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)

Früh, Martin; Cathomas, Richard; Siano, Marco; Tscherry, Gregor; Zippelius, Alfred; Mamot, Christoph; Erdmann, Andreas; Krasniqi, Fatima; Rauch, Daniel; Simcock, Mathew; Küttel, Erika; Fustier, Pierre; Pless, Miklos; Swiss Group for Clinical Cancer Research, (2013). 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). Clinical lung cancer, 14(1), pp. 34-39. Elsevier 10.1016/j.cllc.2012.04.001

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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.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology
UniBE Contributor:	Rauch, Daniel
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1525-7304
Publisher:	Elsevier
Language:	English
Submitter:	Marianne Zahn
Date Deposited:	12 May 2014 11:58
Last Modified:	05 Dec 2022 14:30
Publisher DOI:	10.1016/j.cllc.2012.04.001
PubMed ID:	22633220
URI:	https://boris.unibe.ch/id/eprint/45067