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Vinflunine - an active chemotherapy for treatment of advanced non-small-cell lung cancer previously treated with a platinum-based regimen: results of a phase II study

Vinflunine - an active chemotherapy for treatment of advanced non-small-cell lung cancer previously treated with a platinum-based regimen: results of a phase II study
Vinflunine - an active chemotherapy for treatment of advanced non-small-cell lung cancer previously treated with a platinum-based regimen: results of a phase II study
A multicentre, single-arm, phase II trial designed to determine the efficacy of single-agent vinflunine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with a platinum-based regimen. The objectives were to assess efficacy in terms of tumour response rate ( primary end point), duration of response, progression-free survival (PFS) and overall survival ( OS), and to evaluate the toxicity associated with this treatment. Patients with advanced NSCLC with progressive disease having failed prior platinum-based first-line treatment for advanced disease. Five responses out of the 63 treated patients were documented by WHO criteria and validated by an independent panel review (IRP), yielding a response rate of 7.9% (95% CI: 2.6-17.6) in the intent-to-treat analysis and 8.3% (95% CI: 2.8-18.4) in the evaluable population. Disease control was achieved in 35 out of 60 evaluable patients (58.3%). The median duration of response (complete response + partial response), according to modified WHO criteria was 7.8 months (95% CI: 4.6-NR). Median PFS was 2.6 months (95% CI: 1.4-3.8), and the median survival was 7.0 months (95% CI: 5.8-9.2). Grades 3 - 4 neutropenia was reported in 50% of patients; febrile neutropenia was observed in two patients (3.2%); grades 3-4 myalgia and grade 3 constipation were experienced by 10 (15.9%) and six (9.5%) of patients, respectively. Constipation was manageable, noncumulative and could be prevented with laxative prophylaxis. The encouraging results from this phase II study with vinflunine warrant further investigations in phase III trials as second- or first-line treatment of advanced non-small-cell lung carcinoma, as a single agent or in combination with other active drugs
vinflunine, phase II study, non-small-cell-lung-cancer
0007-0920
1383-1388
Bennouna, J.
da93980d-1083-4669-a661-5b8b7a7a7923
Breton, J.L.
f98317ca-a079-409f-acb1-b6f760b94650
Tourani, J.M.
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Ottensmeier, C.
42b8a398-baac-4843-a3d6-056225675797
O'Brien, M.
8f471ec3-2a15-4f39-a1f8-d0c485b102e3
Kosmidis, P.
5952087c-9a41-4d8e-ab7d-1288281e433a
Huat, T.E.
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Pinel, M.C.
fe208d96-5f51-4a4b-8b85-f9eceea055fa
Colin, C.
de4915f4-e4d1-47b3-93cb-a58f3ac3dc6a
Douillard, J.Y.
cbb4b50f-e039-49f2-8cd2-592dd03b993b
Bennouna, J.
da93980d-1083-4669-a661-5b8b7a7a7923
Breton, J.L.
f98317ca-a079-409f-acb1-b6f760b94650
Tourani, J.M.
af6993cd-d13a-416e-9777-0d4fb6964bda
Ottensmeier, C.
42b8a398-baac-4843-a3d6-056225675797
O'Brien, M.
8f471ec3-2a15-4f39-a1f8-d0c485b102e3
Kosmidis, P.
5952087c-9a41-4d8e-ab7d-1288281e433a
Huat, T.E.
6dd3e63e-0b08-434e-bced-df13f79b3de8
Pinel, M.C.
fe208d96-5f51-4a4b-8b85-f9eceea055fa
Colin, C.
de4915f4-e4d1-47b3-93cb-a58f3ac3dc6a
Douillard, J.Y.
cbb4b50f-e039-49f2-8cd2-592dd03b993b

Bennouna, J., Breton, J.L., Tourani, J.M., Ottensmeier, C., O'Brien, M., Kosmidis, P., Huat, T.E., Pinel, M.C., Colin, C. and Douillard, J.Y. (2006) Vinflunine - an active chemotherapy for treatment of advanced non-small-cell lung cancer previously treated with a platinum-based regimen: results of a phase II study. British Journal of Cancer, 94 (10), 1383-1388. (doi:10.1038/sj.bjc.6603106).

Record type: Article

Abstract

A multicentre, single-arm, phase II trial designed to determine the efficacy of single-agent vinflunine in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with a platinum-based regimen. The objectives were to assess efficacy in terms of tumour response rate ( primary end point), duration of response, progression-free survival (PFS) and overall survival ( OS), and to evaluate the toxicity associated with this treatment. Patients with advanced NSCLC with progressive disease having failed prior platinum-based first-line treatment for advanced disease. Five responses out of the 63 treated patients were documented by WHO criteria and validated by an independent panel review (IRP), yielding a response rate of 7.9% (95% CI: 2.6-17.6) in the intent-to-treat analysis and 8.3% (95% CI: 2.8-18.4) in the evaluable population. Disease control was achieved in 35 out of 60 evaluable patients (58.3%). The median duration of response (complete response + partial response), according to modified WHO criteria was 7.8 months (95% CI: 4.6-NR). Median PFS was 2.6 months (95% CI: 1.4-3.8), and the median survival was 7.0 months (95% CI: 5.8-9.2). Grades 3 - 4 neutropenia was reported in 50% of patients; febrile neutropenia was observed in two patients (3.2%); grades 3-4 myalgia and grade 3 constipation were experienced by 10 (15.9%) and six (9.5%) of patients, respectively. Constipation was manageable, noncumulative and could be prevented with laxative prophylaxis. The encouraging results from this phase II study with vinflunine warrant further investigations in phase III trials as second- or first-line treatment of advanced non-small-cell lung carcinoma, as a single agent or in combination with other active drugs

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Published date: 25 April 2006
Keywords: vinflunine, phase II study, non-small-cell-lung-cancer

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Local EPrints ID: 62686
URI: https://eprints.soton.ac.uk/id/eprint/62686
ISSN: 0007-0920
PURE UUID: 1f50e2a7-8e20-46d0-964f-f9058604f3a1

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Date deposited: 04 Sep 2008
Last modified: 13 Mar 2019 20:27

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Contributors

Author: J. Bennouna
Author: J.L. Breton
Author: J.M. Tourani
Author: C. Ottensmeier
Author: M. O'Brien
Author: P. Kosmidis
Author: T.E. Huat
Author: M.C. Pinel
Author: C. Colin
Author: J.Y. Douillard

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