A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versusradiotherapy alone in inoperable cancer of the cervix
J. Herod et al., A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versusradiotherapy alone in inoperable cancer of the cervix, ANN ONCOL, 11(9), 2000, pp. 1175-1181
Background: Phase II studies have shown primary (neo-adjuvant) chemotherapy
with bleomycin, ifosfamide and cisplatin (BIP) is active against inoperabl
e cervical cancer. We present here results of a randomised phase III multic
entre trial comparing radical radiotherapy with neo-adjuvant BIP chemothera
py followed by radical radiotherapy in patients with inoperable cervical ca
ncer, designed to discover whether this combination might improve survival.
Patients and methods: Patients with inoperable cervical carcinoma were rand
omised to pelvic radiotherapy alone [RT] or two to three cycles of bleomyci
n 30 units/24-hour infusion, ifosfamide 5 g/m(2)/24 hours, and cisplatin 50
mg/m(2)) chemotherapy followed by pelvic radiotherapy (BIP + RT). Randomis
ation was stratified by stage and radiotherapy centre.
Results: One hundred seventy-two eligible women were randomised into this t
rial; eighty-six to RT and eighty-six to BIP + RT. A total of 190 cycles of
chemotherapy were given. Median follow-up for the 47 patients still alive
is 9 years with a minimum follow-up of 3 years. Complete or partial respons
e occurred in 51 of 86 (59%) of those randomised to RT and 60 of 86 (69%) o
f those randomised to BIP + RT. The difference between response rates does
not reach statistical significance (chi(2) = 2.06, P = 0.15). Median surviv
al is two years with an actuarial survival at five years of 32% (95% confid
ence interval (95% CI): 25%-39%). There is no significant difference betwee
n the treatment groups (chi(log-rank)(2) = 0.11, P = 0.74).
Conclusions: This study does not show any survival benefit from the use of
neo-adjuvant BIP chemotherapy in advanced cervical cancer.