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Phase II Trial of Oral Topotecan and Intravenous Carboplatin With G-CSF Support in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer

A North Central Cancer Treatment Group Study

Bryce, Alan H., MD*; Mattar, Bassam, MD; Hillman, Shauna L., MS*; Adjei, Alex A., MD; Kugler, John W., MD§; Rowland, Kendrith Jr., MD; Wender, Donald B., MD; Soori, Gamini, MD**; Perez, Edith A., MD††; Jett, James R., MD*

American Journal of Clinical Oncology: August 2010 - Volume 33 - Issue 4 - p 353-357
doi: 10.1097/COC.0b013e3181b0c27f
Original Articles: Thoracic
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Objectives: The objective of this study was to evaluate the response rate and toxicities of the combination of oral topotecan and carboplatin in patients with untreated extensive stage small cell lung cancer (ES-SCLC). Previous studies have suggested improved outcomes with a topoisomerase I inhibitor in combination with a platinum agent.

Methods: Twenty-six patients with previously untreated, ES-SCLC were evaluable in this phase II trial. All patients received oral topotecan 2.0 mg/m2 per day on days 1 through 5 and carboplatin at an area under curve of 5 on day 5. Treatment was repeated every 21 days up to a total of 6 cycles. All patients received G-CSF.

Results: There were no complete responses and 16 partial responses, for an overall response rate of 62% (95% CI: 41–80). Median time to progression was 6.0 months (95% CI: 4–8), with a median overall survival of 12 months (95% CI: 8–16). This study was closed to accrual early with 26 of a planned 39 patients enrolled because of grade 5 adverse events in 4 (15%) patients (3 neutropenic infections, 1 sudden cardiac death). Eighty-five percent of patients experienced grade 3 or higher hematologic events. The most common severe nonhematologic events included diarrhea, vomiting, dyspnea, hypoxia, and hypotension.

Conclusions: Although this drug regimen has activity as first-line therapy in ES-SCLC, it is associated with excessive hematologic toxicity, which occurred in spite of growth factor support. Despite promising survival estimates, this particular combination and dose level of oral topotecan and carboplatin cannot be recommended.

From the *Mayo Clinic and Mayo Foundation, Rochester, MN; †Wichita Community Clinical Oncology Program, Wichita, KS; ‡Roswell Park Cancer Institute, Buffalo, NY; §Illinois Oncology Research Association CCOP, Peoria, IL; ¶Carle Cancer Center CCOP, Urbana, IL; ∥Siouxland Hematology-Oncology Associates, Sioux City, IA; **Missouri Valley Cancer Consortium, Omaha, NE; and ††Mayo Clinic Jacksonville, Jacksonville, FL.

Supported by Public Health Service grants CA-25224, CA-37404, CA-35431, CA-35113, CA-35195, CA-35103, CA-63849, CA-35269, CA-52352, CA-37417, CA-35272, and CA-63848.

The study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic.

Additional participating institutions: Duluth CCOP, Duluth, MN 55805 (Daniel A. Nikcevich, MD, PhD); Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA 52403 (Martin Wiesenfeld, MD); Meritcare Hospital CCOP, Fargo ND 58122 (Preston D. Steen, MD); Ochsner CCOP, New Orleans, LA 70121 (Carl G. Kardinal, MD); Rapid City Regional Oncology Group, Rapid City, SD 57709 (Larry P. Ebbert, MD); Centracare Clinic, St. Cloud, MN 56301 (Harold E. Windschitl, MD); and Michigan Cancer Consortium, Ann Arbor, MI 48106 (Philip Stella, MD).

Reprints: Alan Haruo Bryce, MD, Santa Barbara Hematology Oncology, 2040 Viborg Road, Suite 140, Solvang, CA 93463. E-mail: abryce@ccsb.org.

© 2010 Lippincott Williams & Wilkins, Inc.