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JGOG 3016

Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomized controlled trial.

Date of Publication:

September 20, 2009

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/19767092/
Hypothesis:

Does weekly paclitaxel dosing improve survival over q3 week paclitaxel dosing for women with ovarian cancer?

Control Arm(s):

PDS (any residual disease)carboplatin AUC 6 over 1 hr paclitaxel 180mg/m2 over 3 hrs every 21 days for 6 cycles (up to 9 cycles)secondary look/debulking allowed

Experimental Arm(s):

PDS (any residual disease)carboplatin AUC 6 over 1 hr every 21 dayspaclitaxel 80mg/m2 over 1 hr every 7 daysfor 6 cycles (up to 9 cycles)secondary look/debulking allowed

Primary End Point:

PFS

Inclusion Criteria:

Japanstage II - IV ovarian adenocarcinoma

Exclusion Criteria:

borderline tumor

Results:

Q3 weeks (n=319) vs dose dense (n=312):hematologic toxicity leading to discontinuation: 43% vs 60% (SS)at least 1 cycle delayed: 67% vs 76% (SS)dose reduction: 35% vs 48% (SS)median follow-up: 29 mosmedian PFS: 17.2 vs 28.0 mos (SS)3yr OS: 65.1% vs 72.1% (SS)grade 3/4 complications: higher in Q3 week group (SS)

Conclusions:

dose dense paclitaxel regimen improved survival compared to conventional q3 week regimen

Reviewer:
Olga T Filippova