(s): Corinne Faivre-Finn
- Abstract
- Presentation
Background:
It has been widespread practice across Europe to irradiate diagnostic or therapeutic chest wall (CW) intervention sites in patients with malignant pleural mesothelioma (MPM) post-procedure - a practice known as prophylactic irradiation of tracts (PIT). This study aims to determine the efficacy of PIT in reducing the incidence of CW metastases following a chest wall procedure in MPM.
Method:
In this multicentre phase III randomised controlled trial, MPM patients following a chest wall procedure were randomised 1: 1 to receive PIT (within 42-days of procedure) or no PIT. Large thoracotomies, needle biopsy sites and indwelling pleural catheters were excluded. PIT was delivered at a dose of 21Gy in 3 fractions over 3 consecutive weekdays using a single electron field adapted to maximise coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CW metastases within 6 months from randomisation, assessed in the intention-to-treat population. Stratification factors included epitheloid histology and intention to give chemotherapy. Trial registration number NCT01604005.
Result:
375 patients (186 PIT and 189 no PIT) were randomised between 06/2012-12/2015 from 54 UK centres. Comparing PIT vs no PIT, %male patients was 89.8/88.4%, median age 72.8/74.6 years, %ECOG PS (0,1,2) 32.2,56.5,11.3/23.8,56.1,20.1%, %confirmed epithelioid histology 79.6/74.1%, and %with intention to give chemotherapy 71.5/71.4%. The chest wall procedures were VATS (58.1/51.3%), open surgical biopsy (2.7/5.3%), local-anaesthetic-thoracoscopy (26.9/27.0%), chest drain (5.9/8.5%) and others (6.5/7.9%) for the PIT vs no PIT arm respectively. Radiotherapy was received as intended by 181/186 patients in the PIT arm. The proportion of CW metastases by 6 months was 6/186 (3.2%) vs 10/189 (5.3%) for the PIT vs no PIT arm respectively (odds ratio 0.60 [95% CI 0.17-1.86]; p=0.44) and by 12 months 15/186 (8.1%) versus 19/189 (10.1%) respectively (OR=0.79 [95% CI 0.36-1.69];p=0.59). Cumulative incidence of CW metastases at 6months/12 months/24 months was 3.3/8.5/10.0% in the PIT arm vs 5.6/10.9/18.7% in the no PIT arm. Evaluable patients who developed CW metastases reported a mean increase in visual analogue scale pain score of 13.3 (p<0.01) compared to baseline. Skin toxicity was the most common radiotherapy-related adverse event in the PIT arm with 96(51.6%) grade 1, 19(10.2%) grade 2, and 1(0.5%) grade 3 radiation dermatitis (CTCAE V4.0). There were no other grade 3 or higher radiotherapy-related adverse events.
Conclusion:
There is no role for the routine use of PIT following diagnostic or therapeutic CW procedures in patients with MPM.
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P3.14 - Radiotherapy (ID 730)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.14-010 - Magnetic Resonance Imaging (MRI) for Lung Cancer Radiotherapy Planning and Treatment (ID 10085)
09:30 - 09:30 | Author(s): Corinne Faivre-Finn
- Abstract
Background:
A potential benefit of integrating MR imaging in the radiotherapy planning and treatment process is the improved soft tissue contrast. However, this benefit may be obscured if there are substantial variations in the way that both target and organs at risk (OARs) are contoured, either at the time of initial simulation or at each fraction. The aim of this work is to develop standardised MR imaging sequences for target and OAR contouring in lung cancer patients for integration into the planning and treatment process for MR image-guided radiotherapy.
Method:
11 lung cancer patients were recruited across 3 European centres using a standardised MR protocol with various soft tissue contrasts as well as numerous respiratory management techniques. All MR images were acquired at 1.5 T with 3.5 mm slice thickness. 7 radiation oncologists and 3 radiologists reviewed the MR images alongside CT and FDG-PET-CT, rigidly registered to tumour area, to determine the most adequate sequences for OAR and tumour visualisation/delineation.
Result:
The most adequate MR sequences were found to be: Radial 3D T1, Turbo Spin Echo (TSE) fat-suppressed (fat-sat), DIXON TSE and T2 TSE (table 1). The sequences aided in visualisation of tumour, nodes and OARs including oesophagus, proximal bronchial tree, trachea, heart, lungs, spinal cord/canal and brachial plexus. The TSE (fat sat) and DIXON TSE gave strong signal from tumour, nodes and brachial plexus, aiding in their visualisation. The motion averaging characteristics ofthe Radial 3D T1 improve image consistency over slices, whereas the TSE sequences can include motion induced distortions.Table 1. The most adequate sequences identified for tumour, node and OAR visualisation. These sequences have been acquired with varying contrast and different respiratory management techniques.
Sequence Respiratory Management Purpose Coverage Radial 3D T1 (fat sat) Radial k-space sampling Tumour, nodes, OARs, spatial reference Ful thorax TSE (fat sat) Respiratory triggered Tumour, nodes, OARs Tumour (if tumour below aortic arch) DIXON TSE Multiple signal averages Brachial plexus, tumour, nodes Tumour and Brachial Plexus (if tumour above aortic arch) T2 TSE Respiratory triggered Tumour, nodes, OARs Full thorax
Conclusion:
A set of MR sequences suitable for lung cancer radiotherapy planning have been identified which provide adequate visualisation of tumour, nodes and OARs. The next step is to acquire these sequences in a set of patients and assess intra-/inter-clinician variability in target and OAR delineation, and develop an MR lung contouring atlas.
