MASPIN's prognostic role in patients with advanced head and neck carcinoma treated with primary chemotherapy (carboplatin plus vinorelbine) and radiotherapy: preliminary evidence
Gino MarioniH. KoussisE. GaioLuciano GiacomelliAndy BertolinEmiliano D’AlessandroA. ScolaGiancarlo OttavianoCosimo de FilippisAntonio JirilloAlberto StaffieriStella Blandamura
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Abstract:
Our very preliminary results support the hypothesis that MASPIN expression in primary head and neck squamous cell carcinoma (HNSCC) may be a valuable parameter for predicting patients' responses to a treatment based on carboplatin plus vinorelbine combined with radiotherapy.The roles of induction chemotherapy and combined chemoradiotherapy in the treatment of locally advanced unresectable HNSCCs have evolved rapidly. MASPIN has a unique tumour-suppressing activity. Experimental evidence has shown that MASPIN suppresses tumour growth, angiogenesis, invasion and metastasis. We investigated the potential prognostic roles of MASPIN and p53 in a series of HNSCCs treated with carboplatin plus vinorelbine combined with radiotherapy.Nineteen consecutive stage III or IV HNSCC patients were recruited. The treatment plan consisted of the administration of carboplatin on day 1 and vinorelbine on days 1 and 8. Four weeks later, carboplatin was administered concomitantly with radiation therapy. Expression of MASPIN and p53 was determined immunohistochemically in HNSCC diagnostic biopsies.A significant inverse relation was found between MASPIN expression and cN staging (p = 0.003). From a prognostic viewpoint, MASPIN expression was directly correlated with chemoradiotherapy response (p = 0.041). Moreover, the log-rank test showed a significant relationship between higher MASPIN expression and longer disease-free survival (p = 0.03), overall survival (p = 0.006) and disease-specific survival (p = 0.007).Keywords:
Maspin
Carboplatin
Vinorelbine
Chemoradiotherapy
Our very preliminary results support the hypothesis that MASPIN expression in primary head and neck squamous cell carcinoma (HNSCC) may be a valuable parameter for predicting patients' responses to a treatment based on carboplatin plus vinorelbine combined with radiotherapy.The roles of induction chemotherapy and combined chemoradiotherapy in the treatment of locally advanced unresectable HNSCCs have evolved rapidly. MASPIN has a unique tumour-suppressing activity. Experimental evidence has shown that MASPIN suppresses tumour growth, angiogenesis, invasion and metastasis. We investigated the potential prognostic roles of MASPIN and p53 in a series of HNSCCs treated with carboplatin plus vinorelbine combined with radiotherapy.Nineteen consecutive stage III or IV HNSCC patients were recruited. The treatment plan consisted of the administration of carboplatin on day 1 and vinorelbine on days 1 and 8. Four weeks later, carboplatin was administered concomitantly with radiation therapy. Expression of MASPIN and p53 was determined immunohistochemically in HNSCC diagnostic biopsies.A significant inverse relation was found between MASPIN expression and cN staging (p = 0.003). From a prognostic viewpoint, MASPIN expression was directly correlated with chemoradiotherapy response (p = 0.041). Moreover, the log-rank test showed a significant relationship between higher MASPIN expression and longer disease-free survival (p = 0.03), overall survival (p = 0.006) and disease-specific survival (p = 0.007).
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Standard first-line chemotherapy regimens in advanced non-small-cell lung cancer (NSCLC) include carboplatin (Paraplatin)/paclitaxel, cisplatin/docetaxel (Taxotere), cisplatin/gemcitabine (Gemzar), and cisplatin/vinorelbine (Navelbine). An informal meta-analysis of 13 randomized trials of these regimens in NSCLC indicates no marked differences in terms of response rates or survival, but toxicity advantages with cisplatin/gemcitabine and cisplatin/vinorelbine regimens. An informal meta-analysis to assess the feasibility of substituting carboplatin for cisplatin in combination with gemcitabine or docetaxel shows no marked differences in efficacy between cisplatin- and carboplatin-containing regimens, although a slight trend favoring carboplatin/gemcitabine treatment may be observed; comparison of toxicity profiles among carboplatin-based regimens suggests advantages for carboplatin/gemcitabine treatment. A formal meta-analysis of 13 trials comparing gemcitabine/platinum combinations with other platinum-based regimens in NSCLC indicates significant improvements in progression-free survival and overall survival with gemcitabine/platinum treatment. On balance, available data suggest that carboplatin/gemcitabine may be the first-line option with the best therapeutic index.
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Recently, differences in tumor biology have been observed between Asian and Caucasian lung cancer patients, resulting in different sensitivities to targeted therapy. To date, all registered third-generation chemotherapeutic agents have been investigated mainly in Caucasians, but little is known whether this data can be transferred to an Asian population. The aim of this study was to provide evidence about the efficacy of chemotherapy in a Chinese population.Three thousand one hundred patients with advanced non-small-cell lung cancer NSCLC, treated between 2002 and 2009 with a platinum-based doublet first-line chemotherapy, including vinorelbine, gemcitabine, docetaxel or paclitaxel, were included for retrospective survival analysis.Overall survival (OS) was 12.1 months and progression free survival (PFS) was four months for all patients. No advantage in OS was seen for any of the four compounds. Gemcitabine was associated with a better PFS compared to the other three (P < 0.001). Docetaxel led to higher response rates, but this finding didn't reach statistical significance (P = 0,054). Chinese patients appear to have longer survival times compared to historical data in Caucasians.Our retrospective analysis suggests, that there is no difference in efficacy of third-generation chemotherapy between Asians and Caucasians.
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Neoadjuvant chemotherapy is obligatory for small-cell lung cancer. When combined with radio-therapy, it reduces the incidence of recurrence and increases the survival rate to a level similar to that seen in non-small-cell lung cancer. Preliminary results suggest that complete remissions (3-year-survival rate 56%) can be achieved through the use of chemotherapy, possibly including high-dose chemotherapy for advanced stage III A cancer. The use of pre-operative chemotherapy in advanced stage III non-small-cell lung cancer is firmly established. In one study the 3-year-survival rate reached 25% in the chemotherapy group as compared to 15% in the group treated by surgery only. Early results of pre-operative chemo- and radiotherapy for stages III A and III B are encouraging. In studies comparing neoadjuvant chemotherapy alone to a combination of neoadjuvant chemo-radiotherapy a higher resection rate (32 to 76%) as well as a longer disease-free survival time could be shown for the combination therapy. To date, a number of innovative neoadjuvant chemoradiotherapy protocols using new substances as well as various modifications of radiotherapy are being studied. It is to be expected that new standard therapies for non-small-cell lung cancer will develop from these studies.
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Objective:To evaluate the treatment outcome and toxicity of vinorelbine based chemotherapy and concurrent radiotherapy in Stage Ⅲ non-small-cell lung cancer.Methods:106 patients were divided randomly into the following groups:group 1 was given to a total dose of 60 GY radiotherapy and four cycles of concurrent chemotherapy(vinorelbine 25 mg/m 2 on Days 1,8,29,36,57,64,85 and 92.carboplatin 300 mg/m 2 on Days 1,29,57 and 85 ).Group 2 was given to a total dose of 60 GY radiotherapy alone.Results:The response rate was 71.4% for group 1 and 42.0% for gruop 2,respectively (P=0.008).The survival rate was 77.39% at 1 year,30.33% at 2 years,the median survival was 18 months for group 1 and compared with 58.65%,15.75%,13 months for group 2,respectively (P=0.0407).Conclusion:Homemade vinorelbine based chemotherapy and concurrent radiotherapy,as described here,is a well-tolerated regimen with acceptable toxicity.More effective treatment schemes are required to improve disease control and overall survival.
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The optimal chemotherapy for concurrent chemoradiotherapy (cCRT) of lung cancer is still unclear.We investigated the therapeutic effect of different chemotherapy regimens for cCRT of lung cancer in 65 patients at our hospital.Of the 65 patients, 53 were male and 12 female. The median age was 64 years and 58 participants had a smoking history. The histological type was adenocarcinoma in 34 cases, squamous cell carcinoma in 22 cases, and others in 9 cases. Induction therapy consisted of cisplatin plus vinorelbine (CDDP+VNR) in 50 cases, and weekly carboplatin plus paclitaxel (CBDCA+PTX) in 15 cases. In all patients, the overall response rate, disease control rate, median progression survival, and median overall survival were 78.5%, 95.4%, 337 days, and 1,037 days, respectively. The median progression-free survival was 337 days in total; it was significantly longer for CDDP+VNR than CBDCA+PTX. The median overall survival was 1,037 days in total; it tended to be slightly longer for CDDP+VNR than CBDCA+PTX.Different chemotherapy regimens for cCRT possibly have different therapeutic effects.
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Current progress in the treatment of unresectable non-small-cell lung cancer (NSCLC) is reviewed. Several new agents including vinorelbine, paclitaxel, docetaxel, gemcitabine, and irinotecan have been shown to have distinct activity for NSCLC. Combinations of a new agent with cisplatin or carboplatin were highly active for advanced NSCLC, and randomized trials are in progress to establish the standard chemotherapy regimen for advanced NSCLC. The effectiveness of concurrent chemoradiotherapy has been established in Japan, while that of induction chemotherapy has yet to be confirmed. Induction chemoradiotherapy may be useful and randomized trials comparing chemotherapy alone with chemoradiotherapy as an induction therapy are needed.
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The platinum chemotherapeutic compounds (cisplatin and carboplatin) are widely used in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC). The introduction of new agents such as paclitaxel and vinorelbine has resulted in the development of combination regimens with improved response rates and survival. Two commonly used regimens, paclitaxel/carboplatin (TP) and vinorelbine/cisplatin (NP), are compared in this pharma-coeconomic analysis.
METHODS: A meta-analysis of available clinical trials was conducted to estimate the clinical effectiveness of TP and NP. Literature and physician interviews provided information on resource utilization and adverse event management (AEM) for these regimens. Treatment models were populated with Medicare reimbursement figures to compare the expected cost of treatment.
RESULTS: The expected cost of the TP and NP regimens was $19,322 and $20,790, respectively. Although the efficacy of these regimens has not been compared in a randomized trial, meta-analysis of regimented phase II and III studies showed no statistically significant differences in response rates. Therefore, equivalent efficacy is assumed in this cost comparison. A 20% variation in the cost of underlying resources yielded a 7% standard deviation in results. This sensitivity analysis showed that the costs of these regimens are insensitive to variations in underlying parameters.
CONCLUSION: This study suggests that TP is the phar-macoeconomic NSCLC treatment of choice when compared to NP. The analysis reveals that low administration and AEM costs are the key drivers in the lower treatment cost of TP.
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7138 Background: A two-drug platinum-based regimen in which cisplatin or carboplatin is combined with a third-generation agent (i.e. paclitaxel, vinorelbine, docetaxel, or G) is the standard first-line treatment for NSCLC patients with good performance status. Encouraging results have recently been reported for nonplatinum regimens composed of two third-generation drugs. Methods: To assess the impact of G on the activity of first-line chemotherapy in NSCLC, we carried out a meta-analysis on data from 4,362 NSCLC patients who were enrolled in 11 randomized trials comparing a G-containing vs. G-free new generation regimens. We constructed 2x2 tables using response to treatment data. For trials with more than one eligible G-free comparator arm, individual comparisons between the G-based treatment arms and each of the comparator arms were analyzed. A general variance-based method was used to estimate the pooled odds ratio (OR) and 95% confidence interval (CI). We assessed for heterogeneity among the trials based on standard methods. Results: Sixteen comparisons contributed to this analysis. G-containing regimens included: G+cisplatin (894), G+docetaxel (565), G+paclitaxel (200 patients), G+vinorelbine (157), G+carboplatin (49). G-free regimens included: vinorelbine+cisplatin (866), carboplatin+paclitaxel (539), docetaxel+cisplatin (494), cisplatin+paclitaxel (439), vinorelbine+carboplatin (159). Comparing G-containing vs. G-free regimens, the OR for progression was 0.867 (CI 95% 0.770–0.977; p = 0.019), with heterogeneity chi-square 11.639 (p = 0.71). No significant difference was observed for complete (OR 0.909, CI 95% 0.556–1.487; P = 0.707) and overall (complete + partial) response (OR 0.987, CI 95% 0.881–1.106; P = 0.819). Conclusions: These data demonstrate that the progression of disease is more likely in patients treated with G-free doublets. Further analyses are required to address whether disease control (objective response + stable disease) is associated with a survival benefit and may therefore be used as a surrogate end point for survival in chemotherapy trials of NSCLC. No significant financial relationships to disclose.
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