Lindemann Kristina, Gibbs Emma, Åvall-Lundqvist Elisabeth, dePont Christensen Rene, Woie Kathrine, Kalling Marten, Auranen Annika, Grenman Seija, Hoegberg Thomas, Rosenberg Per, Skeie-Jensen Tone, Hjerpe Elisabet, Dørum Anne, Gebski Val, Kristensen Gunnar
Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.
Br J Cancer. 2017 Feb 14;116(4):455-463. doi: 10.1038/bjc.2016.435. Epub 2017 Jan 24.
Chemotherapy in platinum-resistant ovarian cancer (PROC) aims for palliation and prolonging of progression-free survival (PFS). This study compares Health-related Quality of Life (HRQoL) and efficacy between single-agent chemotherapy and tamoxifen in PROC.
Patients with PROC were randomised (2 : 1) to chemotherapy (weekly paclitaxel 80 mg m or four weekly pegylated liposomal doxorubicin 40 mg m) or tamoxifen 40 mg daily. The primary end point was HRQoL. Secondary end points were PFS by RECIST and overall survival (OS).
Between March 2002 and December 2007, 156 and 82 patients were randomised to chemotherapy and tamoxifen, respectively. In the chemotherapy arm, a significantly larger proportion of patients experienced a worsening in their social functioning. There was no difference in the proportion of patients experiencing improvement of gastrointestinal symptoms. Median PFS on tamoxifen was 8.3 weeks (95% CI, 8.0-10.4) compared with 12.7 weeks (95% CI, 9.0-16.3) on chemotherapy (HR, 1.54; 95% CI, 1.16-2.05; log-rank P=0.003). There was no difference in OS between the treatment arms.
Patients on chemotherapy had longer PFS but experienced more toxicity and poorer HRQoL compared with tamoxifen. Control over gastrointestinal symptoms was not better on chemotherapy. These data are important for patient counselling and highlight the need to incorporate HRQoL end points in studies of PROC.
铂耐药卵巢癌（PROC）的化疗旨在缓解症状并延长无进展生存期（PFS）。本研究比较了PROC中单药化疗与他莫昔芬在健康相关生活质量（HRQoL）和疗效方面的差异。
将PROC患者按2∶1随机分组，分别接受化疗（每周紫杉醇80mg/m或每四周聚乙二醇脂质体阿霉素40mg/m）或每日服用他莫昔芬40mg。主要终点为HRQoL。次要终点为根据RECIST标准评估的PFS和总生存期（OS）。
在2002年3月至2007年12月期间，分别有156例和82例患者被随机分配至化疗组和他莫昔芬组。在化疗组中，有显著更多比例的患者社会功能恶化。在胃肠道症状改善的患者比例方面无差异。他莫昔芬组的中位PFS为8.3周（95%CI，8.0 - 10.4），而化疗组为12.7周（95%CI，9.0 - 16.3）（风险比，1.54；95%CI，1.16 - 2.05；对数秩检验P = 0.003）。两组之间的OS无差异。
与他莫昔芬相比，接受化疗的患者PFS更长，但毒性更大且HRQoL更差。化疗对胃肠道症状的控制并无更好效果。这些数据对患者咨询很重要，并突出了在PROC研究中纳入HRQoL终点的必要性。
