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)

Objective: To prospectively evaluate the impact of adjuvant chemoradiation (RT + CIS) versus radiation (RT) on quality of life (QOL) and patient-reported outcomes (PROs) among patients with intermediate-risk, stage I-IIA cervical cancer treated with radical hysterectomy and pelvic lymphadenectomy. Methods: Patients enrolled in GOG-0263 completed PRO/QOL assessments at baseline, 3, 7, and 36 weeks using the FACT-Cx Trial Outcome Index (FACT-Cx TOI), FACT/GOG-Neurotoxicity subscale (FACT/GOG-Ntx-4), the worst pain item from the Brief Pain Inventory (BPI), and five gastrointestinal/genitourinary (GI/GU) symptom items. Linear mixed models adjusted for baseline score, treatment, age, performance status, and country. Results: Among 316 randomized eligible patients (RT + CIS: n = 158; RT: n = 158), questionnaire completion rates were 98 %, 90 %, 88 %, and 81 % at baseline, weeks 3, 7, and 36, respectively. Patients receiving RT + CIS reported a mean FACT-Cx TOI score 5.1 points lower than RT at 3 weeks (97.5 % CI: −8.6 to −1.6; p = 0.004) and 6.3 points lower at 7 weeks (97.5 % CI: −10.2 to −2.4; p = 0.002). By 36 weeks, scores had returned to baseline in both groups, with no significant difference (p = 0.386). Patient-reported neuropathy scores (FACT/GOG-Ntx-4) did not differ significantly between groups at any time point (p = 0.82). Patient-reported GI/GU symptoms and pain worsened at 3 weeks in both arms, followed by recovery to baseline by 36 weeks. Conclusion: QOL declined in both groups after treatment initiation, with greater short-term deterioration in the RT + CIS group. By 36 weeks, QOL and other PROs returned to baseline in both groups. Neuropathy, GI/GU symptoms, and pain showed no significant differences between treatment arms over time.