Low-dose fractionated radiation and chemotherapy prior to definitive chemoradiation in locally advanced carcinoma of the uterine cervix: Results of a prospective phase II clinical trial

• Radiobiological synergistic effect of low-dose radiation as chemopotentiator in carcinoma cervix is demonstrated in a phase II trial.
• This is a novel, clinically viable neoadjuvant option for locally advanced carcinoma cervix.
• The regimen had acceptable acute and chronic toxicities with 84% disease control at a median follow-up of 30 months.

BackgroundWe investigated the feasibility of neoadjuvant low-dose radiation and chemotherapy with paclitaxel and carboplatin (LDCRT) before radical chemoradiation (CRT) and assessed the feasibility, efficacy, and response rate to such a regimen.MethodsThis is a single-arm phase II trial of 24 patients, with locally advanced squamous cell carcinoma of the cervix (stage IIB–IIIB). Patients received low-dose fractionated radiotherapy, carboplatin (AUC × 5) and paclitaxel (175 mg/m2), three weekly for two cycles followed by CRT. The primary end point was overall and disease-free survival.ResultsMean age of the patients at diagnosis was 50 years; Radiological complete or partial response rate was 40% and 60%, respectively, post-LDCRT. The median follow-up was 30 months (24–36 months). Both overall and progression–free survivals at 2.5 years were 84%. Grade 3/4 toxicities were 24% hematological toxicity during LDCRT and 46% during CRT (hematological: 42%, non-hematological: 4%).ConclusionA good response rate is achieved by low-dose radiation and chemotherapy with carboplatin and paclitaxel followed by radical CRT. This treatment regimen is feasible and effective as evidenced by the acceptable toxicity and 84% local control at 2.5 years.

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