RESUMEN
BACKGROUND: Neoadjuvant chemoradiotherapy is the treatment of choice in advanced rectal cancer, even though there are many patients who will not benefit from it. There are still no effective methods for predicting which patients will respond or not. The present study aimed to define the genomic profile of rectal tumors and to identify alterations that are predictive of response in order to optimize therapeutic strategies. METHODS: Forty-eight candidates for neoadjuvant chemoradiotherapy were recruited and their pretherapy biopsies analyzed by array Comparative Genomic Hybridization (aCGH). Pathologic response was evaluated by tumor regression grade. RESULTS: Both Hidden Markov Model and Smoothing approaches identified similar alterations, with a prevalence of DNA gains. Non responsive patients had a different alteration profile from responsive ones, with a higher number of genome changes mainly located on 2q21, 3q29, 7p22-21, 7q21, 7q36, 8q23-24, 10p14-13, 13q12, 13q31-34, 16p13, 17p13-12 and 18q23 chromosomal regions. CONCLUSIONS: This exploratory study suggests that an in depth characterization of chromosomal alterations by aCGH would provide useful predictive information on response to neoadjuvant chemoradiotherapy and could help to optimize therapy in rectal cancer patients.The data discussed in this study are available on the NCBI Gene Expression Omnibus [GEO: GSE25885].
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Biomarcadores de Tumor/genética , Quimioradioterapia Adyuvante , Terapia Neoadyuvante , Neoplasias del Recto/genética , Neoplasias del Recto/terapia , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos/administración & dosificación , Análisis por Conglomerados , Hibridación Genómica Comparativa , Femenino , Fluorouracilo/administración & dosificación , Humanos , Inmunohistoquímica , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
OBJECTIVE: High-dose chemotherapy (HDCT) represents an option as salvage treatment for patients with resistant/refractory germ cell tumor (GCT). The objective of this retrospective analysis was to evaluate the long-term results of a single-center experience with salvage HDCT for GCT patients, and to validate the prognostic model proposed by Einhorn and colleagues [9]. MATERIALS AND METHODS: Between 1986 and 2003, 100 GCT patients received salvage HDCT consisting of high-doses of carboplatin, etoposide ± cyclophosphamide, or ifosfamide. Twenty-four patients underwent a second HDCT cycle, and in 1 case, a third cycle was given with a median interval time of 6 weeks (range, 5-10). RESULTS: With a median follow-up of 8 years (range, 3-17); 6 of 32 (19%) patients with resistant GCT and 1 of 19 (5%) patients with cisplatin-refractory disease have been continuously disease-free, while none of the 16 patients with absolutely cisplatin-refractory GCT were alive at 1 year from HDCT treatment. In the PBPC era, HDCT appeared to be inapplicable in 32% of patients, mainly due to progressive disease during the induction/mobilizing phase. The prognostic model by Einhorn et al. for tandem HDCT did categorize our patients treated with a single HDCT cycle or low-dose intensity regimens in a very similar manner, but with inferior overall results. CONCLUSIONS: Long-term results with a single HDCT cycle or a low dose-intensity multicycle HDCT regimen remained poor in patients with adverse prognostic features. The tandem HDCT regimen represents a major option for refractory GCTs and relapsed tumors in third-line or later therapy, while a single course of HDCT should be abandoned for these patients.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Terapia Recuperativa , Adolescente , Adulto , Carboplatino/administración & dosificación , Ciclofosfamida/administración & dosificación , Resistencia a Antineoplásicos , Etopósido/administración & dosificación , Femenino , Estudios de Seguimiento , Humanos , Ifosfamida/administración & dosificación , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Factores de Tiempo , Adulto JovenRESUMEN
Oligodendrogliomas are rare primary brain tumors with variable patient outcomes which are not always adequately accounted for by clinical or pathological variables. The present study evaluated the prognostic implications of chromosome 1p and 19q status in a set of 23 low grade oligodendrogliomas (OGD II), and correlated the results with patient outcome. Loss of heterozygosity (LOH) and fluorescent in situ hybridization (FISH) analyses, the most widely used standard procedures, were used. 1p and 19q deletions were found in 65 and 61% of cases, respectively, using FISH and in 78 and 72% of cases using LOH. Both deletions were found in 56 and 64% of patients using FISH and LOH, respectively. Concordance between the results from the two techniques, determined by the Kappa statistics, ranged from fair to substantial depending on whether single or combined deletions were considered. Our results showed that the molecular alterations are associated with age and tumor localization. With regard to the impact of chromosomal alterations on clinical outcome, chromosome 19q deletions detected by LOH would seem to indicate a subgroup of patients at a higher risk of relapse, although the small number of patients recruited does not permit any definitive conclusions to be drawn. Further studies are now ongoing to determine whether this methodological approach could be potentially useful in low grade oligodendrogliomas to better characterize chromosomal alterations of 1p/19q and identify subgroups of patients with a higher risk of disease recurrence.
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Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/genética , Cromosomas Humanos Par 19/genética , Cromosomas Humanos Par 1/genética , Oligodendroglioma/diagnóstico , Oligodendroglioma/genética , Adulto , Anciano , Aberraciones Cromosómicas , Deleción Cromosómica , Femenino , Humanos , Pérdida de Heterocigocidad , Masculino , Persona de Mediana Edad , PronósticoRESUMEN
PURPOSE: To assess whether six courses of paclitaxel are effective as consolidation treatment in patients with advanced epithelial ovarian cancer who are in complete response after first-line paclitaxel/platinum-based chemotherapy. PATIENTS AND METHODS: Patients with stages IIb to IV disease in clinical or pathologic complete response after six courses of paclitaxel/platinum-based chemotherapy were randomly allocated to either observation (ie, control) or six courses of paclitaxel 175 mg/m(2) every 3 weeks (ie, maintenance). RESULTS: Two hundred patients were randomly assigned from March 1999 to July 2006. Because of the low accrual rate, an unplanned interim analysis of futility according to the Bayesian approach was performed. Grade 2 or greater motor neurotoxicity and sensory neurotoxicity were reported in 11.3% and 28.0% of the paclitaxel-arm patients, respectively. After a median follow-up of 43.5 months, 107 patients (53%) had experienced relapse, and 48 patients (24%) had died. Two-year progression-free survival rates were 54% (95% CI, 43% to 64%) and 59% (95% CI, 49% to 69%; P = not significant) in the control and maintenance arms, respectively. Corresponding 2-year overall survival rates were 90% (95% CI, 84% to 97%) and 87% (95% CI, 80% to 94%; P = not significant), respectively. The Cox model showed that residual disease after initial surgery (macroscopic v no macroscopic residuum; hazard ratio [HR], 1.91; 95%CI, 1.21 to 3.03) and stage (IIIc to IV v others; HR, 3.10; 95% CI, 1.13 to 8.48) were independent prognostic factors for progression-free survival, whereas the treatment arm (maintenance v control) had no prognostic relevance. CONCLUSION: A consolidation treatment with six cycles of paclitaxel does not prolong progression-free survival or overall survival in patients in complete response after first-line paclitaxel/platinum-based regimens.
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Neoplasias Ováricas/tratamiento farmacológico , Paclitaxel/uso terapéutico , Adolescente , Adulto , Anciano , Anemia/inducido químicamente , Antineoplásicos Fitogénicos/administración & dosificación , Antineoplásicos Fitogénicos/efectos adversos , Antineoplásicos Fitogénicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Células Epiteliales/patología , Femenino , Humanos , Leucopenia/inducido químicamente , Persona de Mediana Edad , Estadificación de Neoplasias , Neutropenia/inducido químicamente , Neoplasias Ováricas/patología , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Platino (Metal)/administración & dosificación , Platino (Metal)/química , Modelos de Riesgos Proporcionales , Resultado del Tratamiento , Adulto JovenRESUMEN
The aim of this paper was to assess whether weekly intravenous 60-mg/m2 paclitaxel for 21 weeks is feasible and effective as maintenance treatment in 64 patients with advanced ovarian cancer who had microscopic residual disease after 6 cycles of paclitaxel/platinum-based chemotherapy. Forty-eight patients completed the planned cycles of weekly paclitaxel. The worst toxicities were grade 2 leukopenia in 22.4% of the patients, grade 2 neutropenia in 25.9%, grade 2 sensorial neurotoxicity in 20.7%, and grade 2 motor neurotoxicity in 6.9%. Seventeen patients underwent a third-look surgery that showed a pathological complete response in 6 (35.3%, 95% confidence interval [CI], 17.3%-59.0%) cases. The 3-year progression-free survival rate was 18% (95% CI, 9.6%-33.8%), and the 3-year overall survival rate was 64% (95% CI, 52.0%-78.0%). Weekly low-dose paclitaxel is a feasible and well-tolerated maintenance treatment.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Paclitaxel/administración & dosificación , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Terapia Combinada , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasia Residual , Compuestos Organoplatinos/administración & dosificación , Compuestos Organoplatinos/efectos adversos , Neoplasias Ováricas/patología , Paclitaxel/efectos adversos , Segunda CirugíaRESUMEN
The efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 biochemotherapy were evaluated in advanced melanoma patients. The schedule consisted of fotemustine (100 mg/m) and cisplatin (75 mg/m) intravenous on day 1, followed by subcutaneous interleukin-2 at a dose of 4.5 MIU on days 3-5 and 8-12 and alpha-interferon at a dose of 3 MU three times/week, every 3 weeks for six cycles. Sixty patients were evaluated for tumour response, 12 of whom had brain metastases (BM). One patient (1.7%) with BM achieved a complete response and partial responses were observed in 10 patients (16.7%), including one BM patient. Overall response rate was 18.4 and 16.6% in BM patients (median response duration 8.2 months). Disease control, defined as overall response and stable disease, was 58.4% in all patients and 75% in patients with BM. Median time to progression was 3.2 months (4.2 months in BM patients). Median overall survival was 8.9 months (7.6 months in BM patients). Toxic events were mild to moderate. This combination was well tolerated and showed acceptable clinical activity, especially in BM patients.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Factores Inmunológicos/uso terapéutico , Inmunoterapia , Interferón-alfa/uso terapéutico , Interleucina-2/uso terapéutico , Melanoma/tratamiento farmacológico , Neoplasias Cutáneas/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias Encefálicas/tratamiento farmacológico , Neoplasias Encefálicas/secundario , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Terapia Combinada , Progresión de la Enfermedad , Femenino , Humanos , Factores Inmunológicos/administración & dosificación , Factores Inmunológicos/efectos adversos , Inmunoterapia/efectos adversos , Interferón-alfa/administración & dosificación , Interferón-alfa/efectos adversos , Interleucina-2/administración & dosificación , Interleucina-2/efectos adversos , Masculino , Melanoma/mortalidad , Melanoma/secundario , Persona de Mediana Edad , Compuestos de Nitrosourea/administración & dosificación , Compuestos de Nitrosourea/efectos adversos , Compuestos Organofosforados/administración & dosificación , Compuestos Organofosforados/efectos adversos , Terapia Recuperativa , Neoplasias Cutáneas/mortalidad , Análisis de SupervivenciaRESUMEN
BACKGROUND: Elderly patients with ovarian carcinoma have a poorer prognosis compared with their younger counterpart, and this depends in most cases on undertreatment. The aim of this study was to evaluate, retrospectively, the pattern of care and the prognosis of elderly patients with platinum-sensitive recurrent ovarian cancer. The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005. PATIENTS AND METHODS: Patients with recurrent ovarian cancer with >6 months of platinum free interval were considered eligible. Four-hundred-ninety-three patient files were collected and 425 were considered eligible and analyzed. Ninety-four patients with age >or=70 years and 331 patients with age <70 years were analyzed. RESULTS: Recurrence free interval (RFI), PS, and number of disease sites were similar among the two groups. A lower proportion of elderly patients underwent secondary cytoreduction (8.9% compared to 23.9%; p=0.0018). The mean number of chemotherapy lines received for recurrence was 2.7 and 2.5 in young and aged patients, respectively. Elderly patients received more frequently at second line single agent platinum than platinum-combination therapy or other non-platinum chemotherapy. The response rate to the second line chemotherapy was higher in younger patients than in the elderly population (CR+PR, younger: 67.2%; elderly: 46.5%; p=0.0004). Median overall survival from recurrence was 30.7 months in the younger patients and 23.6 months in the elderly group (p=0.0037). At multivariate analysis, number of disease sites (>1 vs. 1), performance status at recurrence (2-3 vs. 0-1), RFI (6-12 months vs. >12 months), age at recurrence, were independently associated with survival. CONCLUSION: Elderly patients with platinum-sensitive recurrent ovarian cancer receive less surgery and chemotherapy. Response to chemotherapy is better in younger patients. Age is an unfavourable factor independently associated to a worst prognosis.
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Anciano , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/tratamiento farmacológico , Compuestos de Platino/uso terapéutico , Adulto , Anciano de 80 o más Años , Antineoplásicos/uso terapéutico , Estudios de Cohortes , Resistencia a Antineoplásicos/efectos de los fármacos , Femenino , Estudios de Seguimiento , Encuestas Epidemiológicas , Humanos , Persona de Mediana Edad , Pronóstico , Recurrencia , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Mucinous ovarian carcinoma have a poorer prognosis compared with other histological subtypes. The aim of this study was to evaluate, retrospectively, the activity of chemotherapy in patients with platinum sensitive recurrent mucinous ovarian cancer. METHODS: The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005. Patients with recurrent ovarian cancer with > 6 months of platinum free interval were considered eligible. RESULTS: Twenty patients with mucinous histotype and 388 patients with other histotypes were analyzed. At baseline, mucinous tumours differed from the others for an higher number of patients with lower tumor grading (p = 0.0056) and less advanced FIGO stage (p = 0.025). At time of recurrence, a statistically significant difference was found in performance status (worse in mucinous, p = 0.024). About 20% of patients underwent secondary cytoreduction in both groups, but a lower number of patients were optimally debulked in the mucinous group (p = 0.03). Patients with mucinous cancer received more frequently single agent platinum than platinum based-combination therapy or other non-platinum schedules as second line therapy (p = 0.026), with a response rate lower than in non-mucinous group (36.4% vs 62.6%, respectively, p = 0.04). Median time to progression and overall survival were worse for mucinous ovarian cancer. Finally, mucinous cancer received a lower number of chemotherapy lines (p = 0.0023). CONCLUSION: This analysis shows that platinum sensitive mucinous ovarian cancer has a poor response to chemotherapy. Studies dedicated to this histological subgroup are needed.
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Adenocarcinoma Mucinoso/tratamiento farmacológico , Adenocarcinoma Mucinoso/patología , Antineoplásicos/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/patología , Adulto , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Resistencia a Antineoplásicos , Femenino , Humanos , Persona de Mediana Edad , Recurrencia , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study is to identify the prognostic factors of a large group of patients with pancreatic cancer who underwent the same regimen of intra-arterial chemotherapy. METHODS: 5-fluorouracil (1000 mg/m2), leucovorin (100 mg/m2), epirubicin (60 mg/m2), and carboplatin (300 mg/m2) were administered every 3 weeks into celiac axis (FLEC regimen). Kaplan-Meyer survival curve for univariate analysis and Cox regression model for multivariate one were used to determine factors predictive of survival. RESULTS: Data of 211 patients with advanced pancreatic cancer who underwent FLEC regimen were analyzed. Eighty-nine had locally advanced disease, and 112 had distant metastases. Median overall survival was 9.2 months. In both univariate and multivariate analyses, pain reduction after treatment (< or =30% of baseline level vs >30%; overall survival, 7.6 vs 11.5 months), stage of disease (III vs IV; overall survival, 10.5 vs 6.6 months), and number of administered cycles (< or =3 vs >3; overall survival, 5.9 vs 12.3 months) were significant and independent predictors of survival. CONCLUSIONS: Pain reduction, stage of disease, and number of administered cycles are independent prognostic factors of overall survival in a multivariate analysis of patients with advanced pancreatic cancer receiving FLEC regimen intra-arterially.
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Adenocarcinoma/tratamiento farmacológico , Neoplasias Pancreáticas/tratamiento farmacológico , Adenocarcinoma/mortalidad , Adulto , Anciano , Análisis de Varianza , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Epirrubicina/administración & dosificación , Epirrubicina/efectos adversos , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Humanos , Infusiones Intraarteriales , Leucovorina/administración & dosificación , Leucovorina/efectos adversos , Masculino , Persona de Mediana Edad , Dolor , Neoplasias Pancreáticas/mortalidad , Pronóstico , Tasa de SupervivenciaRESUMEN
PURPOSE: To evaluate the accuracy of the Palliative Prognostic Score (PaP score) in selecting metastatic gastrointestinal or nonsmall-cell lung cancer patients candidate to palliative chemotherapy. MATERIALS AND METHODS: The PaP score was calculated in 173 patients with advanced, pretreated gastrointestinal or nonsmall-cell lung cancer before starting a further line of chemotherapy with palliative aim. Symptom distress score was calculated using the Edmonton Symptom Assessment System (ESAS) before every course of chemotherapy. Univariate analysis of survival was performed using the logrank test; multivariate analysis was performed using the Cox regression model. Symptom distress scores were compared using multivariate analysis of variance test for repeated measures, and overall symptom distress score was compared using analysis of variance test for repeated measures. RESULTS: Overall median survival was 26 weeks; in PaP score class A it was 32 weeks, and in class B 8 weeks (p < 0.0001). No patient was classified in class C. The two-class PaP score resulted in an independent prognostic factor (p = 0.022), as well as Karnofsky performance status (p = 0.002) and colorectal cancer (p = 0.017). A trend towards worsening of symptom distress was observed in the entire population and in class A. The high number of missed data did not permit an adequate analysis in class B. CONCLUSIONS: The PaP score seems to discriminate patients who could benefit by palliative chemotherapy from those who could better benefit by supportive and palliative approach. However, the data are insufficient to validate the use of the PaP score in patients to be treated with palliative chemotherapy, and further trials should be planned to assess its ability to improve the quality of care in oncology and the appropriateness in the choice of palliative chemotherapy.
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Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Gastrointestinales/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Cuidados Paliativos/métodos , Selección de Paciente , Índice de Severidad de la Enfermedad , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/clasificación , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Femenino , Neoplasias Gastrointestinales/clasificación , Neoplasias Gastrointestinales/mortalidad , Humanos , Estado de Ejecución de Karnofsky , Neoplasias Pulmonares/clasificación , Neoplasias Pulmonares/mortalidad , Masculino , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , Pronóstico , Análisis de Supervivencia , Cuidado Terminal/métodosRESUMEN
OBJECTIVE: Our work evaluated the potential role of basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) serum levels with respect to that of conventional serum tumour markers, CEA and CA 15-3, in monitoring the course of metastatic breast cancer in 56 female patients treated with cytotoxic chemotherapy. METHODS: VEGF and bFGF concentrations were determined using a quantitative sandwich enzyme immunoassay technique. The positive predictive value (PPV) of each marker and of marker combinations for different types of clinical response was calculated. RESULTS: The highest PPV for overall disease control was shown by bFGF (70%), which also showed the highest PPV for both partial response (36.4%) and stable disease (63.2%). CEA showed the highest predictive value for progression (69.2%). A combined increase in CEA and bFGF or VEGF was associated with disease progression in all patients. CONCLUSIONS: Information provided by angiogenic factor levels seems to be independent of and is possibly complementary to that provided by conventional serum markers. bFGF showed the maximum predictive value for disease control and provided additional information to that obtained from CEA or CA 15-3 evaluation. It could therefore be a promising candidate for monitoring response to chemotherapy in advanced breast cancer.
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Proteínas Angiogénicas/sangre , Biomarcadores de Tumor/sangre , Neoplasias de la Mama/sangre , Neoplasias de la Mama/patología , Factor 2 de Crecimiento de Fibroblastos/sangre , Factor A de Crecimiento Endotelial Vascular/sangre , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Metástasis de la Neoplasia , Posmenopausia , Premenopausia , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: We present our experience of therapeutic vaccination using dendritic cells (DC) pulsed with autologous tumor antigens in patients with advanced melanoma. METHODS: Twenty-one pretreated advanced melanoma patients were vaccinated with autologous DC pulsed with 100 microg/ml of autologous-tumor-lysate (ATL) or -homogenate (ATH) and 50 microg/ml of keyhole limpet hemocyanin (KLH). The first 8 patients were treated subcutaneously or intradermally with immature-DC (iDC) (range 4.5-82 x 10(6)) and the remaining 13 intradermally with in vitro matured DC (mDC) (range 1.2-26 x 10(6)). Subcutaneous interleukin-2 (3 x 10(6) IU) was administered from days 3 to 7 of each treatment cycle. RESULTS: Three of the 8 iDC patients obtained stabilizations (SD), each of 6 months' duration. The 13 mDC patients showed 1 complete response (8 months), 1 partial response (3 months), 2 mixed responses (6 and 12 months) and 3 SD (9, 7+, and 3+ months). Overall responses (OR) were observed in 4/21 (19%) patients, or 4/13 (30.7%) considering mDC treatment only. 10/21 (47.6%) patients showed non progressive disease (NPD), with 7/13 (53.8%) cases of NPD for mDC-treated patients. No major toxicities were observed. The positive delayed-type hypersensitivity (DTH) test to ATL/ATH and/or KLH correlated with increased overall survival (OS). Median OS was 24 months (range 3-45) for the 10 DTH-positive (1 iDC and 9 mDC) and 5 months (range 3-14) for the 11 DTH-negative patients (P < 0.001). The in vitro evaluation of gamma IFN-secreting T-cells in 10 patients showed good correlation with both DTH (75%) and clinical outcome (70%). CONCLUSION: Vaccination using DC pulsed with ATL/ATH and KLH in advanced melanoma patients is well tolerated and can induce a clinical response, especially when mDC are used. Successful immunization, verified by positive DTH, leads to longer survival.
RESUMEN
BACKGROUND: It has been proposed that extending the platinum-free interval with intervening non-platinum therapy increases the efficacy of a later re-treatment with platinum in platinum-sensitive recurrent ovarian cancer. This hypothesis is based on data from small series and although it has not been validated prospectively, this strategy has entered general practice in Italy in the last years. The SOCRATES study retrospectively assessed the pattern of care of a cohort of patients with recurrent platinum-sensitive ovarian cancer observed in the years 2000-2002 in 37 Italian centres. Data were collected between April and September 2005. METHODS: Patients with recurrent ovarian cancer with a platinum-free interval >6 months were eligible. 493 patient files were collected and 428 were eligible and analyzed. RESULTS: The interval from the end of the 1st line to relapse was 6-12 months in 164 patients (39.5%) and >12 months in 251 cases (60.5%). Patients received a 2nd (100%), 3rd (80.1%), 4th (50.2%), 5th (28.3%), and 6th (11.9%) line of chemotherapy. At 2nd line 282 (65.9%) received platinum (group A), while 146 (34.1%) received non-platinum chemotherapy (group B). In the latter group, 67 patients received platinum at later progression (group B1), while 79 never received platinum (group B2). Median time to platinum re-treatment was 20 and 23.1 months in patients of groups A and B1, respectively. The response rate to the first platinum received was 74.4 and 57.4% in groups A and B1, respectively (p = 0.02). Group B2 was characterized by the worst response rate and survival. At multivariate analysis time of first platinum re-treatment (2nd line vs. later; p = 0.0132; OR = 2.34) and age (p = 0.0029; OR = 2.41) was independently associated with a higher possibility of response to platinum. CONCLUSIONS: With the limits of a retrospective study, our data question the hypothesis that extending the platinum-free interval with an intervening non-platinum therapy in patients with recurrent platinum-sensitive ovarian cancer improves the response rate of a further platinum re-treatment.