Skip to main content
Erschienen in: Cancer Chemotherapy and Pharmacology 5/2010

01.10.2010 | Original Article

Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer

verfasst von: Kazuhiro Yanagihara, Kenichi Yoshimura, Miyuki Niimi, Hiroyasu Yasuda, Takahiko Sasaki, Takafumi Nishimura, Hiroshi Ishiguro, Shigemi Matsumoto, Toshiyuki Kitano, Masashi Kanai, Akiko Misawa, Harue Tada, Satoshi Teramukai, Tadashi Mio, Masanori Fukushima

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 5/2010

Einloggen, um Zugang zu erhalten

Abstract

Purpose

The purpose of the present phase II study was to evaluate both the efficacy and toxicity of the combination of S-1 and docetaxel in previously treated patients with locally advanced or metastatic non-small cell lung cancer.

Methods

Thirty-eight previously treated patients with non-small cell lung cancer were treated with S-1 (80 mg/m2, days 1–14, oral) and docetaxel (40 mg/m2, day 1, intravenous) every 3 weeks.

Results

No complete response was observed, and seven patients had a partial response, yielding an overall response rate of 18.4% (95% CI, 7.7–34.3%). The median overall survival time and 1-year overall survival rate were 16.1 months and 60%, respectively. The median progression-free survival time was 4.4 months. Myelosuppression was the main toxicity with grade 3 or 4 neutropenia and leukopenia in 50 and 21%, respectively. There was no irreversible toxicity in this study.

Conclusions

The combination of S-1 and docetaxel is well tolerable and has substantial activity for patients with locally advanced or metastatic non-small cell lung cancer. A phase III trial comparing docetaxel with or without S-1 would warrant further investigation.
Literatur
1.
Zurück zum Zitat National Cancer Institute: Surveillance, Epidemiology, and End Results (SEER) Program. SEER Stat Database, National Cancer Institute, Surveillance Research Program, Cancer Statistics Branch. http://www.seer.cancer.gov/ Accessed 3 March 2009 National Cancer Institute: Surveillance, Epidemiology, and End Results (SEER) Program. SEER Stat Database, National Cancer Institute, Surveillance Research Program, Cancer Statistics Branch. http://​www.​seer.​cancer.​gov/​ Accessed 3 March 2009
2.
Zurück zum Zitat Shepherd FA, Dancey J, Ramlau R et al (2000) A prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095–2103PubMed Shepherd FA, Dancey J, Ramlau R et al (2000) A prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095–2103PubMed
3.
Zurück zum Zitat Fossella FV, DeVore R, Kerr RN et al (2000) Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 18:2354–2362PubMed Fossella FV, DeVore R, Kerr RN et al (2000) Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 18:2354–2362PubMed
4.
Zurück zum Zitat Shirasaka T, Shimamoto Y, Fukushima M (1993) Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 53:4004–4009PubMed Shirasaka T, Shimamoto Y, Fukushima M (1993) Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 53:4004–4009PubMed
5.
Zurück zum Zitat Furuse K, Kawahara M, Hasegawa K et al (2001) Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer. Int J Clin Oncol 6:236–241CrossRefPubMed Furuse K, Kawahara M, Hasegawa K et al (2001) Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer. Int J Clin Oncol 6:236–241CrossRefPubMed
6.
Zurück zum Zitat Kubota K, Kawahara M, Ogawara M et al (2008) Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol 9:1135–1142CrossRefPubMed Kubota K, Kawahara M, Ogawara M et al (2008) Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol 9:1135–1142CrossRefPubMed
7.
Zurück zum Zitat Maruyama R, Nishiwaki Y, Tamura T et al (2008) Phase III study, V-15–32, of gefitinib versus docetaxel in previously treated Japanese patients with non–small-cell lung cancer. J Clin Oncol 26:4244–4252CrossRefPubMed Maruyama R, Nishiwaki Y, Tamura T et al (2008) Phase III study, V-15–32, of gefitinib versus docetaxel in previously treated Japanese patients with non–small-cell lung cancer. J Clin Oncol 26:4244–4252CrossRefPubMed
8.
Zurück zum Zitat Wada Y, Yoshida K, Suzuki T et al (2006) Synergistic effects of docetaxel and S-1 by modulating the expression of metabolic enzymes of 5-fluorouracil in human gastric cancer cell lines. Int J Cancer 119:783–791CrossRefPubMed Wada Y, Yoshida K, Suzuki T et al (2006) Synergistic effects of docetaxel and S-1 by modulating the expression of metabolic enzymes of 5-fluorouracil in human gastric cancer cell lines. Int J Cancer 119:783–791CrossRefPubMed
9.
Zurück zum Zitat Takahashi I, Emi Y, Kakeji Y et al (2005) Increased antitumor activity in combined treatment TS-1 and docetaxel. A preclinical study using gastric cancer xenografts. Oncology 68:130–137CrossRefPubMed Takahashi I, Emi Y, Kakeji Y et al (2005) Increased antitumor activity in combined treatment TS-1 and docetaxel. A preclinical study using gastric cancer xenografts. Oncology 68:130–137CrossRefPubMed
10.
Zurück zum Zitat Suto A, Kubota T, Fukushima M et al (2006) Antitumor effect of combination of S-1 and docetaxel on the human breast cancer xenograft transplanted into SCID mice. Oncol Rep 15:1517–1522PubMed Suto A, Kubota T, Fukushima M et al (2006) Antitumor effect of combination of S-1 and docetaxel on the human breast cancer xenograft transplanted into SCID mice. Oncol Rep 15:1517–1522PubMed
11.
Zurück zum Zitat Yamaguchi K, Shimamura T, Hyodo I et al (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94:1803–1808CrossRefPubMed Yamaguchi K, Shimamura T, Hyodo I et al (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94:1803–1808CrossRefPubMed
12.
Zurück zum Zitat Gridelli C, Ardizzoni A, Ciardiello F et al (2008) Second-line treatment of advanced non-small cell lung cancer [state of the art: concise review]. J Thorac Oncol 3:430–440CrossRefPubMed Gridelli C, Ardizzoni A, Ciardiello F et al (2008) Second-line treatment of advanced non-small cell lung cancer [state of the art: concise review]. J Thorac Oncol 3:430–440CrossRefPubMed
13.
Zurück zum Zitat Nelli F, Naso G, De Pasquale Ceratti A et al (2004) Weekly vinorelbine and docetaxel as second-line chemotherapy for pretreated non-small cell lung cancer patients: a phase I-II trial. J Chemother 16:392–399PubMed Nelli F, Naso G, De Pasquale Ceratti A et al (2004) Weekly vinorelbine and docetaxel as second-line chemotherapy for pretreated non-small cell lung cancer patients: a phase I-II trial. J Chemother 16:392–399PubMed
14.
Zurück zum Zitat Pectasides D, Kalofonos HP, Samantas E et al (2001) An out-patient second-line chemotherapy with gemcitabine and vinorelbine in patients with non-small cell lung cancer previously treated with cisplatin-based chemotherapy. Anticancer Res 21:3005–3010PubMed Pectasides D, Kalofonos HP, Samantas E et al (2001) An out-patient second-line chemotherapy with gemcitabine and vinorelbine in patients with non-small cell lung cancer previously treated with cisplatin-based chemotherapy. Anticancer Res 21:3005–3010PubMed
15.
Zurück zum Zitat Spiridonidis CH, Laufman LR, Carman L et al (2001) Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. Ann Oncol 12:89–94CrossRefPubMed Spiridonidis CH, Laufman LR, Carman L et al (2001) Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. Ann Oncol 12:89–94CrossRefPubMed
16.
Zurück zum Zitat Takeda K, Negoro S, Tamura T et al (2009) Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol 20:835–841CrossRefPubMed Takeda K, Negoro S, Tamura T et al (2009) Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol 20:835–841CrossRefPubMed
17.
Zurück zum Zitat Hanna N, Shepherd FA, Fossella FV et al (2004) Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589–1597CrossRefPubMed Hanna N, Shepherd FA, Fossella FV et al (2004) Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589–1597CrossRefPubMed
18.
Zurück zum Zitat Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Hainsworth JD (2005) Erlotinib in previously treated non–small-cell lung cancer. N Eng J Med 323:123–132CrossRef Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Hainsworth JD (2005) Erlotinib in previously treated non–small-cell lung cancer. N Eng J Med 323:123–132CrossRef
19.
Zurück zum Zitat Spigel DR, Lin M, O’Neill V et al (2008) Final survival and safety results from a multicenter, open-label, phase 3b trial of erlotinib in patients with advanced non small cell lung cancer. Cancer 112:2749–2755CrossRefPubMed Spigel DR, Lin M, O’Neill V et al (2008) Final survival and safety results from a multicenter, open-label, phase 3b trial of erlotinib in patients with advanced non small cell lung cancer. Cancer 112:2749–2755CrossRefPubMed
20.
Zurück zum Zitat Kubota K, Nishiwaki Y, Tamura T et al (2008) Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non-small cell lung cancer: a phase II study. J Thorac Oncol 3:1439–1445CrossRefPubMed Kubota K, Nishiwaki Y, Tamura T et al (2008) Efficacy and safety of erlotinib monotherapy for Japanese patients with advanced non-small cell lung cancer: a phase II study. J Thorac Oncol 3:1439–1445CrossRefPubMed
21.
Zurück zum Zitat Ramlau R, Gervais R, Krzakowski M et al (2006) Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. J Clin Oncol 24:2800–2807CrossRefPubMed Ramlau R, Gervais R, Krzakowski M et al (2006) Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. J Clin Oncol 24:2800–2807CrossRefPubMed
22.
Zurück zum Zitat Jones S, Thompson D, Barton J et al (2008) A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer 9:154–159CrossRefPubMed Jones S, Thompson D, Barton J et al (2008) A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer 9:154–159CrossRefPubMed
23.
Zurück zum Zitat Takiguchi Y, Moriya T, Asaka-Amano Y et al (2007) Phase II study of weekly irinotecan and cisplatin for refractory or recurrent non-small cell lung cancer. Lung Cancer 58:253–259CrossRefPubMed Takiguchi Y, Moriya T, Asaka-Amano Y et al (2007) Phase II study of weekly irinotecan and cisplatin for refractory or recurrent non-small cell lung cancer. Lung Cancer 58:253–259CrossRefPubMed
24.
Zurück zum Zitat Chen YM, Perng RP, Tsai CM, Whang-Peng J (2006) A phase II trial of gemcitabine plus UFUR combination chemotherapy in non-small-cell lung cancer patients failing previous chemotherapy. Lung Cancer 52:333–338CrossRefPubMed Chen YM, Perng RP, Tsai CM, Whang-Peng J (2006) A phase II trial of gemcitabine plus UFUR combination chemotherapy in non-small-cell lung cancer patients failing previous chemotherapy. Lung Cancer 52:333–338CrossRefPubMed
25.
Zurück zum Zitat Atagi S, Kawahara M, Kusunoki Y et al (2008) Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer. J Thorac Oncol 3:1012–1017CrossRefPubMed Atagi S, Kawahara M, Kusunoki Y et al (2008) Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer. J Thorac Oncol 3:1012–1017CrossRefPubMed
26.
Zurück zum Zitat Ajani JA, Faust J, Ikeda K et al (2005) Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 23:6957–6965CrossRefPubMed Ajani JA, Faust J, Ikeda K et al (2005) Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 23:6957–6965CrossRefPubMed
27.
Zurück zum Zitat Yamamoto N, Tamura T, Kamiya Y et al (2000) Correlation between docetaxel clearance and estimated cytochrome P450 activity by urinary metabolite of exogenous cortisol. J Clin Oncol 18:2301–2308PubMed Yamamoto N, Tamura T, Kamiya Y et al (2000) Correlation between docetaxel clearance and estimated cytochrome P450 activity by urinary metabolite of exogenous cortisol. J Clin Oncol 18:2301–2308PubMed
28.
Zurück zum Zitat Sekine I, Yamamoto N, Nishio K, Saijo N (2008) Emerging ethnic differences in lung cancer therapy. Br J Cancer 99:1757–1762CrossRefPubMed Sekine I, Yamamoto N, Nishio K, Saijo N (2008) Emerging ethnic differences in lung cancer therapy. Br J Cancer 99:1757–1762CrossRefPubMed
29.
Zurück zum Zitat Park SR, Park MS, Park YL et al (2007) CYP2A6 genetic polymorphism as a predictive marker for clinical outcomes in patients with metastatic gastric carcinoma treated with S-1 plus docetaxel. 2007 ASCO Annual Meeting Proceedings. J Clin Oncol 25:230s (abstr 4633) Park SR, Park MS, Park YL et al (2007) CYP2A6 genetic polymorphism as a predictive marker for clinical outcomes in patients with metastatic gastric carcinoma treated with S-1 plus docetaxel. 2007 ASCO Annual Meeting Proceedings. J Clin Oncol 25:230s (abstr 4633)
Metadaten
Titel
Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer
verfasst von
Kazuhiro Yanagihara
Kenichi Yoshimura
Miyuki Niimi
Hiroyasu Yasuda
Takahiko Sasaki
Takafumi Nishimura
Hiroshi Ishiguro
Shigemi Matsumoto
Toshiyuki Kitano
Masashi Kanai
Akiko Misawa
Harue Tada
Satoshi Teramukai
Tadashi Mio
Masanori Fukushima
Publikationsdatum
01.10.2010
Verlag
Springer-Verlag
Erschienen in
Cancer Chemotherapy and Pharmacology / Ausgabe 5/2010
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-009-1239-7

Weitere Artikel der Ausgabe 5/2010

Cancer Chemotherapy and Pharmacology 5/2010 Zur Ausgabe

Alphablocker schützt vor Miktionsproblemen nach der Biopsie

16.05.2024 alpha-1-Rezeptorantagonisten Nachrichten

Nach einer Prostatabiopsie treten häufig Probleme beim Wasserlassen auf. Ob sich das durch den periinterventionellen Einsatz von Alphablockern verhindern lässt, haben australische Mediziner im Zuge einer Metaanalyse untersucht.

Mammakarzinom: Senken Statine das krebsbedingte Sterberisiko?

15.05.2024 Mammakarzinom Nachrichten

Frauen mit lokalem oder metastasiertem Brustkrebs, die Statine einnehmen, haben eine niedrigere krebsspezifische Mortalität als Patientinnen, die dies nicht tun, legen neue Daten aus den USA nahe.

Labor, CT-Anthropometrie zeigen Risiko für Pankreaskrebs

13.05.2024 Pankreaskarzinom Nachrichten

Gerade bei aggressiven Malignomen wie dem duktalen Adenokarzinom des Pankreas könnte Früherkennung die Therapiechancen verbessern. Noch jedoch klafft hier eine Lücke. Ein Studienteam hat einen Weg gesucht, sie zu schließen.

Viel pflanzliche Nahrung, seltener Prostata-Ca.-Progression

12.05.2024 Prostatakarzinom Nachrichten

Ein hoher Anteil pflanzlicher Nahrung trägt möglicherweise dazu bei, das Progressionsrisiko von Männern mit Prostatakarzinomen zu senken. In einer US-Studie war das Risiko bei ausgeprägter pflanzlicher Ernährung in etwa halbiert.

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.