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Phase II clinical trial with gemcitabine and paclitaxel sequential monotherapy as first-line treatment for advanced non-small-cell lung cancer (SLCG 01-04)

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Phase II clinical trial with gemcitabine and paclitaxel sequential monotherapy as first-line treatment for advanced non-small-cell lung cancer (SLCG 01-04)

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dc.contributor.author Iranzo, Vega es_ES
dc.contributor.author Sirera Pérez, Rafael es_ES
dc.contributor.author Carrato, Alfredo es_ES
dc.contributor.author Cabrera, Andrea es_ES
dc.contributor.author Jantus, Eloísa es_ES
dc.contributor.author Guijarro, Ricardo es_ES
dc.contributor.author Sanmartín, Elena es_ES
dc.contributor.author Blasco, Ana es_ES
dc.contributor.author Gil, Mireia es_ES
dc.contributor.author Gómez Aldaraví, Lorenzo es_ES
dc.contributor.author González Larriba, José Luis es_ES
dc.contributor.author Massuti, Bertomeu es_ES
dc.contributor.author Velasco, Amalia es_ES
dc.contributor.author Provencio, Mariano es_ES
dc.contributor.author Rosell, Rafael es_ES
dc.contributor.author Camps, Carlos es_ES
dc.date.accessioned 2016-06-01T11:34:48Z
dc.date.available 2016-06-01T11:34:48Z
dc.date.issued 2011-06
dc.identifier.issn 1699-048X
dc.identifier.uri http://hdl.handle.net/10251/65054
dc.description.abstract [EN] Background: In advanced-stage (IIIB or IV) non-small-cell lung cancer (NSCLC), combination chemotherapy has demonstrated response rates of 20% and a 1-year survival rate of 30%. We conducted a multicentre, open-label, nonrandomised phase II trial to determine the efficacy and tolerability of sequential monotherapy with gemcitabine followed by paclitaxel in chemotherapy-naïve patients with advanced NSCLC. Materials and methods: Between December 2002 and July 2004, the Spanish Lung Cancer Group (SLCG) conducted a study in which 34 patients with advanced (stage IIIB or IV) NSCLC received 1200 mg/m2 of i.v. gemcitabine on days 1, 8 and 15 of each 28-day cycle for a total of 3 cycles followed by 100 mg/m2 of weekly i.v. paclitaxel for a maximum of 8 weeks. If objective response or stable disease was achieved, 70 mg/m2 of weekly i.v. paclitaxel was maintained until disease progression was evident or toxic effects were intolerable. Lung Cancer Symptom Scale (LCSS) analysis was performed. Baseline levels of serum VEGF, EGFR, telomerase reverse transcriptase (hTERT) and K-ras mutations were analysed. The primary endpoint was the objective response rate. Results: The median age of the 34 patients who were enrolled was 67 years (range 46-77), but later 8 patients were excluded; 78.8% were men, 81.8% had performance status 1 and also 81.8% had metastatic disease at diagnosis. The objective response rate was 28% (95% CI, 14.2-47.8); the median overall survival was 7.2 months (95% CI, 2.1-12.3) and the median time to progression (TTP) was 3.1 months (95% CI, 2.5-5.3). Grade 3 or 4 drug-related haematological toxicities were observed in 6 patients. Patients with lower baseline serum VEGF levels had significantly longer survival. Conclusions: Sequential therapy with gemcitabine followed by paclitaxel was well tolerated with a low proportion of grade 3 or 4 adverse events, the absence of unexpected toxicity and with an improvement in quality of life. Unfortunately, the response rate did not meet the minimally required rate of 20% and the study was prematurely closed. VEGF was identified as a poor prognostic factor for TTP and survival. © 2011 Feseo. es_ES
dc.language Inglés es_ES
dc.publisher Springer es_ES
dc.relation.ispartof Clinical & Translational Oncology es_ES
dc.rights Reserva de todos los derechos es_ES
dc.subject EGFR es_ES
dc.subject HTERT es_ES
dc.subject Non-small-cell lung cancer es_ES
dc.subject Pharmacogenomics es_ES
dc.subject Sequential monotherapy es_ES
dc.subject VEGF es_ES
dc.subject Epidermal growth factor receptor es_ES
dc.subject Gemcitabine es_ES
dc.subject Paclitaxel es_ES
dc.subject Telomerase reverse transcriptase es_ES
dc.subject Vasculotropin es_ES
dc.subject Adult es_ES
dc.subject Advanced cancer es_ES
dc.subject Aged es_ES
dc.subject Alopecia es_ES
dc.subject Anemia es_ES
dc.subject Anorexia es_ES
dc.subject Article es_ES
dc.subject Blood toxicity es_ES
dc.subject Cancer staging es_ES
dc.subject Cancer survival es_ES
dc.subject Chemotherapy induced emesis es_ES
dc.subject Clinical article es_ES
dc.subject Controlled study es_ES
dc.subject Diarrhea es_ES
dc.subject Dose response es_ES
dc.subject Drug dose reduction es_ES
dc.subject Drug dose sequence es_ES
dc.subject Drug efficacy es_ES
dc.subject Drug hypersensitivity es_ES
dc.subject Drug tolerability es_ES
dc.subject Drug withdrawal es_ES
dc.subject Enzyme blood level es_ES
dc.subject Fatigue es_ES
dc.subject Febrile neutropenia es_ES
dc.subject Female es_ES
dc.subject Heart disease es_ES
dc.subject Human es_ES
dc.subject Lung non small cell cancer es_ES
dc.subject Male es_ES
dc.subject Monotherapy es_ES
dc.subject Multicenter study es_ES
dc.subject Multiple cycle treatment es_ES
dc.subject Mutational analysis es_ES
dc.subject Nausea es_ES
dc.subject Neuropathy es_ES
dc.subject Neutropenia es_ES
dc.subject Oncogene K ras es_ES
dc.subject Overall survival es_ES
dc.subject Paresthesia es_ES
dc.subject Peripheral neuropathy es_ES
dc.subject Phase 2 clinical trial es_ES
dc.subject Primary health care es_ES
dc.subject Prognosis es_ES
dc.subject Protein blood level es_ES
dc.subject Quality of life es_ES
dc.subject Sensory neuropathy es_ES
dc.subject Survival time es_ES
dc.subject Thrombocytopenia es_ES
dc.subject Treatment duration es_ES
dc.subject Treatment response es_ES
dc.subject Adenocarcinoma es_ES
dc.subject Antineoplastic Combined Chemotherapy Protocols es_ES
dc.subject Carcinoma, Large Cell es_ES
dc.subject Carcinoma, Non-Small-Cell Lung es_ES
dc.subject Carcinoma, Squamous Cell es_ES
dc.subject Deoxycytidine es_ES
dc.subject Humans es_ES
dc.subject Lung Neoplasms es_ES
dc.subject Lymphatic Metastasis es_ES
dc.subject Middle Aged es_ES
dc.subject Neoplasm Recurrence, Local es_ES
dc.subject Survival Rate es_ES
dc.subject Treatment Outcome es_ES
dc.subject.classification MICROBIOLOGIA es_ES
dc.title Phase II clinical trial with gemcitabine and paclitaxel sequential monotherapy as first-line treatment for advanced non-small-cell lung cancer (SLCG 01-04) es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.1007/s12094-011-0675-0
dc.rights.accessRights Cerrado es_ES
dc.contributor.affiliation Universitat Politècnica de València. Departamento de Biotecnología - Departament de Biotecnologia es_ES
dc.description.bibliographicCitation Iranzo, V.; Sirera Pérez, R.; Carrato, A.; Cabrera, A.; Jantus, E.; Guijarro, R.; Sanmartín, E.... (2011). Phase II clinical trial with gemcitabine and paclitaxel sequential monotherapy as first-line treatment for advanced non-small-cell lung cancer (SLCG 01-04). Clinical & Translational Oncology. 13(6):411-418. doi:10.1007/s12094-011-0675-0 es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://dx.doi.org/10.1007/s12094-011-0675-0 es_ES
dc.description.upvformatpinicio 411 es_ES
dc.description.upvformatpfin 418 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.description.volume 13 es_ES
dc.description.issue 6 es_ES
dc.relation.senia 220989 es_ES
dc.description.references Rapp E, Pater JL, Willan A et al (1988) Chemotherapy can prolong survival in patients with advanced non-small-cell lung cancer: report of a Canadian multicenter randomized trial. J Clin Oncol 6:633–641 es_ES
dc.description.references Schiller JH, Harrington D, Belani CP et al (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92–98 es_ES
dc.description.references Pfister DG, Johnson DH, Azzoli CG et al (2004) American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 22:330–353 es_ES
dc.description.references (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 311:899–909 es_ES
dc.description.references Rixe O, Gatineau M, Jauffret E et al (2005) Sequential administration of docetaxel followed by cisplatin-vindesine: a pilot study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Bull Cancer 92:E1–E6 es_ES
dc.description.references Norton L, Day R (1991) Potential innovations in scheduling of cancer chemotherapy. Important Adv Oncol 57–72 es_ES
dc.description.references Grossi F, Aita M, Follador A et al (2007) Sequential, alternating, and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer: a review of the literature. Oncologist 12:451–464 es_ES
dc.description.references Poon D, Foo KF, Chew L et al (2006) Phase II trial of gemcitabine and cisplatin sequentially administered in Asian patients with unresectable or metastatic non-small cell lung cancer. Ann Acad Med Singapore 35:33–37 es_ES
dc.description.references Hirsh V, Latreille J, Kreisman H et al (2005) Sequential therapy with Vinorelbine followed by Gemcitabine in patients with metastatic non small cell lung cancer (NSCLC), performance status (PS) 2, or elderly with comorbidities: a multicenter phase II trial. Lung Cancer 49:117–123 es_ES
dc.description.references Hesketh PJ, Chansky K, Lau DH et al (2006) Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2: a phase II trial of the Southwest Oncology Group (S0027). J Thorac Oncol 1:537–544 es_ES
dc.description.references Marsland TA, Garfield DH, Khan MM et al (2005) Sequential versus concurrent paclitaxel and carboplatin for the treatment of advanced non-small cell lung cancer in elderly patients and patients with poor performance status: results of two Phase II, multicenter trials. Lung Cancer 47:111–120 es_ES
dc.description.references Martoni AA, Bernardi A, Quercia S (2006) Trastuzumab plus estrogen suppression as salvage treatment in a case of liver failure due to metastatic breast cancer. Anticancer Res 26:3739–3744 es_ES
dc.description.references Camps C, Sirera R, Bremnes RM et al (2006) Quantification in the serum of the catalytic fraction of reverse telomerase: a useful prognostic factor in advanced non-small cell lung cancer. Anticancer Res 26:4905–4909 es_ES
dc.description.references Camps C, Sirera R, Bremnes R et al (2005) Is there a prognostic role of K-ras point mutations in the serum of patients with advanced non-small cell lung cancer? Lung Cancer 50:339–346 es_ES
dc.description.references Crowley J, Pauler DA (2006) Handbook of statistics in clinical oncology. Chapman & Hall/CRC, Boca Raton, FL, pp 289–333 es_ES
dc.description.references Bonomi P, Kim K, Fairclough D et al (2000) Comparison of survival and quality of life in advanced non small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. J Clin Oncol 18:623–631 es_ES
dc.description.references Le Chevalier T, Brisgand D, Douillard JY et al (1994) Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol 12:360–367 es_ES
dc.description.references Day RS (1986) Treatment sequencing, asymmetry, and uncertainty: protocol strategies for combination chemotherapy. Cancer Res 46:3876–3885 es_ES
dc.description.references Feliu J, Martin G, Lizon J et al (2001) Sequential therapy in advanced non-small-cell lung cancer with weekly paclitaxel followed by cisplatingemcitabine-vinorelbine. A phase II study. Ann Oncol 12:1369–1374 es_ES
dc.description.references Edelman MJ, Clark JI, Chansky K et al (2004) Randomized phase II trial of sequential chemotherapy in advanced non-small cell lung cancer (SWOG 9806): carboplatin/gemcitabine followed by paclitaxel or cisplatin/vinorelbine followed by docetaxel. Clin Cancer Res 10:5022–5026 es_ES
dc.description.references Manegold C, Thatcher N, Kortsik C et al (2005) A phase II/III randomized study in advanced nonsmall cell lung cancer (NSCLC) with first line combination versus sequential gemcitabine (G) and docetaxel (D): update on quality of life (QoL), toxicity, and costs. J Clin Oncol 23(16S):7057 es_ES
dc.description.references Ramanathan RK, Belani CP (1997) Chemotherapy for advanced non-small cell lung cancer: past, present, and future. Semin Oncol 24:440–454 es_ES
dc.description.references Gatzemeier U, Shepherd FA, Le Chevalier T et al (1996) Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 32A:243–248 es_ES
dc.description.references Cerny T, Kaplan S, Pavlidis N et al (1994) Docetaxel (Taxotere) is active in nonsmall-cell lung cancer: a phase II trial of the EORTC Early Clinical Trials Group (ECTG). Br J Cancer 70:384–387 es_ES
dc.description.references Viens P, Palangie T, Janvier M et al (1999) Firstline high-dose sequential chemotherapy with rGCSF and repeated blood stem cell transplantation in untreated inflammatory breast cancer: toxicity and response (PEGASE 02 trial). Br J Cancer 81:449–456 es_ES
dc.description.references Wandt H, Birkmann J, Denzel T et al (1999) Sequential cycles of high-dose chemotherapy with dose escalation of carboplatin with or without paclitaxel supported by G-CSF mobilized peripheral blood progenitor cells: a phase I/II study in advanced ovarian cancer. Bone Marrow Transplant 23:763–770 es_ES
dc.description.references Bonadonna G (1992) Evolving concepts in the systemic adjuvant treatment of breast cancer. Cancer Res 52:2127–2137 es_ES
dc.description.references Delbaldo C, Michiels S, Syz N et al (2004) Benefits of adding a drug to a single-agent or a 2-agent chemotherapy regimen in advanced non-smallcell lung cancer: a meta-analysis. JAMA 292: 470–484 es_ES
dc.description.references Gralla RJ, Thatcher N (2004) Quality-of-life assessment in advanced lung cancer: considerations for evaluation in patients receiving chemotherapy. Lung Cancer 46[Suppl 2]:S41–S47 es_ES
dc.description.references Spano JP, Lagorce C, Atlan D et al (2005) Impact of EGFR expression on colorectal cancer patient prognosis and survival. Ann Oncol 16:102–108 es_ES
dc.description.references Selvaggi G, Novello S, Torri V et al (2004) Epidermal growth factor receptor overexpression correlates with a poor prognosis in completely resected non-small-cell lung cancer. Ann Oncol 15:28–32 es_ES
dc.description.references Bremnes RM, Camps C, Sirera R (2006) Angiogenesis in non-small cell lung cancer: the prognostic impact of neoangiogenesis and the cytokines VEGF and bFGF in tumours and blood. Lung Cancer 51:143–158 es_ES
dc.description.references Laack E, Kohler A, Kugler C et al (2002) Pretreatment serum levels of matrix metalloproteinase-9 and vascular endothelial growth factor in non-small-cell lung cancer. Ann Oncol 13:1550–1557 es_ES


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