A phase II trial of the Src-kinase inhibitor saracatinib after four cycles of chemotherapy for patients with extensive stage small cell lung cancer: NCCTG trial N-0621.

Autor: Molina JR; Division of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States. Electronic address: molina.julian@mayo.edu., Foster NR; Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States., Reungwetwattana T; Division of Medical Oncology, Department of Internal Medicine, Ramathibodi Hospital, Bangkok, Thailand., Nelson GD; Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States., Grainger AV; Columbus Oncology & Hematology, Inc., 810 Jasonway Avenue, Suite A, Columbus, OH 43214l, United States., Steen PD; MeritCare Hospital CCOP, 820 4(th) Street North, Fargo, ND 58102, United States., Stella PJ; St. Joseph Mercy Cancer Center, 5301 McAuley Drive, Suite C-139, Ypsilanti, MI 48197, United States., Marks R; Division of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States., Wright J; CTEP Program, National Cancer Institute, Executive Plaza North, Suite 7115A, Rockville, MD 20852-7426, United States., Adjei AA; Roswell Park Cancer Institute, Elm and Carlton Street, Buffalo, NY 14263, United States.
Jazyk: angličtina
Zdroj: Lung cancer (Amsterdam, Netherlands) [Lung Cancer] 2014 Aug; Vol. 85 (2), pp. 245-50. Date of Electronic Publication: 2014 May 01.
DOI: 10.1016/j.lungcan.2014.03.004
Abstrakt: Introduction: To assess the efficacy and the Src-kinase inhibitor saracatinib (AZD-0530) after four cycles of platinum-based chemotherapy for extensive stage small cell lung cancer (SCLC).
Methods: Patients with at least stable disease received saracatinib at a dose of 175 mg/day by mouth until disease progression, unacceptable toxicity, or patient refusal. The primary endpoint was the 12-week progression-free survival (PFS) rate from initiation of saracatinib treatment. Planned interim analysis in first 20 patients, where 13 or more patients alive and progression-free at 12-weeks would allow continued enrollment to 40 total patients.
Results: All 23 evaluable patients received platinum based standard chemotherapy. Median age was 58 years (range: 48-82). 96% of patients had a performance status of 0/1. Median of two cycles given (range: 1-34). All 23 (100%) patients have ended treatment, most for disease progression (19/23). The 12-week PFS rate was 26% (6/23; 95% CI: 10-48%). From start of standard chemotherapy, median PFS was 4.7 months (95% CI: 4.5-5.1) and median OS was 11.2 months (95% CI: 9.9-13.8). Eight (35%) and three (13%) patients experienced at least one grade 3/4 or grade 4 AE, respectively. Commonly occurring grade 3/4 adverse events were thrombocytopenia (13%), fatigue (9%), nausea (9%), and vomiting (9%).
Conclusions: Saracatinib at a dose of 175 mg/day by mouth is well tolerated. However, the PFS rate observed at the pre-planned interim analysis did not meet the criteria for additional enrollment.
(Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
Databáze: MEDLINE
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