PMID- 28681218 OWN - NLM STAT- MEDLINE DCOM- 20180416 LR - 20181113 IS - 1559-131X (Electronic) IS - 1357-0560 (Linking) VI - 34 IP - 8 DP - 2017 Aug TI - Cisplatin with dose-dense paclitaxel before and after radical hysterectomy for locally advanced cervical cancer: a prospective multicenter phase II trial with a dose-finding study. PG - 134 LID - 10.1007/s12032-017-0992-4 [doi] 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/m(2), day 1) with paclitaxel (70 or 80 mg/m(2), 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/m(2). 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. FAU - Tanioka, Maki AU - Tanioka M AUID- ORCID: 0000-0002-6558-2246 AD - Department of Medical Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan. makitanioka123456@yahoo.co.jp. FAU - Yamaguchi, Satoshi AU - Yamaguchi S AD - Gynecologic Oncology, Hyogo Cancer Center, Akashi, Japan. FAU - Shimada, Muneaki AU - Shimada M AD - Gynecologic Oncology Division, Tohoku University Hospital, Sendai, Japan. FAU - Nagao, Shoji AU - Nagao S AD - Gynecologic Oncology, Saitama University International Medical Center, Hidaka, Japan. FAU - Takehara, Kazuhiro AU - Takehara K AD - Obstetrics and Gynecology, Kure Medical Center/Chugoku Cancer Center, Kure, Japan. FAU - Nishimura, Masato AU - Nishimura M AD - Obstetrics and Gynecology, School of Medicine University of Tokushima, Tokushima, Japan. FAU - Morita, Satoshi AU - Morita S AD - Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan. FAU - Negoro, Shunichi AU - Negoro S AD - Department of Medical Oncology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan. FAU - Fujiwara, Kiyoshi AU - Fujiwara K AD - Gynecologic Oncology, Hyogo Cancer Center, Akashi, Japan. FAU - Kigawa, Junzo AU - Kigawa J AD - Gynecologic Oncology Division, Tottori University Hospital, Yonago, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20170705 PL - United States TA - Med Oncol JT - Medical oncology (Northwood, London, England) JID - 9435512 RN - P88XT4IS4D (Paclitaxel) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Cisplatin/administration & dosage MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Hysterectomy MH - Middle Aged MH - Nausea/chemically induced MH - Neutropenia/chemically induced MH - Paclitaxel/administration & dosage MH - Treatment Outcome MH - Uterine Cervical Neoplasms/*drug therapy/pathology/*surgery OTO - NOTNLM OT - Cervical cancer OT - Cisplatin OT - Dose dense OT - Paclitaxel OT - Pathological complete response OT - Phase II EDAT- 2017/07/07 06:00 MHDA- 2018/04/17 06:00 CRDT- 2017/07/07 06:00 PHST- 2017/04/22 00:00 [received] PHST- 2017/06/30 00:00 [accepted] PHST- 2017/07/07 06:00 [entrez] PHST- 2017/07/07 06:00 [pubmed] PHST- 2018/04/17 06:00 [medline] AID - 10.1007/s12032-017-0992-4 [pii] AID - 10.1007/s12032-017-0992-4 [doi] PST - ppublish SO - Med Oncol. 2017 Aug;34(8):134. doi: 10.1007/s12032-017-0992-4. Epub 2017 Jul 5.