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Bending the Curve Trial by Trial
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OUTBACK

Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK)

Phase 3N = 926NCT01414608

Population
Adults with histologically confirmed squamous, adenosquamous or adenocarcinoma of the cervix, FIGO 2008 stage IB1 with nodal involvement or stage IB2, II, IIIB or IVA, ECOG performance status 0-2
Design
Multicentre, open-label, randomised (1:1) phase 3 trial at 157 hospitals in Australia, China, Canada, New Zealand, Saudi Arabia, Singapore and the USA. Control: cisplatin 40 mg/m2 weekly for 5 weeks with 45.0-50.4 Gy external-beam radiotherapy plus brachytherapy. Experimental: the same chemoradiotherapy followed by four 21-day cycles of carboplatin (AUC 5) and paclitaxel (155 mg/m2). 926 patients were randomised; 919 were eligible and analysed.
Primary endpoint
OS
Arms
  • Chemoradiotherapy only (control, n = 461): Weekly cisplatin 40 mg/m2 for 5 weeks with external-beam radiotherapy and brachytherapy
  • Chemoradiotherapy then adjuvant carboplatin-paclitaxel (experimental, n = 465): Standard cisplatin chemoradiotherapy, then four cycles of carboplatin (AUC 5) and paclitaxel (155 mg/m2) every 21 days
People
Mileshkin LR, Australia and New Zealand Gynaecological Oncology Group (ANZGOG)
OSHR 0.90 (95% CI 0.70–1.17)Δ 60-month OS+1 points
Show the numbers
Results reported for OUTBACK
EndpointAnalysisChemoradiotherapy then adjuvant carboplatin-paclitaxelChemoradiotherapy onlyEffect
OSITT (all eligible patients who were randomly assigned: 456 chemoradiotherapy only, 463 adjuvant chemotherapy)primarymedian follow-up 60 monthsMileshkin 202372% at 5 y (67–76%)71% at 5 y (66–75%)HR 0.90 (95% CI 0.70–1.17)P=0.81Difference in 5-year overall survival 1% (95% CI -6 to 7). The most common clinically significant grade 3-4 adverse events were decreased neutrophils (20% vs 8%) and anaemia (18% vs 8%); serious adverse events occurred in 30% with adjuvant chemotherapy versus 22%.
Results reported for OUTBACK
EndpointAnalysisChemoradiotherapy then adjuvant carboplatin-paclitaxelChemoradiotherapy onlyEffect
OSITT (all eligible patients who were randomly assigned: 456 chemoradiotherapy only, 463 adjuvant chemotherapy)primarymedian follow-up 60 monthsMileshkin 202372% at 5 y (67–76%)71% at 5 y (66–75%)HR 0.90 (95% CI 0.70–1.17)P=0.81Difference in 5-year overall survival 1% (95% CI -6 to 7). The most common clinically significant grade 3-4 adverse events were decreased neutrophils (20% vs 8%) and anaemia (18% vs 8%); serious adverse events occurred in 30% with adjuvant chemotherapy versus 22%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.90.7–1.17
Primary publication: Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, et al. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(5):468-482. PubMedDOI

Appears in

Sources

  1. Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, et al. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(5):468-482.

    PubMedDOI