Chemoradiation Reduces Short-Term QOL vs Radiation Alone in Cervical Cancer

Despite similar 36-week results, chemoradiation showed a statistically significant difference in QOL scores at 3 and 7 weeks vs radiation therapy alone.

Chemoradiation led to a more significant drop in quality of life (QOL) than those who received adjuvant radiation therapy alone, although both yielded a decline in QOL among patients with intermediate risk, stage I or IIA cervical cancer who were treated with initial radical hysterectomy and pelvic lymphadenectomy, according to results from the randomized phase 3 GOG-0263 trial (NCT01101451) presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO).¹

Patient-reported mean FACT-Cx TOI QOL scores were 80.1 (SD, 15.4) with chemoradiation and 83.3 (SD, 15.4) with radiation alone at baseline; 71.4 (SD, 15.3) and 79.0 (SD, 16.4), respectively, at 3 weeks (least squares mean difference, 5.1; 97.5% CI; 1.6-8.6); 71.8 (SD, 17.1) and 80.1 (SD, 17.0) at 7 weeks (difference, 6.3; 97.5% CI, 2.4-10.2); and 88.1 (SD, 12.3) and 88.8 (SD, 15.5) at 36 weeks (difference -2; 97.5% CI, -5.5 to 1.6). Differences at 3 weeks and 7 weeks were considered statistically significant.

Mean FACT/GOG-Ntx subscale scores were not significantly different at 36 weeks. At baseline, the mean patient-reported score was 14.5 (SD, 2.5) with chemoradiation and 14.9 (SD, 2.1) with radiation alone at baseline; at 3 weeks, scores were 14.6 (SD, 2.7) and 14.7 (SD, 2.2); at 7 weeks, scores were 14.5 (SD, 2.5) and 14.1 (SD, 3.0); and at 36 weeks, scores were 13.7 (SD, 3.3) and 13.5 (SD, 3.7).

After adjusting for age, performance status, baseline score, and country, no significant difference for treatment-related adverse events (TRAEs) of genitourinary nature or brief pain inventory (BPI) nature was found. Regarding genitourinary TRAEs, the mean patient-reported score was 2.9 with chemoradiation and 3 with radiation alone at baseline; 2.3 and 2.6, respectively, at 3 weeks; 2.5 and 2.4 at 7 weeks; and 3.1 and 3.1 at 36 weeks. For BPI worst pain score, scores were 2.3 and 2.3 at baseline; 2.5 and 2.7 at 3 weeks; 2.7 and 2.4 and 7 weeks; and 1.6 and 1.7 at 36 weeks.

“Both groups of patients experienced a decline of QOL after starting treatment, with patients on [chemoradiation] reporting a more significant drop,” presenting author Alexandra Smick, MD, a Gynecologic Oncology fellow at the University of California, Los Angeles, and fellow authors wrote. “There were higher rates of objectively measured AEs in [chemoradiation] compared to [radiation therapy], but similar to prior published studies.”

Trial QOL analyses consisted of 158 patients in the chemoradiation group and 158 patients in the radiation therapy alone group. The questionnaires used were FACT-Cx, Fact-Cx TOI, GOG/FACT-Ntx short subscale. TRAEs, and BPI.

A Secondary end point was to compare the FACT-Cx TOI and FACT/GOG-NTx subscale between both treatment groups over time. The exploratory end point was to compare the TRAEs and BPI between both treatment groups over time.

In the chemoradiation arm and the radiation alone arm, 97% and 98% of patients completed the survey at baseline; 91% and 89% completed it at week 3; 85% and 91% completed it at week 7; and 81% and 90% completed it at week 36. The most commonly cited reasons for missing the survey were institutional errors (27.5% and 47.8%), being lost to follow-up (28.9% and 7.2%), refusal (10.1% and 17.4%), and other reasons (15.9% and 20.3%).

Regarding grade 3 and 4 toxicities, anemia occurred in 3.7% of the chemoradiation group and 0.6% of the radiation alone group; neutropenia occurred in 16.8% and 1.2%; gastrointestinal toxicities occurred in 7.5% and 5.9%; and neurological toxicities occurred in 0.6% and 1.2%. By 36 weeks, almost all of the AEs were returned to pre-treatment levels.

At 3 weeks, patient-reported mean stomach cramp score was 3 with chemoradiation and 2.9 with radiation therapy alone; mean digest food well score was 2.1 and 2.4; mean diarrhea score was 2.6 and 2.4; and mean bowel control score was 2.1 and 2.3.

No differences were observed in overall survival and recurrence-free survival between arms in the trial.

The GOG-0263 trial is the first clinical trial based in the US to prospectively examine patient-reported outcomes and QOL in early-stage cervical cancer.

Reference

Chase DM, Huang Wei HQ, Koh WJ, et al. Patient-reported outcomes (PROs) on a randomized phase III clinical trial of adjuvant radiation (RT) versus chemoradiation (RT+CIS) in intermediate risk, stage I/IIA cervical cancer treated with initial radical hysterectomy and pelvic lymphadenectomy (NCT #01101451). Presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO); March 14-17, 2025; Seattle, WA.