Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Müllerian tumors

• Published in: Gynecologic oncology Vol. 112; no. 2; pp. 394 - 399
• Main Authors: Matulonis, Ursula A, Krag, Karen J, Krasner, Carolyn N, Atkinson, Tina, Horowitz, Neil S, Lee, Hang, Penson, Richard T
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2009
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin - administration & dosage; Carboplatin - adverse effects; Chemotherapy; Combined Modality Therapy; Disease-Free Survival; Elderly; Endometrial Neoplasms - drug therapy; Endometrial Neoplasms - surgery; Fallopian Tube Neoplasms - drug therapy; Fallopian Tube Neoplasms - surgery; Female; Genital Neoplasms, Female - drug therapy; Genital Neoplasms, Female - surgery; Hematology, Oncology and Palliative Medicine; Humans; Mixed Tumor, Mullerian - drug therapy; Mixed Tumor, Mullerian - surgery; Obstetrics and Gynecology; Older patients; Ovarian cancer; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - surgery; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Peritoneal Neoplasms - drug therapy; Peritoneal Neoplasms - surgery; Prospective Studies; Quality of Life; Older patients; Chemotherapy; Elderly; Ovarian cancer
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2008.10.015

Abstract Objectives The primary objective was to determine the completion rate of 6 cycles of paclitaxel and carboplatin chemotherapy with no dose reductions in patients ≥ 70 years of age. Methods Phase II study of intravenous (IV) carboplatin Area Under the Curve (AUC) of 5 and paclitaxel 175 mg/m2 given to patients ≥ 70 years of age, had any stage Müllerian cancer, and an ECOG performance status (PS) of 0–2. Results Twelve patients were enrolled (median age of 82 years, range 75 to 86 years). Six of 12 completed 6 cycles of chemotherapy with no dose reductions. Three patients died on study precipitating study closure; one with refractory cancer following cycle 1, one of aspiration pneumonia after cycle 1, and one with sudden death on day 5 of cycle 6. Patients undergoing upfront debulking surgery tolerated chemotherapy better compared to patients receiving neoadjuvant chemotherapy. Grade 3 or higher hematologic toxicities included 2 patients with febile neutropenia (17%). ≥ Grade 3 non-hematologic toxicities included fatigue (8%), nausea (8%), constipation (8%), obstipation (8%), vomiting (8%), and hypoxia (8%). Conclusions In this prospective trial of standard carboplatin and paclitaxel chemotherapy in a heterogeneous population of elderly patients, chemotherapy was well tolerated by patients who underwent upfront debulking surgery, had a PS of 0–1, and had few comorbidities. Patients not undergoing upfront debulking surgery because of either advanced cancer or poor surgical risk had excess morbidity/mortality. Prospective studies to identify risk factors for toxicity prediction are needed.