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).
RCT Entities:
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).
Authors: R Pearcey; M Brundage; P Drouin; J Jeffrey; D Johnston; H Lukka; G MacLean; L Souhami; G Stuart; D Tu Journal: J Clin Oncol Date: 2002-02-15 Impact factor: 44.544
Authors: M Morris; P J Eifel; J Lu; P W Grigsby; C Levenback; R E Stevens; M Rotman; D M Gershenson; D G Mutch Journal: N Engl J Med Date: 1999-04-15 Impact factor: 91.245
Authors: C W Whitney; W Sause; B N Bundy; J H Malfetano; E V Hannigan; W C Fowler; D L Clarke-Pearson; S Y Liao Journal: J Clin Oncol Date: 1999-05 Impact factor: 44.544
Authors: W A Peters; P Y Liu; R J Barrett; R J Stock; B J Monk; J S Berek; L Souhami; P Grigsby; W Gordon; D S Alberts Journal: J Clin Oncol Date: 2000-04 Impact factor: 44.544
Authors: J J Zarbá; A V Jaremtchuk; P Gonzalez Jazey; M Keropian; R Castagnino; C Mina; G Arroyo Journal: Ann Oncol Date: 2003-08 Impact factor: 32.976
Authors: H M Keys; B N Bundy; F B Stehman; L I Muderspach; W E Chafe; C L Suggs; J L Walker; D Gersell Journal: N Engl J Med Date: 1999-04-15 Impact factor: 91.245