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


CONCLUSIONS
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.
Ando
Masahiro
M
Division of Internal Medicine, Tuboi Cancer Center Hospital, Fukushima, Japan.
Kobayashi
Kunihiko
K
Yoshimura
Akinobu
A
Kurimoto
Futoshi
F
Seike
Masahiro
M
Nara
Michiya
M
Moriyama
Gaku
G
Mizutani
Hideki
H
Hibino
Suguru
S
Gemma
Akihiko
A
Okano
Tetsuya
T
Shibuya
Masahiko
M
Kudoh
Shoji
S
D000368:Aged; D000863:Antacids / Q000008:administration & dosage; D000930:Antidiarrheals / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008277:Magnesium Oxide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017693:Sodium Bicarbonate / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D014867:Water
D000863:Antacids; D000930:Antidiarrheals; D014867:Water; D008277:Magnesium Oxide; D000077146:Irinotecan; D017693:Sodium Bicarbonate; D002945:Cisplatin; D002166:Camptothecin