Combined intraperitoneal and intravenous chemotherapy for women with optimally debulked ovarian cancer: results from an intergroup phase II trial.
OBJECTIVE
The median survival time for women with optimally debulked adenocarcinoma of the ovary treated with intravenous (IV) chemotherapy is 41 to 52 months, and the 2-year survival rate is 65% to 70%. Recent studies evaluating intraperitoneal (IP) chemotherapy have reported a median survival time of 49 to 63 months and 2-year survival rates of 70% to 80%. This phase II trial was undertaken to evaluate the feasibility of and 2-year survival rate achieved by the combination of IP paclitaxel, IP cisplatin, and IV paclitaxel in women with optimally debulked, stage III ovarian cancer.


METHODS
Treatment consisted of paclitaxel 135 mg/m(2) IV over 24 hours on days 1 to 2, cisplatin 100 mg/m(2) IP on day 2, and paclitaxel 60 mg/m(2) IP on day 8 administered every 21 days for six cycles.


RESULTS
In 68 assessable women with optimal stage III ovarian cancer, the 2-year survival rate was 91%, and the median survival time was 51 months. The 2-year disease-free survival rate was 66%, and median disease-free survival time was 33 months. Ninety-six percent of all patients experienced at least one grade 3 to 4 adverse event during therapy, with the most common events being neutropenia (79%), nausea (50%), vomiting (34%), and fatigue/malaise/lethargy (24%). Seventy-one percent of patients completed all six cycles of IV/IP therapy as planned.


CONCLUSIONS
Combined IV and IP chemotherapy with cisplatin and paclitaxel is associated with a very promising 2-year survival rate in women with optimally debulked ovarian cancer. The ultimate impact of this approach on overall survival requires further evaluation in a randomized trial setting.
Rothenberg
Mace L
ML
Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. mace.rothenberg@vanderbilt.edu
Liu
P Y
PY
Braly
Patricia S
PS
Wilczynski
Sharon P
SP
Hannigan
Edward V
EV
Wadler
Scott
S
Stuart
Gavin
G
Jiang
Caroline
C
Markman
Maurie
M
Alberts
David S
DS
D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects
D017239:Paclitaxel; D002945:Cisplatin