TY - JOUR
T1 - Cisplatin with dose-dense paclitaxel before and after radical hysterectomy for locally advanced cervical cancer
T2 - a prospective multicenter phase II trial with a dose-finding study
AU - Tanioka, Maki
AU - Yamaguchi, Satoshi
AU - Shimada, Muneaki
AU - Nagao, Shoji
AU - Takehara, Kazuhiro
AU - Nishimura, Masato
AU - Morita, Satoshi
AU - Negoro, Shunichi
AU - Fujiwara, Kiyoshi
AU - Kigawa, Junzo
N1 - Funding Information:
This study was supported by SGSG and grants from the Japanese Foundation for Multidisciplinary Treatment of Cancer.
Publisher Copyright:
© 2017, Springer Science+Business Media, LLC.
PY - 2017/8/1
Y1 - 2017/8/1
N2 - The aim of this study is to evaluate the outcome and safety of the multidisciplinary strategy using cisplatin plus dose-dense paclitaxel (dose-dense TP) before and after radical hysterectomy (RH) for stage IB2, IIA2, or IIB patients with cervical cancer. In the dose-finding phase, 12 patients received 3 cycles of cisplatin (75 mg/m2, day 1) with paclitaxel (70 or 80 mg/m2, days 1, 8, and 15) every 21 days as neoadjuvant chemotherapy (NAC). In the phase II study, 51 patients received 3 cycles of dose-dense TP at the recommended dose as NAC, and another 2 cycles of the same regimen after RH. The primary endpoint was 2-year progression-free survival (PFS). The secondary endpoints were 2-year overall survival (OS), adverse events (AEs), response rate (RR), and pathological complete response (pCR) rates. The recommended dose of paclitaxel at dose-finding phase was 80 mg/m2. In the phase II study, 34 patients (66.7%) had FIGO stage IIB disease. The RR and pCR rates were 94 and 28%. With a median follow-up duration of 58 months, each of the 2- and 5-year PFS rates was 88.2%, the 2- and 5-year OS rates were 94.1 and 88.2%, respectively. The incidence of grade 3/4 AEs was neutropenia (34%), nausea (12%), appetite loss (10%), fatigue (6%), and anemia (6%). Febrile neutropenia was uncommon (2%). Dose-dense TP before and after RH achieved a good long-term survival and was feasible for patients with locally advanced cervical cancer.
AB - The aim of this study is to evaluate the outcome and safety of the multidisciplinary strategy using cisplatin plus dose-dense paclitaxel (dose-dense TP) before and after radical hysterectomy (RH) for stage IB2, IIA2, or IIB patients with cervical cancer. In the dose-finding phase, 12 patients received 3 cycles of cisplatin (75 mg/m2, day 1) with paclitaxel (70 or 80 mg/m2, days 1, 8, and 15) every 21 days as neoadjuvant chemotherapy (NAC). In the phase II study, 51 patients received 3 cycles of dose-dense TP at the recommended dose as NAC, and another 2 cycles of the same regimen after RH. The primary endpoint was 2-year progression-free survival (PFS). The secondary endpoints were 2-year overall survival (OS), adverse events (AEs), response rate (RR), and pathological complete response (pCR) rates. The recommended dose of paclitaxel at dose-finding phase was 80 mg/m2. In the phase II study, 34 patients (66.7%) had FIGO stage IIB disease. The RR and pCR rates were 94 and 28%. With a median follow-up duration of 58 months, each of the 2- and 5-year PFS rates was 88.2%, the 2- and 5-year OS rates were 94.1 and 88.2%, respectively. The incidence of grade 3/4 AEs was neutropenia (34%), nausea (12%), appetite loss (10%), fatigue (6%), and anemia (6%). Febrile neutropenia was uncommon (2%). Dose-dense TP before and after RH achieved a good long-term survival and was feasible for patients with locally advanced cervical cancer.
KW - Cervical cancer
KW - Cisplatin
KW - Dose dense
KW - Paclitaxel
KW - Pathological complete response
KW - Phase II
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U2 - 10.1007/s12032-017-0992-4
DO - 10.1007/s12032-017-0992-4
M3 - Article
C2 - 28681218
AN - SCOPUS:85021915490
SN - 1357-0560
VL - 34
JO - Medical Oncology
JF - Medical Oncology
IS - 8
M1 - 134
ER -
