Quality of Life (QoL)

QoL will be assessed prospectively with the internationally established and validated questionnaires of the European Organization for Research and Treatment of Cancer (EORTC).

The EORTC questionnaires are free for academic use and can be downloaded per request in several languages.

The basic module EORTC QLQ-C30 is of general use for all cancer sites and consists of five functional scales (physical, emotional, social, role and cognitive functioning), a global health status/QoL scale and several symptom scales commonly reported by cancer patients. The cervical cancer module EORTC QLQ-CX24 covers typical disease and treatment related symptoms and items regarding sexuality. In addition, 6 clinically relevant items of the endometrial module EORTC EN-25 will be added with the permission of the EORTC QoL group.

The time points of assessment are scheduled according to the morbidity assessment.

QOL Analyses: In QoL reports, patients with baseline and at least one additional EORTC QLQ follow up will be included. In patients with local and/or nodal and/or systemic evidence of disease in follow-up, the EORTC QLQ data will be censored at the time of recurrence. QoL outcomes will be calculated and linearly transformed according to the scoring manual of the EORTC QoL group; results reported in mean scores (ranging from 0-100) with standard deviation and/or 95% confidence interval. Results will be analyzed regarding differences in subscales over time in EMBRACE 2 patients and differences between the reference general population and EMBRACE 2 patients.

In addition, clinically relevant selected endpoints will be analyzed regarding their pattern of manifestation with prevalence rates, reflecting the proportion of patients with a symptom in relation to all patients included at certain follow-up visits.

Within EMBRACE 1, quality of life has been evaluated 2016 in 744 patients over time and the outcomes were compared to an age-matched female reference population [1].

It has been shown that patients’ general QoL and functioning levels in daily life were impaired before treatment compared to that of reference data. Several tumor-related symptoms resolved after treatment, and functioning levels returned to comparable scores of the reference population, indicating a transient impact of diagnosis and treatment. However, several treatment-related symptoms and problems do develop and persist, either immediately or gradually after treatment.

In addition, morbidity reports of the EMBRACE study on organs at risk, such as bowel [2], bladder [3], vagina [4] and furthermore limb edema [5], fatigue syndrome, insomnia and hot flashes [6] were presented with physician assessed CTCAE morbidity in conjunction with patient reported outcome from the EORTC questionnaires.

A new methodological approach is currently under development and will be validated in EMBRACE I data, which will allow for an analysis of late, persistent, substantial and treatment-related patient reported symptoms (“LAPERS”).

Contact person:

Kathrin Kirchheiner, Remi Nout

References

[1] Kirchheiner K, Pötter R, Tanderup K, Lindegaard JC, Haie-Meder C, Petric P, et al. Health-Related Quality of Life in Locally Advanced Cervical Cancer Patients after Definitive Chemoradiation Therapy Including Image Guided Adaptive Brachytherapy: An Analysis from the EMBRACE Study. Int J Radiat Oncol Biol Phys 2016;94:1088–98. doi:10.1016/j.ijrobp.2015.12.363.

[2] Jensen NBK, Kirchheiner K, Fokdal LU, Lindegaard JC, Kirisits C, Mazeron R, et al. Bowel morbidity in cervix cancer after RCHT+IGABT; physician and patient reported outcome - EMBRACE. Radiother Oncol 2017;123:S26–7. doi:10.1016/S0167-8140(17)30500-5.

[3] Fokdal LU, Kirchheiner K, Kibsgaard Jensen N, Lindegaard JC, Kirisits K, Chagari C, et al. Physician assessed and patient reported bladder morbidity after RCHT and IGABT for cervical cancer. Radiother Oncol 2017;123:S23–4. doi:10.1016/S0167-8140(17)30496-6.

[4] Kirchheiner K, Nout RA, Tanderup K, Lindegaard JC, Westerveld H, Haie-Meder C, et al. Manifestation pattern of early-late vaginal morbidity after definitive radiation (Chemo)therapy and image-guided adaptive brachytherapy for locally advanced cervical cancer: An analysis from the embrace study. Int J Radiat Oncol Biol Phys 2014;89:88–95. doi:10.1016/j.ijrobp.2014.01.032.

[5] Najjari Jamal D, Smet S, Bk Jensen N, Fokdal L, Lindegaard JC, Kirisits C, et al. Physician assessed and patient reported limb edema after RCHT + IGABT for cervical cancer (EMBRACE). Radiother Oncol 2017. doi:10.1016/S0167-8140(17)30497-8.

[6] Smet S, Najjari-Jamal D, Bk Jensen N, Fokdal L, Lindegaard JC, Kirisits C, et al. Fatigue, insomnia, hot flashes (CTCAE) after definitive RCHT+IGABT for cervical cancer (EMBRACE). Radiother. Oncol., vol. 123, Elsevier Masson SAS; 2017, p. S22–3. doi:10.1016/S0167-8140(17)30495-4.