Originally published as JCO Early Release 10.1200/JCO.2008.19.3235 on March 16 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Eckardt, J. R. Articles by Breitz, H. B. Search for Related Content PubMed PubMed Citation Articles by Eckardt, J. R. Articles by Breitz, H. B. Social Bookmarking                            What's this?

Phase II Study of Picoplatin As Second-Line Therapy for Patients With Small-Cell Lung Cancer

From the Center for Cancer Care and Research, St Louis, MO; Sverdlovsk Regional Oncology Center, Ekaterinburg; Republican Oncology Center, Ufa, Republic of Bashkortostan; and Regional Clinical Hospital #1, Krasnodar, Russian Federation; Veterans Affairs Sierra Nevada Health System, Reno, NV; and Poniard Pharmaceuticals, South San Francisco, CA.

Corresponding author: John R. Eckardt, MD, Dava Oncology, 8150 N Central Expy, Campbell Centre, South Tower, Suite 1515, Dallas, TX 75206; e-mail: jeckardt{at}davaonc.com.

Purpose This study was designed to confirm the efficacy and safety of picoplatin, a cisplatin analog designed to overcome platinum resistance, in patients with small-cell lung cancer (SCLC) with platinum-refractory/-resistant disease.

Patients and Methods All patients received intravenous picoplatin 150 mg/m² every 3 weeks. Tumor response, progression-free survival, and overall survival were evaluated. Adverse events were assessed for frequency, severity, and relationship to treatment. Quality of life was assessed with the Lung Cancer Symptom Scale instrument.

Results Seventy-seven patients were treated with picoplatin (median number of cycles, two; range one to 10). Three patients (4%) had a partial response, 33 (43%) had stable disease (four of these were unconfirmed partial responses), 36 (47%) had progressive disease, and five were not assessable for response. Median progression-free survival was 9.1 weeks (95% CI, 7.0 to 12.1 weeks). Median overall survival was 26.9 weeks (95% CI, 21.1 to 33.4). The most common grade 3 and 4 toxicities were thrombocytopenia (48%), neutropenia (25%), and anemia (20%). The most commonly reported adverse events of any severity included thrombocytopenia (64%), anemia (49%), neutropenia (39%), nausea (27%), fatigue (16%), and dyspnea (16%). No severe neurotoxicity or nephrotoxicity were observed. There were no treatment-related deaths.

Conclusion Picoplatin demonstrated clinical efficacy in platinum-refractory SCLC. The major toxicity was hematologic. These results warrant further evaluation in this patient population.

Supported by Poniard Pharmaceuticals Inc, South San Francisco, CA.

Presented in part at the 12th World Conference on Lung Cancer, September 2-6, 2007, Seoul, South Korea; 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 1st European Lung Cancer Conference, April 23-26, 2008, Geneva, Switzerland (abstr 2198).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?