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Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial.

التفاصيل البيبلوغرافية
العنوان: Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial.
المؤلفون: Wong YN; Fox Chase Cancer Center, Philadelphia, PA. Electronic address: yuningwong123@gmail.com., Manola J; Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA., Hudes GR; Fox Chase Cancer Center, Philadelphia, PA., Roth BJ; Indiana University, Indianapolis, IN., Moul JW; Walter Reed Army Medical Center, Washington, DC., Barsevick AM; Fox Chase Cancer Center, Philadelphia, PA., Scher RM; Fox Chase Cancer Center, Philadelphia, PA., Volk MJ; Saint Vincent Hospital, Green Bay, WI., Vaughn DJ; University of Pennsylvania, Philadelphia, PA., Williams SD; Indiana University, Indianapolis, IN., Fisch MJ; University of Virginia, Charlottesville, VA., Cella D; Evanston Hospital, Evanston, IL., Carducci MA; Johns Hopkins University, Baltimore, MD., Wilding G; University of Wisconsin Carbone Cancer Center, Madison, WI.
المصدر: Clinical genitourinary cancer [Clin Genitourin Cancer] 2018 Apr; Vol. 16 (2), pp. e315-e322. Date of Electronic Publication: 2017 Oct 16.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 101260955 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-0682 (Electronic) Linking ISSN: 15587673 NLM ISO Abbreviation: Clin Genitourin Cancer Subsets: MEDLINE
أسماء مطبوعة: Publication: <2009-> : [New York] : Elsevier
Original Publication: Dallas, Tex. : Cancer Information Group, c2005-
مواضيع طبية MeSH: Antineoplastic Combined Chemotherapy Protocols/*administration & dosage , Estramustine/*administration & dosage , Paclitaxel/*administration & dosage , Prostatic Neoplasms, Castration-Resistant/*drug therapy, Administration, Intravenous ; Administration, Oral ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Drug Administration Schedule ; Estramustine/adverse effects ; Humans ; Male ; Middle Aged ; Paclitaxel/adverse effects ; Prostate-Specific Antigen/metabolism ; Prostatic Neoplasms, Castration-Resistant/metabolism ; Survival Analysis ; Treatment Outcome
مستخلص: Introduction: This multicenter phase 2 study assessed the combination of estramustine and weekly paclitaxel with metastatic castration-resistant prostate cancer (CRPC).
Patients and Methods: We enrolled 77 patients who had received no prior chemotherapy for CRPC between 1998 and 2000; a total of 74 subjects were eligible for the study. Each 8-week cycle included paclitaxel 90 mg/m 2 provided intravenously weekly for 6 weeks, followed by 2 weeks off therapy and oral estramustine 280 mg twice daily for 3 days beginning 24 hours before the first dose of paclitaxel. The primary end point was rate of objective or prostate-specific antigen (PSA) response at 16 weeks. A 50% response rate was considered of further interest.
Results: Eligible patients received a median of 3 cycles (range, 1-10 cycles). The response rate among patients with measurable disease was 34% (95% confidence interval [CI], 19-52). The PSA response rate was 58% (95% CI, 47-70). Clinical benefit rate was 45% (95% CI, 33-57). The median progression-free survival was 5.9 months (95% CI, 4.4-6.7). The median overall survival was 17.6 months (95% CI, 14.6-20.8). The most common clinical grade 3/4 toxicities were fatigue (14%) and sensory neuropathy (7%). Grade 3/4 hematologic toxicities included lymphopenia (21%) and anemia (9%). There was one toxicity-related death. Quality-of-life scores improved by week 8, but the change was not statistically significant.
Conclusion: The combination has activity defined by PSA declines in CRPC but did not meet the protocol-specified end point for efficacy as defined by objective response rate. Since this study was conducted, more effective, better-tolerated regimens have been developed.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
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معلومات مُعتمدة: U10 CA180802 United States CA NCI NIH HHS; UG1 CA189956 United States CA NCI NIH HHS; U10 CA180858 United States CA NCI NIH HHS; U10 CA180795 United States CA NCI NIH HHS; U10 CA180857 United States CA NCI NIH HHS; U10 CA180847 United States CA NCI NIH HHS; UG1 CA189828 United States CA NCI NIH HHS; U10 CA180820 United States CA NCI NIH HHS; U10 CA180794 United States CA NCI NIH HHS; U10 CA180799 United States CA NCI NIH HHS
فهرسة مساهمة: Keywords: Castration resistant; Chemotherapy; Clinical trials; Metastases; Prostate cancer
المشرفين على المادة: 35LT29625A (Estramustine)
EC 3.4.21.77 (Prostate-Specific Antigen)
P88XT4IS4D (Paclitaxel)
تواريخ الأحداث: Date Created: 20171128 Date Completed: 20190204 Latest Revision: 20190401
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC5975965
DOI: 10.1016/j.clgc.2017.10.001
PMID: 29173976
قاعدة البيانات: MEDLINE
الوصف
تدمد:1938-0682
DOI:10.1016/j.clgc.2017.10.001