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01.03.2008 | Original Article

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

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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 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.

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

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

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

Argiris A, Murren JR (2001) Advances in chemotherapy for small cell lung cancer: single-agent activity of newer agents. Cancer J 7:228–235PubMed

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

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

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

Masuda N, Kudoh S, Fukuoka M (1996) Irinotecan (CPT-11): pharmacology and clinical applications. Crit Rev Oncol Hematol 24:3–26PubMedCrossRef

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.

Simon GR, Wagner H (2003) Small cell lung cancer. Chest 123:259S–271SPubMedCrossRef

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

Titel: Phase II trial of gemcitabine and irinotecan in previously treated patients with small-cell lung cancer
verfasst von: Fumiyoshi Ohyanagi
Atsushi Horiike
Yoshio Okano
Yukitoshi Satoh
Sakae Okumura
Yuichi Ishikawa
Ken Nakagawa
Takeshi Horai
Makoto Nishio
Publikationsdatum: 01.03.2008
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 3/2008
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-007-0496-6

Springer Medizin

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