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Gynecol Oncol. 2009 Feb;112(2):394-9. doi: 10.1016/j.ygyno.2008.10.015. Epub 2008 Dec 5.

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

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Department of Medical Oncology Dana-Farber Cancer Institute, Boston, MA 02115, USA.



The primary objective was to determine the completion rate of 6 cycles of paclitaxel and carboplatin chemotherapy with no dose reductions in patients > or =70 years of age.


Phase II study of intravenous (IV) carboplatin Area Under the Curve (AUC) of 5 and paclitaxel 175 mg/m(2) given to patients > or =70 years of age, had any stage Müllerian cancer, and an ECOG performance status (PS) of 0-2.


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%). > or =Grade 3 non-hematologic toxicities included fatigue (8%), nausea (8%), constipation (8%), obstipation (8%), vomiting (8%), and hypoxia (8%).


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.

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