Weekly administration of irinotecan (CPT-11) plus cisplatin for refractory or relapsed small cell lung cancer

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 44; no. 1; pp. 121 - 127
• Main Authors: Ando, Masahiro, Kobayashi, Kunihiko, Yoshimura, Akinobu, Kurimoto, Futoshi, Seike, Masahiro, Nara, Michiya, Moriyama, Gaku, Mizutani, Hideki, Hibino, Suguru, Gemma, Akihiko, Okano, Tetsuya, Shibuya, Masahiko, Kudoh, Shoji
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01-04-2004; Elsevier Science
• Subjects: Aged; Antacids - administration & dosage; Antidiarrheals - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Carcinoma, Small Cell - drug therapy; Carcinoma, Small Cell - pathology; Cisplatin - administration & dosage; CPT-11; Diarrhea; Drug Administration Schedule; Enterocolitis; Female; Humans; Lung neoplasms; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Magnesium Oxide - administration & dosage; Male; Medical sciences; Middle Aged; Neutropenia - chemically induced; Pneumology; Sodium Bicarbonate - administration & dosage; Survival Analysis; Treatment Outcome; Tumors of the respiratory system and mediastinum; Water; Diarrhea; CPT-11; Enterocolitis; Lung neoplasms; Antineoplastic agent; Lung disease; Respiratory disease; Lung cancer; Malignant tumor; Cisplatin; Refractory; Irinotecan; Small cell carcinoma
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2003.10.003

Purpose: Weekly administrations of CPT-11 plus cisplatin together with an anti-diarrheal program, the Oral Alkalization and Control of Defecation [
Int J Cancer 1999;83:491;
Int J Cancer 2001;92:269;
Cancer Res 2002;62:179], were evaluated in this phase II study for patients with refractory or relapsed small cell lung cancer.
Methods: Patients were treated by weekly administrations of 60
mg/m
2 CPT-11 plus 30
mg/m
2 cisplatin on Days 1, 8 and 15 over 4 weeks. Coinciding with the infusions and for 4 days thereafter, the anti-diarrheal program was practiced using orally administered sodium bicarbonate, magnesium oxide and basic water.
Results: Twenty-five patients who had prior treatments of etoposide and platinum containing regimens (16 refractory patients and nine relapsed patients) were entered. The mean dose-intensities of CPT-11 and cisplatin were 154.8 and 77.4
mg/m
2 per course, respectively. Therefore, 86% of the planned dose was delivered. There were 20 partial responses and an overall response rate of 80% (95% confidence interval, 62–96%) was obtained. The median time to progression and the median survival after starting this regimen were 3.6 and 7.9 months, respectively. The major toxicity was myelosuppression. Grades 3 and 4 neutropenia occurred in 24 and 12% of patients, respectively. One patient with febrile neutropenia was experienced, and Grade 3 diarrhea was observed in 8%. But there was no treatment death.
Conclusion: Weekly administrations of CPT-11 plus cisplatin together with Oral Alkalization and Control of Defecation provide a practical and well tolerated regimen that was active for refractory or relapsed small cell lung cancer.