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.

Abstract

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.

• Authors: Maki Tanioka, Satoshi Yamaguchi, Muneaki Shimada, Shoji Nagao, Kazuhiro Takehara, Masato Nishimura, Satoshi Morita, Shunichi Negoro, Kiyoshi Fujiwara, Junzo Kigawa
• Journal: Medical oncology (Northwood, London, England) (Med Oncol) Vol. 34 Issue 8 Pg. 134 (Aug 2017) ISSN: 1559-131X [Electronic] United States
• PMID: 28681218 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Paclitaxel
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Female
• Humans
• Hysterectomy
• Middle Aged
• Nausea (chemically induced)
• Neutropenia (chemically induced)
• Paclitaxel (administration & dosage)
• Treatment Outcome
• Uterine Cervical Neoplasms (drug therapy, pathology, surgery)