Top Line: Does adjuvant chemotherapy following definitive chemoradiation for cervical cancer improve survival?
The Study: In the OUTBACK trial, 919 patients with FIGO 2008 IB1 (with positive nodes) through IVA cervical cancer were randomized to treatment with standard chemoradiation (plus brachytherapy boost) with or without adjuvant chemotherapy. They received 45-50.4Gy pelvic radiation with weekly cisplatin (40mg/m2) followed by a brachytherapy boost. Adjuvant chemo consisted of 4 cycles of carboplatin and paclitaxel given every 3 weeks. 77% of patients completed all planned chemoradiation. Of those in the adjuvant chemo arm, 70% completed all the planned therapy. At 5 years, the addition of adjuvant chemo did not improve overall survival (72% v 71%), progression-free survival (63% v 62%), or cervical-cancer specific death (24% v 21%). Even when comparing only those who completed all treatment, there were no differences in survival. Adjuvant chemo also did not reduce the rate of distant metastasis (13% v 15%). So, what did adjuvant chemo do? It increased grade 3 toxicity from 62→ 81%.
TBL: The addition of 4 cycles of adjuvant carboplatin and paclitaxel to definitive chemoradiation for cervical cancer does not improve disease or survival outcomes. | Mileshkin, Lancet Oncol 2023
The Study: In the OUTBACK trial, 919 patients with FIGO 2008 IB1 (with positive nodes) through IVA cervical cancer were randomized to treatment with standard chemoradiation (plus brachytherapy boost) with or without adjuvant chemotherapy. They received 45-50.4Gy pelvic radiation with weekly cisplatin (40mg/m2) followed by a brachytherapy boost. Adjuvant chemo consisted of 4 cycles of carboplatin and paclitaxel given every 3 weeks. 77% of patients completed all planned chemoradiation. Of those in the adjuvant chemo arm, 70% completed all the planned therapy. At 5 years, the addition of adjuvant chemo did not improve overall survival (72% v 71%), progression-free survival (63% v 62%), or cervical-cancer specific death (24% v 21%). Even when comparing only those who completed all treatment, there were no differences in survival. Adjuvant chemo also did not reduce the rate of distant metastasis (13% v 15%). So, what did adjuvant chemo do? It increased grade 3 toxicity from 62→ 81%.
TBL: The addition of 4 cycles of adjuvant carboplatin and paclitaxel to definitive chemoradiation for cervical cancer does not improve disease or survival outcomes. | Mileshkin, Lancet Oncol 2023