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JGOG 0505

Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial JCOG0505

Date of Publication:

July 1, 2015

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/25732161/
Hypothesis:

Does carboplatin/paclitaxel lead to similar survival compared to cisplatin/paclitaxel in women with advanced or recurrent cervical cancer?

Control Arm(s):

paclitaxel 135mg/m2 over 24hrs day 1cisplatin 50mg/m2 dat 2q21 days x6 cycles max

Experimental Arm(s):

paclitaxel 175mg/m2 over 3hrscarboplatin AUC 5]q21 days x6 cycles max

Primary End Point:

OS (non-inferiority)

Inclusion Criteria:

age 20-75yrsstage IVB, prersistent or 1st or 2nd recurrencesquamous, adenosquamous, adeno

Exclusion Criteria:

>1 prior platinum regimen>0 prior taxane

Results:

cis/paclitaxel (n=123) vs carbo/paclitaxel (n=121):median f/u: 17.6mosnoninferiority OS: HR 0.994 90%CI 0.789-1.253 (SS)median OS: 18.3 vs 17.5 mosno prior platinum, median OS: 23.2 vs 13 mos (SS)grade 3/4 toxicities higher with cisplatin - febrile neutropenia, Cr elevationgrade 3/4 toxicities higher is carboplatin - thrombocytopenia, neuropathy

Conclusions:

Carboplatin/paclitaxel is not inferior to cisplatin/paclitaxel in women with advanced or recurrent cervical cancer.

Reviewer:
Olga T Filippova