Cancer Res Treat.  2022 Apr;54(2):396-405. 10.4143/crt.2021.393.

Influence of Concurrent and Adjuvant Temozolomide on Health-Related Quality of Life of Patients with Grade III Gliomas: A Secondary Analysis of a Randomized Clinical Trial (KNOG-1101 Study)

• Ahn GS
• Hwang K
• Kim TM
• Park CK
• Chang JH
• Jung TY
• Kim JH
• Nam DH
• Kim SH
• Yoo H
• Hong YK
• Kim EY
• Lee DE
• Joo J
• Kim YJ
• Choe G
• Choi BS
• Kang SG
• Kim JH
• Kim CY

• KMID: 2528209
• DOI: http://doi.org/10.4143/crt.2021.393

Abstract

Purpose
The KNOG-1101 study showed improved 2-year PFS with temozolomide during and after radiotherapy compared to radiotherapy alone for patients with anaplastic gliomas. This trial investigates the effect of concurrent and adjuvant temozolomide on health-related quality of life (HRQoL).
Materials and Methods
In this randomized, open-label, phase II trial, 90 patients with World Health Organization grade III glioma were enrolled across multiple centers in South Korea between March 2012 to February 2015 and followed up through 2017. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) and 20-item EORTC QLQ-Brain Neoplasm (QLQ-BN20) were used to compare HRQoL between patients assigned to concurrent chemoradiotherapy with temozolomide followed by 6 cycles of adjuvant temozolomide (arm A) and radiotherapy (RT) alone (arm B).
Results
Of the 90 patients in the study, 84 patients (93.3%) completed the baseline HRQoL questionnaire. Emotional functioning, fatigue, nausea and vomiting, dyspnea, constipation, appetite loss, diarrhea, seizures, itchy skin, drowsiness, hair loss, and bladder control were not affected by the addition of temozolomide. All other items did not differ significantly between arm A and arm B throughout treatment. Global health status particularly stayed consistent at the end of adjuvant temozolomide (p=0.47) and at the end of RT (p=0.33).
Conclusion
The addition of concurrent and adjuvant temozolomide did not show negative influence on HRQoL with improvement of progression-free survival for patients with anaplastic gliomas. The absence of systematic and clinically relevant changes in HRQoL suggests that an overall long-term net clinical benefit exists for concurrent and adjuvant temozolomide.

Keyword

Quality of life; Anaplastic glioma; 1p/19q co-deletion; Temozolomide; Chemotherapy

Figure

• 

  Fig. 1 Recruitment and inclusion of patients in the study (CONSORT diagram). Data includes the number of patients in each category (baseline, alive, and progression-free) who completed the HRQoL questionnaire. CCRT, concurrent chemoradio therapy; HRQoL, health-related quality-of-life; RT, radiotherapy; TMZ, temozolomide.

• 

  Fig. 2 (A) Stable health-related quality of life (European Organization for Research and Treatment of Cancer [EORTC] Functional Items) during treatment. High score on functional scale indicates healthy level of functioning. Baseline refers to the magnetic resonance imaging (MRI) visit before concurrent chemoradiotherapy (CCRT) or radiotherapy (RT) only begins. Temozolomide (TMZ) or after RT refers to the MRI visit either after CCRT with temozolomide or after radiotherapy alone. End of treatment refers to the MRI visit after the 6 cycles of adjuvant temozolomide or after 6 months since the end of radiotherapy alone. (B) Stable health-related quality of life (EORTC Symptom and Brain Module Items) during progression-free time. High score on symptomatic and brain module scale indicates problematic levels.

Reference

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