GYOEDU

GOG 169

Phase III Study of Cisplatin With or Without Paclitaxel in Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

Date of Publication:

August 1, 2004

Pubmed Link:

https://pubmed.ncbi.nlm.nih.gov/15284262/

Hypothesis:

Does the addition of paclitaxel improve response to treatment in women with advanced or recurrent squamous cell cervical cancer being treated with cisplatin?

Control Arm(s):

cisplatin 50mg/m2 q21 days x6 cycles (more allowed if responding)

Experimental Arm(s):

paclitaxel 135mg/m2 over 24hrsfollowed by cisplatin 50mg/m2 q21 days x6 cycles (more allowed if responding)

Primary End Point:

partial or complete response to treatment

Inclusion Criteria:

squamous cellstage IVB, persistent, recurrentnot amenable to surgery/RT

Exclusion Criteria:

non-measurable lesionprior non-RT sensitizing chemotherapycraniospinal metastases

Results:

cisplatin (n=132) vs cisplatin/paclitaxel (n=132):prior RT: 92% vs 91%objective response: 19% vs 36% (SS)median PFS no prior chemo/RT: 3.0 vs 4.9mos (SS)median OS no prior chemo/RT: 8.9 vs 9.9mos (NS)grade 3/4 anemia more common in combination arm

Conclusions:

Addition of paclitaxel to cisplatin improves response rates in women with advanced or recurrent squamous cell cervical cancer

Reviewer:

Olga T Filippova