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


METHODS
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.


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%). > or =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.
Matulonis
Ursula A
UA
Department of Medical Oncology Dana-Farber Cancer Institute, Boston, MA 02115, USA. ursula_matulonis@dfci.harvard.edu
Krag
Karen J
KJ
Krasner
Carolyn N
CN
Atkinson
Tina
T
Horowitz
Neil S
NS
Lee
Hang
H
Penson
Richard T
RT
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy / Q000601:surgery; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy / Q000601:surgery; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D018200:Mixed Tumor, Mullerian / Q000188:drug therapy* / Q000601:surgery; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life
D016190:Carboplatin; D017239:Paclitaxel