Weekly Cisplatin 20 mg/m2 in Patients with Carcinoma of Cervix receiving Pelvic Radiotherapy at Srinagarind Hospital: A Randomized Controlled Trial

Objectives: To evaluate treatment response and acute treatment-related toxicity of concurrentchemoradiotherapy with cisplatin 20 mg/m2 , compared to 40 mg/m2 as the standard, in locally advancedcervical cancer. Study design: A prospective randomized controlled trial in Srinagarind Hospital, Faculty ofMedicine, Khon Kaen University, Khon Kaen. Subjects: 140 patients, ≤ 60 years old with biopsy-proven previouslyuntreated invasive carcinoma of cervix, FIGO stage IB2-IVA, undergoing concurrent chemoradiotherapy withadequate bone marrow, renal and liver functions, between April and December 2009.
Methods: All patientswere randomly assigned (half in each group)to receive weekly cisplatin at a dose of 40 mg/m2 compared to 20mg/m2, concurrent with radiotherapy for 6 cycles. Main outcome measuresincluded clinical response, cytologicalresponse, and acute treatment-related toxicity.
Results: All 140 patients completed 6 cycles of weekly cisplatin.80% had squamous cell carcinomas; about half were FIGO stage IIIB. The 40 mg/m2 group showed unplannedinterruptions in 13/70 (18.6%), which was significantly different from the 5/70 (7.1%) in the 20 mg/m2 group(p=0.02), resulting in prolonged treatment time (p=0.026). Complete responses were found in 69/70 (98.6%) and68/70 (97.1%), respectively, with no significant difference. Hematological and gastrointestinal toxicities weremost frequently observed. Acute toxicities in the first group was significantly higher when compared to thesecond group (p<0.05) as follows; grade 1-2 leukopenia (14.8% vs. 6.4%), grade 1-2 neutropenia (9.3% vs.2.6%), grade 2 N/V (3.8% vs. 1%), grade 2 diarrhea (2.4% vs. 0.7%), and grade 1 sensory neuropathy (4.5% vs.1.2%). No treatment related deaths were encountered.
Conclusion: This prospective trial has sufficient data tosupport the conclusion that concurrent chemoradiotherapy with weekly cisplatin 40 mg/m2 in locally advancedcervical cancer gives good treatment outcomes. When reducing the cisplatin dose to 20 mg/m2, treatment responseswere still comparable to the standard, but acute toxicity could be reduced. However, there are insufficient datato assess long term treatment outcomes and late treatment related toxicity, because of the short follow-up time.