1783O - Patient reported outcomes from a randomized phase II trial comparing standard-dose with high-dose twice daily (BID) thoracic radiotherapy (TRT) in limited stage small cell lung cancer (LS SCLC)

Background

Concurrent chemoradiotherapy is the standard treatment of LS SCLC. BID TRT of 45 Gy is the most recommended schedule. Only 30% are cured, and there is a need for better treatment. A higher TRT dose might improve local control and survival, and we conducted a phase II trial comparing BID TRT of 45 Gy with 60 Gy. There have been major concerns about toxicity from BID TRT. Here we present the patient reported health-related quality of life (HRQoL) from our trial.

Methods

Patients received 4 courses of platinum/etoposide (PE) and were randomized to receive TRT of 45 or 60 Gy after the second PE-course. Responders received prophylactic cranial irradiation (PCI) of 25-30 Gy. Patients reported HRQoL on the EORTC QLQ C30/LC13 at weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation), 16 (end of PCI), 22, 32, 42 and 52. Primary HRQoL-endpoints were dysphagia, dyspnea, global QoL and physical function. A difference in mean score of ≥10 was considered clinically relevant.

Results

Between 2014-2018, 160 patients eligible for the present analyses were enrolled. Median age was 65, 58% women, 10% had PS 2 and 81% stage III. There were no significant differences in objectively assessed toxicity, and there was less radiotoxicity than in many previous studies. The high-dose arm achieved a significantly improved 2-year survival (primary endpoint) (46% vs. 70%; p=.002) and median overall survival (23 vs. 42 months; p=.027). The completion rate of questionnaires at each timepoint ranged from 61%-76%. Patients reported an increase in dysphagia from TRT with a max. level at w8 (45 Gy: mean score 45.1 points, 60 Gy: 51.9). 60 Gy patients had more dysphagia at w12 (45 Gy: 18.3, 60 Gy: 32.8) and w16 (45 Gy: 7.3, 60 Gy: 18.4), but after w22, the level of dysphagia returned to pre-treatment values in both arms. There were no significant differences in dyspnea, global quality of life or physical functioning, or on any other HRQoL scales, at any timepoint.

Conclusions

High-dose BID TRT significantly improved survival and was well tolerated both in terms of toxicity and patient reported HRQoL, though some patients on the high-dose arm needed a longer time to recover from radiation-induced dysphagia.

Clinical trial identification

NCT02041845.

Editorial acknowledgement

Legal entity responsible for the study

NTNU-Norwegian University of Science and Technology.

Funding

The Norwegian Cancer Society and The Liaison Committee for Education, Research and Innovation in Central Norway.

Disclosure

All authors have declared no conflicts of interest.