At present, doctors are not sure whether women with early cervical cancer who have had their womb and pelvic lymph nodes removed should be given radiotherapy. If the woman has a combination of certain risk factors that put her at high risk of having a recurrence of her cancer, doctors often think that it would be a good idea to give her radiotherapy. However, radiotherapy has never been shown to improve overall survival for these women and the combination of surgery and radiotherapy increases the risk of side effects and complications. We searched for all the available randomised controlled trials (RCTs) that assessed whether radiotherapy (with or without chemotherapy) could improve survival in these women.
We found only two trials that compared the use of radiotherapy with no radiotherapy in women with early cervical cancer who had had their womb and pelvic lymph nodes removed and who were at risk of having a recurrence of their cancer. These two trials enrolled 397 women. When we combined the findings from these two trials, we found that, on average, women who received radiotherapy were between 40% and 90% less likely to have a relapse of their cancer within 5 years than women who did not. However, because of the low number of deaths in the trials, we could not confirm whether radiotherapy helped to prolong life: our best estimate was that, 5 years after treatment, women who received radiotherapy were about 20% more likely to be alive than those who did not, but this estimate may not be very accurate and women's actual prospects could be anywhere between being three times more likely to be alive and being 60% more likely to be dead.
Although women who had radiotherapy tended to have more complications than women who did not, we could not be sure whether this was due to chance rather than the radiotherapy because few women reported complications.
The main limitations of the review were that we did not find any trials that evaluated a combination of radiotherapy and chemotherapy and that the two trials of radiotherapy gave very little information about side effects.
We found evidence, of moderate quality, that radiation decreases the risk of disease progression compared with no further treatment, but little evidence that it might improve overall survival, in stage IB cervical cancer. The evidence on serious adverse events was equivocal.
This is an updated version of the original Cochrane review first published in Issue 4, 2009. There is an ongoing debate about the indications for, and value of, adjuvant pelvic radiotherapy after radical surgery in women with early cervical cancer. Certain combinations of pathological risk factors are thought to represent sufficient risk for recurrence, that they justify the use of postoperative pelvic radiotherapy, though this has never been shown to improve overall survival, and use of more than one type of treatment (surgery and radiotherapy) increases the risks of side effects and complications.
To evaluate the effectiveness and safety of adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, chemoradiation) after radical hysterectomy for early-stage cervical cancer (FIGO stages IB1, IB2 or IIA).
For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 4, 2008. The Cochrane Gynaecological Cancer Group Trials Register, MEDLINE (January 1950 to November 2008), EMBASE (1950 to November 2008). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For this update, we extended the database searches to September 2011 and searched the MetaRegister for ongoing trials.
Randomised controlled trials (RCTs) that compared adjuvant therapies (radiotherapy, chemotherapy followed by radiotherapy, or chemoradiation) with no radiotherapy or chemoradiation, in women with a confirmed histological diagnosis of early cervical cancer who had undergone radical hysterectomy and dissection of the pelvic lymph nodes.
Two review authors independently abstracted data and assessed risk of bias. Information on grade 3 and 4 adverse events was collected from the trials. Results were pooled using random-effects meta-analyses.
Two RCTs, which compared adjuvant radiotherapy with no adjuvant radiotherapy, met the inclusion criteria; they randomised and assessed 397 women with stage IB cervical cancer. Meta-analysis of these two RCTs indicated no significant difference in survival at 5 years between women who received radiation and those who received no further treatment (risk ratio (RR) = 0.8; 95% confidence interval (CI) 0.3 to 2.4). However, women who received radiation had a significantly lower risk of disease progression at 5 years (RR 0.6; 95% CI 0.4 to 0.9).
Although the risk of serious adverse events was consistently higher if women received radiotherapy rather than no further treatment, these increased risks were not statistically significant, probably because the rate of adverse events was low.