Gemcitabine (G) /carboplatin (C) surveillance study in patients with advanced or metastatic non-small cell lung cancer (NSCLC): Survival update of a phase II study of a 21 versus 28-day schedule

Obasaju, Coleman K.; Ye, Z.; Jorge, Juan; Hatfield, Alan K.

doi:10.1200/jco.2004.22.14_suppl.7134

Cited by 3 publications

(1 citation statement)

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“…In this regimen, several patients were unable to receive the day 15 dose of gemcitabine due to myelosuppression. Therefore, randomized phase II studies were conducted to compare the administration of gemcitabine (2 weeks on, 1 week off) and carboplatin on a 3weekly basis to 4-weekly administration [70,71]. The results of the two studies demonstrated comparable efficacy between the two schedules.…”

Section: Optimization Of Chemotherapy Schedulementioning

confidence: 99%

Free Flap Head and Neck Reconstruction After Cancer Therapy: Current State of the Art

Lykoudis¹,

Salmas²,

Assimakopoulos

2006

CCTR

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Non-small cell lung cancer (NSCLC) remains the most common cause of cancer-related mortality worldwide. Considerable progress has been made in recent times that have led to improved outcome for patients with all stages of NSCLC. There is increasing evidence that systemic therapy is integral for the treatment of all stages of NSCLC. Adjuvant chemotherapy has been proven in multiple recent trials to improve survival for patients with surgically resected early stage NSCLC. A combined modality approach consisting of external beam radiation and systemic chemotherapy is regarded as the standard of care for patients with locally advanced, unresectable NSCLC (LA-NSCLC), where it has curative potential. However, for patients with advanced stage or metastatic disease, treatment continues to be palliative, though benefits in survival and quality of life have been established with systemic therapy. While platinum combinations continue to be central to therapy of NSCLC, non-platinum two-drug regimens utilizing novel agents such as the taxanes, gemcitabine, pemetrexed and irinotecan are also in clinical use. The emergence of molecularly targeted agents has also widened the therapeutic arena for NSCLC. Survival benefit has been noted with erlotinib, an inhibitor of the epidermal growth factor receptor, for patients who progressed following 1 or 2 prior chemotherapy regimens. Another targeted approach that has recently emerged as a front-runner is anti-angiogenic therapy. Bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (VEGF), improved survival when combined with chemotherapy for patients with advanced stage non-squamous NSCLC. These exciting developments have contributed to optimism for NSCLC patients and also fuelled enthusiasm among researchers. This article reviews the pivotal clinical trials that have led to important changes in the treatment paradigms for NSCLC in recent years.

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Section: Optimization Of Chemotherapy Schedulementioning

confidence: 99%

Free Flap Head and Neck Reconstruction After Cancer Therapy: Current State of the Art

Lykoudis¹,

Salmas²,

Assimakopoulos

2006

CCTR

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A Randomized Phase II Trial Using Two Different Treatment Schedules of Gemcitabine and Carboplatin in Patients with Advanced Non–Small-Cell Lung Cancer

Masters¹,

Argiris

Hahn

et al. 2006

Journal of Thoracic Oncology

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Background: Gemcitabine and carboplatin combination therapy is an active and tolerable regimen in the treatment of non-small-cell lung cancer (NSCLC). Twenty-eight-and 21-day regimens without day-15 administration of gemcitabine are common; however, it remains unclear which offers the optimal therapeutic index. Methods: This trial evaluated two schedules of the combination of gemcitabine and carboplatin: gemcitabine (1100 mg/m 2 on days 1 and 8) plus carboplatin (area under the curve ϭ 5 on day 8) every 28 days, or gemcitabine (1000 mg/m 2 on days 1 and 8) plus carboplatin (area under the curve ϭ 5 on day 1) every 21 days. Eligible patients in this trial had stage IIIB (with malignant pleural effusion) or stage IV NSCLC with no prior chemotherapy. The primary objective was to evaluate progression-free survival, with secondary objectives of overall survival, response rate, and toxicity. Results: One hundred patients were randomized and enrolled from October of 2000 to January of 2002 into this multi-institutional study (48 for the 28-day regimen and 52 for the 21-day regimen). Baseline demographics were well matched, and a majority of patients (85%) enrolled with stage IV disease. Median progression-free survival and response rates were 3.8 months and 22.9%, respectively, with the 28-day regimen, and 4.9 months and 40.4%, respectively, with the 21-day regimen. Median survival was 8.7 months with the 28-day regimen and 8.0 months for the 21-day regimen. One-and 2-year survival rates were 34.7% and 8.7%, respectively, with the 28-day regimen, and 36.5% and 16.8%, respectively, with the 21-day regimen. Differences in progression-free survival (logrank statistic, p ϭ 0.5786), response rate (Fisher's exact test, p ϭ 0.0859) and overall survival (log-rank statistic, p ϭ 0.3568) were not statistically significant. Grade 3 to 4 hematologic toxicities occurred with a greater frequency in the 21-day regimen. No grade 3 to 4 nonhematologic toxicity (except nausea/vomiting with the 28-day regimen) was observed in more than 10% of patients in either treatment arm. Conclusion: Gemcitabine plus carboplatin is active and well tolerated in advanced NSCLC. Both regimens may be considered for further study. Although the 21-day regimen appeared to be associated with preferable outcomes, differences between treatment groups were not statistically significant.

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A Randomized Phase II Trial Using Two Different Treatment Schedules of Gemcitabine and Carboplatin in Patients with Advanced Non???Small-Cell Lung Cancer

Masters

Argiris²,

Hahn³

et al. 2006

Journal of Thoracic Oncology

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Gemcitabine (G) /carboplatin (C) surveillance study in patients with advanced or metastatic non-small cell lung cancer (NSCLC): Survival update of a phase II study of a 21 versus 28-day schedule

Cited by 3 publications

References 0 publications

Free Flap Head and Neck Reconstruction After Cancer Therapy: Current State of the Art

Free Flap Head and Neck Reconstruction After Cancer Therapy: Current State of the Art

A Randomized Phase II Trial Using Two Different Treatment Schedules of Gemcitabine and Carboplatin in Patients with Advanced Non–Small-Cell Lung Cancer

A Randomized Phase II Trial Using Two Different Treatment Schedules of Gemcitabine and Carboplatin in Patients with Advanced Non???Small-Cell Lung Cancer

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