Adjuvant chemotherapy does not improve outcome in patients with locally advanced cervical cancer

Results of the randomised, phase 3 OUTBACK trial do not support the use of adjuvant chemotherapy after chemoradiation in women with locally advanced cervical cancer. At 5 years, both overall and progression-free survival were similar in the respective treatment arms.

The standard treatment for locally advanced disease is chemoradiation followed by brachytherapy. However, a significant percentage of women still relapse and die from the development of distant metastatic disease [1]. A randomised trial suggested additional benefit of the use of concurrent cisplatin-gemcitabine and radiation followed by 2 cycles of cisplatin-gemcitabine [2].

The randomised, phase 3 OUTBACK trial (ACTRN12610000732088) was designed to determine the effects of adjuvant chemotherapy after chemoradiation on survival. Eligible women (n=919) had locally advanced cervical cancer (FIGO 2008 stage IB1 and node positive, IB2, II, IIIB, or IVA) that was suitable for primary treatment with chemoradiation with curative intent. The participants were randomised 1:1 to either standard cisplatin-based chemoradiation (control) or standard cisplatin-based chemoradiation followed by adjuvant chemotherapy with 4 cycles of carboplatin and paclitaxel. Adjuvant chemotherapy was started in 361 (78%) women assigned to receive it. The median follow-up was 60 months. The primary endpoint was overall survival at 5 years. Secondary endpoints included progression-free survival, adverse events, and patterns of disease recurrence. Prof. Linda Mileshkin (Peter MacCallum Cancer Center, Australia) presented the results [3].

At 5 years, overall survival was similar in both arms (71% vs 72%). Progression-free survival was also similar (63% vs 61%). Adverse events of grade 3–5 within a year of randomisation occurred in 81% of patients who were assigned and received adjuvant chemotherapy versus 62% assigned control. There was no evidence of differences between treatment groups in adverse events beyond 1 year of randomisation. Global Health Quality of Life Scores were worse during adjuvant therapy and 3 to 6 months thereafter but similar from months 12 to 36.

1. Narayan K, et al. Int J Gynecol Cancer. 2009;19(5):912-918.
2. Dueñas-González A, et al. J Clin Oncol. 2011;29:1678–1685.
3. Mileshkin LR, et al. Adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone: The randomized phase III OUTBACK Trial (ANZGOG 0902, RTOG 1174, NRG 0274). Abstract LBA3, ASCO 2021 Virtual Meeting, 4–8 June.

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Posted on 12 August, 202117 August, 2021