A phase I study of 3-day topotecan and cisplatin in elderly patients with small-cell lung cancer.
OBJECTIVE
The aim of this phase I study was to determine the maximum-tolerated dose (MTD) in elderly patients with small-cell lung cancer (SCLC).


METHODS
Patients aged over 75 years with previously untreated SCLC were enrolled in this study. Both topotecan and cisplatin were administered on days 1-3 and repeated every 3 weeks. The starting dose of topotecan was 0.5 mg/m2/day, while cisplatin was fixed at the dose of 20 mg/m2/day. Patients with limited disease (LD) SCLC received thoracic irradiation after the completion of chemotherapy.


RESULTS
Twenty-one elderly patients were enrolled in this study and received a total of 59 cycles. The major hematological toxicity was neutropenia and non-hematological toxicities including diarrhea were generally mild and reversible. The MTD of topotecan was determined as 1.2 mg/m2/day. The recommended phase II study dose of topotecan was determined as 1.0 mg/m2/day with cisplatin 20 mg/m2/day daily for 3 days. An objective response was observed in 6 of 10 patients (60%) with LD-SCLC and 6 of 11 (55%) with extensive disease (ED) SCLC. The median survival time in patients with LD-SCLC and those with ED-SCLC were 16.0 and 11.0 months, respectively.


CONCLUSIONS
The combination chemotherapy of 3-day topotecan and cisplatin appears to be tolerable and effective in elderly patients with SCLC.
Fujiwara
Keiichi
K
Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Okayama 701-1192, Japan. keiichi@okayama3.hosp.go.jp
Ueoka
Hiroshi
H
Kiura
Katsuyuki
K
Tabata
Masahiro
M
Takigawa
Nagio
N
Hotta
Katsuyuki
K
Umemura
Shigeki
S
Sugimoto
Keisuke
K
Shibayama
Takuo
T
Kamei
Haruhito
H
Harita
Shingo
S
Okimoto
Niro
N
Tanimoto
Mitsune
M
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects
D000970:Antineoplastic Agents; D019772:Topotecan; D002945:Cisplatin