Hainsworth J D, Erland J B, Kalman L A, Schreeder M T, Greco F A
Sarah Cannon-Minnie Pearl Cancer Center, Centennial Medical Center, Nashville, TN 37203, USA.
J Clin Oncol. 1997 Jun;15(6):2385-93. doi: 10.1200/JCO.1997.15.6.2385.
To evaluate the efficacy and toxicity of a novel chemotherapy combination that includes paclitaxel, carboplatin, and extended-schedule etoposide in the treatment of patients with carcinoma of unknown primary tumor site.
Fifty-five patients with carcinoma of unknown primary tumor site were treated with the following regimen, administered every 21 days: paclitaxel 200 mg/m2 by 1-hour intravenous (I.V.) infusion on day 1, carboplatin at an estimated area under the concentration-time curve (AUC) of 6.0 on day 1, and etoposide 50 mg alternated with 100 mg orally on days 1 through 10. Responding patients received a total of four courses of treatment. The following histologies were included: adenocarcinoma, 30 patients; poorly differentiated carcinoma (PDC) or poorly differentiated adenocarcinoma (PDA), 21; poorly differentiated neuroendocrine carcinoma, three; and squamous carcinoma, one.
Twenty-five of 53 assessable patients (47%; 95% confidence interval [CI], 33% to 61%) had major objective responses to treatment (seven complete responses). Response rates were similar in patients with adenocarcinoma versus PDC (45% and 48%, respectively). The actuarial median survival time for the entire group was 13.4 months. The regimen was well tolerated, with only seven hospitalizations for treatment of neutropenia and fever (4% of courses) and no treatment-related deaths.
The combination of paclitaxel, carboplatin, and extended-schedule etoposide is highly active and well tolerated in patients with carcinoma of unknown primary tumor site. Response rates and survival in this multicenter community-based trial compare favorably with all previously studied empiric regimens. In addition, this regimen is substantially less toxic and easier to administer than the cisplatin-based regimens previously used in this setting. If this level of efficacy is confirmed, this treatment should be considered standard first-line therapy in patients with carcinoma of unknown primary tumor site.
评估一种包含紫杉醇、卡铂和延长疗程依托泊苷的新型化疗方案治疗原发肿瘤部位不明的癌症患者的疗效和毒性。
55例原发肿瘤部位不明的癌症患者接受以下每21天一次的治疗方案:第1天静脉输注1小时给予紫杉醇200mg/m²,第1天给予卡铂,其浓度-时间曲线下面积(AUC)估计为6.0,第1至10天依托泊苷50mg与100mg交替口服。缓解的患者共接受四个疗程的治疗。纳入的组织学类型如下:腺癌30例;低分化癌(PDC)或低分化腺癌(PDA)21例;低分化神经内分泌癌3例;鳞状细胞癌1例。
53例可评估患者中有25例(47%;95%置信区间[CI],33%至61%)对治疗有主要客观反应(7例完全缓解)。腺癌患者与PDC患者的缓解率相似(分别为45%和48%)。整个组的精算中位生存时间为13.4个月。该方案耐受性良好,仅7例因中性粒细胞减少和发热住院治疗(占疗程的4%),且无治疗相关死亡。
紫杉醇、卡铂和延长疗程依托泊苷联合方案在原发肿瘤部位不明的癌症患者中具有高活性且耐受性良好。在这项基于多中心社区的试验中,缓解率和生存率与所有先前研究的经验性方案相比具有优势。此外,该方案的毒性明显低于先前在此情况下使用的基于顺铂的方案,且更易于给药。如果这种疗效水平得到证实,该治疗应被视为原发肿瘤部位不明的癌症患者的标准一线治疗方案。