Document Detail

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: multi-institutional phase-II trial.
MedLine Citation:
PMID:  21665254     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The primary end-point of this multi-institutional phase-II trial was to assess results in terms of overall survival after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment-naive epithelial ovarian cancer (EOC) with advanced peritoneal involvement. Secondary end-points were treatment morbi-mortality and outcome effects of time to subsequent adjuvant systemic chemotherapy (TTC).
METHODS: Twenty-six women with stage III-IV EOC were prospectively enrolled in 4 Italian centers to undergo CRS and closed-abdomen HIPEC with cisplatin and doxorubicin. Then they received systemic chemotherapy with carboplatin (AUC 6) and paclitaxel (175 mg/m(2)) for 6 cycles.
RESULTS: Macroscopically complete cytoreduction was achieved in 15 patients; only minimal residual disease (≤2.5 mm) remained in 11. Major complications occurred in four patients and postoperative death in one. After a median follow-up of 25 months, 5-year overall survival was 60.7% and 5-year progression-free survival 15.2% (median 30 months). Excluding operative death, all the patients underwent systemic chemotherapy at a median of 46 days from combined treatment (range: 29-75). The median number of cycles per patient was 6 (range: 1-8). The time to chemotherapy did not affect the OS or PFS.
CONCLUSIONS: In selected patients with advanced stage EOC, upfront CRS and HIPEC provided promising results in terms of outcome. Morbidity was comparable to aggressive cytoreduction without HIPEC. Postoperative recovery delayed the initiation of adjuvant systemic chemotherapy but not sufficiently to impact negatively on survival. These data warrant further evaluation in a randomized clinical trial.
Marcello Deraco; Shigeki Kusamura; Salvatore Virzì; Francesco Puccio; Antonio Macrì; Ciro Famulari; Massimiliano Solazzo; Serena Bonomi; Domenico Rosario Iusco; Dario Baratti
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article     Date:  2011-06-12
Journal Detail:
Title:  Gynecologic oncology     Volume:  122     ISSN:  1095-6859     ISO Abbreviation:  Gynecol. Oncol.     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-07-18     Completed Date:  2011-09-19     Revised Date:  2012-04-18    
Medline Journal Info:
Nlm Unique ID:  0365304     Medline TA:  Gynecol Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  215-20     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Peritoneal Surface Malignancy Program, Department of Surgery, National Cancer Institute, via Venezian 1, 20133 Milan, Italy.
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MeSH Terms
Antineoplastic Agents / administration & dosage*,  therapeutic use
Combined Modality Therapy
Hyperthermia, Induced / methods*
Injections, Intraperitoneal
Middle Aged
Neoplasm Staging
Neoplasms, Glandular and Epithelial / mortality,  pathology,  therapy*
Ovarian Neoplasms / mortality,  pathology,  therapy*
Peritoneal Neoplasms / mortality,  secondary,  therapy*
Reg. No./Substance:
0/Antineoplastic Agents
Comment In:
Gynecol Oncol. 2012 Apr;125(1):279-81   [PMID:  22233688 ]
Gynecol Oncol. 2011 Aug;122(2):207-8   [PMID:  21763889 ]

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