Phase I/II study of weekly paclitaxel plus carboplatin and gemcitabine as first-line treatment of advanced-stage ovarian cancer: Pathologic complete response and longitudinal assessment of impact on cognitive functioning Journal Article

  

Authors:	Hensley, M. L.; Correa, D. D.; Thaler, H.; Wilton, A.; Venkatraman, E.; Sabbatini, P.; Chi, D. S.; Dupont, J.; Spriggs, D.; Aghajanian, C.
Article Title:	Phase I/II study of weekly paclitaxel plus carboplatin and gemcitabine as first-line treatment of advanced-stage ovarian cancer: Pathologic complete response and longitudinal assessment of impact on cognitive functioning
Abstract:	Background.: To determine the pathologic complete response rate of advanced ovarian cancer to weekly paclitaxel plus gemcitabine and carboplatin with filgrastim, and assess the longitudinal impact of this regimen on quality-of-life and cognitive functioning. Methods.: Fourteen patients with advanced ovarian, peritoneal, or fallopian tube cancer were treated in the phase I portion of the study. Initial doses were paclitaxel: 60 mg/m2 days 1, 8, and 15; gemcitabine: 800 mg/m2 days 1 and 8; and carboplatin: area under the curve (AUC) 5 day 1, every 21 days for 6 cycles with filgrastim. Twenty-seven patients were treated at the phase II dose. Pathologic response was assessed by second-look laparoscopy in patients with complete response. Patients completed longitudinal assessments of quality-of-life and cognitive functioning. Results.: Maximally tolerated doses were paclitaxel: 80 mg/m2 days 1 and 8; gemcitabine: 800 mg/m2 days 1 and 8; and carboplatin: AUC 5 day 1, every 21 days. Forty-eight percent of patients (13/27) experienced at least 1 grade 3 nonhematologic toxicity. Fifty percent (95% confidence interval [CI], 31-69%) of assessable patients achieved pathologic complete response. Median progression-free survival was 27.3 months (95% CI, 17.7 months to not reached), and overall survival 43.6 months (95% CI, 42 months to not reached). Cognitive functioning did not decline during or after chemotherapy. More highly educated women reported a perceived decline in concentration and memory while on chemotherapy. Quality-of-life scores were maintained during therapy. Conclusions.: Fifty percent of patients with advanced-stage ovarian cancer achieved pathologic complete response to weekly paclitaxel plus gemcitabine and carboplatin. Cognitive functioning did not decline by objective measures, although highly educated women reported subjective impairment. © 2006 Elsevier Inc. All rights reserved.
Keywords:	adult; cancer survival; clinical article; treatment response; aged; disease-free survival; middle aged; overall survival; clinical trial; fatigue; area under the curve; cancer combination chemotherapy; cancer growth; diarrhea; gemcitabine; paclitaxel; disease free survival; chemotherapy; laparoscopy; neoplasms; ovarian neoplasms; carboplatin; quality of life; ovary cancer; peritoneum cancer; phase 2 clinical trial; blood toxicity; nausea; antineoplastic combined chemotherapy protocols; peripheral neuropathy; drug administration schedule; patient assessment; dose-response relationship, drug; dyspnea; syncope; confidence interval; chemotherapy induced emesis; longitudinal studies; education; experience; scoring system; cognition; cognitive defect; headache; maximum tolerated dose; phase 1 clinical trial; uterine tube carcinoma; memory disorder; cognition disorders; toxicity; recombinant granulocyte colony stimulating factor; deoxycytidine; anaphylaxis; wellbeing; quality-of-life; ovarian; cognitive functioning; advanced disease; first-line treatment
Journal Title:	Gynecologic Oncology
Volume:	102
Issue:	2
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2006-08-01
Start Page:	270
End Page:	277
Language:	English
DOI:	10.1016/j.ygyno.2005.12.042
PUBMED:	16490239
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-33746003335&partnerID=40&md5=8bb908c6f0357572619b604eacd95095
Notes:	--- - "Cited By (since 1996): 13" - "Export Date: 4 June 2012" - "CODEN: GYNOA" - "Source: Scopus"

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