Biweekly Administration of Docetaxel and Gemcitabine for Elderly Patients with Advanced Non-Small Cell Lung Cancer: A Phase II Study

Syrigos, Kostas; Karapanagiotou, Eleni; Charpidou, Andriani; Dilana, Kalliopi; Dannos, Ioannis; Dionellis, Georgios; Rigopoulou, Anna; Georgatou, Niki; Roussos, Charalambos

doi:10.1179/joc.2007.19.4.438

Cited by 18 publications

(16 citation statements)

References 10 publications

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“…Most DT-associated HSR (95%) occur during the first or second infusion [6,18], and in some cases, it only takes 1 mg of DT for HSR to develop [19,20]. Symptoms include dyspnea or bronchospasm (81%), urticaria, flushing (74%), hypotension and angioedema [21,22]. Sudden death may occur [19].…”

Section: Introductionmentioning

confidence: 99%

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Syrigou¹,

Dannos²,

Κοττέας³

et al. 2011

Int Arch Allergy Immunol

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Background: Docetaxel (DT) is an extensively used taxane, frequently associated with hypersensitivity reactions. The aim of this study was to record the epidemiological and clinical features of hypersensitivity to DT in non-small cell lung cancer patients in order to obtain useful information concerning the management of these patients. We also developed a desensitization protocol and evaluated its clinical application. Methods: We retrospectively reviewed records of 620 non-small cell lung cancer patients treated with DT-containing regimens in the adjuvant, first-, second- or next-line setting. Data from 102 patients who had exhibited hypersensitivity reactions were analyzed according to the Common Toxicity Criteria for Adverse Events version 3.0. Five patients were chosen for the desensitization protocol. We applied the standard protocol for parenteral desensitization to β-lactam antibiotics, and DT treatment was carried out with a series of 10-fold dilutions in sufficient volume to administer the total dose. Results: One hundred and two patients (16.5%) were recorded as having hypersensitivity to DT. Reactions were observed after approximately 2.5 ± 1.0 cycles. Only 14 patients (14/620, 2%) developed grade 3–4 hypersensitivity. Reactions were more likely in patients during second- or third-line chemotherapy, but no other correlation (age, gender, atopic status) was observed. Five patients completed a parenteral desensitization protocol and continued their treatment uneventfully. Conclusions: Hypersensitivity reactions to DT respond quickly to discontinuation along with appropriate supportive care. Premedication and increased infusion time may allow readministration. The desensitization protocol that we developed provides a reliable alternative to permanent discontinuation of DT.

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Section: Introductionmentioning

confidence: 99%

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Syrigou¹,

Dannos²,

Κοττέας³

et al. 2011

Int Arch Allergy Immunol

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“…Docetaxel is a promoter of microtubular stabilization that has shown as single-agent response rates of 20-25% in chemotherapy naïve lung cancer patients [10,11]. Gemcitabine, a deoxycytidine analogue, has demonstrated a satisfactory role as first-line agent alone or in combination in NSCLC treatment [12]. A randomized study comparing the combination therapies of docetaxel/gemcitabine versus vinorelbine/cisplatin showed promising results and less toxicity for the former group [13].…”

Section: Discussionmentioning

confidence: 97%

“…An increased performance status was associated with a corresponding increase, more than twice as much, in hazard of dying (Hz ratio = 2.66, 95%CI: 0.94-7.5; P = 0.047). Patients with PS = 0 presented a median survival time of 13 months (95% CI: [9][10][11][12][13][14][15][16][17][18][19][20]. For patients with PS = 1, it was only 9 months (95% CI: 5-11).…”

Section: Response and Survivalmentioning

confidence: 99%

A phase II study of sequential docetaxel and gemcitabine followed by docetaxel and carboplatin as first-line therapy for non-small cell lung cancer

et al. 2008

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Our study involves a preliminary phase II trial, which evaluates the activity, feasibility and tolerability of a sequential combination of docetaxel and gemcitabine followed by docetaxel and carboplatin, as first-line treatment for inoperable NSCLC. Twenty-six chemo-naïve patients aged less than 75 years with histologically or cytologically confirmed unresectable stage IIIB, IV or relapsed post-operative metastatic NSCLC were included in the study. Gemcitabine 1,250 mg/m(2) was administered and was followed by docetaxel 65 mg/m(2). Treatment was administered on days 1 and 14 in a 28-day cycle for three consecutive cycles. If patients had no progressive disease after three cycles of chemotherapy, they received another three cycles of docetaxel 65 mg/m(2) followed by carboplatin AUC5 on day 1 in a 21-day cycle. Recombinant human granocyte colony-stimulating factor (rhG-CSF) was given prophylactically. In addition, all patients received standard pre- and post- treatment with oral dexamethasone. Response rates at three cycles were: 19% achieved a partial response (PR), 46% had stable disease (SD) and 23% had progressive disease. At six cycles, 8% of the patients maintained PR, 19% showed SD and 35% had progressive disease. The median time-to-disease progression was 6 months. The median survival time of patients was 10 months while, at the end of the first year, the patients who managed to get through the complete therapy (20 patients) had a survival rate of 38%. This detailed analysis of 20 patients showed that 80% of the patients survived for up to 6 months, 38% up to 12 months and 19% for more than a year. The only risk factor associated with the hazard of death among the factors studied was the performance status of the patients. Patients with PS=0 presented a median survival time of 13 months and those with PS=1, it was only 9 months. Non-haematological and haematological toxic effects were generally mild to moderate and entirely manageable.

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“…Docetaxel in combination with gemcitabine was well tolerated in older patients and was associated with an RR of approximately 30% and median survival duration of 7 months [25]. In addition, promising efficacy and safety results were reported with biweekly administration of docetaxel plus gemcitabine in older patients with NSCLC [29].…”

Section: Phase II Studiesmentioning

confidence: 88%

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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Biweekly Administration of Docetaxel and Gemcitabine for Elderly Patients with Advanced Non-Small Cell Lung Cancer: A Phase II Study

Cited by 18 publications

References 10 publications

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

A phase II study of sequential docetaxel and gemcitabine followed by docetaxel and carboplatin as first-line therapy for non-small cell lung cancer

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

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