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Cancer patients with chemotherapy-induced anaemia (CIA) often experience cancer-related fatigue (CRF). Darbepoetin alfa (DA) once every 3 weeks (q3w) is an effective and well tolerated erythropoiesis-stimulating agent. This study evaluated DA effectiveness and psychometric properties of the Functional Assessment of Cancer Therapy Fatigue-Subscale (FACT-F) and the Fatigue Symptom Inventory (FSI) in CIA patients.This was a single-centre, prospective study in 100 patients with solid tumour and moderate to severe CRF (visual analogue scale [VAS-F] ≥ 30 mm) who received DA 500 μg q3w during chemotherapy (CT). Clinical data, VAS-F, FACT-F and FSI scores were collected at the beginning and at the end of CT (EOCT).Mean age was 62.7 years (SD: 12.1), 53.0% were women, 92.0% had ECOG 0-1 and 64% had stage IV tumours. Mean haemoglobin (Hb) significantly increased from baseline 10.2 g/dl to 11.3 g/dl at EOCT. Sixty-five percent of patients showed haematopoietic response at any study point (Hb ≥ 12 g/dl or an increase of ≥ 2 g/dl from baseline), 77% achieved Hb ≥ 11 g/dl and 7% required blood transfusions from week 5 to EOCT. CRF improvement was demonstrated by significant changes in VAS-F, FACT-F and FSI scores (decreases of 21.54, 3.56 and 12.97 points, respectively). FACT-F and FSI questionnaires showed high internal consistency (Cronbach's alpha of 0.98 and 0.98 for FACT-F and FSI, respectively, at the end of study) and satisfactory intra-class coefficients (FACT-F, r=0.73; FSI, r=0.83). There were significant correlations between scores and Hb changes (FACT-F, r=-0.44; FSI, r=-0.54).DA 500 μg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF.

Advanced pancreatic cancer has a bad prognosis, with a median overall survival (OS) no longer than 4-6 months. Since the end of last century, monotherapy with gemcitabine has remained the elective therapy, but new schedules are needed in order to improve these results. We aim to evaluate the efficacy of tegafur and levofolinic acid (LV) associated with gemcitabine, as well as its toxicity, progression-free survival and OS in advanced pancreatic cancer.An open-label, multicentric, prospective, non-controlled trial was carried out on patients with advanced or disseminated pancreatic cancer. Gemcitabine 1250 mg/m² was administered on the 1st and 8th days of the cycle, tegafur 750 mg/m²/day for 21 consecutive days and LV 25 mg/day continuously, every 28 days, with a maximum of six cycles. The primary variable was tumour overall response rate (ORR). Secondarily, time to progression (TTP), OS and scheme toxicity were determined.Forty patients were recruited; the male/female ratio was 30:10, with a mean age of 61 years. Forty percent had a Karnofsky index of 90% or 100%. Only 11 patients (27%) completed the six cycles of treatment, but more than 50% received three or more cycles. Dose intensity was 89.56% for gemcitabine and 87.36% for tegafur. Efficacy ORR was 22.5% (CI 95%, 6-37%). TTP was 3.87 months (CI 95%, 2.1-5.6), time to treatment failure was 2.97 months (CI 95%, 2.43-4.67) and OS 6.3 months (CI 95%, 4-7). The chemotherapeutic combination was well accepted; most haematologic and non-haematologic toxicities were grade 1 or 2. The most prevalent grade 3/4 toxicities were asthenia (30%), liver biochemistry disorders (25%), diarrhoea (15%) and stomatitis (12%).The administration of gemcitabine, associated with oral tegafur and leucovorin, has activity against advanced pancreatic cancer, with an adequate toxicity profile.

Docetaxel and erlotinib are used as second-line treatment of advanced non-small-cell lung cancer. With the aim of assessing whether sequential administration of both could avoid possible negative interactions and optimize the benefit obtained, a clinical trial was designed. Outcomes showed improved progression-free survival and disease control rates compared with erlotinib alone, proving the absence of antagonism between them on this basis. Introduction: The purpose of this study was to assess whether an intercalated dosing schedule of erlotinib and docetaxel could avoid possible negative interactions and optimize the benefit obtained as second-line therapy in non-small-cell lung cancer (NSCLC) patients. Patients and Methods: A phase II randomized clinical trial was designed for advanced NSCLC patients in whom previous chemotherapy treatment had failed. The experimental arm with 33 patients consisted of erlotinib 150 mg/d orally, intermittent administration on days 2 to 16 every 21 days, combined with docetaxel 75 mg/m(2) every 21 days; the control arm with 35 patients consisted of erlotinib 150 mg/d orally, administered continuously. The study's primary end point was the proportion of patients who remained progression-free at 6 months in the 2 arms. Results: The proportion of patients who remained progression-free at 6 months was of 5 patients (15%) in the intercalated arm and 3 patients (9%) in the erlotinib monotherapy arm respectively. Median progression-free survival (PFS) was 3.0 versus 2.1 months (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.39-1.06; P = .086). Median overall survival (OS) was 7.5 and 5.2 months (HR, 0.70; 95% CI, 0.41-1.19; P = .19). Disease control rates were 51.7% and 36.4%, respectively. No new safety signals were observed. Conclusion: Erlotinib and docetaxel with intermittent administration of erlotinib improved PFS, OS, and disease control rates compared with erlotinib alone. All of our results indicated that an intercalated dosing schedule of erlotinib and docetaxel could be more efficient than erlotinib treatment alone. Therefore, further studies should be developed in a larger number of patients. This study has shown the absence of antagonism between docetaxel and erlotinib when given in an intercalated fashion.

Circulating endothelial cells (CEC) play an important role in tumor neovascularization and may have prognostic value in cancer patients. This study was designed to investigate the role of CEC as a marker for predicting platinum plus pemetrexed first-line chemotherapy efficacy in advanced non-squamous non-small cell lung cancer (NSCLC). A prospective study was performed whose main objective was to study whether the numbers of CEC at baseline and prior to the second and third cycle of chemotherapy were response predictors. Sixty-nine patients received cisplatin plus pemetrexed, and peripheral blood samples were performed at baseline and after second and third cycle. Separation and CEC count were performed using inmunomagnetic separation (CellSearch). The CEC count in 4 mL of peripheral blood was obtained prior to the first, second, and third cycle of treatment. Baseline levels and evolution of CEC were correlated with response to treatment according to RECIST criteria after three cycles of treatment. Sixty-nine patients were included: 43 (64.2 %) received cisplatin/pemetrexed and 24 (35.8 %) carboplatin/pemetrexed. Range of baseline CEC: 8–965 (mean of 153 cel/4 mL). The results after 3 cycles were: 25 partial responses (36.2 %), 17 cases of stabilization of disease (24.6 %), 16 of progressive disease (23.2 %) and 11 non-evaluables (16 %). No significant relationship between the baseline CEC count and response was found (p value = 0.831). Increase >50 % between the first and second cycle was correlated significantly with progression disease (p = 0.008). Patients who had a baseline CEC count greater than the mean (>153 cells/4 mL) showed longer progression-free survival and global survival without statistical significance. In this homogeneous group of patients with NSCLC, there is no correlation between response to treatment and CEC baseline levels. The increase in CEC numbers after the first cycle could be a negative predictive factor.

The present study aims to describe the hematological response to darbepoetin alfa (DA) under daily clinical practice conditions in anemic elderly patients with non-myeloid tumors receiving chemotherapy.This was a prospective, observational, multicenter study in elderly (≥65 years) patients with non-myeloid cancer receiving DA (500 μg every 3 weeks) for chemotherapy-induced anemia (hemoglobin [Hb] level ≤11.0 g/dL).A total of 102 anemic patients with solid tumors and 51 with hematological malignancies were included in 28 centers in Spain. Mean age (±SD) was 73.4 (±5.8) years, and mean baseline Hb level was 10.0 (±0.8) g/dL. DA was administered for a median of 8 weeks. Of the 115 subjects with a post-baseline Hb value, the percentage of patients who achieved a hematopoietic response (Hb increase ≥2 g/dL or reaching ≥12 g/dL without transfusions in the previous 28 days) was 69.7% (95% CI 56.1% to 83.3%). Functional Assessment of Cancer Therapy-Fatigue subscale scores increased during the study (median change 1.0 [Q1 -5.0, Q3 9.0], P = 0.04). One patient (0.7%) experienced a non-serious adverse reaction (cutaneous rash).The study results suggest that DA is an effective and well-tolerated therapy for the treatment of chemotherapy-induced anemia in elderly patients.

Lung cancer represents one of the most common malignant diseases. Many investigations are used in the staging study including, most recently, PET. We present a case of cystic cerebral metastases (with no oedema) from a small cell carcinoma which were not detected by PET.

Purpose This study presents data on the feasibility and possible benefits of a psychological intervention that uses virtual reality to induce positive emotions on adult hospitalized patients with metastatic cancer. The patient’s satisfaction and perceived utility was also examined. Method The sample was composed of 19 patients (53 % men, aged from 29 to 85 years old; x = 60.9; standard deviation = 14.54). The intervention consisted of four 30-min sessions during 1 week in which patients navigated through virtual environments designed to induce joy or relaxation. Mood was assessed before and after each session using the Visual Analog Scale. Patient satisfaction was assessed after each session and at the end of the intervention. Qualitative data were also collected with open-ended questions. Results There were no major difficulties with the use of devices, and any difficulties that did arise were solved through practice. There were adequate levels of pleasantness and perceived utility of the proposed intervention. The main perceived benefits were distraction, entertainment, and promotion of relaxation states. Regarding mood changes, an increase in positive emotions and a decrease in negative emotions were also detected. Conclusions The intervention was positively assessed and rated as minimally uncomfortable. Future actions are discussed as well as the need to implement brief interventions that take into account the patients’ medical state and physical discomfort level, especially with those in the advanced stages of disease.

Our objective was to determine the association between C-reactive protein (CRP) levels at initiation of anemia treatment and response in solid tumor patients with chemotherapy (CT)-induced anemia. This was a multicenter, prospective, observational study which included adult patients with solid tumor initiating treatment for CT-induced anemia. Data were collected up to 16 weeks, or until premature discontinuation. We included 98 patients (median age 62.5 years, 64 % males, 57 % with ECOG 0–1, 85.7 % at stages III–IV and 54.1 % undergoing palliative CT). Mean (SD) Hb levels at baseline were 10.3 (0.9) g/dL (85.7 %

In Psycho-oncology, VR has been utilized mainly to manage pain and distress associated to medical procedures and chemotherapy, with very few applications aimed at promotion of wellbeing in hospitalized patients. Considering this, it was implemented a psychological intervention that uses VR to induce positive emotions on adult oncology inpatients with the purpose of evaluating its utility to improve emotional wellbeing in this population.Sample was composed of 33 patients (69.7% men, aged from 41 to 85 years old; X=62.1; SD=10.77). Intervention lasted 4 sessions of 30 minutes, along one week. In these sessions, two virtual environments designed to induce joy or relaxation were used. Symptoms of depression and anxiety (Hospital Anxiety and Depression Scale, HADS) and level of happiness (Fordyce Scale) were assessed before and after the VR intervention. Also, Visual Analogue Scales (VAS) were used to assess emotional state and physical discomfort before and after each session.There were significant improvements in distress and level of happiness after the VR intervention. Also, it was detected an increment in positive emotions and a decrease in negative emotions after sessions.Results emphasize the potential of VR as a positive technology that can be used to promote wellbeing during hospitalization, especially considering the shortness of the intervention and the advanced state of disease of the participants. Despite the encouraging of these results, it is necessary to confirm them in studies with larger samples and control groups.

Lung cancer is one of the most common malignant diseases. Many tests and techniques are used in the staging of this disease, including positron emission tomography. This is probably the most recently introduced test and is capable of providing information on all the structures affected by malignancy. We present a case of a false positive result due to increased splenic uptake of the tracer.

e19017 Background: The standard treatment for elderly patients in advanced NS-NSCLC is not defined. The aim of this study was to evaluate the efficacy and safety profile of the combination of carbo...

5-Fluorouracil-induced gastro-intestinal toxicity predominantly affects the upper and the lower gastro-intestinal tract. Although 5-fluorouracil (5-FU) can cause severe small-bowel toxicity, this has been reported only in 6 patients with colon carcinoma receiving 5-FU-based therapy. The presentation was extensive ulceration and inflammation of the small bowel with no involvement of the colon. We report another case of this toxicity, and discuss the diagnosis and mechanisms by which 5-FU can induce small-bowel toxicity.

Intestinal obstruction is very common in cancer patients and occurs in 80% of cases with malignant aetiology. Hence, aggressive treatment is needed in most cases. The occlusion can be caused by luminal obstruction, paralysis of the intestinal muscle or carcinomatosis with mesentery involvement. The clinical case we present is that of a patient diagnosed as having lung cancer and who was admitted with paralytic ileus following treatment with vinorelbine; a vinca alkaloid whose main characteristic toxicities include neutropenia and peripheral neuropathy. Also, on rare occasions, the drug can cause paralysis of the ileum due to autonomic neuropathy. Hence, before administering aggressive treatment to an occlusive syndrome, cases that could benefit from conservative treatment should be ruled out.

5-Fluorouracil-induced gastro-intestinal toxicity predominantly affects the upper and the lower gastro-intestinal tract. Although 5-fluorouracil (5-FU) can cause severe small-bowel toxicity, this has been reported only in 6 patients with colon carcinoma receiving 5-FU-based therapy. The presentation was extensive ulceration and inflammation of the small bowel with no involvement of the colon. We report another case of this toxicity, and discuss the diagnosis and mechanisms by which 5-FU can induce small-bowel toxicity.

Intestinal obstruction is very common in cancer patients and occurs in 80% of cases with malignant aetiology. Hence, aggressive treatment is needed in most cases. The occlusion can be caused by luminal obstruction, paralysis of the intestinal muscle or carcinomatosis with mesentery involvement. The clinical case we present is that of a patient diagnosed as having lung cancer and who was admitted with paralytic ileus following treatment with vinorelbine; a vinca alkaloid whose main characteristic toxicities include neutropenia and peripheral neuropathy. Also, on rare occasions, the drug can cause paralysis of the ileum due to autonomic neuropathy. Hence, before administering aggressive treatment to an occlusive syndrome, cases that could benefit from conservative treatment should be ruled out.

e20705 Background: Hyponatremia in the cancer patient is usually caused by the syndrome of inappropriate antidiuretic hormone (SIADH). Other factors may cause hypovolemic hyponatremia, diarrhea, and vomiting. It’s present in 47% of cancer admissions. Introduction of vaptans acting as V2-receptor antagonists considerably improved the unconvincing results of conventional treatment consisting of fluid restriction potentially combined with sodium supplementation and/or demeclocycline therapy. Methods: We present a retrospective analysis of hyponatremic cancer patients treated with Tolvaptan. 45 patients, [31 men 14 women], median age 69 years old. 31.1 % had lung cancer, 17,6% other tumors, 11,1% colorectal and 11,1% prostate cancer. Histology: 53,3% Adenocarinoma, 15,6% SCLC, 15,2% others and 5,6% Epidermoid.The mean of the lowest sodium level was associated with squamous histology (Na 118 mEq/L). Descriptively, older patients (>66 y) had lower levels of Na compared to those younger than 66y (Na 122 mEq/L vs Na124 mEq/L). Median of Na at diagnosis of hyponatremia was 124 mEq/L,"waiting period" days before starting treatment,1d (SD= 1,745). Duration treatment [ Sodium levels out of risk according to the doctor criteria]. Results: Participants improved significantly after treatment period (p=.000). There were no differences in TOLVAPTAN improvements between patients with ≤ 124 mEq/L vs >124 mEq/L (p=.142), but patients with Na ≤ 124 mEq/L tend to achieved higher levels of sodium at the end of treatment (p=.016). No significant differences between different histology, location, "waiting period", duration of treatment, or age. However, Men significantly improved after treatment with tolvaptan (p=.000) and women do not showed significant changes (p=.753) (women had significantly higher pretreatment sodium level than men (122.4 mEq/L vs. 126.2 mEq/L,(p= .05). Conclusions: Tolvaptan is effective in the treatment of hyponatremia in patients with differents histological cancers especially with levels lower than 124 mEq/L. Tolvaptan had good safety profile with no side effects. A short course of two days and low dose (15mg/p.o./d ) with Tolvaptan restored safe Sodium levels.

e16025 Background: Due to hospital control difficulties of patients with HNC, a phase II with oral fluoropyrimidines was conducted. Oral administration of 5-FU itself is not feasible owing to the high activity of dihydropyridine dehydrogenase (DPD) in the gut wall. To bypass this problem, oral fluoropyrimidine derivatives were developed in the form of 5-FU prodrugs. This phase II Trial focuses on the oral 5-FU prodrug tegafur to allow similar responses and toxicities. On the other hand a secondary objective was to correlate the effect of CDDP that induces renal injury through multiple pathways. For that reason, the correlation between Mg/Cr and Toxicity was studied. Methods: From 2006 to 2011 seventeen patients with locally advanced head and neck carcinomas were treated in our institution. A phase II clinical trial was conducted as neoadjuvant treatment [docetaxel 75 m2 d-1, cisplatin 75 mgm2 d-1, and tegafur 800 mg twice daily for 14 days, administered every 21 days with GCSF support]. If tumor response, patients received radiotherapy (RT) 70 Gy concomitant with weekly cisplatin 25mg/m2. If no response, palliative surgery or RT or/second line of chemotherapy was administered.) Results: Sixteen were male, one female, three died (2 sepsis secondary to neutropenia grade IV/ 1 secondary to direct tumor complication after 1st course of chemotherapy). Only 14 patients were evaluable for response [mean age was 54,24]. Toxicity grade >2 was present in a range [13,33-21,43%]. Partial responses (PR) were present in 9 patients (52,94%), complete response or no evidence of disease in 3 (17,63%). After RT witth weekly cisplatin the diseas control was 70,57%. An association trend was detected between hypomagnesaemia and a greater toxicity. Conclusions: The implementation of an oral chemotherapy regimen has been feasible and effective with similar results to other studies. The idiosyncrasy of patients with HNC have kept their prized autonomy and independence. A new study is in progress to assess more accurately magnesium levels as predictors of severe toxicities when platinum is used.

4587 Background: The effect of pemetrexed in MUC is not well characterized. Vinflunine is the standar second-line in MUC with adjusted benefits and no more drugs have been aproved. SOGUG reports a systematic review of MUC patient series with high activity of P in monotherapy. Methods: Patients with locally advanced urothelial carcinoma and/or MUC whom received P 500 mg/m(2) every 21 days with folic acid and vitamin B12 supplementation, were elected. These patients received P in second, third or fourth-line of chemotherapy. Results: 44 patients have been reported (39males), median age 62 [41-82]. Of all 44 patients; 21, 22, and 1 patients received P as second-line, third and fourth-line respectively. A median of 4 courses were administered [1-12] and disease control (SD+PR+CR) was achieved in 19 patients for an overall control rate of 43.2%. Four groups with significant differences in PFS (p=.033) were established (1.bone-metastasis, 2.visceral-metastasis, 3. nodal-visceral-metastasis and 4.nodal-metastasis). OS was significant between 2nd and 4th group (p=.036) . Mean PFS and OS were 125days [17-606] and 219days [17-1168] respectively for all 44 patients. Mean PFS and OS of 8 patients with bone metastasis were 75 days and 134 days. Mean PFS and OS of 10 patients with visceral metastasis were 65 days and 144 days. Mean PFS and OS of 8 patiens with nodal+visceral metastasis were 154 and 228 days. Mean PFS and OS of 18 patients with nodal metastasis were 166 days and 299 days. Conclusions: Our longer and multicenter follow-up shows that single agent P in monotherapy as second, third and fourth line in MUC is associated with high activity and long-time survival specially in metastatic nodal MUC. These results suggest that P as monotherapy requires to be further studied, more patients are being collected.

e19546 Background: The EORTC (European Organisation for Research and Treatment of Cancer) recommends in cancer patients receiving chemotherapy and/or radiotherapy, that treatment with erythropoieti...

e15006 Background: The traditional end point for adjuvant clinical trials is overall survival (OS). Short-term disease-free survival (DFS) has been accepted as a surrogate of 5-year OS in colorectal cancer trials. Nevertheless, recent adjuvant trials have not shown a consistent improvement in OS despite a significant improvement in DFS. Two reasons may explain this effect: 1) a delay in relapse produced by treatment, not affecting the cure rate, or 2) more effective treatments in relapsing patients which delay death, hiding a real difference in cure rates. The aim of this project is to study the relationship between DFS and OS in trials of early colorectal cancer. Methods: Phase III comparative trials in colorectal cancer were searched in databases and cancer meetings. Trials were split to build and validate the model. United States 2000 population life table data were obtained from Berkeley Mortality Database. Survival curves were modelled according to a cured fraction following a Weibull distribution and a relapsing fraction following a binomial distribution. DFS was modelled as time to a single event and OS was modelled as time to two events. Cured fraction was estimated and odds ratio (OR) with 95% confidence interval was calculated for experimental arms. Time to achieve a plateau in DFS was estimated as the curve point with a risk of relapse below 1%. Regression analysis between DFS and OS was performed for different intervals of follow up. Results: Thirty six study arms reporting DFS were analyzed to build the model. The model is consistent with an annual event rate of 0.33. DFS curves with this event rate predict a mean cure rate of 0.58 (range: 0.11–0.73). Estimated time to achieve a plateau in DFS is 9.3 years (range: 8.3–11.2 years). Significance of OR is coherent with hazard ratio reported in the studies. Trials finished after 1999 show more OS related to DFS. Regression analysis between DFS and OS show changing parameters at different intervals of follow up and some non-linearities. Trial validation, and analysis with trials reporting relapse free survival will be presented. Conclusions: Follow up of up to 10 years in colon adjuvant trials appears to be appropriate to reliably detect benefit in OS instead of a delay effect on relapse. No significant financial relationships to disclose.

19097 Background: Platinum-based therapy remains a key component in the firs-line treatment of patients (pts) with advanced NSCLC. The docetaxel-carboplatin combination is active and well tolerated...

13009 Background: Dose dense chemotherapy has been advocated as a way to improve results in patients with cancer. Increasing dose (and the area under the curve of concentration-time, AUC) may increase response and toxicity, limiting clinical benefit. For phase-specific agents such as GEM, different schedules with the same dose and AUC may produce different patterns of efficacy and toxicity. Partial comparisons between schedules in clinical trials are not able to design optimal schedules. A systematic analysis of all different schedules of GEM, integrating clinical, pharmacodynamic and pharmacokinetic data in a mathematical model may provide an optimum. Methods: Clinical trials of single agent GEM in advanced pancreas, lung and breast carcinoma have been searched in PubMed, references of published clinical trials, and presentations in cancer meetings. Prognostic factors (age, sex, sex, performance status, previous chemotherapy, stage), schedule details (dose, time and frequency of infusions), response rate and toxicity (hematological, mucosal, skin and diarrhea) were analyzed in a multivariate model. In vitro data (concentration and time of exposure) and pharmacokinetic/pharmacodynamic data were included in the model, estimating the AUC above a concentration threshold (AUCt) obtained for every clinical schedule. Results: Ninety five clinical trials including 7917 patients with cancer of the pancreas (39 trials), lung (45 trials) or breast cancer (11 trials) were pooled. GEM was administered at doses of 90–2800 mg/m2 (median 1000 mg/m2) infused in 0.5–24 hours (median 0.5 h). Except for 1 schedule, treatment was repeated for 1–7 consecutive weeks (median 3) followed by a 2 week rest period. Response rate was 2.7–33.3% (median 8%) for pancreas, 0–38.5% (median 18.5%) for lung and 0–37.1% (median 20%) for breast cancer. Epithelial toxicity was inferior to hematological toxicity (grade 3/4: 0% vs 11% for leucopenia). A mathematical model was applied to 24 different schedules. Conclusions: GEM schedules in literature show great homogeneity, most of them 1000 mg/m2 for 3 consecutive weeks followed by a 2 week rest period. The model allows simulations to optimize concentration over 12 nM. No significant financial relationships to disclose.

19654 Background: CIA is often associated with debilitating fatigue and reduced QoL. DA can effectively treat CIA when administered once every 3 weeks (Q3W).This study aims to compare the psychometrics of the Functional Assessment of Cancer Therapy Fatigue Subscale (FACT-F) and The Fatigue Symptom Inventory (FSI) in CIA pts treated with DA Q3W. Methods: Longitudinal single- centre prospective study in adult pts with solid tumours undergoing chemotherapy (CT) and with mild to moderate cancer-related fatigue (CRF) (Visual Analogue Scale (VAS) =30 mm). Pts with haemoglobin (HB) levels No significant financial relationships to disclose.

17016 Background: Platinum therapy has been the backbone treatment in NSCLC. The concomitant use of platinum derivatives and taxanes has shown high antitumoral activity with moderate toxicity. To improve the therapeutic index of this combination, we performed a study with biweekly carboplatin and docetaxel. Primary objective was determination of objective response rate (ORR). Secondary objectives were time to progression, tolerability and overall survival. Methods: Patients histologically confirmed of non-small cell lung cancer, aged ≥ 18, ECOG PS 0–2, measurable lesion according RECIST criteria, adequate bone marrow, renal and hepatic function were included. Prior chemotherapy was not allowed. Patients received treatment with a combination of Docetaxel 50 mg/m2 and Carboplatin AUC-4 each 15 days for a maximum of 8 cycles. Results: Fifty patients were included between March 2004 and July 2005, 84% were male, median age was 63 years old (range 48–77), 78% had ECOG PS 0–1 and 64% of patients had stage IV. Histology was squamous cell carcinoma (54%) adenocarcinoma (36%) and large cell carcinoma (10%). A total 316 cycles were administrated (median 7, Range 1–12). Over 46 evaluable patients for response, one achieved CR, 13 PR, 21 SD and 11 PD, with an overall response rate of 30.5% (95% CI: 17.2–43.8). Median follow up of patients is 8.3 months, with a median TTP of 6.3 months and median overall survival of 11.1 months. Grade 3–4 toxicity per patient was: neutropenia (22.0%), asthenia (16.0%), anaemia (10.0%), thrombocytopenia (2%), mucositis (2%) and nauseas (2%). Conclusions: These results suggest that biweekly schedule of carboplatin / docetaxel is a safe and active regimen in first line advanced NSCLC patients. No significant financial relationships to disclose.

2124 Background: Dose density of chemotherapy has been advocated as a way to improve results in patients with cancer. While increasing dose, and the area under the curve of concentration-time (AUC), may increase response, it also increases toxicity, reducing the clinical benefit. For phase-specific agents such as TAX, different schedules with the same dose and AUC may produce different patterns of efficacy and toxicity. Partial comparisons between schedules in clinical trials may answer which of two or three schedules is better, but not which schedule is optimal. A systematic analysis of all different schedules of TAX, integrating clinical, pharmacodynamic and pharmacokinetic data in a mathematical model may provide an optimum, as was previously provided for fluorouracil (Proc ASCO 2004; 23:a2139). Methods: Clinical trials of single agent TAX in advanced breast and lung cancer have been searched in PubMed, references of published clinical trials, and presentations in cancer meetings. Prognostic factors (a...