West H L, Crowley J J, Vance R B, Franklin W A, Livingston R B, Dakhil S R, Giguere J K, Rivkin S E, Kraut M, Chansky K, Gandara D R
Swedish Cancer Institute/Puget Sound Oncology Consortium, Seattle, WA 98104, USA.
Ann Oncol. 2005 Jul;16(7):1076-80. doi: 10.1093/annonc/mdi215. Epub 2005 Apr 28.
There are no published prospective trials of chemotherapy for advanced bronchioloalveolar carcinoma (BAC), a subtype of non-small-cell lung cancer for which there is no current standard therapy. This phase II study assesses the efficacy and toxicity of 96-h paclitaxel in chemotherapy-naive patients with advanced BAC.
Patients with histologically confirmed stage IIIB (with pleural effusion) or stage IV BAC were eligible. Treatment consisted of paclitaxel 35 mg/m2/24 h continuously infused over 96 h (days 1-4) every 21 days for up to six courses.
A total of 58 eligible patients were enrolled. The objective response rate was 14% (all partial responses, 9% confirmed); 40% of patients demonstrated stable disease. The median progression-free and overall survivals were 5 and 12 months, respectively. Grade 3 or greater toxicities included neutropenia/granulocytopenia (43%), febrile neutropenia (12%), infection (22%), and stomatitis/pharyngitis (10%); there were five treatment-related deaths.
S9714 represents the first prospective multi-institutional cooperative group trial focusing on treatment outcomes in BAC. Studies targeting this population are feasible, and while first-line paclitaxel administered as a prolonged infusion is active in this setting, toxicities limits the utility of this regimen. S9714 serves as a historical control for BAC patients against which future therapeutic approaches can be compared.
对于晚期细支气管肺泡癌（BAC），尚无已发表的前瞻性化疗试验。BAC是非小细胞肺癌的一种亚型，目前尚无标准治疗方案。这项II期研究评估了96小时紫杉醇对初治晚期BAC患者的疗效和毒性。
组织学确诊为IIIB期（伴有胸腔积液）或IV期BAC的患者符合条件。治疗方案为每21天连续96小时（第1 - 4天）静脉输注紫杉醇35mg/m²/24小时，共六个疗程。
共纳入58例符合条件的患者。客观缓解率为14%（均为部分缓解，9%经确认）；40%的患者疾病稳定。无进展生存期和总生存期的中位数分别为5个月和12个月。3级或更高级别的毒性包括中性粒细胞减少/粒细胞减少（43%）、发热性中性粒细胞减少（12%）、感染（22%）和口腔炎/咽炎（10%）；有5例治疗相关死亡。
S9714是首个针对BAC治疗结局的前瞻性多机构合作组试验。针对该人群的研究是可行的，虽然一线长时间输注紫杉醇在此情况下有活性，但毒性限制了该方案的应用。S9714作为BAC患者的历史对照，可用于比较未来的治疗方法。
