Abstract | PURPOSE: PATIENTS AND METHODS: Patients with SCLC limited disease unfit for intensive chemotherapy or those with extensive disease received JM216 120 mg/m(2)/d for 5 consecutive days every 3 weeks. Individual dose escalation to 140 mg/m(2)/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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Authors | E Fokkema, H J Groen, J Bauer, D R Uges, C Weil, I E Smith |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 17
Issue 12
Pg. 3822-7
(Dec 1999)
ISSN: 0732-183X [Print] United States |
PMID | 10577855
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents
- Organoplatinum Compounds
- Platinum
- satraplatin
|
Topics |
- Aged
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Carcinoma, Small Cell
(blood, drug therapy, mortality)
- Female
- Humans
- Lung Neoplasms
(blood, drug therapy, mortality)
- Male
- Middle Aged
- Organoplatinum Compounds
(adverse effects, therapeutic use)
- Platinum
(blood)
- Treatment Outcome
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