Hensley Martee L, Correa Denise D, Thaler Howard, Wilton Andrew, Venkatraman Ennapadam, Sabbatini Paul, Chi Dennis S, Dupont Jakob, Spriggs David, Aghajanian Carol
Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 275 York Avenue, New York, NY 10021, USA.
Gynecol Oncol. 2006 Aug;102(2):270-7. doi: 10.1016/j.ygyno.2005.12.042. Epub 2006 Feb 20.
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.
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/m(2) days 1, 8, and 15; gemcitabine: 800 mg/m(2) 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.
Maximally tolerated doses were paclitaxel: 80 mg/m(2) days 1 and 8; gemcitabine: 800 mg/m(2) 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.
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.
确定晚期卵巢癌对每周一次紫杉醇联合吉西他滨及卡铂加用非格司亭的病理完全缓解率，并评估该方案对生活质量和认知功能的长期影响。
14例晚期卵巢、腹膜或输卵管癌患者接受了本研究的I期治疗。初始剂量为：紫杉醇60mg/m²，第1、8和15天；吉西他滨800mg/m²，第1和8天；卡铂曲线下面积（AUC）5，第1天，每21天一次，共6个周期，并加用非格司亭。27例患者接受II期剂量治疗。对完全缓解的患者通过二次剖腹探查评估病理反应。患者完成了生活质量和认知功能的纵向评估。
最大耐受剂量为：紫杉醇80mg/m²，第1和8天；吉西他滨800mg/m²，第1和8天；卡铂AUC 5，第1天，每21天一次。48%的患者（13/27）经历了至少1次3级非血液学毒性。50%（95%置信区间[CI]，31 - 69%）的可评估患者达到病理完全缓解。中位无进展生存期为27.3个月（95%CI，17.7个月至未达到），总生存期为43.6个月（95%CI，42个月至未达到）。化疗期间及化疗后认知功能未下降。受教育程度较高的女性报告在化疗期间注意力和记忆力有感知到的下降。治疗期间生活质量评分得以维持。
50%的晚期卵巢癌患者对每周一次紫杉醇联合吉西他滨及卡铂达到病理完全缓解。尽管受教育程度较高的女性报告有主观损害，但客观测量显示认知功能未下降。
