Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer

F. Cappuzzo, S. Novelle, F. De Marinis, V. Franciosi, M. Maur, A. Ceribelli, V. Lorusso, F. Barbieri, L. Castaldini, E. Crucitta, L. Marini, S. Bartolini, G. V. Scagliotti, L. Crino

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Abstract

This phase II study evaluated the response rate and tolerability of gemcitabine-oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage HIB or IV NSCLC received gemcitabine 1000 mg m2 on days 1 and 8, followed by oxaliplatin 130 mg m 2 on day 1. Cycles were repeated every 21 days for up to six cycles. From February 2002 to May 2004, 60 patients were enrolled into the study in seven Italian institutions. We observed one complete response (1.7%) and 14 partial responses (23.3%), for an overall response rate of 25.0% (95% confidence interval, 14.7-37.9%). The median duration of response was 5.9 months (range 1.5- 17.1 months). With a median follow-up of 6.7 months, median time to progressive disease and overall survival were 2.7 (range 1.9-3.4 months) and 7.3 months (range 7.2-8.6 months), respectively. The main grade 3-4 haematological toxicities were transient neutropenia in 11.7% and thrombocytopenia in 8.3% of the patients. Nausea/vomiting was the main grade 3-4 nonhaematological toxicity, occurring in 10.0% of the patients. Two (3.3%) patients developed grade 3 neurotoxicity. Our results show that gemcitabine-oxaliplatin chemotherapy is active and well tolerated in patients with advanced NSCLC, deserving further study, especially for patients not eligible to receive cisplatin.

Original languageEnglish
Pages (from-to)29-34
Number of pages6
JournalBritish Journal of Cancer
Volume93
Issue number1
DOIs
Publication statusPublished - Jul 11 2005

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oxaliplatin
gemcitabine
Non-Small Cell Lung Carcinoma
Drug Therapy
Neutropenia

Keywords

  • Chemotherapy
  • Gemcitabine
  • Non-small-cell lung cancer
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer. / Cappuzzo, F.; Novelle, S.; De Marinis, F.; Franciosi, V.; Maur, M.; Ceribelli, A.; Lorusso, V.; Barbieri, F.; Castaldini, L.; Crucitta, E.; Marini, L.; Bartolini, S.; Scagliotti, G. V.; Crino, L.

In: British Journal of Cancer, Vol. 93, No. 1, 11.07.2005, p. 29-34.

Research output: Contribution to journalArticle

Cappuzzo, F, Novelle, S, De Marinis, F, Franciosi, V, Maur, M, Ceribelli, A, Lorusso, V, Barbieri, F, Castaldini, L, Crucitta, E, Marini, L, Bartolini, S, Scagliotti, GV & Crino, L 2005, 'Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer', British Journal of Cancer, vol. 93, no. 1, pp. 29-34. https://doi.org/10.1038/sj.bjc.6602667
Cappuzzo, F. ; Novelle, S. ; De Marinis, F. ; Franciosi, V. ; Maur, M. ; Ceribelli, A. ; Lorusso, V. ; Barbieri, F. ; Castaldini, L. ; Crucitta, E. ; Marini, L. ; Bartolini, S. ; Scagliotti, G. V. ; Crino, L. / Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer. In: British Journal of Cancer. 2005 ; Vol. 93, No. 1. pp. 29-34.
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abstract = "This phase II study evaluated the response rate and tolerability of gemcitabine-oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage HIB or IV NSCLC received gemcitabine 1000 mg m2 on days 1 and 8, followed by oxaliplatin 130 mg m 2 on day 1. Cycles were repeated every 21 days for up to six cycles. From February 2002 to May 2004, 60 patients were enrolled into the study in seven Italian institutions. We observed one complete response (1.7{\%}) and 14 partial responses (23.3{\%}), for an overall response rate of 25.0{\%} (95{\%} confidence interval, 14.7-37.9{\%}). The median duration of response was 5.9 months (range 1.5- 17.1 months). With a median follow-up of 6.7 months, median time to progressive disease and overall survival were 2.7 (range 1.9-3.4 months) and 7.3 months (range 7.2-8.6 months), respectively. The main grade 3-4 haematological toxicities were transient neutropenia in 11.7{\%} and thrombocytopenia in 8.3{\%} of the patients. Nausea/vomiting was the main grade 3-4 nonhaematological toxicity, occurring in 10.0{\%} of the patients. Two (3.3{\%}) patients developed grade 3 neurotoxicity. Our results show that gemcitabine-oxaliplatin chemotherapy is active and well tolerated in patients with advanced NSCLC, deserving further study, especially for patients not eligible to receive cisplatin.",
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AU - Cappuzzo, F.

AU - Novelle, S.

AU - De Marinis, F.

AU - Franciosi, V.

AU - Maur, M.

AU - Ceribelli, A.

AU - Lorusso, V.

AU - Barbieri, F.

AU - Castaldini, L.

AU - Crucitta, E.

AU - Marini, L.

AU - Bartolini, S.

AU - Scagliotti, G. V.

AU - Crino, L.

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N2 - This phase II study evaluated the response rate and tolerability of gemcitabine-oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage HIB or IV NSCLC received gemcitabine 1000 mg m2 on days 1 and 8, followed by oxaliplatin 130 mg m 2 on day 1. Cycles were repeated every 21 days for up to six cycles. From February 2002 to May 2004, 60 patients were enrolled into the study in seven Italian institutions. We observed one complete response (1.7%) and 14 partial responses (23.3%), for an overall response rate of 25.0% (95% confidence interval, 14.7-37.9%). The median duration of response was 5.9 months (range 1.5- 17.1 months). With a median follow-up of 6.7 months, median time to progressive disease and overall survival were 2.7 (range 1.9-3.4 months) and 7.3 months (range 7.2-8.6 months), respectively. The main grade 3-4 haematological toxicities were transient neutropenia in 11.7% and thrombocytopenia in 8.3% of the patients. Nausea/vomiting was the main grade 3-4 nonhaematological toxicity, occurring in 10.0% of the patients. Two (3.3%) patients developed grade 3 neurotoxicity. Our results show that gemcitabine-oxaliplatin chemotherapy is active and well tolerated in patients with advanced NSCLC, deserving further study, especially for patients not eligible to receive cisplatin.

AB - This phase II study evaluated the response rate and tolerability of gemcitabine-oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage HIB or IV NSCLC received gemcitabine 1000 mg m2 on days 1 and 8, followed by oxaliplatin 130 mg m 2 on day 1. Cycles were repeated every 21 days for up to six cycles. From February 2002 to May 2004, 60 patients were enrolled into the study in seven Italian institutions. We observed one complete response (1.7%) and 14 partial responses (23.3%), for an overall response rate of 25.0% (95% confidence interval, 14.7-37.9%). The median duration of response was 5.9 months (range 1.5- 17.1 months). With a median follow-up of 6.7 months, median time to progressive disease and overall survival were 2.7 (range 1.9-3.4 months) and 7.3 months (range 7.2-8.6 months), respectively. The main grade 3-4 haematological toxicities were transient neutropenia in 11.7% and thrombocytopenia in 8.3% of the patients. Nausea/vomiting was the main grade 3-4 nonhaematological toxicity, occurring in 10.0% of the patients. Two (3.3%) patients developed grade 3 neurotoxicity. Our results show that gemcitabine-oxaliplatin chemotherapy is active and well tolerated in patients with advanced NSCLC, deserving further study, especially for patients not eligible to receive cisplatin.

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