Hussain S A, Palmer D H, Lloyd B, Collins S I, Barton D, Ansari J, James N D
Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.
Oncol Lett. 2012 Apr 1;3(4):855-859. doi: 10.3892/ol.2012.563. Epub 2012 Jan 12.
The aim of this study was to investigate the outcome of patients with muscle-invasive bladder cancer (MIBC) receiving neo-adjuvant chemotherapy (neo-CT) using a cisplatin-based regimen fractionated on days 1 and 8 of a 21-day cycle prior to organ-preservation (chemoradiation) or cystectomy. Patients with stage T2-T4, N0, M0, transitional cell carcinoma (TCC) of the bladder with a calculated glomerular filtration rate (GFR) ≥40 ml/min were eligible for inclusion in the study. Neo-CT comprised of gemcitabine (1,000 mg/m(2) d1, d8, q21) plus cisplatin (35 mg/m(2) d1, d8, q21) for four cycles. Following the administration of neo-CT, patients underwent surgery or radiotherapy (RT) with or without concurrent chemotherapy (CRT), based on the response to neo-CT and clinician and patient preference. A total of 23 patients were recruited: 21 males and 2 females; median age, 69 years (range, 49-85); stage T2=11, T3A=7, T3B=5, grade 2=1, grade 3=22. One patient progressed prior to neo-CT. In total, 75 cycles of neo-CT were administered. Treatment was well-tolerated with only one episode of neutropenic sepsis. Three of 22 patients developed early progression and did not receive radical treatment. For the remaining 19 patients, choice of definitive treatment (surgery vs. RT/CRT) was based on response to neo-CT. Eight patients had residual disease at cystoscopy following the completion of neo-CT; six patients underwent surgery and two underwent RT/CRT. A total of 11 patients had a complete response (CR) to neo-CT, nine of whom were treated by RT/CRT, with the remaining two declining radical treatment. Median follow-up for alive patients was 57 months (range, 4.4-68.5). Three-year survival was 37% (95% CI 17-58%) and 5-year survival was 31% (95% CI 15-52%). Neo-CT is effective and well-tolerated in MIBC. This split-dose cisplatin regimen facilitates treatment in an outpatient setting and allows inclusion of patients with compromised GFR.
本研究旨在调查肌层浸润性膀胱癌（MIBC）患者接受新辅助化疗（neo-CT）的疗效，该化疗采用基于顺铂的方案，在器官保留（放化疗）或膀胱切除术之前，于21天周期的第1天和第8天进行分次给药。膀胱移行细胞癌（TCC）患者，分期为T2-T4、N0、M0，计算的肾小球滤过率（GFR）≥40 ml/min，符合纳入本研究的条件。新辅助化疗包括吉西他滨（1000 mg/m²，第1天、第8天，每21天重复）加顺铂（35 mg/m²，第1天、第8天，每21天重复），共四个周期。新辅助化疗给药后，根据对新辅助化疗的反应以及临床医生和患者的偏好，患者接受手术或放疗（RT），可联合或不联合同步化疗（CRT）。共招募了23例患者：21例男性和2例女性；中位年龄69岁（范围49-85岁）；T2期=11例，T3A期=7例，T3B期=5例，2级=1例，3级=22例。1例患者在新辅助化疗前病情进展。总共进行了75个周期的新辅助化疗。治疗耐受性良好，仅发生1例中性粒细胞减少性败血症。22例患者中有3例出现早期进展，未接受根治性治疗。对于其余19例患者，确定性治疗（手术与RT/CRT）的选择基于对新辅助化疗的反应。新辅助化疗完成后，8例患者膀胱镜检查有残留病灶；6例患者接受了手术，2例接受了RT/CRT。共有11例患者对新辅助化疗完全缓解（CR），其中9例接受了RT/CRT治疗，其余2例拒绝根治性治疗。存活患者的中位随访时间为57个月（范围4.4-68.5个月）。3年生存率为37%（95%CI 17-58%），5年生存率为31%（95%CI 15-52%）。新辅助化疗在MIBC中有效且耐受性良好。这种分剂量顺铂方案便于在门诊环境中进行治疗，并允许纳入GFR受损的患者。
