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Int J Clin Oncol. 2016 Dec;21(6):1120-1127. Epub 2016 Jun 24.

Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass.

Author information

1
Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan. tshoji@iwate-med.ac.jp.
2
Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
3
Department of Obstetrics and Gynecology, National Hospital Organization Kokura Medical Center, Kokura, Japan.
4
Department of Gynecology, Miyama Hospital, Oshu, Japan.
5
Department of Gynecology, Medical Coat Hachinohe West Hospital, Hachinohe, Japan.

Abstract

BACKGROUND:

We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy.

SUBJECTS AND METHODS:

The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m2 was intravenously administered on day 1 and CPT-11 at 70 mg/m2 was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS).

RESULTS:

The antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6-93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210-334) and 500 ml (range, 393-898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors.

CONCLUSION:

NAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis.

KEYWORDS:

Bulky mass; CDDP; CPT-11; Cervical cancer; NAC

PMID:
27342833
PMCID:
PMC5124439
DOI:
10.1007/s10147-016-1008-7
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

None of the authors of this manuscript has any conflicts of interest to declare.

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