TY - JOUR
T1 - Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer
T2 - Southwest Oncology Group Study S0009
AU - Tiersten, Amy D.
AU - Liu, P. Y.
AU - Smith, Harriet O.
AU - Wilczynski, Sharon P.
AU - Robinson, William R.
AU - Markman, Maurie
AU - Alberts, David S.
N1 - Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA32102, CA38926, CA12213, CA46368, CA105409, CA13612, CA46441, CA35262, CA45560, CA22433, CA67575, CA12644, CA35176, CA86780, CA46368, CA58861, CA58723, CA52654, CA35281, CA35261 and supported in part by Oncotech.
PY - 2009/3
Y1 - 2009/3
N2 - Objective: Intraperitoneal (IP) chemotherapy prolongs survival in optimally reduced ovarian cancer patients. For patients in whom optimal debulking cannot be achieved, one could incorporate IP therapy post-operatively if the cancer was optimally debulked following neoadjuvant chemotherapy. We sought to evaluate overall survival (OS), progression-free survival (PFS), percent of patients optimally debulked and toxicity in patients treated with this strategy. Methods: Women with adenocarcinoma by biopsy or cytology with stage III/IV (pleural effusions only) epithelial ovarian, fallopian tube or primary peritoneal carcinoma that presented with bulky disease were treated with neoadjuvant intravenous (IV) paclitaxel 175 mg/m2 and carboplatin AUC 6 q 21 days × 3 cycles followed by surgery (if ≥ 50% decrease in CA125). If optimally debulked they received IV paclitaxel 175 mg/m2 and IP carboplatin AUC 5 (day 1) and IP paclitaxel 60 mg/m2 (day 8) q 28 days × 6 cycles. Results: Sixty-two patients were registered. Four were ineligible. Fifty-six were evaluated for neoadjuvant chemotherapy toxicities. One patient died of pneumonia. Five patients had grade 4 toxicity, including neutropenia (3), anemia, leukopenia, anorexia, fatigue, muscle weakness, respiratory infection, and cardiac ischemia. Thirty-six patients had debulking surgery. Two had grade 4 hemorrhage. Twenty-six patients received post-cytoreduction chemotherapy. Four had grade 4 neutropenia. At a median follow-up of 21 months, median PFS is 21 months and median OS is 32 months for all 58 patients. PFS and OS for the 26 patients who received IV/IP chemotherapy is 29 and 34 months respectively. Conclusions: These results compare favorably with other studies of sub-optimally debulked patients.
AB - Objective: Intraperitoneal (IP) chemotherapy prolongs survival in optimally reduced ovarian cancer patients. For patients in whom optimal debulking cannot be achieved, one could incorporate IP therapy post-operatively if the cancer was optimally debulked following neoadjuvant chemotherapy. We sought to evaluate overall survival (OS), progression-free survival (PFS), percent of patients optimally debulked and toxicity in patients treated with this strategy. Methods: Women with adenocarcinoma by biopsy or cytology with stage III/IV (pleural effusions only) epithelial ovarian, fallopian tube or primary peritoneal carcinoma that presented with bulky disease were treated with neoadjuvant intravenous (IV) paclitaxel 175 mg/m2 and carboplatin AUC 6 q 21 days × 3 cycles followed by surgery (if ≥ 50% decrease in CA125). If optimally debulked they received IV paclitaxel 175 mg/m2 and IP carboplatin AUC 5 (day 1) and IP paclitaxel 60 mg/m2 (day 8) q 28 days × 6 cycles. Results: Sixty-two patients were registered. Four were ineligible. Fifty-six were evaluated for neoadjuvant chemotherapy toxicities. One patient died of pneumonia. Five patients had grade 4 toxicity, including neutropenia (3), anemia, leukopenia, anorexia, fatigue, muscle weakness, respiratory infection, and cardiac ischemia. Thirty-six patients had debulking surgery. Two had grade 4 hemorrhage. Twenty-six patients received post-cytoreduction chemotherapy. Four had grade 4 neutropenia. At a median follow-up of 21 months, median PFS is 21 months and median OS is 32 months for all 58 patients. PFS and OS for the 26 patients who received IV/IP chemotherapy is 29 and 34 months respectively. Conclusions: These results compare favorably with other studies of sub-optimally debulked patients.
KW - Neoadjuvant chemotherapy
KW - Ovarian cancer
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UR - http://www.scopus.com/inward/citedby.url?scp=60449103699&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2008.10.028
DO - 10.1016/j.ygyno.2008.10.028
M3 - Article
C2 - 19138791
AN - SCOPUS:60449103699
SN - 0090-8258
VL - 112
SP - 444
EP - 449
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -