Carboplatin and Paclitaxel Plus ASA404 as First-Line Chemotherapy for Extensive-Stage Small-Cell Lung Cancer: A Multicenter Single Arm Phase II Trial (SAKK 15/08)

被引：18

作者：

Frueh, Martin ^{[1
]}

Cathomas, Richard ^{[2
]}

Siano, Marco ^{[1
]}

Tscherry, Gregor ^{[3
]}

Zippelius, Alfred ^{[4
]}

Mamot, Christoph ^{[5
]}

Erdmann, Andreas ^{[6
]}

Krasniqi, Fatima ^{[4
]}

Rauch, Daniel

Simcock, Mathew

Kuettel, Erika

Fustier, Pierre ^{[7
]}

Pless, Miklos ^{[8
]}

机构：

[1] Cantonal Hosp St Gallen, Dept Oncol & Hematol, St Gallen, Switzerland

[2] Cantonal Hosp Graubunden, Dept Med Oncol, Chur, Switzerland

[3] Hosp Uster, Dept Med, Uster, Switzerland

[4] Univ Basel Hosp, Dept Med Oncol, CH-4031 Basel, Switzerland

[5] Cantonal Hosp Aarau, Dept Med Oncol, Aaru, Switzerland

[6] Cantonal Hosp Baden, Dept Med, Baden, Switzerland

[7] Swiss Grp Clin Canc Res, Coordinating Ctr, SAKK, Bern, Switzerland

[8] Kantonsspital Winterthur, Dept Med Oncol, Winterthur, Switzerland

来源：

CLINICAL LUNG CANCER | 2013年 / 14卷 / 01期

关键词：

Extensive stage small cell lung cancer; Phase II trial; Serotonin; Small cell; Vascular disrupting; Vascular disruptive agent; 5,6-DIMETHYLXANTHENONE-4-ACETIC ACID DMXAA; CROSS-RESISTANT CHEMOTHERAPY; PLATINUM-BASED CHEMOTHERAPY; TUMOR-NECROSIS-FACTOR; FLAVONE-8-ACETIC ACID; ANTIVASCULAR AGENT; RANDOMIZED-TRIAL; CISPLATIN; DOXORUBICIN; ETOPOSIDE;

D O I：

10.1016/j.cllc.2012.04.001

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We explored the tumor-vascular disrupting agent ASA404 plus carboplatin and paclitaxel in extensive-stage small-cell lung cancer. The trial was prematurely closed after 17 patients. Progression-free survival (PFS) at 24 weeks, median PFS, overall response rate, and 1-year survival were 41%, 7 months, 94%, and 57%, respectively. No unexpected toxicities occurred. Although the overall response rate was high, PFS was not prolonged. Introduction: Small-cell lung cancer (SCLC) is a highly vascularized tumor. ASA404 is a tumor vascular disrupting agent. This is the first trial to report the effects of combining chemotherapy with ASA404 in SCLC. Methods: Patients with untreated metastatic SCLC were treated with carboplatin (area under curve, 6) plus paclitaxel (175 mg/m(2)) plus ASA404 (1800 mg/m(2)) on day 1 every 21 days for up to 6 cycles. The primary endpoint was the progression-free survival (PFS) rate at 24 weeks. Results: Median age was 61 years; 53% were women, 41% had weight loss; and 96% had a performance status of 0-1. Twelve patients completed all 6 cycles, and most adverse events were related to chemotherapy. Median PFS and time to progression were 7.0 months (95% CI, 5.7-9.4 months) and 7.5 months (95% CI, 5.7-9.4 months), respectively. The progression-free survival (PFS) rate at 24 weeks was 41% (95% CI, 18%-65%). The overall response rate was 94%. The median overall survival time was 14.2 months (95% CI, 8.2-16.0 months) and 1-year survival was 57%. The median follow-up time was 17.7 months. Due to negative results with ASA404 in non-small-cell lung cancer trials, the trial was stopped prematurely after 17 of 56 planned patients were being accrued. Conclusions: This is the first report of a clinical trial with a vascular disrupting agent in SCLC. No unexpected toxicity was observed. PFS was not prolonged with carboplatin and paclitaxel plus ASA404. Clinical Lung Cancer, Vol. 14, No. 1, 34-9 (C) 2013 Elsevier Inc. All rights reserved.

引用

页码：34 / 39

页数：6

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