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document
Intraperitoneal cisplatin versus no further treatment : 8-year results of EORTC 55875 , a randomized phase III study in ovarian cancer patients with a pathologically complete remission after platinum-based intravenous chemotherapy . First-line intravenous chemotherapy ( CT ) following debulking surgery is associated with prolonged survival , in particular in patients who achieve a pathological complete remission ( pCR ) at second-look surgery but in whom a high rate of relapses still occurs . Between 1988 and 1997 , 153 patients in pCR following platinum-based intravenous CT were randomized between four courses of intraperitoneal cisplatin ( P ) ( 90 mg/m2 every 3 weeks ) or observation . Overall survival ( OS ) was the primary endpoint , while progression-free survival ( PFS ) was a secondary endpoint . This intent-to-treat analysis includes 16 patients who were not eligible and 17 patients who had protocol violations . The two groups were well balanced in terms of age ( median = 55 years ) , performance status ( 78 % P.S . O ) , FIGO stage ( 96 % stage III ) , histology ( serous in 66 % ) , grade ( 2 or 3 in 80 % ) , and residuum before intravenous CT ( > 1 cm in 40 % ) . Intraperitoneal CT was delivered mainly through intraperitoneal catheters ( Port-a-Cath 61 % and Tenckhoff 25 % ) . Side effects of intraperitoneal cisplatin included vomiting [ > or =grade 2 ( 82 % ) ] , rise in serum creatinine [ > or =grade 2 ( 14 % ) ] , abdominal pain [ grade 1-2 ( 38 % ) ] , and neurotoxicity [ grade 2-3 ( 15 % ) ] . After a median follow-up of 8 years , 80 patients ( 52 % ) have progressed with no difference in the pattern of relapse between the two groups and 75 patients ( 49 % ) have died ; the respective hazard ratios for PFS and OS with 95 % CI are 0.89 ( 0.59-1.33 ) and 0.82 ( 0.52-1.29 ) . These results are suggestive of a treatment benefit but do not support a change in clinical practice . Other randomized clinical trials of intraperitoneal CT are reviewed and briefly discussed .
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Intervention_Pharmacological
Intraperitoneal cisplatin
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Intervention_Physical
platinum-based intravenous chemotherapy
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Intervention_Physical
First-line intravenous chemotherapy
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Intervention_Physical
platinum-based intravenous CT
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Intervention_Pharmacological
four courses of intraperitoneal cisplatin ( P ) ( 90 mg/m2 every 3 weeks )
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Intervention_Control
observation
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Intervention_Pharmacological
Intraperitoneal CT
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Intervention_Pharmacological
intraperitoneal cisplatin
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Outcome_Mortality
prolonged survival
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Outcome_Mortality
Overall survival ( OS )
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Outcome_Adverse-effects
vomiting
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Outcome_Adverse-effects
rise in serum creatinine
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Outcome_Adverse-effects
abdominal pain
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Outcome_Adverse-effects
neurotoxicity
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Outcome_Adverse-effects
pattern of relapse
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Outcome_Mortality
died
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Participant_Condition
ovarian cancer patients with a pathologically complete remission after platinum-based intravenous chemotherapy .