The evidence supporting this regimen comes from a GOG randomised trial of radiation therapy in combination with three concurrent chemotherapy regimens, cisplatin alone; cisplatin, fluorouracil and hydroxyurea; and hydroxyurea alone in patients with locally advanced cervical cancer. Women had primary untreated invasive squamous cell, adenosquamous or adenocarcinoma of the cervix stage IIB, III, or IVA, without involvement of the para-aortic lymph nodes. 526 women were enrolled between 1992 and 1987, and median duration of follow up was 35 months.r
An updated analysis of the long-term follow-up data was consistent with the original report showing an improvement in PFS and OS for both cisplatin-containing arms compared with hydroxyurea (p <0.001). There was no observed increase in late toxicity with cisplatin-based chemoradiation therapy.r
A meta-analysis of 18 randomised trials confirm that chemoradiation therapy reduced local and distant recurrence and progression and improved disease free survival in patients with cervical cancer.r
Efficacy
Both groups that received cisplatin had a higher rate of progression-free survival than the group that received hydroxyurea alone (p <0.001 for both comparisons). The relative risks of progression of disease or death were 0.57 (95% confidence interval, 0.42 to 0.78) in group 1 and 0.55 (95% CI, 0.40 to 0.75) in group 2, as compared with group 3. The overall survival rate was significantly higher in groups 1 and 2 than in group 3, with relative risks of death of 0.61 (95% CI, 0.44 to 0.85) and 0.58 (95% CI, 0.41 to 0.81), respectively.r
Toxicity
There were no treatment related deaths. The highest combined frequency of grade 3 and 4 adverse event was associated with the three drug combination.r
Table of Adverse Effects:r
© New England Journal of Medicine 1999