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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 |
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