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01-11-2015 | Gynecologic Oncology

Feasibility and Safety of Negative-Balance Isolated Pelvic Perfusion in Patients with Pretreated Recurrent or Persistent Uterine Cervical Cancer

Authors: Satoru Murata, MD, PhD, Shiro Onozawa, MD, PhD, Fumie Sugihara, MD, Atsuhiro Sakamoto, MD, PhD, Tatsuo Ueda, MD, PhD, Hidenori Yamaguchi, MD, PhD, Daisuke Yasui, MD, Takahiko Mine, MD, PhD, Shinichiro Kumita, MD, PhD

Published in: Annals of Surgical Oncology | Issue 12/2015

Abstract

Background

Second-line therapy has limited activity in patients with recurrent or persistent uterine cervical cancer that has progressed after chemoradiation and palliative chemotherapy. The purpose of this study was to evaluate the efficacy of negative-balance isolated pelvic perfusion (NIPP) in patients with pretreated recurrent/persistent uterine cervical cancer.

Methods

Between April 2004 and May 2013, a total of 26 patients with recurrent or persistent uterine cervical cancer previously treated with platinum-based systemic chemotherapy and/or chemoradiotherapy received NIPP therapy at our institution, consisting of a 30-min isolated pelvic perfusion with cisplatin and fluorouracil, followed by isolated pelvic dialysis. Primary endpoints were response rate (RR) and progression-free survival (PFS), while secondary endpoints were overall survival (OS) and safety. Platinum pharmacokinetics were also evaluated.

Results

The RR was 57.7 % (complete response, five patients; partial response, ten patients). The median PFS and OS after NIPP therapy were 11.0 (95 % confidence interval [CI] 6.6–15.4) and 25.1 (95 % CI 17.1–33.1) months, respectively. PFS was significantly better in patients without intestinal involvement (p = 0.016) or dissemination (p < 0.001). Survival rates at 1, 2, and 3 years after initial NIPP therapy were 65.2, 50.4, and 13.4 %, respectively. The plasma pelvic-to-systemic exposure ratios were 15.4 and 15.8, based on the maximum concentration and the concentration–time curve, respectively. Most adverse events were mild (grade 1–2) (Common Terminology Criteria for Adverse Events, version 3.0). Severe neutropenia (grade 3 or higher) occurred in only 7.7 % of patients.

Conclusions

NIPP appears to be an effective and feasible method for patients with pretreated recurrent or persistent cervical cancer.

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Title: Feasibility and Safety of Negative-Balance Isolated Pelvic Perfusion in Patients with Pretreated Recurrent or Persistent Uterine Cervical Cancer
Authors: Satoru Murata, MD, PhD
Shiro Onozawa, MD, PhD
Fumie Sugihara, MD
Atsuhiro Sakamoto, MD, PhD
Tatsuo Ueda, MD, PhD
Hidenori Yamaguchi, MD, PhD
Daisuke Yasui, MD
Takahiko Mine, MD, PhD
Shinichiro Kumita, MD, PhD
Publication date: 01-11-2015
Publisher: Springer US
Published in: Annals of Surgical Oncology / Issue 12/2015
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-015-4494-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Feasibility and Safety of Negative-Balance Isolated Pelvic Perfusion in Patients with Pretreated Recurrent or Persistent Uterine Cervical Cancer

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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