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Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies
Published on: February 6, 2019
Quality of life in paediatric solid tumours: a randomised study of metronomic chemotherapy versus placebo
Raja Pramanik1, Sandeep Agarwala2, Vishnubhatla Sreenivas3
1Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, Delhi, India.
Insights
Metronomic chemotherapy did not significantly improve health-related quality of life (HRQoL) in children with progressive solid tumors compared to placebo. Assessments showed no meaningful differences in HRQoL scores between treatment groups.
Area of Science:
- Pediatric Oncology
- Clinical Trials
- Quality of Life Research
Background:
- Health-related quality of life (HRQoL) is a critical endpoint in pediatric cancer research.
- Assessing HRQoL helps understand the patient experience beyond survival metrics.
Purpose of the Study:
- To compare HRQoL in children with progressive solid tumors receiving metronomic chemotherapy versus placebo.
- To determine if metronomic chemotherapy impacts patient-reported and parent-reported HRQoL.
Main Methods:
- A double-blinded, placebo-controlled randomized study involving 108 children.
- HRQoL was measured using the PedsQOL Cancer module V.3 at baseline, 9 weeks, and 18 weeks.
- Analysis included comparisons of mean scores and minimal clinically important differences.
Main Results:
- No statistically significant difference in HRQoL change was observed between the metronomic chemotherapy and placebo groups from baseline to 9 weeks.
- This lack of difference was consistent across child-reported and parent-reported scores, as well as individual domain scores.
- No significant differences were found when analyzing specific subgroups, including bone sarcomas, other tumors, responders, and non-responders.
Conclusions:
- Metronomic chemotherapy did not demonstrate a significant benefit in improving HRQoL for pediatric patients with progressive solid tumors compared to placebo.
- The findings align with other survival endpoint results from the same study.
- Further research may be needed to explore alternative strategies for enhancing quality of life in this patient population.
Objective:
Health-related quality of life (HRQoL) is an important outcome for paediatric cancer studies. We compared the HRQoL between patients of progressive paediatric solid tumours randomised to metronomic chemotherapy versus placebo.
Methods:
In this double-blinded, placebo-controlled randomised study of 108 children with progressive malignancies, HRQoL was evaluated using the PedsQOL Cancer module V.3 at baseline (A1), A2 (9 weeks or earlier if progressed) or A3 (18 weeks or earlier if progressed).
Results:
There was no statistically significant difference in the change in quality of life produced by each arm from A1 to A2 in either mean total scores or individual domain scores, reported by children or their parents. On analysing the response according to the minimal clinically important difference, defined as an improvement by 4.5 points, we found no significant differences, be it among bone-sarcomas, other tumours, responders (those who received ≥9 weeks of treatment) or non-responders.
Conclusions:
The present study concludes that there was no significant difference in HRQoL, between the patients in the two arms at second and later assessments. This is consistent with the other survival endpoints in the study.
Trial Registration Number:
Clinical trial registration: clinicaltrials.gov Identifier: NCT01858571.
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