Intraperitoneal cisplatin versus no further treatment: 8-year results of EORTC 55875, a randomized phase III study in ovarian cancer patients with a pathologically complete remission after platinum-based intravenous chemotherapy
| العنوان: | Intraperitoneal cisplatin versus no further treatment: 8-year results of EORTC 55875, a randomized phase III study in ovarian cancer patients with a pathologically complete remission after platinum-based intravenous chemotherapy |
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| المؤلفون: | Giovanna Scarfone, Ahmad Awada, Anne Floquet, Livia Giurgea, Phb Willemse, Janusz Emerich, Jan B. Vermorken, Ignace Vergote, Martine Piccart, Corneel Coens |
| المساهمون: | Faculteit Medische Wetenschappen/UMCG |
| المصدر: | International journal of gynecological cancer International Journal of Gynecological Cancer, 13, 196-203. LIPPINCOTT WILLIAMS & WILKINS |
| بيانات النشر: | BMJ, 2003. |
| سنة النشر: | 2003 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, CARCINOMA, Cyclophosphamide, medicine.medical_treatment, Antineoplastic Agents, intraperitoneal, ovarian neoplasm, REGIMENS, chemotherapy, Gastroenterology, Disease-Free Survival, HIGH-DOSE CISPLATIN, Internal medicine, CYCLOPHOSPHAMIDE, medicine, Clinical endpoint, Humans, PERITONEAL-CAVITY, ADRIAMYCIN, Infusions, Intravenous, Survival analysis, Aged, Ovarian Neoplasms, Chemotherapy, Performance status, business.industry, Hazard ratio, Obstetrics and Gynecology, Middle Aged, Debulking, Survival Analysis, METHOTREXATE, Surgery, Europe, Treatment Outcome, Oncology, ETOPOSIDE, Vomiting, TRIAL, Female, PENETRATION, Cisplatin, medicine.symptom, business, Injections, Intraperitoneal, medicine.drug |
| الوصف: | First-line intravenous chemotherapy (CT) following debulking surgery is associated with prolonged survival, in particular in patients who achieve a pathological complete remission (pCR) at second-look surgery but in whom a high rate of relapses still occurs. Between 1988 and 1997, 153 patients in pCR following platinum-based intravenous CT were randomized between four courses of intraperitoneal cisplatin (P) (90 mg/m2 every 3 weeks) or observation. Overall survival (OS) was the primary endpoint, while progression-free survival (PFS) was a secondary endpoint. This intent-to-treat analysis includes 16 patients who were not eligible and 17 patients who had protocol violations. The two groups were well balanced in terms of age (median = 55 years), performance status (78% P.S. O), FIGO stage (96% stage III), histology (serous in 66%), grade (2 or 3 in 80%), and residuum before intravenous CT (>1 cm in 40%). Intraperitoneal CT was delivered mainly through intraperitoneal catheters (Port-a-Cath 61% and Tenckhoff 25%). Side effects of intraperitoneal cisplatin included vomiting [≥grade 2 (82%)], rise in serum creatinine [≥grade 2 (14%)], abdominal pain [grade 1–2 (38%)], and neurotoxicity [grade 2–3 (15%)].After a median follow-up of 8 years, 80 patients (52%) have progressed with no difference in the pattern of relapse between the two groups and 75 patients (49%) have died; the respective hazard ratios for PFS and OS with 95% CI are 0.89 (0.59–1.33) and 0.82 (0.52–1.29). These results are suggestive of a treatment benefit but do not support a change in clinical practice. Other randomized clinical trials of intraperitoneal CT are reviewed and briefly discussed. |
| تدمد: | 1525-1438 1048-891X |
| DOI: | 10.1111/j.1525-1438.2003.13360.x |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1597a5be81f153349701151cb8c1bca6 https://doi.org/10.1111/j.1525-1438.2003.13360.x |
| Rights: | RESTRICTED |
| رقم الانضمام: | edsair.doi.dedup.....1597a5be81f153349701151cb8c1bca6 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15251438 1048891X |
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| DOI: | 10.1111/j.1525-1438.2003.13360.x |