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http://tor.imng.com/tor/gynecologic/80949a.html% h j E! s* @% b8 p+ ~
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Hormone therapy may be option in treatment resistant ovarian cancer
8 U9 a2 x% K& Y" J1 NPatients with platinum- and taxane-resistant ovarian cancer who were treated with either paclitaxel or pegylated doxorubicin had slightly better progression-free survival than did those treated with tamoxifen in a randomized Nordic Society of Gynecological Oncology study.
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The findings of the trial, NSGC-OC-0101, nonetheless, suggest that tamoxifen is a valid option for palliative care in this population, Dr. Gunnar B. Kristensen reported.2 M! }0 C! {6 w% j0 g& q4 t- w
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The study enrolled 241 women with platinum and taxane treatment resistance and early relapse. They were randomized 2:1 to receive chemotherapy with either intravenous paclitaxel (weekly) or intravenous pegylated doxorubicin (every 4 weeks) as determined prior to randomization by the treating clinician or to receive oral tamoxifen (daily).
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Median progression-free survival was 87 days for the chemotherapy arm of the trial (99 days in 69 patients given paclitaxel, and 84 days in 82 patients given doxorubicin), compared with 62 days in 74 patients who received tamoxifen (P = .024). Sixteen patients were not treated. & n2 W0 o2 p" \* q2 _
: j; v1 Z8 k# b J. p' ^1 p' SThe difference between the chemotherapy and tamoxifen groups was small but statistically significant, noted Dr. Kristensen of the Norwegian Radium Hospital, Oslo.
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Overall survival was longer with chemotherapy, but did not differ significantly between the chemotherapy and tamoxifen groups (328 days vs. 278 days; P = .56).9 G. A' [" G v6 p& C' q. U
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Quality of life—rather than survival—was the primary outcome measure in this study. Because patients with early relapse of ovarian cancer generally have poor response to further treatment, quality of life becomes an important factor in this population. Data have been lacking, however, in comparison of treatment with best supportive care.
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" q1 e7 ~ }+ P7 o3 RAt the time of Dr. Kristensen?s presentation, quality of life analyses were still pending. Thus, the clinical importance of slightly prolonged progression-free survival with chemotherapy remained unclear, he said.
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: ~% W. a% x4 X0 u1 Q1 T3 eThe most common adverse events in both arms were nausea and vomiting. Given that no difference was seen in overall survival and that all three treatments were well tolerated, he concluded the findings suggest tamoxifen therapy is a valid option in ovarian cancer patients who fail to respond to platinum and taxane therapies.' R# w. n5 s+ v- C* ?0 _1 M7 j1 A
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Patients given paclitaxel received 80 mg/m2 once each week in the trial; those given doxorubicin received 40 mg/m2 once every 4 weeks, and those given tamoxifen received 40 mg daily. Patients were evaluated for tumor response by computed tomography, magnetic resonance imaging, or ultrasound every 8 weeks, and were treated until their disease progressed.3 @, ~( p$ n \) D/ @0 R7 B$ K' \
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Before randomization, 131 patients had received one line of chemotherapy, 63 had received two, and 42 had received three. Dose reduction was required in four (6%) of the paclitaxel patients, and in seven (9%) of the doxorubicin patients.3 G* o& M6 R) f
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NSGO-OC-0101 was supported by unrestricted educational grants from Bristol-Myers Squibb Co. and Schering-Plough Corp.
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8 Y' p2 P/ s7 T. @实验入组的病人是铂类和紫杉醇耐药的,一部分接受化疗,另一部分接受它莫昔芬,化疗组的PFS、OS比他莫昔芬组都好一些,但他莫昔份组的副作用明显小。
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! s6 d0 c2 Z1 o; n+ ^现在的指南推荐只有CA125上升而无症状的病人可以尝试包括他莫昔芬在内的内分泌治疗。
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