A sinGle-arm phase II study to assess efficacy, tOxicity, and quAlity of life following 27Gy in 6 fractions palliative intensity modulated radiotherapy with early integration of palliative care (GOAL27-6).

OBJECTIVE

The aim of GOAL27-6 was to evaluate quality of life (QoL) of patients and caregivers, following 27 Gy in 6 fractions palliative IMRT with early integration of palliative care (PC).

METHODS

This study included patients with head and neck squamous cell cancer unsuitable for curative treatment, who would accept upfront PC referral. The primary endpoints were QoL assessed with FACT-HN, and treatment-toxicity with CTCAE_v5.0. The secondary endpoints included caregivers' QoL measured with CarGoQoL, treatment-response and survival. Improvement and deterioration in QoL for FACT-HN was pre-defined as ≥ 5% & ≥-10% of the total score respectively, and ≥ 3.65 & ≥-4.13 global-index points respectively for CarGoQoL.

RESULTS

The mean FACT-HN scores of 32 eligible patients increased by 5% and 8% at week-12 and 18 (standard deviation SD = 26) post-27 Gy/6f respectively. Seventeen patients (53%) experienced QoL-improvement, 6 (19%) maintained the same, 9 (28%) reported deterioration. There was no ≥ Grade 3 treatment-toxicity. Of the 30 eligible caregivers: 20 (67%) experienced QoL-improvement, 8 (27%) remained the same, 2 (7%) deteriorated. The mean CarGoQoL global-index increased by 6.65(SD = 22) and 8.40(SD = 16) points at week-12 and 18 respectively. Eighteen patients (56%) had complete/partial response, 7 (22%) stable disease and 7 (22%) progressed. The median survival of patients with improved/maintained QoL was 10 months, compared to 4.4 months in patients with deteriorated QoL (p < 0.001). The Spearman correlation between treatment-response and patients' QoL was ρ = 0.23 (p = 0.13).

CONCLUSION

Combined 27 Gy/6f IMRT with early PC integration can overall improve patients and caregivers' QoL. With weak correlation between treatment-response and QoL, patients/caregivers' QoL goals may benefit from early exploration.