Intra-patient alternated dose escalation of paclitaxel and gemcitabine versus paclitaxel followed by fixed dose rate infusion of gemcitabine in fit elderly non-small cell lung cancer patients

Comella, Pasquale; Putzu, Carlo; Massidda, B.; Condemi, G.; Cataldis, Giuseppe De; Barbato, Enrico; Gambardella, A.; Avallone, Antonio; Franco, Luca

doi:10.1016/j.lungcan.2006.12.015

Cited by 5 publications

(4 citation statements)

References 36 publications

(51 reference statements)

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“…Hopefully, the statistically powered (n ϭ 833) phase III trial of gemcitabine in patients with advanced pancreatic cancer (E6201) may provide a clear indication for clinical response and a survival advantage, although the interim analyses do not show a clinical benefit. 10 In general, gemcitabine was well tolerated in both arms 12,17,19 ; however, in some studies, increased incidences of hematologic and/or other adverse effects were reported with the FDR arm. 9,13,16,20…”

Section: Is There a Clinical Advantage Of Fdr Gemcitabine?mentioning

confidence: 96%

“…15 Other investigations in the same disease did not show any clinical benefit with FDR gemcitabine in combination with either carboplatin, 18 cisplatin, 16 or paclitaxel. 19 The inconsistency regarding clinical results may result from patient population differences: small numbers, heterogeneous disease, and heavily pretreated patients with extremely low response rate. Hopefully, the statistically powered (n ϭ 833) phase III trial of gemcitabine in patients with advanced pancreatic cancer (E6201) may provide a clear indication for clinical response and a survival advantage, although the interim analyses do not show a clinical benefit.…”

Section: Is There a Clinical Advantage Of Fdr Gemcitabine?mentioning

confidence: 99%

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Questions About Gemcitabine Dose Rate: Answered or Unanswered?

Gandhi

2007

JCO

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Section: Is There a Clinical Advantage Of Fdr Gemcitabine?mentioning

confidence: 96%

Section: Is There a Clinical Advantage Of Fdr Gemcitabine?mentioning

confidence: 99%

Questions About Gemcitabine Dose Rate: Answered or Unanswered?

Gandhi

2007

JCO

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“…Paclitaxel has also been studied in combination with nonplatinum agents. Comella and colleagues evaluated paclitaxel and gemcitabine in two randomized phase II studies [50,51]. Doublet treatment comprising paclitaxelgemcitabine or gemcitabine-vinorelbine was associated with a significantly longer OS time compared with pacli-taxel or gemcitabine monotherapy (HR, 0.76; 95% CI, 0.59 -0.99), without an greater toxicity [51].…”

Section: First-line Therapymentioning

confidence: 99%

The Role of the Taxanes in the Treatment of Older Patients with Advanced Stage Non-Small Cell Lung Cancer

Ramalingam

Khuri

2009

The Oncologist

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The treatment of older patients with advanced nonsmall cell lung cancer (NSCLC) represents a considerable challenge for physicians. A patient's suitability for chemotherapy is frequently based solely on chronologic age; as a consequence, older patients with NSCLC are less likely to receive standard chemotherapy than younger patients. Although age-related factors, such as comorbid illness, should be taken into consideration when assessing a patient's suitability for treatment, fit and functionally independent older patients should be considered candidates for standard chemotherapy. The taxanes are widely used in the treatment of advancedstage NSCLC and are well tolerated in older patients. The efficacy of both paclitaxel and docetaxel has been studied in older patients and appears to be comparable with that seen in younger patients either as monotherapy or in combination with a platinum compound as first-line therapy. In addition to the available evidence, prospective evaluation of novel agents in elderlyspecific or -enriched studies is necessary to guide the treatment of older patients with NSCLC. The Oncologist

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“…40 The association of gemcitabine and taxanes has been extensively studied in phase II trials with response rates averaging approximately 30%. [41][42][43][44] A pooled analysis of six clinical trials conducted by the Hellenic Oncology Research Group showed comparable efficacy and toxicity of GD combinations between younger (70 years) and older (70 years) patients. 45 However, a recently published phase III trial of GD vs docetaxel alone in elderly patients and subjects with poor performance status showed no survival improvement for the combination arm, suggesting that single agent chemotherapy should remain the standard of care for these groups of patients.…”

Section: Gemcitabine In Elderly Patientsmentioning

confidence: 99%

Gemcitabine for the treatment of advanced nonsmall cell lung cancer

Cappuzzo¹

2009

OTT

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Gemcitabine is a pyrimidine nucleoside antimetabolite agent which is active in several human malignancies, including nonsmall cell lung cancer (NSCLC). Because of its acceptable toxicity profile, with myelosuppression being the most common adverse event, gemcitabine can be safely combined with a number of cytotoxic agents, including platinum derivatives and new-generation anticancer compounds. In fact, the combination of gemcitabine and cisplatin is a first-line treatment for patients with advanced NSCLC, pharmacoeconomic data indicating that it represents the most cost-effective regimen among platinum-based combinations with thirdgeneration cytotoxic drugs. The drug has been investigated in the context of nonplatinum-based regimens in a number of prospective clinical trials, and might provide a suitable alternative for patients with contraindications to platinum. Recently, gemcitabine-based doublets have been successfully tested in association with novel targeted agents with encouraging results, providing further evidence for the role of the drug in the treatment of NSCLC. In the last few years several attempts have been pursued in order to identify molecular predictors of gemcitabine activity, and recent data support the feasibility of genomic-based approaches to customize treatment with the ultimate goal of improving patient outcome.

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Intra-patient alternated dose escalation of paclitaxel and gemcitabine versus paclitaxel followed by fixed dose rate infusion of gemcitabine in fit elderly non-small cell lung cancer patients

Cited by 5 publications

References 36 publications

Questions About Gemcitabine Dose Rate: Answered or Unanswered?

Questions About Gemcitabine Dose Rate: Answered or Unanswered?

The Role of the Taxanes in the Treatment of Older Patients with Advanced Stage Non-Small Cell Lung Cancer

Gemcitabine for the treatment of advanced nonsmall cell lung cancer

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