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N. Groom



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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
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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)

      11:00 - 12:30  |  Author(s): N. Groom

      • Abstract
      • Presentation
      • Slides

      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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    OA 01 - The New Aspect of Radiation Therapy (ID 652)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Radiotherapy
    • Presentations: 1
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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)

      11:00 - 12:30  |  Author(s): N. Groom

      • Abstract
      • Presentation
      • Slides

      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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