Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer

Alberto Chiappori, George Simon, Charles Williams, Eric Haura, Caio Rocha-Lima, Henry Wagner, Gerold Bepler, Scott Antonia

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Rationale: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival. Objectives: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen. Methods: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. Treatment consisted of gemcitabine, 1,000 mg/m2, on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m2, on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles. Results: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6% (9/38 patients, 95% confidence interval, CI, 11-40%), with 15.8% (6/38 patients, 95% CI, 6-31%) and 12.5% (3/24 patients, 95% CI, 3-32%) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5%. Conclusion: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC.

Original languageEnglish
Pages (from-to)382-390
Number of pages9
JournalOncology
Volume68
Issue number4-6
DOIs
StatePublished - Aug 1 2005

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docetaxel
gemcitabine
Carboplatin
Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
Malignant Pleural Effusion

Keywords

  • Carboplatin
  • Docetaxel
  • Gemcitabine
  • Lung cancer
  • Sequential chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer. / Chiappori, Alberto; Simon, George; Williams, Charles; Haura, Eric; Rocha-Lima, Caio; Wagner, Henry; Bepler, Gerold; Antonia, Scott.

In: Oncology, Vol. 68, No. 4-6, 01.08.2005, p. 382-390.

Research output: Contribution to journalArticle

Chiappori, A, Simon, G, Williams, C, Haura, E, Rocha-Lima, C, Wagner, H, Bepler, G & Antonia, S 2005, 'Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer', Oncology, vol. 68, no. 4-6, pp. 382-390. https://doi.org/10.1159/000086979
Chiappori, Alberto ; Simon, George ; Williams, Charles ; Haura, Eric ; Rocha-Lima, Caio ; Wagner, Henry ; Bepler, Gerold ; Antonia, Scott. / Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer. In: Oncology. 2005 ; Vol. 68, No. 4-6. pp. 382-390.
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abstract = "Rationale: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival. Objectives: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen. Methods: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. Treatment consisted of gemcitabine, 1,000 mg/m2, on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m2, on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles. Results: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6{\%} (9/38 patients, 95{\%} confidence interval, CI, 11-40{\%}), with 15.8{\%} (6/38 patients, 95{\%} CI, 6-31{\%}) and 12.5{\%} (3/24 patients, 95{\%} CI, 3-32{\%}) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5{\%}. Conclusion: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC.",
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T1 - Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer

AU - Chiappori, Alberto

AU - Simon, George

AU - Williams, Charles

AU - Haura, Eric

AU - Rocha-Lima, Caio

AU - Wagner, Henry

AU - Bepler, Gerold

AU - Antonia, Scott

PY - 2005/8/1

Y1 - 2005/8/1

N2 - Rationale: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival. Objectives: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen. Methods: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. Treatment consisted of gemcitabine, 1,000 mg/m2, on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m2, on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles. Results: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6% (9/38 patients, 95% confidence interval, CI, 11-40%), with 15.8% (6/38 patients, 95% CI, 6-31%) and 12.5% (3/24 patients, 95% CI, 3-32%) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5%. Conclusion: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC.

AB - Rationale: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival. Objectives: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen. Methods: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. Treatment consisted of gemcitabine, 1,000 mg/m2, on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m2, on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles. Results: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6% (9/38 patients, 95% confidence interval, CI, 11-40%), with 15.8% (6/38 patients, 95% CI, 6-31%) and 12.5% (3/24 patients, 95% CI, 3-32%) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5%. Conclusion: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC.

KW - Carboplatin

KW - Docetaxel

KW - Gemcitabine

KW - Lung cancer

KW - Sequential chemotherapy

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