Concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy for women with locally advanced carcinoma of the uterine cervix--final results of a prospective phase II-study.
OBJECTIVE
To evaluate the efficacy and toxicity of ifosfamide and cisplatin administered concomitantly with low-dose rate brachyradiotherapy followed by consolidation chemotherapy in the treatment of locally advanced squamous cell carcinoma (LASCC) or adeno/adenosquamous carcinoma of the uterine cervix.


METHODS
Sixty-two patients with primary uterine cervical cancer were enrolled between August 1999 and November 2004. The patients had to have FIGO-stage IB2 bulky to IVA disease, biopsy-proven squamous cell or adeno/adenosquamous carcinoma of the uterine cervix. The patients were to receive external radiotherapy (50 Gy in 25 fractions); ifosfamide 2 g/m2 plus cisplatin 75 mg/m2 was applied concomitantly during two low-dose rate brachyradiotherapy applications; the planned dose to point A was 85 Gy in total. After the completion of radiotherapy, i.e. external and concomitant chemobrachyradiotherapy, four cycles of consolidation chemotherapy with the same drug combination were to be administered.


RESULTS
The clinical complete response rate according to WHO-classification (assessed after the completion of the whole treatment procedures by gynecologic and radiologic evaluation and cervical biopsy) was 100%. After a median follow-up of 49 months (range 11-74 months), the recurrence-free and overall survival rates were 88.7%, respectively. The most frequent early toxicities were grade 3 and 4 leukopenias occurring in 25% and 11% of the cycles, respectively. Major delayed local complications occurred in 10 patients (16.1%).


CONCLUSIONS
These results indicate that concomitant chemobrachyradiotherapy with ifosfamide and cisplatin followed by consolidation chemotherapy with the same drug combination is a highly efficacious and very promising treatment protocol for patients with locally advanced LASCC or adeno/adenosquamous carcinoma of the uterine cervix.
Vrdoljak
Eduard
E
Center of Oncology, Clinical Hospital Split, Spinciceva 1, Split, Croatia. eduard.vrdoljak@st.htnet.hr
Omrcen
Tomislav
T
Novaković
Zana Saratlija
ZS
Jelavić
Tihana Boraska
TB
Prskalo
Tomislav
T
Hrepić
Dario
D
Hamm
Wolfgang
W
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D002945:Cisplatin; D007069:Ifosfamide