Chemotherapy followed by radiotherapy versus radiotherapy alone in locally advanced cervical cancer: a randomized study.
Between August 1990 and January 1992, 184 patients with squamous cell carcinoma of the cervix, FIGO stage IIB-IVA, were randomized to receive either two cycles of bleomycin, ifosfamide-mesna, and cis-platinum (BIP) chemotherapy (CT) followed by radiotherapy (RT) ("CT-RT group," n = 94) or RT alone (RT group, n = 90). In the CT-RT group, of 89 evaluable patients, 64 responded: complete response (CR) 4 (4.5%) and partial response 60 (67.5%). Of the remaining 25 patients, 23 had stable disease and 2 progressed. Eighty of 89 patients completed RT as planned. Following RT 56 (70%) achieved CR, 19 (23.7%) had residual disease, and 5 (6.3%) had progressed. CT responders had a better response to RT: 83% (49/59) vs 33.3% (7/21), P < 0.01). The stage of disease, histologic grade, duration of symptoms, and history of smoking had no influence on the response to CT. Patients aged > 45 years and those with Hb > 10 g/dl had significantly better response. Nausea/vomiting, alopecia, grade I-II myelosuppression, diarrhea, and mucositis were the major side effects of CT. Two patients died of CT toxicity. In the RT group, 88 patients were evaluable: 61 (69.3%) patients achieved CR, 25 had residual disease, and 2 progressed. The side effects of RT were cystitis, proctitis, and local skin reaction. These were equally distributed between the two groups. There was no significant difference in overall and disease-free survival in the two groups.
Kumar
L
L
Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi.
Kaushal
R
R
Nandy
M
M
Biswal
B M
BM
Kumar
S
S
Kriplani
A
A
Singh
R
R
Rath
G K
GK
Kochupillai
V
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects; D011882:Radiotherapy, High-Energy; D012074:Remission Induction; D016019:Survival Analysis; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
D001761:Bleomycin; D002945:Cisplatin; D007069:Ifosfamide