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).

Abstract

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.

• Authors: Martin Früh, Richard Cathomas, Marco Siano, Gregor Tscherry, Alfred Zippelius, Christoph Mamot, Andreas Erdmann, Fatima Krasniqi, Daniel Rauch, Mathew Simcock, Erika Küttel, Pierre Fustier, Miklos Pless, Swiss Group for Clinical Cancer Research
• Journal: Clinical lung cancer (Clin Lung Cancer) Vol. 14 Issue 1 Pg. 34-9 (Jan 2013) ISSN: 1938-0690 [Electronic] United States
• PMID: 22633220 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Xanthones
• vadimezan
• Carboplatin
• Paclitaxel

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bone Neoplasms (secondary)
• Carboplatin (administration & dosage)
• Disease-Free Survival
• Female
• Humans
• Kaplan-Meier Estimate
• Liver Neoplasms (secondary)
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Paclitaxel (administration & dosage)
• Small Cell Lung Carcinoma (drug therapy, secondary)
• Treatment Outcome
• Xanthones (administration & dosage)