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Phase II Study of Oral Platinum Drug JM216 as First-Line Treatment in Patients With Small-Cell Lung Cancer

From the University Hospital Groningen, Groningen, the Netherlands; Centre Pluridisciplinaire d'Oncologie, Lausanne, Switzerland; Clinical Cancer Research Unit, Bristol-Myers Squibb, Brussels, Belgium, and Princeton, NJ; and the Royal Marsden Hospital, Surrey, United Kingdom.

Address reprint requests to H.J.M. Groen, MD, PhD, Department of Pulmonary Diseases, University Hospital Groningen, PO Box 30001, 9700 RB Groningen, the Netherlands; email h.j.m.groen{at}int.azg.nl

PURPOSE: This multicenter phase II trial was performed to determine tumor efficacy and tolerance of the oral platinum drug JM216 in patients with small-cell lung cancer (SCLC).

PATIENTS AND METHODS: Patients with SCLC limited disease unfit for intensive chemotherapy or those with extensive disease received JM216 120 mg/m²/d for 5 consecutive days every 3 weeks. Individual dose escalation to 140 mg/m²/d was allowed if toxicity was grade 2 according to the National Cancer Institute Common Toxicity Criteria. Tumor response was evaluated according to World Health Organization criteria.

RESULTS: Twenty-seven patients were assessable for toxicity and 26 for tumor response. Eighty-eight cycles were administered. Common Toxicity Criteria grade 3 and 4 hematologic toxicities were neutropenia in 15.9% and 3.7%, lymphocytopenia in 47.6% and 17.1%, and thrombocytopenia in 19.5% and 10.3% of cycles, respectively. One patient suffered from neutropenic fever. Nausea, vomiting, and diarrhea were the most common nonhematologic toxicities. Except for grade 4 diarrhea in one patient, no grade 4 nonhematologic toxicity was observed. No severe neurotoxicity or nephrotoxicity was observed. Tumor response rate was 10 of 26 (38%; 95% confidence interval, 19% to 58%), excluding five unconfirmed partial responses. No complete responses were observed. Median overall time to progression was 110 days (range, 5 to 624 days). Median overall survival time was 210 days (range, 5 to 624 days).

CONCLUSION: Oral JM216 is active in previously untreated patients with SCLC and shows mild toxicities.

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