Weekly paclitaxel and carboplatin (PC-W) for patients with primary advanced ovarian cancer: results of a multicenter phase-II study of the NOGGO

• Published in: Cancer chemotherapy and pharmacology 2008-02, Vol.61 (2), p.243-250
• Main Authors: Sehouli, Jalid, Stengel, Dirk, Mustea, Alexander, Camara, Oumar, Keil, Elke, Elling, Dirk, Ledwon, Peter, Christiansen, Bernd, Klare, Peter, Gebauer, Gerhard, Schwarz, Marina, Lichtenegger, Werner
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Alopecia - chemically induced; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents, Phytogenic - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Area Under Curve; Biological and medical sciences; Blood Cell Count; Body Surface Area; Cancer Research; Carboplatin - administration & dosage; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Humans; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Neurotoxicity Syndromes - physiopathology; Oncology; Original Article; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - pathology; Paclitaxel - administration & dosage; Pharmacology. Drug treatments; Pharmacology/Toxicology; Regression Analysis; Survival Analysis; Tumors
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-007-0466-z

Objectives To study the toxicity and efficacy of weekly paclitaxel and carboplatin (PC-W) in women with primary ovarian cancer Methods This investigation extended a phase-I dose finding study and was approved by the institutional review boards of all participating institutions. Between 1999 and 2003, women with radically resected ovarian cancer of FIGO stages II B to IV were enrolled at 17 German centres. Patients received weekly paclitaxel at a dose of 100 mg/m 2 , followed by carboplatin AUC 2. After a first treatment block consisting of six cycles of chemotherapy, patients had a treatment-free interval of 14 days, followed by a second block of six cycles. Treatment was completed by a 28-days break and a final block of six cycles. Results Altogether, 129 women with a mean age of 59 ± standard deviation 11 years entered the study. Most patients (82.9%) had serous papillary carcinoma of FIGO stage III (72.9%) and IV (20.9%). Participants received 1,851 cycles of chemotherapy; averaging 14.3 ± 4.3 cycles each patient. PC-W produced low rates of peripheral neuropathy (grade 3: 2.3%, 95% confidence interval [CI] 0.5–6.6%), with rapid recovery after 3 months. However, 72 patients had grade III/IV anaemia (55.8%, 95% CI 46.8–64.5%). There were 36 events of grade III/IV leukopenia (27.9%, 95% CI 20.4–36.5%). One patient sustained neutropenic fever. CA-125- and objective response was noted in 73.9% (95% CI 64.7–81.8%) and 55.6% (95% CI 41.4–69.1%) of patients. Median progression free and overall survival was 21 and 43 months, respectively. Conclusions PC-W is feasible; a randomized study is warranted to compare this new regimen with conventional 3-weekly treatment.