Oxaliplatin or Paclitaxel in Patients With Platinum-Pretreated Advanced Ovarian Cancer: A Randomized Phase II Study of the European Organization for Research and Treatment of Cancer Gynecology Group

• Published in: Journal of clinical oncology Vol. 18; no. 6; pp. 1193 - 1202
• Main Authors: PICCART, M. J, GREEN, J. A, VAN GLABBEKE, M, LACOMBE, D, PINEL, M.-C, PECORELLI, S, JIMENEZ LACAVE, A, REED, N, VERGOTE, I, BENEDETTI-PANICI, P, BONETTI, A, KRISTELLER-TOME, V, MENDIOLA FERNANDEZ, C, CURRAN, D
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01-03-2000; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic agents; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Carboplatin - therapeutic use; Chemotherapy; Cisplatin - therapeutic use; Female; Humans; Medical sciences; Middle Aged; Organoplatinum Compounds - therapeutic use; Ovarian Neoplasms - drug therapy; Paclitaxel - therapeutic use; Pharmacology. Drug treatments; Quality of Life; Survival Analysis; Human; Antineoplastic agent; Relapse; Carcinoma; Malignant tumor; Cisplatin; Female genital diseases; Ovarian diseases; Ovary; Chemotherapy; Randomization; Oxaliplatin; Treatment; Taxane derivatives; Phase II trial; Paclitaxel; Adult; Female; Advanced stage; Pretreatment; Comparative study; Platinum II Complexes
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2000.18.6.1193

This was a multicentric, open, randomized, phase II study of single-agent paclitaxel and oxaliplatin to evaluate the efficacy of oxaliplatin in a relapsing progressive ovarian cancer patient population and to analyze the safety profile and impact of both agents on quality of life, time to progression, and survival.
Eighty-six patients with platinum-pretreated advanced ovarian cancer were randomly assigned to two arms: 41 received paclitaxel at 175 mg/m(2) over 3 hours every 3 weeks, and 45 received oxaliplatin at 130 mg/m(2) over 2 hours every 3 weeks. For inclusion, patients had to have a performance status of 0 to 2 and to have received at least one and no more than two prior cisplatin- and/or carboplatin-containing chemotherapy regimens within the last 12 months.
Seven confirmed responses were observed in each arm, for an overall response rate in the total treated population of 17% (95% confidence interval [CI], 7% to 32%) in the paclitaxel arm and 16% (95% CI, 7% to 29%) in the oxaliplatin arm. Median time to progression was 14 weeks and 12 weeks, and overall survival was 37 weeks and 42 weeks in the paclitaxel and oxaliplatin arms, respectively. Among 63 patients with a 0- to 6-month progression-free, platinum-free interval, there were five objective responses with paclitaxel in 31 patients and two objective responses with oxaliplatin in 32 patients. Nine patients (22%) in the paclitaxel arm had grade 3 or 4 neutropenia (National Cancer Institute of Canada [NCIC] Common Toxicity Criteria). Two patients (4%) experienced grade 3 thrombocytopenia in the oxaliplatin arm. Maximum grade (grade 3) NCIC neurosensory toxicity was experienced by three patients (7%) in the paclitaxel arm and by four patients (9%) in the oxaliplatin arm.
Single-agent oxaliplatin at 130 mg/m(2) every 3 weeks is active with moderate toxicity in patients with cisplatin-/carboplatin-pretreated advanced ovarian cancer.