A phase II study of induction therapy with carboplatin and gemcitabine among patients with locally advanced non-small cell lung cancer

Aerts, J.G.J. V.; Surmont, V.; van Klaveren, R.J.; Tan, K.Y.; Senan, S.; van Wijhe, G.; Vernhout, R.; Verhoeven, G.T.; Hoogsteden, H.C.; van Meerbeeck, J.P.

doi:10.1097/01243894-200607000-00006

Title

A phase II study of induction therapy with carboplatin and gemcitabine among patients with locally advanced non-small cell lung cancer

Author

Aerts, J.G.J. V.

Surmont, V.

van Klaveren, R.J.

Tan, K.Y.

Senan, S.

van Wijhe, G.

Vernhout, R.

Verhoeven, G.T.

Hoogsteden, H.C.

van Meerbeeck, J.P.

Abstract

Introduction: The objectives of this trial were to evaluate the activity and safety of gemcitabine carboplatin as induction therapy in patients with locally advanced non-small cell lung cancer Methods: Patients received two cycles of gemcitabine (1250 mg/m(2) on day 1 and 8), plus carboplatin (area under the curve = 5 on day 1), after which response was established. Patients received a third course only in the case of an objective response (OR). Non-responding patients were directly irradiated. Toxicity was assessed according to the NCI-CTC version 2, radiation toxicity was assessed according to RTOG criteria. Response evaluation was performed according to RECIST criteria. Results: We identified 42 patients, of whom 37 were eligible. Of these, 51% (95% CI, 34%-68%) achieved an OR, all partial responses. No disease progression on therapy was established. Toxicity was mostly hematological: 35% trombocytopenia grade 3 and 4, and 40% neutropenia grade 3 and 4. No severe bleeding or hospitalization because of febrile neutropenia occurred. Conclusions: Gemcitabine and carboplatin administered according to a 3-week schedule is an active and safe induction regimen. Pending the results of a phase III study, we believe that it is a reasonable alternative among patients for whom cisplatin-based chemotherapy is contraindicated.

Language

English

Source (journal)

Journal of thoracic oncology / International Association for the Study of Lung Cancer [Aurora, Colo.] - Hagerstown, Md, 2006, currens

Publication

Hagerstown, Md : Lippincott Williams & Wilkins , 2006

ISSN

1556-0864 [print]

1556-1380 [online]

DOI

10.1097/01243894-200607000-00006

Volume/pages