Purpose: The aim of this study was to evaluate the compliance, response, and side effects of weekly gemcitabine (125 mg/m(2)) given concomitantly with standard weekly cisplatin (40 mg/m(2)) and pelvic radiotherapy for primary treatment of cervical cancer stage IB2-IVA in the first seven Thai cases.
Materials and methods: Weekly gemcitabine at a dose of 125 mg/m(2) was given concomitantly with cisplatin at 40 mg/m(2) for six cycles with concurrent radiotherapy in primary therapy of stage IB2-IVA cervical cancer. Radiation consisted of 5000 cGy in 25 daily fractions combined with brachytherapy to take point A to about 8600 cGy.
Results: Using weekly gemcitabine at a dose of 125 mg/m(2) with cisplatin at a dose of 40 mg/m(2), five of seven patients demonstrated a dose-limiting toxicity (DLT). DLTs consisted of nephrotoxicity in three cases and bone marrow suppression in two cases. Only one of seven patients could go through six cycles. All 5 living patients had a clinically complete response.
Conclusions: Weekly gemcitabine at a dose of 125 mg/m(2) with cisplatin at a dose of 40 mg/m(2) given concurrently with primary pelvic radiotherapy resulted in an excellent response but unacceptable toxicities for Thai women. The trial protocol was changed by reducing the cisplatin dosage to 20 mg/m(2).