GYOEDU

ICON 8

Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma treatment (ICON8): primary progression free survival analysis results from a GCIG phase 3 randomised controlled trial

Date of Publication:

November 29, 2019

Pubmed Link:

https://pubmed.ncbi.nlm.nih.gov/31791688/

Hypothesis:

Dose-dense weekly paclitaxel in first-line treatment of ovarian cancer in a predominantly European patient group will improve survival outcomes

Control Arm(s):

Group 2: Carboplatin (AUC 5-6) q3w + Paclitaxel 80mg/m^2 q1w (C/DDT) Group 3: Carboplatin (AUC 2) + Paclitaxel 80mg/m^2 q1w (WC/DDT)

Experimental Arm(s):

Group 1: Carboplatin (AUC 5-6) + Paclitaxel 175mg/m^2 q3w (C/T)

Primary End Point:

PFS and OS

Inclusion Criteria:

Stage IC-IV histologically confirmed epithelial ovarian/PP/FT carcinoma (Those with Stage IC or IIA- mandatory high-risk subtypes (HGS, CC, G3) PS 0-2, Adequate hematologic, renal, hepatic fxn Must be able to start chemo w/in 8 weeks of IPS (immediate primary surgery) \*Neoadjuvant chemo and DPS (delayed primary surgery) allowed \*No planned surgery allowed

Exclusion Criteria:

Results:

C/T (Group 1) vs C/DDT (Group 2) vs WC/DDT (group 3) - 1566 women- 522 vs 523 vs 521 - PFS/death at 3 years: 24.4 vs 24.9 vs 25.3 mos (NS) (Restricted Mean Survival Time) - Median PFS 17.7 mos vs 20.8 mos vs 21 mos (NS) - Grade 3 or 4 toxic effects: 42% vs 62% vs 53% (NS) - ≥ Grade 2 neuropathy: 27% vs 24% vs 22% (NS) Preplanned subgroup: IPS vs DPS: - IPS PFS 32.6 vs 33 vs 33 mos (NS) (Restricted Mean Survival Time) - DPS PFS 18.6 vs 19.1 vs 19.6 mos (NS) (Restricted Mean Survival Time)

Conclusions:

Weekly dose-dense paclitaxel should not be incorporated as a standard-of-care component of first-line multimodality treatment of epithelial ovarian cancer for women who are not of Japanese ethnic origin.

Reviewer:

Laurel Berry