Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC)

Luis E. Raez, Edgardo S. Santos, Gilberto Lopes, Manuel F. Rosado, Lawrence Negret, Caio Rocha-Lima, Kalhed Tolba, Nancy Farfan, Kara Hamilton-Nelson, Orlando Silva, Eloy Roman

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.

Original languageEnglish
Pages (from-to)347-353
Number of pages7
JournalLung Cancer
Volume53
Issue number3
DOIs
StatePublished - Sep 1 2006

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oxaliplatin
docetaxel
Non-Small Cell Lung Carcinoma
Confidence Intervals
Safety
Survival
Drug Therapy
Neutropenia
Platinum
Hyperglycemia
Anemia

Keywords

  • Advanced disease
  • Chemotherapy
  • Docetaxel
  • First-line therapy
  • Non-small-cell lung cancer
  • Oxaliplatin

ASJC Scopus subject areas

  • Oncology

Cite this

Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC). / Raez, Luis E.; Santos, Edgardo S.; Lopes, Gilberto; Rosado, Manuel F.; Negret, Lawrence; Rocha-Lima, Caio; Tolba, Kalhed; Farfan, Nancy; Hamilton-Nelson, Kara; Silva, Orlando; Roman, Eloy.

In: Lung Cancer, Vol. 53, No. 3, 01.09.2006, p. 347-353.

Research output: Contribution to journalArticle

Raez, LE, Santos, ES, Lopes, G, Rosado, MF, Negret, L, Rocha-Lima, C, Tolba, K, Farfan, N, Hamilton-Nelson, K, Silva, O & Roman, E 2006, 'Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC)', Lung Cancer, vol. 53, no. 3, pp. 347-353. https://doi.org/10.1016/j.lungcan.2006.05.023
Raez, Luis E. ; Santos, Edgardo S. ; Lopes, Gilberto ; Rosado, Manuel F. ; Negret, Lawrence ; Rocha-Lima, Caio ; Tolba, Kalhed ; Farfan, Nancy ; Hamilton-Nelson, Kara ; Silva, Orlando ; Roman, Eloy. / Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC). In: Lung Cancer. 2006 ; Vol. 53, No. 3. pp. 347-353.
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abstract = "Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93{\%} had stage IV disease and 28{\%} had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37{\%} (90{\%} confidence interval [CI], 22-55{\%}). Median PFS was 4.6 months (95{\%} CI, 2.6-6.5 months); 12-month PFS was 14.8{\%} (95{\%} CI, 3.4-34.0{\%}). Median OS was 10.9 months (95{\%} CI, 8.9-16.8 months); 12-month OS was 40{\%} (95{\%} CI, 19-61{\%}) and 18-month OS was 16{\%} (95{\%} CI, 1-46{\%}). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14{\%} of patients) and hyperglycemia (10{\%}); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.",
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AU - Raez, Luis E.

AU - Santos, Edgardo S.

AU - Lopes, Gilberto

AU - Rosado, Manuel F.

AU - Negret, Lawrence

AU - Rocha-Lima, Caio

AU - Tolba, Kalhed

AU - Farfan, Nancy

AU - Hamilton-Nelson, Kara

AU - Silva, Orlando

AU - Roman, Eloy

PY - 2006/9/1

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N2 - Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.

AB - Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.

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