Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy as upfront therapy for advanced epithelial ovarian cancer: multi-institutional phase-II trial
| Autor: | Francesco Puccio, Serena Bonomi, Ciro Famulari, Salvatore Virzì, Marcello Deraco, Massimiliano Solazzo, Dario Baratti, Shigeki Kusamura, Domenico Rosario Iusco, Antonio Macrì |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Oncology
Adult medicine.medical_specialty medicine.medical_treatment Antineoplastic Agents Carcinoma Ovarian Epithelial chemistry.chemical_compound Internal medicine medicine Carcinoma Humans Doxorubicin Neoplasms Glandular and Epithelial Stage (cooking) Peritoneal Neoplasms Aged Neoplasm Staging Ovarian Neoplasms Chemotherapy business.industry Obstetrics and Gynecology Hyperthermia Induced Middle Aged medicine.disease Minimal residual disease Combined Modality Therapy Carboplatin Surgery Clinical trial chemistry Hyperthermic intraperitoneal chemotherapy Female business Injections Intraperitoneal medicine.drug |
| Popis: | 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 (175mg/m 2 ) for 6 cycles. Results. Macroscopically complete cytoreduction was achieved in 15 patients; only minimal residual disease (≤2.5mm) remained in 11. Major complications occurred in four patients and postoperative death in one. After a median follow-up of 25months, 5-year overall survival was 60.7% and 5-year progression-free survival 15.2% (median 30months). Excluding operative death, all the patients underwent systemic chemotherapy at a median of 46days 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. |
| Databáze: | OpenAIRE |
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