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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 3/2008

01-03-2008 | Original Article

Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer

Authors: Fumiyoshi Ohyanagi, Atsushi Horiike, Yoshio Okano, Yukitoshi Satoh, Sakae Okumura, Yuichi Ishikawa, Ken Nakagawa, Takeshi Horai, Makoto Nishio

Published in: Cancer Chemotherapy and Pharmacology | Issue 3/2008

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Abstract

Purpose

To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer (SCLC).

Patients and methods

SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible. Patients were required to have a performance status of 0–2 and adequate organ function. Treatment consisted of gemcitabine (1,000 mg/m2) and irinotecan (150 mg/m2) on days 1 and 15 of a 28 day cycle.

Results

Thirty-one patients were enrolled and 30 patients received protocol treatment (10 had refractory disease and 20 had sensitive disease). The median age was 64 years, and the median performance status was one. An objective response was obtained in 36.7% (95% CI: 17.3.1–56.0%) of the patients. The median overall survival time was 14.4 months, and the 1 year survival rate was 51%. The chief grade 3/4 toxicities included neutropenia (42%), thrombocytopenia (3%), diarrhea (9%), and liver dysfunction (3%). The only grade 4 toxicities were one case of grade 4 neutropenia (3.3%) and one case of grade 4 thrombocytopenia (3.3%).

Conclusion

Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC.
Literature
1.
Stupp R, Monnerat C, Turrisi AT 3rd et al (2004) Small cell lung cancer: state of the art and future perspectives. Lung Cancer 45:105–117PubMedCrossRef
2.
Noda K, Nishiwaki Y, Kawahara M et al (2002) Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 346:85–91PubMedCrossRef
3.
von Pawel J, Schiller JH, Shepherd FA et al (1999) Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol 17:658–667
4.
Argiris A, Murren JR (2001) Advances in chemotherapy for small cell lung cancer: single-agent activity of newer agents. Cancer J 7:228–235PubMed
5.
Noble S, Goa KL (1997) Gemcitabine. A review of its pharmacology and clinical potential in non-small cell lung cancer and pancreatic cancer. Drugs 54:447–472PubMed
6.
Cormier Y, Eisenhauer E, Muldal A et al (1994) Gemcitabine is an active new agent in previously untreated extensive small cell lung cancer (SCLC). A study of the National Cancer Institute of Canada Clinical Trials Group. Ann Oncol 5:283–285PubMed
7.
Masters GA, Declerck L, Blanke C et al (2003) Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597. J Clin Oncol 21:1550–1555PubMedCrossRef
8.
Masuda N, Kudoh S, Fukuoka M (1996) Irinotecan (CPT-11): pharmacology and clinical applications. Crit Rev Oncol Hematol 24:3–26PubMedCrossRef
9.
Masuda N, Fukuoka M, Kusunoki Y et al (1992) CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 10:1225–1229PubMed
10.
Bahadori HR, Lima CM, Green MR et al (1999) Synergistic effect of gemcitabine and irinotecan (CPT-11) on breast and small cell lung cancer cell lines. Anticancer Res 19:5423–5428PubMed
11.
Kanzawa F, Saijo M (1997) In vitro interaction between gemcitabine and other anticancer drugs using a novel three-dimensional model. Semin Oncol 24(Supp l7):7–16
12.
Nishio M, Ohyanagi F, Taguch F et al (2005) Phase I study of combination chemotherapy with gemcitabine and irinotecan for non-small cell lung cancer. Lung Cancer 48:115–119PubMedCrossRef
13.
Ohyanagi F, Taguchi F, Horai T et al (2006) Phase II study of combination chemotherapy with gemcitabine and irinotecan in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy Regimens. Jpn J Clin Oncol 36:547–551PubMedCrossRef
14.
Simon R (1987) How large should a phase II trial of a new drug be? Cancer Treat Rep 71:1079–1085PubMed
15.
16.
Masuda N, Matsui K, Negoro S et al (1998) Combination of irinotecan and etoposide for treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 16:3329–3334PubMed
17.
Ardizzoni A, Manegold C, Gaafar R et al (1999) Combination chemotherapy with cisplatin and topotecan as second-Line treatment of sensitive (S) and refractory (R) small cell lung cancer (SCLC): an EORTC LCCG Phase II Study (Meeting abstract). Proc Am Soc Clin Oncol 18:478a
18.
Sprandio J, Langer C, Lusch C et al (1999) Phase II study of daily oral etoposide and hexamethylmelamine (altretamine) in relapsed small cell lung carcinoma (SCLC) (Meeting abstract). Proc Am Soc Clin Oncol 18:478a
19.
Rushing D, Tipping S, Clouse L et al (1999) Phase I study of the combination of irinotecan (CPT–11) and paclitaxel (taxol) in previously treated patients (pts) with small cell carcinoma of the lung (SCCL) (Meeting abstract). Proc Am Soc Clin Oncol 18:478a
20.
Agelaki S, Agelidou A, Blazogiannakis G et al (1999) A phase II study of paclitaxel (P) and carboplatin (C) as second-line treatment in patients with small cell lung cancer. Eur J Cancer 35:S258CrossRef
21.
Schuette W, Nagel S, Juergens S et al (2005) Phase II trial of gemcitabine/irinotecan in refractory or relapsed small-cell lung cancer. Clin Lung Cancer 7:133–137PubMedCrossRef
22.
Agelaki S, Syrigos K, Christophylakis C et al (2004) A multicenter phase II study of the combination of irinotecan and gemcitabine in previously treated patients with small-cell lung cancer. Oncology 66:192–196PubMedCrossRef
23.
Rocha-Lima C, Herndon J 2nd, Lee M et al (2007) Phase II trial of irinotecan/gemcitabine as second-line therapy for relapsed and refractory small-cell lung cancer: cancer and Leukemia Group B Study 39902. Ann Oncol 18:331–337PubMedCrossRef
24.
Beutler E, Gelbart T, Demina A (1998) Racial variability in the UDP-glucuronosyltransferase 1 (UGT1A1) promoter: a balanced polymorphism for regulation of bilirubin metabolism? Proc Natl Acad Sci USA 95:8170–8174PubMedCrossRef
25.
Hanna N, Bunn PA Jr, Langer C et al (2006) Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 24:2038–2043PubMedCrossRef
Metadata
Title
Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer
Authors
Fumiyoshi Ohyanagi
Atsushi Horiike
Yoshio Okano
Yukitoshi Satoh
Sakae Okumura
Yuichi Ishikawa
Ken Nakagawa
Takeshi Horai
Makoto Nishio
Publication date
01-03-2008
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 3/2008
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-007-0496-6

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