1. For patients with localized endometrial cancer recurrence, adding cisplatin to radiation therapy did not appear to improve progression-free survival when compared to radiation therapy alone.
2. For patients with localized endometrial cancer recurrence, adding cisplatin to radiation therapy resulted in higher rates of acute toxicity, when compared to radiation therapy alone.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In this prospective randomized, multicenter, clinical trial, 156 eligible patients with locally recurrent endometrial cancer (confined to the vagina and or lymph nodes) were randomly assigned to receive either radiation therapy versus radiation therapy with concurrent cisplatin. The primary end point was whether or not the addition of cisplatin to radiation therapy would improve progression-free survival. Secondary endpoints included overall survival, toxicity, and estimations of the prognostic and predictive significance of factors for progression-free survival and overall survival. This study found that there was no significant difference, for progression-free survival, between the radiation therapy group and the chemoradiation therapy group.
Click to read the study in JCO
In-Depth [randomized clinical trial]: 156 eligible patients with recurrent endometrial cancer, confined to the vagina and/or lymph nodes, were enrolled in this prospective clinical trial between February 2008 and August 2020; of these 156 patients, 74 went on to receive radiation therapy, and 82 went on to receive chemoradiation therapy. All patients in the study received external beam radiation therapy to the whole pelvis, followed by a radiation boost. The 82 patients assigned to receive chemoradiation, received concurrent, weekly cisplatin; of these, only 71 completed the 5 cycles of cisplatin as planned. By the 3-year mark, 73% of patients who had received radiation therapy alone were free from disease, compared to only 62% of those who received radiation therapy + cisplatin. Aside from GI events, acute toxicities were higher in patients who received radiation therapy + cisplatin. 57% of patients in the chemoradiation group developed grade 3 toxicity, compared to 31% in the radiation therapy group. Limitations of this study include the small sample size as well as patient demographics (mostly white / non-Hispanic women between the ages of 60 and 79, with low-grade endometroid cancer confined to the vagina). There may have been a component of selection bias in this study as well; investigators may have preferentially enrolled patients with low-risk / small-volume disease into this study. For this reason, it may be difficult to apply the findings in this study to a broad patient demographic or patients with higher-grade tumours / more extensive recurrences.
Image: PD
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