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Bending the Curve Trial by Trial
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NACTcervix

Neoadjuvant chemotherapy followed by radical surgery versus concomitant chemotherapy and radiotherapy in patients with stage IB2, IIA or IIB squamous cervical cancer

Phase 3N = 635NCT00193739

Population
Patients aged 18 to 65 years with stage IB2, IIA or IIB squamous cervical cancer
Design
Single-centre, phase III randomised controlled trial, September 2003 to February 2015: three cycles of neoadjuvant paclitaxel and carboplatin once every 3 weeks followed by radical hysterectomy (with postoperative adjuvant radiation or chemoradiotherapy if indicated), or radiotherapy with weekly cisplatin for 5 weeks. 635 patients were randomised and 633 included in the final analysis.
Primary endpoint
DFS
Arms
  • Neoadjuvant chemotherapy then radical surgery (experimental, n = 316): Three cycles of paclitaxel and carboplatin every 3 weeks, then radical hysterectomy, with adjuvant radiation or chemoradiotherapy if indicated
  • Concomitant chemoradiation (control, n = 317): Radiotherapy with weekly cisplatin for 5 weeks
People
Gupta S
DFSHR 1.38 (95% CI 1.02–1.87)Δ 60-month DFS−7.4 pointsOSHR 1.025 (95% CI 0.752–1.398)Δ 60-month OS+0.7 points
Show the numbers
Results reported for NACTcervix
EndpointAnalysisNeoadjuvant chemotherapy then radical surgeryConcomitant chemoradiationEffect
DFSPatients in the final analysis (633 of 635 randomised)Survival without relapse or death related to cancerprimarymedian follow-up 58.5 monthsGupta 201869.3% at 5 y76.7% at 5 yHR 1.38 (95% CI 1.02–1.87)P=0.038Hazard ratio is for the neoadjuvant chemotherapy plus surgery group relative to concomitant chemoradiation. Delayed toxicities at 24 months or later, neoadjuvant chemotherapy plus surgery versus chemoradiation: rectal 2.2% vs 3.5%, bladder 1.6% vs 3.5%, vaginal 12.0% vs 25.6%.
OSPatients in the final analysis (633 of 635 randomised)primarymedian follow-up 58.5 monthsGupta 201875.4% at 5 y74.7% at 5 yHR 1.025 (95% CI 0.752–1.398)P=0.87Secondary endpoint.
Results reported for NACTcervix
EndpointAnalysisNeoadjuvant chemotherapy then radical surgeryConcomitant chemoradiationEffect
DFSPatients in the final analysis (633 of 635 randomised)Survival without relapse or death related to cancerprimarymedian follow-up 58.5 monthsGupta 201869.3% at 5 y76.7% at 5 yHR 1.38 (95% CI 1.02–1.87)P=0.038Hazard ratio is for the neoadjuvant chemotherapy plus surgery group relative to concomitant chemoradiation. Delayed toxicities at 24 months or later, neoadjuvant chemotherapy plus surgery versus chemoradiation: rectal 2.2% vs 3.5%, bladder 1.6% vs 3.5%, vaginal 12.0% vs 25.6%.
OSPatients in the final analysis (633 of 635 randomised)primarymedian follow-up 58.5 monthsGupta 201875.4% at 5 y74.7% at 5 yHR 1.025 (95% CI 0.752–1.398)P=0.87Secondary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS1.381.02–1.87
OS1.0250.752–1.398
Primary publication: Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, et al. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018;36(16):1548-1555. PubMedDOI

Appears in

Sources

  1. Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, et al. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018;36(16):1548-1555.

    PubMedDOI