GOG 109/SWOG 8797 trial
In this phase III trial, 243 high risk patients were randomised to receive adjuvant pelvic radiation therapy (RT) (n = 116) alone vs RT and concurrent chemoradiation therapy (n = 127).r High risk patients were defined as stage 1A2, 1B or 2A cervical malignancy with any of the following: positive pelvic lymph node, positive parametrium or positive surgical margin. Patients receiving RT were prescribed a dose 49.3Gy in 29 fractions, and chemotherapy consisted of 4 cycles of cisplatin (70 mg/m2, day 1) and infusional 5FU (1000 mg/m2/day, days 1-4), with the first two cycles given concurrent with RT. The primary end point was overall survival, and secondary end points included progression-free survival, recurrence rates and toxicity. Data was analysed after a median follow-up of 42 months.
Patients receiving the CRT regimen vs RT alone had a statistically significant improvement in 4 year estimated progression-free survival (80% vs 63% respectively) and 4 year estimated overall survival 81% vs 71% for the CRT and RT alone groups respectively. The hazard ratios for 4 year estimated overall survival and 4 year estimated progression-free survival were 1.96 (p = 0.007) and 2.01 (p = 0.003) respectively. Pelvic and extrapelvic recurrences were less frequent in those patients receiving the CRT regimen. Overall, 15.7% of patients who received CRT relapsed, compared with 33.6% in the RT alone group. There was no statistically significant differences in the pattern of recurrence between the two treatment arms (p = 0.20).
© JCO Peters et al 2000r
© JCO Peters et al 2000r
A systematic review and meta-analysis performed by Yang and colleagues analysed 4 studies which included patients with both high-risk and intermediate-risk features.r They showed that in the 461 patients included in the metanalysis, there was a significant improvement in overall survival with a significant reduction of local recurrence (RR = 0.26, 95% CI: 0.14-0.51, p < 0.0001), and distant recurrence (RR = 0.41, 95% CI: 0.26-0.63, p < 0.0001) in the patients who received adjuvant chemoradiation therapy compared with adjuvant radiation therapy alone.
Intermediate risk patients
The current standard of care for patients with intermediate risk disease is adjuvant radiation therapy alone, however some retrospective studies have shown a potential benefit in PFS and OS with the addition of concurrent chemotherapy. The GOG 0263 trial is currently investigating the role of concurrent chemotherapy in this cohort and is expected to be completed at the end of 2020.