Skip to main content
Top
Published in: Cancer Chemotherapy and Pharmacology 1/2018

01-01-2018 | Original Article

A phase II study of biweekly gemcitabine and carboplatin in completely resected stage IB-IIIA non-small cell lung cancer

Authors: Reiko Sakurai, Yoshio Tomizawa, Akihiro Yoshii, Yosuke Miura, Hiroaki Tsurumaki, Kyoichi Kaira, Noriaki Sunaga, Osamu Kawashima, Takeshi Hisada, Masanobu Yamada, Ryusei Saito

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2018

Login to get access

Abstract

Purpose

We conducted a prospective study to evaluate the efficacy and safety of biweekly gemcitabine and carboplatin combination treatment in patients with resected non-small cell lung cancer (NSCLC).

Methods

Patients with completely resected stage IB to IIIA NSCLC were treated with four cycles of gemcitabine (1000 mg/m2, days 1 and 15) plus carboplatin [area under the time-concentration curve (AUC) 5 mg/mL/min, day 1] every 4 weeks as adjuvant chemotherapy.

Results

Forty-three patients were enrolled in this study. The median number of treatment cycles was four. The completion rate of chemotherapy was 79.1%. Major grade 3/4 hematological adverse events included leukocytopenia (27.9%) and neutropenia (53.5%), whereas non-hematological toxicities were generally mild. Ten patients (23.3%) required chemotherapy treatment schedule delay, and one patient required one dose level reduction because of drug fever. Median disease-free survival was 78.6 months [95% confidence interval (CI) 39.5–not reached (NA)] and median overall survival was not reached (95% CI 83.7–NA).

Conclusions

Biweekly administration of gemcitabine and carboplatin is effective and well tolerated for patients with completely resected NSCLC as an adjuvant chemotherapy.
Literature
1.
2.
go back to reference Peters S, Weder W, Dafni U et al (2014) Lungscape: resected non-small-cell lung cancer outcome by clinical and pathological parameters. J Thorac Oncol 9:1675–1684CrossRefPubMed Peters S, Weder W, Dafni U et al (2014) Lungscape: resected non-small-cell lung cancer outcome by clinical and pathological parameters. J Thorac Oncol 9:1675–1684CrossRefPubMed
3.
go back to reference Buffoni L, Vavalà T, Novello S (2016) Adjuvant therapy of resected non-small cell lung cancer: can we move forward? Curr Treat Options Oncol 17:54CrossRefPubMed Buffoni L, Vavalà T, Novello S (2016) Adjuvant therapy of resected non-small cell lung cancer: can we move forward? Curr Treat Options Oncol 17:54CrossRefPubMed
4.
go back to reference Pignon JP, Tribodet H, Scagliotti GV et al (2008) Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE collaborative group. J Clin Oncol 26:3552–3559CrossRefPubMed Pignon JP, Tribodet H, Scagliotti GV et al (2008) Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE collaborative group. J Clin Oncol 26:3552–3559CrossRefPubMed
5.
go back to reference Douillard JY, Tribodet H, Aubert D et al (2010) Adjuvant cisplatin and vinorelbine for completely resected non-small cell lung cancer. J Thorac Oncol 5:220–228CrossRefPubMed Douillard JY, Tribodet H, Aubert D et al (2010) Adjuvant cisplatin and vinorelbine for completely resected non-small cell lung cancer. J Thorac Oncol 5:220–228CrossRefPubMed
6.
go back to reference Okumura N, Sonobe M, Okabe K et al (2017) Feasibility of adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 for completely resected non-small-cell lung cancer: results of the setouchi lung cancer group study 1001. Int J Clin Oncol 22:274–282CrossRefPubMed Okumura N, Sonobe M, Okabe K et al (2017) Feasibility of adjuvant chemotherapy with S-1 plus carboplatin followed by single-agent maintenance therapy with S-1 for completely resected non-small-cell lung cancer: results of the setouchi lung cancer group study 1001. Int J Clin Oncol 22:274–282CrossRefPubMed
7.
go back to reference Schmid-Bindert G, Engel-Riedel W, Reck M et al (2015) A randomized phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patinets with completely resected stage IB or II non-small-cell lung cancer. Lung Cancer 90:397–404CrossRefPubMed Schmid-Bindert G, Engel-Riedel W, Reck M et al (2015) A randomized phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patinets with completely resected stage IB or II non-small-cell lung cancer. Lung Cancer 90:397–404CrossRefPubMed
8.
9.
go back to reference Ohe Y, Ohashi Y, Kubota K et al (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-arm cooperative study in Japan. Ann Oncol 18:317–323CrossRefPubMed Ohe Y, Ohashi Y, Kubota K et al (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-arm cooperative study in Japan. Ann Oncol 18:317–323CrossRefPubMed
10.
go back to reference Scagliotti GV, Parikh P, von Pawel J et al (2008) Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26:3543–3551CrossRefPubMed Scagliotti GV, Parikh P, von Pawel J et al (2008) Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26:3543–3551CrossRefPubMed
11.
go back to reference Zatloukal P, Petruzelka L, Zemanov M et al (2003) Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer 41:321–331CrossRefPubMed Zatloukal P, Petruzelka L, Zemanov M et al (2003) Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer 41:321–331CrossRefPubMed
12.
go back to reference Tomizawa Y, Ishihara S, Iijima H et al (2007) A phase I dose escalation study of biweekly gemcitbine and carbopatin in completely resected stage IB-IIIA nonsmall cell lung cancer. Am J Clin Oncol 30:498–502CrossRefPubMed Tomizawa Y, Ishihara S, Iijima H et al (2007) A phase I dose escalation study of biweekly gemcitbine and carbopatin in completely resected stage IB-IIIA nonsmall cell lung cancer. Am J Clin Oncol 30:498–502CrossRefPubMed
13.
go back to reference Jiang J, Liang X, Zhou X et al (2007) A meta-analysis of randomized controlled trials comparing carboplatin-based to cisplatin-based chemotherapy in advanced non-small cell lung cancer. Lung Cancer 57:348–358CrossRefPubMed Jiang J, Liang X, Zhou X et al (2007) A meta-analysis of randomized controlled trials comparing carboplatin-based to cisplatin-based chemotherapy in advanced non-small cell lung cancer. Lung Cancer 57:348–358CrossRefPubMed
14.
go back to reference Ardizzoni A, Boni L, Tiseo M, CISCA (CISplatin versus CArboplatin) Meta-analysis Group et al (2007) Cisplatin versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst 99:847–857CrossRefPubMed Ardizzoni A, Boni L, Tiseo M, CISCA (CISplatin versus CArboplatin) Meta-analysis Group et al (2007) Cisplatin versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst 99:847–857CrossRefPubMed
15.
go back to reference Hotta K, Matsuo K, Ueoka H et al (2004) Meta-analysis of randomized clinical trials comparing cisplatin to carboplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol 22:3852–3859CrossRefPubMed Hotta K, Matsuo K, Ueoka H et al (2004) Meta-analysis of randomized clinical trials comparing cisplatin to carboplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol 22:3852–3859CrossRefPubMed
16.
go back to reference Abratt RP, Bezwoda WR, Falkson G et al (1994) Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study. J Clin Oncol 12:1535–1540CrossRefPubMed Abratt RP, Bezwoda WR, Falkson G et al (1994) Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study. J Clin Oncol 12:1535–1540CrossRefPubMed
17.
go back to reference Anderson H, Lund B, Bach F et al (1994) Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 12:1821–1826CrossRefPubMed Anderson H, Lund B, Bach F et al (1994) Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 12:1821–1826CrossRefPubMed
18.
go back to reference Gatzemeier U, Shepherd FA, Le Chevalier T et al (1996) Activity of gemcitabine in patients with non-small cell lung cancer: a multicenter, extended phase II study. Eur J Cancer 32A:243–248CrossRefPubMed Gatzemeier U, Shepherd FA, Le Chevalier T et al (1996) Activity of gemcitabine in patients with non-small cell lung cancer: a multicenter, extended phase II study. Eur J Cancer 32A:243–248CrossRefPubMed
19.
go back to reference Winton T, Livingston R, Johnson D et al (2005) Vinorelbine plus cisplatin vs observation in resected non-small-cell lung cancer. N Engl J Med 352:2589–2597CrossRefPubMed Winton T, Livingston R, Johnson D et al (2005) Vinorelbine plus cisplatin vs observation in resected non-small-cell lung cancer. N Engl J Med 352:2589–2597CrossRefPubMed
20.
go back to reference Douillard J, Rosell R, De Lena M et al (2006) Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer [Adjuvant Navelbine International Trialist Association (ANITA)]: a randomized controlled trial. Lancet Oncol 7:719–727CrossRefPubMed Douillard J, Rosell R, De Lena M et al (2006) Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer [Adjuvant Navelbine International Trialist Association (ANITA)]: a randomized controlled trial. Lancet Oncol 7:719–727CrossRefPubMed
21.
go back to reference Lopez-Vivanco G, Viteri A, Barcelo R et al (2005) Biweekly administration of cisplatin/gemcitabine in advanced nonsmall cell lung cancer. Am J Clin Oncol 28:501–507CrossRefPubMed Lopez-Vivanco G, Viteri A, Barcelo R et al (2005) Biweekly administration of cisplatin/gemcitabine in advanced nonsmall cell lung cancer. Am J Clin Oncol 28:501–507CrossRefPubMed
22.
go back to reference Uramoto H, Nakanishi R, Nagashima A et al (2010) A randomized phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer. Anticancer Res 30:4695–4700PubMed Uramoto H, Nakanishi R, Nagashima A et al (2010) A randomized phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel versus carboplatin plus gemcitabine in patients with completely resected non-small cell lung cancer. Anticancer Res 30:4695–4700PubMed
23.
go back to reference Usami N, Yokoi K, Hasegawa Y et al (2010) Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial. Int J Clin Oncol 15:583–587CrossRefPubMed Usami N, Yokoi K, Hasegawa Y et al (2010) Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial. Int J Clin Oncol 15:583–587CrossRefPubMed
Metadata
Title
A phase II study of biweekly gemcitabine and carboplatin in completely resected stage IB-IIIA non-small cell lung cancer
Authors
Reiko Sakurai
Yoshio Tomizawa
Akihiro Yoshii
Yosuke Miura
Hiroaki Tsurumaki
Kyoichi Kaira
Noriaki Sunaga
Osamu Kawashima
Takeshi Hisada
Masanobu Yamada
Ryusei Saito
Publication date
01-01-2018
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 1/2018
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-017-3439-x

Other articles of this Issue 1/2018

Cancer Chemotherapy and Pharmacology 1/2018 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine