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GOG 204

Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study

Date of Publication:

October 1, 2009

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/19720909/
Hypothesis:

Are any of the other platinum-based double superior to cisplatin/paclitaxel in women with advanced or recurrence cervical cancer?

Control Arm(s):

paclitaxel 135mg/m2 over 24hrs day 1cisplatin 50mg/m2 day 2q3wks, x6 cycles (more if responding)

Experimental Arm(s):

(1) vinorelbine 30mg/m2 day 1 and 8cisplatin 50mg/m2 day 1, q3wks(2) gemcitabine 1000mg/m2 day 1 and 8cisplatin 50mg/m2 day 1, q3wks(3) topotecan 0.75mg/m2 days 1, 2, and 3cisplatin 50mg/m2 day 1, q3wks

Primary End Point:

OS (equivalence)

Inclusion Criteria:

stage IVB, persistent, or recurrent cervical cancersquamous, adenosquamous, adeno

Exclusion Criteria:

non-measurable diseaseprior chemotherapyCNS metastases

Results:

cis/paclitaxel (n=103) vs (1) (n=108) vs (2) (n=112) vs (3) (n=111):Response rate: 29.1% vs 25.9% vs 22.3% vs 23.4%grade 4/5 neutropenia: lowest in (2)most grade 2 alopecia with cisplatin/paclitaxelmedian OS: 12.87 vs 9.99 vs 10.28 vs 10.25 mos (NS)median PFS: 5.82 vs 3.98 vs 4.70 vs 4.57 mos (NS)

Conclusions:

None of the tested doublets are superior to cisplatin/paclitaxel in women with advanced or recurrent cervical cancer.

Reviewer:
Olga T Filippova