Fractionated administration of irinotecan and cisplatin for treatment of extensive-disease small-cell lung cancer: A phase II study

Nagio Takigawa, Keiichi Fujiwara, Hiroshi Ueoka, Katsuyuki Kiura, Masahiro Tabata, Akio Hiraki, Takuo Shibayama, Yoshihiko Segawa, Haruhito Kamei, Shunkichi Hiraki, Mitsune Tanimoto, Mine Harada

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Abstract

Background: A combination of irinotecan (CPT-11) and cisplatin (CDDP) was shown to be effective for extensive-disease small-cell lung cancer (ED-SCLC). To take maximum advantage of the synergistic effect between CPT-11 and CDDP, we designed a fractionated administration schedule. Patients and Methods: Between August 1995 and September 1998, 15 previously untreated patients with ED-SCLC were enrolled. Both CPT-11 at a dose of 50 mg/m2 and CDDP at a dose of 60 mg/m2 were given on days 1 and 8, and repeated every 4 weeks up to four cycles. Results: Fifteen patients were assessed for response and survival, and fourteen for toxicity. Although twelve patients (80.0%; 95% confidence interval, 51.9-95.7) achieved an objective response, complete response (CR) was not obtained. The median survival time and the actual 1-year survival rate were 9.4 months and 40.0%, respectively. Grade 3 or 4 leukopenia, neutropenia and diarrhea occurred in 71.4%, 100% and 14.3% of the patients, respectively. Enrollment into this study was stopped because CR, which was the primary endpoint, was not obtained in the consecutive 15 patients and the survival appeared to be inferior to the previous multi-institutional study (Kudoh et al, Clin Oncol 16: 1068-1074, 1998). The projected dose intensity in the present study was lower in CPT-11 and higher in CDDP compared to that in the previous report. Conclusion: These results suggest that the dose intensity of CPT-11 may have a major role on the activity of SCLC in this combination.

Original languageEnglish
Pages (from-to)557-560
Number of pages4
JournalAnticancer Research
Volume23
Issue number1 B
Publication statusPublished - Jan 2003

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irinotecan
Small Cell Lung Carcinoma
Cisplatin
Survival
Therapeutics
Leukopenia
Neutropenia
Diarrhea
Appointments and Schedules
Survival Rate

Keywords

  • Cisplatin
  • Extensive-disease small-cell lung cancer
  • Fractionated administration
  • Irinotecan
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Fractionated administration of irinotecan and cisplatin for treatment of extensive-disease small-cell lung cancer : A phase II study. / Takigawa, Nagio; Fujiwara, Keiichi; Ueoka, Hiroshi; Kiura, Katsuyuki; Tabata, Masahiro; Hiraki, Akio; Shibayama, Takuo; Segawa, Yoshihiko; Kamei, Haruhito; Hiraki, Shunkichi; Tanimoto, Mitsune; Harada, Mine.

In: Anticancer Research, Vol. 23, No. 1 B, 01.2003, p. 557-560.

Research output: Contribution to journalArticle

Takigawa, N, Fujiwara, K, Ueoka, H, Kiura, K, Tabata, M, Hiraki, A, Shibayama, T, Segawa, Y, Kamei, H, Hiraki, S, Tanimoto, M & Harada, M 2003, 'Fractionated administration of irinotecan and cisplatin for treatment of extensive-disease small-cell lung cancer: A phase II study', Anticancer Research, vol. 23, no. 1 B, pp. 557-560.
Takigawa, Nagio ; Fujiwara, Keiichi ; Ueoka, Hiroshi ; Kiura, Katsuyuki ; Tabata, Masahiro ; Hiraki, Akio ; Shibayama, Takuo ; Segawa, Yoshihiko ; Kamei, Haruhito ; Hiraki, Shunkichi ; Tanimoto, Mitsune ; Harada, Mine. / Fractionated administration of irinotecan and cisplatin for treatment of extensive-disease small-cell lung cancer : A phase II study. In: Anticancer Research. 2003 ; Vol. 23, No. 1 B. pp. 557-560.
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abstract = "Background: A combination of irinotecan (CPT-11) and cisplatin (CDDP) was shown to be effective for extensive-disease small-cell lung cancer (ED-SCLC). To take maximum advantage of the synergistic effect between CPT-11 and CDDP, we designed a fractionated administration schedule. Patients and Methods: Between August 1995 and September 1998, 15 previously untreated patients with ED-SCLC were enrolled. Both CPT-11 at a dose of 50 mg/m2 and CDDP at a dose of 60 mg/m2 were given on days 1 and 8, and repeated every 4 weeks up to four cycles. Results: Fifteen patients were assessed for response and survival, and fourteen for toxicity. Although twelve patients (80.0{\%}; 95{\%} confidence interval, 51.9-95.7) achieved an objective response, complete response (CR) was not obtained. The median survival time and the actual 1-year survival rate were 9.4 months and 40.0{\%}, respectively. Grade 3 or 4 leukopenia, neutropenia and diarrhea occurred in 71.4{\%}, 100{\%} and 14.3{\%} of the patients, respectively. Enrollment into this study was stopped because CR, which was the primary endpoint, was not obtained in the consecutive 15 patients and the survival appeared to be inferior to the previous multi-institutional study (Kudoh et al, Clin Oncol 16: 1068-1074, 1998). The projected dose intensity in the present study was lower in CPT-11 and higher in CDDP compared to that in the previous report. Conclusion: These results suggest that the dose intensity of CPT-11 may have a major role on the activity of SCLC in this combination.",
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T1 - Fractionated administration of irinotecan and cisplatin for treatment of extensive-disease small-cell lung cancer

T2 - A phase II study

AU - Takigawa, Nagio

AU - Fujiwara, Keiichi

AU - Ueoka, Hiroshi

AU - Kiura, Katsuyuki

AU - Tabata, Masahiro

AU - Hiraki, Akio

AU - Shibayama, Takuo

AU - Segawa, Yoshihiko

AU - Kamei, Haruhito

AU - Hiraki, Shunkichi

AU - Tanimoto, Mitsune

AU - Harada, Mine

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N2 - Background: A combination of irinotecan (CPT-11) and cisplatin (CDDP) was shown to be effective for extensive-disease small-cell lung cancer (ED-SCLC). To take maximum advantage of the synergistic effect between CPT-11 and CDDP, we designed a fractionated administration schedule. Patients and Methods: Between August 1995 and September 1998, 15 previously untreated patients with ED-SCLC were enrolled. Both CPT-11 at a dose of 50 mg/m2 and CDDP at a dose of 60 mg/m2 were given on days 1 and 8, and repeated every 4 weeks up to four cycles. Results: Fifteen patients were assessed for response and survival, and fourteen for toxicity. Although twelve patients (80.0%; 95% confidence interval, 51.9-95.7) achieved an objective response, complete response (CR) was not obtained. The median survival time and the actual 1-year survival rate were 9.4 months and 40.0%, respectively. Grade 3 or 4 leukopenia, neutropenia and diarrhea occurred in 71.4%, 100% and 14.3% of the patients, respectively. Enrollment into this study was stopped because CR, which was the primary endpoint, was not obtained in the consecutive 15 patients and the survival appeared to be inferior to the previous multi-institutional study (Kudoh et al, Clin Oncol 16: 1068-1074, 1998). The projected dose intensity in the present study was lower in CPT-11 and higher in CDDP compared to that in the previous report. Conclusion: These results suggest that the dose intensity of CPT-11 may have a major role on the activity of SCLC in this combination.

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