Radiation ± Chemotherapy Shows Worse Short-Term QOL in Cervical Cancer

Quality of life (QOL) showed short-term declines in patients with intermediate-risk cervical cancer following receipt of adjuvant radiation or chemoradiotherapy (CRT), although QOL and other patient-reported outcomes (PROs) returned to baseline by 36 weeks, according to findings from the phase 3 GOG-0263 trial (NCT01101451) published in Gynecologic Oncology.¹

Per Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) evaluations, the mean scores at baseline were 83.3 in patients who received radiotherapy and 80.1 among those who received CRT. In each respective group, mean FACT-Cx TOI scores declined to 79.0 and 71.4 at 3 weeks, and 80.1 and 71.8 at 7 weeks. At 36 weeks after treatment initiation, the mean scores were 88.8 vs 88.1, showing no significant differences between groups (P = .386).

Based on FACT/GOG-Neurotoxicity subscale (FACT/GOG-NTx-4) assessments, the mean scores at baseline were 14.9 in the radiation alone group and 14.5 in the CRT group. The mean scores in each group were 14.7 vs 14.6 at 3 weeks, 14.1 vs 14.5 at 7 weeks, and 13.5 vs 13.7 at 36 weeks. Investigators reported no significant differences in FACT/GOG-Ntx-4 scores at any period after adjusting for age, ECOG performance status, baseline scores, and treatment country (P = .82).

Regarding other patient-reported symptoms, including bowel control, stomach cramps, food digestion, and diarrhea, those in the radiation alone and CRT groups experienced worse symptoms at 3 weeks before having gradual improvements to baseline by 36 weeks. Investigators did not observe any significant differences in these outcomes at any period when adjusting for age, ECOG performance status, baseline scores, and treatment countries.

“A decline in health-related QOL was observed in both treatment arms approximately 3 weeks after starting therapy, with significantly greater deterioration in the [CRT] group at both 3 and 7 weeks. By 9 months, QOL had returned to baseline in both groups, although completion rates for QOL/PRO questionnaires fell below 90% at that time,” lead study author Dana M. Chase, MD, a professor of Clinical Obstetrics and Gynecology in the Division of Gynecologic Oncology at David Geffen School of Medicine of the University of California, Los Angeles, wrote with coauthors in the publication.¹ “These observations highlight the ongoing need to develop interventions that meaningfully address the patient experience during adjuvant treatment for early-stage cervical cancer. Few strategies have been specifically tested to reduce treatment-related toxicity in this setting, particularly during weeks 3 to 4 of treatment.”

In the phase 3 GOG-0263 trial, 316 patients were randomly assigned to receive either radiation alone (n = 158) or CRT (n = 158) following completion of initial radical hysterectomy and pelvic lymphadenectomy. All patients received conventional 4-field radiotherapy or intensity modulated radiation therapy to a total dose of 50.4 Gy in 28 fractions once daily for 5 days each week across approximately 5.5 weeks. In the CRT arm, patients also received concurrent cisplatin at 40 mg/m² once per week for up to 6 cycles.

The trial’s primary end point was recurrence-free survival (RFS) at 3 years.² Secondary end points included overall survival (OS) at 3 years and adverse effects.

Regarding the QOL and PRO analysis, the primary objectives were to assess the impact of CRT on health-related QOL vs radiation alone, based on FACT-Cx TOI scores, and chemotherapy-related neurotoxicity per FACT-GOG-NTx-4 scores. Exploratory analyses included 5 additional PROs on gastrointestinal and genitourinary symptoms, as well as pain severity using Brief Pain Inventory scores.

Patients 18 years and older with pathologically proven stage I to IIA primary cervical cancer with squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma histology initially managed with standard radical hysterectomy and pelvic lymphadenectomy were eligible for enrollment on the trial. Having a GOG performance status of 0 to 2 was an additional requirement for study entry.

In the radiation alone and CRT groups, respectively, most patients were 40 to 49 years old (38.2% vs 32.7%), Asian (50.7% vs 55.1%), and not Hispanic (90.1% vs 89.1%). Additionally, most patients had an ECOG performance status of 0 (87.5% vs 82.3%), stage I disease at diagnosis (93.4% vs 92.5%), deep stromal invasion (57.2% vs 63.9%), and positive lymphovascular space invasion (74.3% vs 74.1%).

When adjusting for factors including age, treatment group, performance status, baseline scores, and assessment time, patients who were Korean reported a mean FACT-Cx TOI score that was 1.4 points lower (95% CI, –1.4 to 4.1) compared with patients from the US across follow-up periods. However, investigators noted that country effect did not significantly correlate with treatment differences regarding FACT-Cx TOI scores.

“Continued integration of PROs into cervical cancer clinical trials will be essential to inform therapeutic development, optimize patient-centered care, and improve survivorship outcomes,” the study authors concluded.¹

References

1. Chase DM, Huang HQ, Deng W, et al. Patient-reported outcomes of a randomized phase III clinical trial of adjuvant radiation versus chemoradiation in intermediate risk, stage I/IIA cervical cancer patients treated with initial radical hysterectomy and pelvic lymphadenectomy (NRG/GOG-0263). Gynecol Oncol. 2025;202:102-109. doi:10.1016/j.ygyno.2025.09.014.
2. Radiation therapy with or without chemotherapy in patients with stage I-IIA cervical cancer who previously underwent surgery. ClinicalTrials.gov. Updated May 23, 2025. Accessed November 20, 2025. https://tinyurl.com/3x77ekbh