Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology–RTOG 1203

Abstract

Purpose NRG Oncology/RTOG 1203 was designed to compare patient-reported acute toxicity and health-related quality of life during treatment with standard pelvic radiation or intensity-modulated radiation therapy (IMRT) in women with cervical and endometrial cancer. Methods Patients were randomly assigned to standard four-field radiation therapy (RT) or IMRT radiation treatment. The primary end point was change in patient-reported acute GI toxicity from baseline to the end of RT, measured with the bowel domain of the Expanded Prostate Cancer Index Composite (EPIC). Secondary end points included change in patient-reported urinary toxicity, change in GI toxicity measured with the Patient-Reported Outcome Common Terminology Criteria for Adverse Events, and quality of life measured with the Trial Outcome Index. Results From 2012 to 2015, 289 patients were enrolled, of whom 278 were eligible. Between baseline and end of RT, the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group ( P = .048), the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group ( P = .03), and the mean Trial Outcome Index score declined 12.8 points in the standard RT group and 8.8 points in the IMRT group ( P = .06). At the end of RT, 51.9% of women who received standard RT and 33.7% who received IMRT reported frequent or almost constant diarrhea ( P = .01), and more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P = .04). Conclusion Pelvic IMRT was associated with significantly less GI and urinary toxicity than standard RT from the patient's perspective.

Visceral adipose ratio as a novel predictor for acute bowel toxicity in patients receiving pelvic radiation: Preliminary dosimetric analysis and clinical validation

“…3 These findings, as well as smaller institutional series, demonstrate that highly conformal radiation techniques which emphasize small bowel sparing can significantly reduce acute and late toxicity associated with pelvic radiation among gynaecologic cancer patients. 3,[22][23][24] However, decreased rates bowel toxicity have not uniformly been observed in studies comparing IMRT versus 3D conformal radiation during the treatment of pelvic cancers. 25 Our efforts to further refine and optimize the clinical utility of bowel bag dose and volume measures will hopefully lead to improved physician ability to counsel patients regarding risk of radiation-related toxicities and to select appropriate radiation treatment modalities for use in a given patient.…”

“…Efforts to minimize radiation dose to the SB constitute a key aspect of radiation treatment planning for gynaecologic cancers. A number of recent studies have clearly demonstrated that modern techniques, such as intensity‐modulated radiotherapy (IMRT), allow greater sparing of the SB during radiation treatment planning and correlate with decreased rates of toxicity . In spite of this, the available literature analysing radiation dose‐volume contributions to SB toxicity is relatively sparse and inconsistent, providing few concrete metrics which physicians can use to estimate a given patient's risk of significant toxicity …”

“…A number of recent studies have clearly demonstrated that modern techniques, such as intensity-modulated radiotherapy (IMRT), allow greater sparing of the SB during radiation treatment planning and correlate with decreased rates of toxicity. 2,3 In spite of this, the available literature analysing radiation dose-volume contributions to SB toxicity is relatively sparse and inconsistent, providing few concrete metrics which physicians can use to estimate a given patient's risk of significant toxicity. 1 The SB as an avoidance structure is challenging to delineate because unlike other organs at risk (OARs) subject to physiologic motion such as lung and bladder, the SB cannot be controlled voluntarily by the patient nor does it move in a predictable fashion, making accurate delineation and associated estimates of radiation dose uncertain.…”

Radiation induced bladder dysfunction in women during the acute and chronic phases following pelvic radiotherapy in a prospective observational cohort

“…The PORTEC-2 trial, which randomized 427 women to either external beam or vaginal brachytherapy, found a sharp, transient increase in urinary urgency immediately after radiotherapy in the external beam but not in the brachytherapy radiation treatment group [16]. The NRG oncology-RTOG 1203 trial of 278 women, found deterioration in LUTS as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, with gradually worsening symptoms during radiotherapy in all domains (function, bother, incontinence, irritation/obstruction), and then improvement at the 4 to 6 week post radiotherapy time point [17]. Roszak et al found a rate of 21 to 26% overall bladder toxicity and 3 to 8% RTOG grade 3 to 4 toxicity during radiotherapy, in a study of 225 female patients receiving pelvic radiotherapy [18].…”

LVSI positive and NX in early endometrial cancer: Surgical restaging (and no further treatment if N0), or adjuvant ERT?

“…The TIME-C trial compared 3D RT versus IMRT in endometrial and cervical patients treated by hysterectomy. In 278 eligible patients the mean EPIC bowel score declined 23.6 points in the standard RT group and 18.6 points in the IMRT group (p ¼ 0.048), and the mean EPIC urinary score declined 10.4 points in the standard RT group and 5.6 points in the IMRT group (p ¼ 0.03) [43]. At the end of RT, more patients who received standard RT were taking antidiarrheal medications four or more times daily (20.4% v 7.8%; P ¼ 0.04).…”