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Initial results of the phase ib/II, I-START trial: Isotoxic accelerated radiotherapy for the treatment of stage II-IIIb NSCLC. [Meeting Abstract}

Lester, Jason Francis, Courtier, Nicholas, Eswar, Chinnamani, Mohammed, Nazia, Fenwick, John, Griffiths, Gareth and Nixon, Lisette Sheena 2018. Initial results of the phase ib/II, I-START trial: Isotoxic accelerated radiotherapy for the treatment of stage II-IIIb NSCLC. [Meeting Abstract}. Journal of Clinical Oncology 36 (15_Sup) , e20551. 10.1200/JCO.2018.36.15_suppl.e20551

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Background: Clinical development of radical Radiotherapy (RT) in NSCLC is currently constrained by a paucity of data on the oesophageal maximum tolerated dose (MTD) when treating with a 20 fraction (#) regimen. Phase I was designed to establish the oesophageal MTD. The primary objective of phase II was to investigate whether this RT regimen is tolerable, safe and sufficiently active to justify inclusion as an experimental arm in future trials. We report toxicity data from the trial. Methods: Patients were sequentially allocated to cohorts of 58Gy, 61Gy and 63Gy to the oesophagus where the oesophagus was within the Planning Target Volume (PTV). Phase I and II recruited concurrently from centres across the UK who had undergone a national RT Quality Assurance process. Patients received 52Gy to 65Gy in 20# over 4 weeks to the PTV, planned according to predefined organ at risk (OAR) constraints (normalised mean lung dose ≤ 17Gy, spinal cord maximum 48Gy to 0.1cm3, Heart 100% < 36Gy, brachial plexus maximum 55Gy to 0.1cm3). Results: Data reported have been grouped according to oesophageal dose. Group Y (48 patients) had an oesophageal dose of ≥55Gy and Group Z (32 patients) < 55Gy (55Gy is a standard UK NSCLC prescription dose). Rates of Grade 3/4 toxicities were highest following treatment in both groups (Y = 6 patients, Z = 2 patients). Fatigue, Cough and Dyspnoea were the most common reported toxicities. One G3 oesophagitis occurred at the end of treatment (patient received 62Gy to the PTV, 61Gy to the oesophagus). 3/80 (3.8%) patient reported pneumonitis (2 at G3, one G5 in a patient with interstitial lung disease diagnosed post enrolment/treatment). Conclusions: Escalation of the prescription dose to 65Gy is safe and feasible if dose volume constraints are met. The rates of G3+ oesophagitis and G3+ pneumonitis were very low. We conclude that the dose to oesophagus is not a limiting factor when considering dose prescription in this setting and this treatment strategy warrants further investigation in a future randomised trial. I-START was developed on behalf of the NCRI Lung CSG, funded by Cancer Research UK (A11535), sponsored by Velindre NHS Trust and run by the Centre for Trials Research, Cardiff University. Clinical trial information: ISRCTN74841904.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Healthcare Sciences
Publisher: American Society of Clinical Oncology
ISSN: 1527-7755
Last Modified: 24 Jan 2022 12:06

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