Two-week hypofractionated radiotherapy vs monthly single fraction radiotherapy in the palliation of advanced gynecological cancers—A phase 2 randomized study
Shalin Dhiman, Bhavana Rai, Venkata Krishna Vamsi Gade, Srinivasa Gulladamane Yogeesha, Minni Arora, Ravi T. Miriyala, Divyesh Kumar, Nagarjun Ballari, Vanita Jain, Sushmita GhoshalABSTRACT
Purpose:
This prospective study compared hypofractionated 2-week radiotherapy with monthly single fraction radiotherapy in advanced gynecological cancers regarding symptom response, quality of life, objective response, and toxicity.
Materials and Methods:
Patients with advanced/metastatic cervical, endometrial, vulvar, or vaginal cancer, unfit for curative therapy, were included. Radiotherapy used standard pelvic portals with Co-60 or 6 MV photons. The 2-week arm received 30 Gy/10 fractions; the single-fraction arm received 8 Gy, up to 3 fractions at monthly intervals. Symptoms, quality of life, and toxicity were assessed using ESAS-r, FACT, CTCAE v5.
Results:
Twenty-five patients were recruited in each arm. The median follow-up was 7.5 months. There was a significant improvement in the symptom scores at 1, 3 and 6 months in both the arms with no significant difference between the two treatment arms. The overall symptomatic response rates in the 2-week RT arm and SFRT arm were 82% for pelvic pain, 96% for vaginal bleeding and 90% for vaginal discharge. The quality of life scores at 1, 3 and 6 months showed significant improvement in all domains in both the arms. The emotional and physical well-being at 3 months were significantly better (P = 0.02 and 0.04) in the 2-week RT arm compared to the SFRT arm. There was no difference in the treatment toxicities.
Conclusion:
Single fraction palliative radiation is comparable to 2-week hypo-fractionated radiotherapy with similar symptom control, toxicities, and improvement in quality of life. This holds significance especially in high volume centers in low middle income countries (LMIC).