Increased dose-intensity of gemcitabine in advanced non small cell lung cancer (NSCLC): a multicenter phase II study in elderly patients from the “polmone toscano group” (POLTO)

Tibaldi, Carmelo; Ricci, Sergio; Russo, F.; Bernardini, Ilaria; Galli, Luca; Chioni, Aldo; Orlandini, Cinzia; Grosso, Anthony; Pegna, Andrea Lopes; Fabbri, Alessandro; Innocenti, F.; Ferrari, Katia; Tognarini, L.; Conte, Pierfranco; Falcone, Alfredo

doi:10.1016/j.lungcan.2004.10.008

Cited by 8 publications

(5 citation statements)

References 24 publications

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“…We hypothesised that the introduction of docetaxel in our first line sequential regimen could enhance the response rate with respect to our previous trial carried out in 110 elderly advanced NSCLC patients treated with gemcitabine alone (Tibaldi et al, 2005). In the present trial, the overall response rate according to an intention to treat analysis was 16.0% that was similar to our previous trial (13.9%).…”

Section: Discussionsupporting

confidence: 82%

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First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Tibaldi¹,

Vasile²,

Antonuzzo

et al. 2008

Br J Cancer

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This multicenter phase II study evaluated, in chemonaive patients with stage IIIB -IV NSCLC, age X70 and with a performance status 0 -2, the activity, efficacy and tolerability of planned sequential administration of gemcitabine 1200 mg m À2 on days 1 and 8 every 3 weeks for three courses followed by three cycles of docetaxel 37.5 mg m À2 on days 1 and 8 every 3 weeks, provided there was no evidence of disease progression. A total of 56 patients entered the study. According to intention-to-treat analysis, the objective response rate was 16.0% (95% CI 7.6 -28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of gemcitabine obtained a conversion to partial response by docetaxel. Median time to progression was 4.8 months (95% CI 3.6 -6.0 months) and median duration of survival was 8.0 months (95% CI 5.6 -10.5 months). The 1-year survival rate was 34%. No grade 4 haematological toxicity was observed and grade 3 neutropenia and thrombocytopenia were reported in 5.4 and 3.6% of the patients, respectively. Grade 3/4 mucositis and grade 3 diarrhoea, both occurred in 3.6% of the patients and grade 3 asthenia was observed in 9% of patients. One patient reported a grade 4 skin toxicity. No treatment-related deaths occurred. Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.

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Section: Discussionsupporting

confidence: 82%

“…In our previous trial, in fact, we reported a median TTP of 3.2 months, a median OS of 5.4 months and 1-year survival rate of 27% (Tibaldi et al, 2005). In addition, the percentage of PS 2 patients enrolled in both trials was similar at 20%.…”

Section: Discussionmentioning

confidence: 57%

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Tibaldi¹,

Vasile²,

Antonuzzo

et al. 2008

Br J Cancer

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“…currently mg/m 2 /week of a given drug [4, 5]. While clinical trials assessing the impact of dose intensification (with or without G-CSF support) have been generally performed on younger cancer patients to date [6,7,8,9,10,11], recently modified CT regimens designed to achieve an adequate DI have been evaluated in the geriatric setting [12,13,14,15,16]. In clinical practice, however, elderly cancer patients are usually treated with conventional CT regimens; in this setting, an adequate DI can rarely be obtained.…”

Section: Introductionmentioning

confidence: 99%

Do Elderly Cancer Patients Achieve an Adequate Dose Intensity in Common Clinical Practice?

Luciani¹,

Marussi²,

Ascione³

et al. 2006

Oncology

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Background: Elderly patients rarely receive adequate dose intensity (DI) using conventional regimens. Possible causes are improper patient assessment, the chemotherapy (CT) regimen chosen, the number and severity of comorbidities, patient compliance and physician experience. To explore this issue, DI was retrospectively analyzed in elderly patients treated with conventional CT regimens for advanced solid cancer. Patients and Methods: Patients ≧69 years were evaluated. All patients had metastatic solid tumors. Comorbidities, performance status (PS), toxicities, number of CT cycles, dose reduction and discontinuation of treatment were recorded. Relative DI (RDI) was calculated and regressed against these parameters. Results: 108 patients were eligible. The most frequent diagnoses were: lung, head-and-neck and colorectal cancer. In 48 patients (44%), their initially scheduled treatment was modified. Mean RDI was 79% (range 19–100%, SD 20.6). Grade 3/4 non-hematological and hematological toxicity occurred in 27 (35/130) and 8% of patients (11/130), respectively. In regression analysis, RDI was significantly associated with hematological toxicity. RDI affected response rate but not overall survival. Conclusions: RDI is significantly affected by toxicity. These data suggest the importance of the treatment schedule and patient selection as predictorsof adequate treatment. Some non-ratable variables, however, might also play a role regarding the dose intensity delivered.

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“…5,6 Dose-dense regimens supported by growth factors in small-cell lung cancer (SCLC) and dose-intense regimens in NSCLC have not yet shown any survival benefit and are not recommended. [7][8][9] Interestingly, a few studies using chemotherapy for breast cancer, osteosarcoma, ovarian cancer, and SCLC have shown that the induction of neutropenia is associated with statistically superior outcomes. 10 -15 Banerji et al 15 showed in our retrospective series of SCLC that patients who developed grades 0 to 2 neutropenia had a median survival of 47 weeks compared with 60 weeks in those patients achieving grades 3 to 4 neutropenia (p ϭ 0.008).…”

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confidence: 99%

Modest Reductions in Dose Intensity and Drug-Induced Neutropenia have No Major Impact on Survival of Patients with Non-small Cell Lung Cancer Treated with Platinum-Doublet Chemotherapy

Brunetto

Carden

Myerson

et al. 2010

Journal of Thoracic Oncology

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Increased dose-intensity of gemcitabine in advanced non small cell lung cancer (NSCLC): a multicenter phase II study in elderly patients from the “polmone toscano group” (POLTO)

Cited by 8 publications

References 24 publications

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

Do Elderly Cancer Patients Achieve an Adequate Dose Intensity in Common Clinical Practice?

Modest Reductions in Dose Intensity and Drug-Induced Neutropenia have No Major Impact on Survival of Patients with Non-small Cell Lung Cancer Treated with Platinum-Doublet Chemotherapy

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