BACKGROUNDIn developing countries, majority of cervical cancer patients present in locally advanced stage, where concomitant chemoradiation is the treatment of choice. Despite treatment, 5-year recurrence free survival is about only 79% for stage IB, IIA disease and 59% for III/IVA disease with about 36.7% failing locally within central pelvis. However, due to huge number of patients and lower number of available radiation installations, there is sometimes a delay in commencement of radiation. Therefore, many oncologists often use neo-adjuvant chemotherapy before external radiation, while others practice hypo-fractionated radiotherapy. However, there is no published data comparing treatment by neoadjuvant chemotherapy or hypofractionation with standard concomitant chemo-radiation.
METHODSHistologically proven squamous cell carcinoma cervix of stage IB2, IIA2-IIB-IVA were included in our study. Patients were randomized to receive either concomitant chemoradiation with a radiation dose of 50 Gy in conventional fractionation and concomitant weekly injection cisplatin 40 mg/m 2 as radio-sensitizer, followed by brachytherapy; or two cycles of neoadjuvant chemotherapy with carboplatin AUC 6 along with injection paclitaxel 175 mg/m 2 followed by hypo-fractionated external beam radiation (42 Gy in 16 fractions over 3.5 weeks) started within 3 weeks of chemotherapy; or three cycles of neoadjuvant chemotherapy with same regimen followed by concomitant chemoradiation. Disease free survival at two years and toxicities of treatment (by Common Terminology Criteria for Adverse Events version 5.0) were statistically compared by one-way ANOVA using IBM SPSS Statistics ® software version 20.
RESULTSPatient characteristics were similar in all arms. Complete response was slightly higher after concomitant chemoradiation. Disease free survival and rectal toxicity were slightly higher following hypo-fractionated radiotherapy. These differences were statistically insignificant. Late toxicity encountered, were limited to grade I-II nephrotoxicity and rectal toxicity. All three modalities of treatment provided comparable outcome in terms of efficacy and toxicities when observed for a two year follow up period.
CONCLUSIONSFor cancer treatment centers overburdened with patients, treatment by hypo-fractionation is a suitable alternative and is statistically non-inferior to the standard practice of concomitant chemoradiation. Studies with larger patient population and longer follow up period need to be conducted to validate inferences.