Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: A randomized, multicenter phase III trial

Georgoulias, Vassilis; Androulakis, Nikolaos; Hatzidaki, Dora; Syrigos, Kostas; Polyzos, Aris; Agelidou, Athina; Varthalitis, Ioannis; Ziras, N.; Agelidou, M.; Chandrinos, Vassilis; Boukovinas, Ioannis; Geroyianni, A.; Vamvakas, L.; Mavroudis, Dimitris

doi:10.1016/j.lungcan.2007.07.021

Cited by 44 publications

(24 citation statements)

References 29 publications

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“…Taxanes – paclitaxel and semisynthetic docetaxel (DT) – are approved as first-line treatment for non-small cell lung cancer (NSCLC) [6,7], breast [8,9] and ovarian [10] carcinomas and are also used in the treatment of numerous other malignancies [11,12,13,14,15]. Paclitaxel is a natural alkaloid isolated from Taxus brevifolia, whereas DT is a semi-synthetic compound produced from 10-deacetylbaccatin III found in Taxus baccata [16].…”

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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“…[22][23][24] Many studies have already investigated different GD regimens, where the two drugs were used at different doses and schedules, as weekly, biweekly and tri-weekly treatments. 8,9,25,26 The clinical results of those studies were similar in term of clinical response and antitumor efficacy. In a randomized clinical trial there were no survival differences detected with D/G versus weekly D in the 223 patients with good performance status (7.2 months vs. 8.0 months, respectively) or in the 122 poor performance status patients (3.8 months vs. 2.9 months, respectively).…”

Section: Discussionmentioning

confidence: 62%

“…TTP were 3.5 and 2.3 months for the DG and D regimen, respectively (p = 0.054). 25,26 with aldesleukine ability of activating in vivo different cytokines networks which include IL-5, TNFα, IFNγ.…”

Section: Discussionmentioning

confidence: 99%

Second-line treatment of non small cell lung cancer by biweekly gemcitabine and docetaxel +/- granulocyte-macrophage colony stimulating factor and low dose aldesleukine

Correale

Miano²,

Remondo³

et al. 2009

Cancer Biology & Therapy

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Background: The antitumor activity of a novel biweekly gemcitabine (G) + docetaxel (D) regimen +/-granulocyte-macrophage colony stimulating factor (GM-CSF) and aldesleukine (IL-2) has been evaluated in a phase II trial in advanced pretreated nonsmall cell lung cancer (NSCLC).Results: The treatment was well tolerated. The 42.3% response rate exceeded the predefined target activity, while time to progression (TTP) and overall survival (OS) were 7 and 11.2 months, respectively. A greater objective response rate (58.3% vs. 28.6%) and an increased number of eosinophils, basophils and activated mononuclear blood cells were observed in those patients who also received cytokine administration.Methods: Twenty-six NSCLC patients received second line G (1,000 mg/m 2 ) and D (75 mg/m 2 ) every 15 days. 12/26 patients also received s.c. GM-CSF (100 μg, days 2-6) and s.c. IL-2 (0.5 MIU/twice daily, days 7-14 and 16-29) by random selection.Conclusion: The biweekly GD regimen is a safe and active secondline treatment in NSCLC. Addition of immune-adjuvant cytokines' may enhance the activity of this therapeutic combination.

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“…The Lung Cancer Group of the Hellenic Oncology Research Group (HORG) conducted several phase III trials comparing either platinum- to non-platinum-based doublets [12,13,14] or different non-platinum-based regimens [15,16]. Eligible patients progressing after or during first-line chemotherapy were subsequently given second-line chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Non-Platinum-Based First-Line Followed by Platinum-Based Second-Line Chemotherapy or the Reverse Sequence in Patients with Advanced Non-Small Cell Lung Cancer: A Retrospective Analysis by the Lung Cancer Group of the Hellenic Oncology Research Group

et al. 2010

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Background: Non-platinum-containing regimens have been proposed as alternatives to platinum-based doublets in the first-line treatment of patients with non-small cell lung cancer (NSCLC). However, conflicting results about their equivalence have been reported. Methods: We reviewed the records of patients enrolled in randomized controlled first-line trials conducted by the Hellenic Oncology Research Group from February 1997 to September 2006. The outcome of patients treated with first-line non-platinum-based chemotherapy who received platinum-based chemotherapy upon progression (cohort A) or platinum-based first-line chemotherapy followed by non-platinum-containing second-line chemotherapy (cohort B) was retrospectively analyzed. Results: Two-hundred and sixty-seven patients were identified in cohort A, and 123 in cohort B. Median follow-up time was 12.5 and 15.7 months for cohorts A and B. A significantly higher response rate and time to tumor progression (TTP) was recorded for patients treated with platinum-based compared to those receiving non-platinum-based first-line chemotherapy (45.5 vs. 21.3%, p < 0.0001 and 5.8 vs. 3.1 months, p= 0.002, respectively). Platinum-based regimens administered as second-line treatment resulted in a 13.1% response rate. TTP for second-line chemotherapy did not differ significantly between the two cohorts. Median overall survival was 13.3 and 15.7 months for cohorts A and B (p = 0.538). Conclusion: Both sequences resulted in similar efficacy in terms of overall survival. Encouraging median survival was achieved for selected patients with NSCLC who received both first- and second-line chemotherapy.

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Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: A randomized, multicenter phase III trial

Cited by 44 publications

References 29 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

Second-line treatment of non small cell lung cancer by biweekly gemcitabine and docetaxel +/- granulocyte-macrophage colony stimulating factor and low dose aldesleukine

Non-Platinum-Based First-Line Followed by Platinum-Based Second-Line Chemotherapy or the Reverse Sequence in Patients with Advanced Non-Small Cell Lung Cancer: A Retrospective Analysis by the Lung Cancer Group of the Hellenic Oncology Research Group

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