Concurrent pelvic radiation with weekly low-dose cisplatin and gemcitabine as primary treatment of locally advanced cervical cancer: A phase II study
Purpose: This study was done to evaluate response, compliance and survival of weekly low dose cisplatin (20 mg/m2) and gemcitabine (125 mg/m2) concurrently with pelvic radiation as primary treatment of stage IIB-IIIB cervical cancer.
Methods: External radiation consisted of 50 Gy/25 fractions using 6-10 MV photon followed by 600 cGy boost to parametrium if it was still felt thickened. Then, intracavitary radiotherapy to deliver 60 Gy at point A. Chemotherapy consisted of gemcitabine at a dose of 125 mg/ m2 was given by i.v infusion over 30 minutes immediately after cisplatin 20 mg/ m2 weekly for 5 weeks during EBRT. Forty–five eligible patients received the treatment protocol.
Results: Toxicity was tolerable and manageable. No grade 4 toxicity while grade 3 was recorded in hematologic one only. In order of frequency; diarrhea, nausea and vomiting, and anemia (50%, 40%, 35.5%) were most common adverse events. Overall clinical response rate was 93.4% with pathological complete response of 62.2%. After median follow-up of 20 months, 2-year survival and progression-free survival rates were 90.5% and 81% respectively.
Conclusion: Weekly combination of low- dose cisplatin and gemcitabine given concurrently with pelvic radiotherapy in primary treatment of locally advanced cervical cancer resulted in a high response rate with a good compliance. Further exploration is needed for the use of this approach prior to incorporating it into routine clinical care through phase III clinical trial.
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