TY - JOUR
T1 - Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix
T2 - A Gynecologic Oncology Group study
AU - Moore, David H.
AU - Blessing, John A.
AU - McQuellon, Richard P.
AU - Thaler, Howard T.
AU - Cella, David
AU - Benda, Jo
AU - Miller, David S.
AU - Olt, George
AU - King, Stephanie
AU - Boggess, John F.
AU - Rocereto, Thomas F.
N1 - Copyright 2004 American Society of Clinical Onocology
PY - 2004
Y1 - 2004
N2 - Purpose: To determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix. Patients and Methods: Eligible patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m2 or C+P (cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle. Results: Of 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9.7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n = 50; C+P, n = 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death. Conclusion: C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL.
AB - Purpose: To determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix. Patients and Methods: Eligible patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m2 or C+P (cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle. Results: Of 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9.7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n = 50; C+P, n = 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death. Conclusion: C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents, Phytogenic/administration & dosage
KW - Antineoplastic Agents/administration & dosage
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Carcinoma, Squamous Cell/drug therapy
KW - Cisplatin/administration & dosage
KW - Drug Administration Schedule
KW - Female
KW - Humans
KW - Middle Aged
KW - Paclitaxel/administration & dosage
KW - Quality of Life
KW - Treatment Outcome
KW - Uterine Cervical Neoplasms/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=4143135504&partnerID=8YFLogxK
U2 - 10.1200/JCO.2004.04.170
DO - 10.1200/JCO.2004.04.170
M3 - Article
C2 - 15284262
AN - SCOPUS:4143135504
SN - 0732-183X
VL - 22
SP - 3113
EP - 3119
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 15
ER -