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
August 1, 2004
Does the addition of paclitaxel improve response to treatment in women with advanced or recurrent squamous cell cervical cancer being treated with cisplatin?
cisplatin 50mg/m2 q21 days x6 cycles (more allowed if responding)
paclitaxel 135mg/m2 over 24hrsfollowed by cisplatin 50mg/m2 q21 days x6 cycles (more allowed if responding)
partial or complete response to treatment
squamous cellstage IVB, persistent, recurrentnot amenable to surgery/RT
non-measurable lesionprior non-RT sensitizing chemotherapycraniospinal metastases
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
Addition of paclitaxel to cisplatin improves response rates in women with advanced or recurrent squamous cell cervical cancer