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10015 Background: We previously demonstrated that interruption of IM treatment after 1, 3, and 5 yrs in responding patients (pts) with advanced GIST are associated with rapid relapse. The impact of IM interruption on secondary resistance and overall survival (OS) with longer-term follow-up was unclear. Methods: This prospective multicenter BFR14 study was initiated in June 2002 and closed for accrual in July 2009. Pts with GIST free of progression after 1, 3 or 5 yrs of IM 400 mg/day were randomly assigned to continue (C arm) or interrupt (I arm) IM. Reintroduction of IM (same dose) upon progression was allowed for pts in the I group. Primary endpoint was Progression Free Survival (PFS). Secondary endpoints included OS and time to secondary resistance (TSR) defined as time to progression under IM treatment (i.e. first progression in the C arm and progression after reintroduction of IM in the I arm). Results: As of January 2011, 434 pts were included in this trial. Fifty-eight, 50 and 27 non progressive pt...

10048 Background: The aim of this work was to characterize patient (pts) characteristics and the mutational status of GIST who benefit the most from IM in term of prolonged response and overall sur...

e15118 Background: The aim of this work was to investigate factors predicting PFS of patients (pts) with mRCC, randomly assigned to: Temsirolimus + bevacizumab (T+B) combination, or sunitinib (S), ...

315 Background: The TORAVA trial, reported at ASCO 2010, was a randomized phase II study aimed to determine the efficacy and safety of temsirolimus and bevacizumab combination. Both efficacy and safety were demonstrated as insufficient. Interestingly, 2 control arms were used in this study, sunitinib (arm B) or bevacizumab and a-interferon (arm C). Both PFS and RR were higher in arm C than arm B (16.8 mths and 39% vs. 8.6 mths and 23.8%). Post-hoc analysis were thus performed to determine the predictive factors for better efficacy. Methods: Overall, 171 pts were randomized in this study, 42 in arm B and 41 in arm C. The study was stratified on PS only, 0–1 vs 2. These 83 pts were analyzed regarding baseline characteristics, and dose reduction. Results: Some important differences were detected in the 2 arms, in favor of arm C: DFI>12mths (29 vs. 39%), good MSKCC risk (31 vs. 39%), Fuhrman grade 1–2 (32 vs. 38%), liver metastases (19 vs. 14.6%), high LDH (17.1 vs. 7.9%). Interestingly, pts who had dose reduction of interferon (27/41 pts) had a longer PFS than those who did not reduced the dose. Updated analyses will be presented. Conclusions: Small randomized trials such as randomized phase II trials are not guaranteed to balance predictive/ prognostic factors across treatment arms. Before interpreting RR and PFS in mRCC, careful analysis of pt characteristics should be performed. However, this study will probably help to determine a population more likely to benefit from bevacizumab-interferon combination. [Table: see text]

1140 Background: Metastatic breast cancer is a very frequent disease but its presentation and evolution vary a lot between patients. However it is very difficult to predict individual evolution. We retrospectively analyzed two prospective cohorts of patients with metastatic breast cancer to evaluate prognostic factors. Methods: The first cohort (A) consisted of 39 patients with metastatic or locally advanced breast cancer treated with first line chemotherapy between September 2004 and October 2007. The second cohort (B) consisted of 114 patients with metastatic or locally advanced breast cancer who relapsed after at least one line of chemotherapy between December 2000 and November 2005 and who received further chemotherapy. In the cohort A the blood samples were drawn before administration of any chemotherapy. In the cohort B the samples were drawn after white blood cell recovery. We performed Kaplan Meier curves with log-rank tests. Results: In the cohort A, 84% of patients had a ductal carcinoma, 81% of...

e19684 Background: Depression in one the most common psychiatric illness in patients with cancer and it is known to reduce quality of life. The study of depression has been a challenge because symp...

TPS165 Background: The combination of 2 agents is an important way to improve treatment efficacy. Phase I trials are required to determine the maximum tolerated doses (MTD) defined by the occurrenc...

10032 Background: We previously showed in the BFR14 study that IM interruption results in increased risk of disease progression (PD) after 1 and 3 years (yr) in non progressing patients (pts). The impact of IM discontinuation on progression free survival (PFS) in responding pts at 5 yrs is unknown. Methods: This prospective multicenter BFR14 study was initiated in 06/02 and completed inclusion in 05/09. After 1, 3, and 5 yrs of IM 400 mg/day, pts free from PD were randomly offered to continue (C arm) or Stop (S arm) IM. Pts allocated to the S arm had to restart IM (same dose) in case of PD. Primary endpoint was PFS. A Bayesian model was implemented for this part of the BFR14 study. Results: Overall, 434 pts were included in the BFR14 study. Fifty-eight (n=26 vs. n=32), 50 (n=25 vs. n=25) and 21 (n=11 vs. n=10) non progressive pts at were randomized at 1, 3 or 5 yrs in the S vs C arms. The 2 yr-PFS were 13% and 16% in the S arms after 1 and 3 years of treatment compared to 62% and 80% in the C arms after 1...

e16073 Background: Neuro-endocrine differentiation is often observed in the evolution of mCRPC. We assessed the efficacy and toxicity of a platin-based chemotherapy regimen in patients with mCPRC and neuro-endocrine differentiation defined by: either increased circulating neuro-endocrine markers (chromogranin A: CgA, Neuron Specific Enolase: NSE) more than 1.5 X normal serum values and/or visceral metastases confirmed with immunihistochemical proof of neuro-endocrine differentiation on pathological sample. Methods: Sixty patients were included (Simon optimal two stages design with P0 = 20%, P1 = 40%, α = 5% and power 90% for a total of 54 evaluable patients) and were treated by the combination of carboplatin AUC 4 d1 IV and etoposide 100 mg/m2/d d1–3 IV every 3 weeks for a maximum of 6 cycles. Efficacy endpoints included PSA and neuro-endocrine marker response rate (defined as a decrease of 50% or greater of the baseline serum value), objective response rate (according to RECIST criteria), and toxicity. Results: Sixty patients were included between April 2005 to January 2008, median age was 67 (range: 45–80). Sixty-seven per cent patients received prior chemotherapy. Patients had bone metastases (78%), lymph nodes involvement (49%), lung metastases (35%), hepatic involvement (33%) and other localizations (17%). The objective response rate was 33% in the 48 assessable patients. A neuro-endocrine response was observed in 28% of 32 evaluable patients for neuro-endocrine marker level (CgA 6%, NSE 25% and both 3%). The PSA response rate was 9%. The most common grade 3–4 treatment-related toxicities were neutropenia (67%), thrombocytopenia (31%), anemia (27%), asthenia (14%) nausea and vomiting grade (12%). There were 6% febrile neutropenia, with one related toxic death. The median follow-up is 9 months. The median response duration was 1.8 months (range: 0.2–13.4 months). The median overall survival is 10 months. Conclusions: Despite an absolute response rate in accordance with the study assumptions, the benefit-risk ratio of this regimen seems unfavourable due to observed toxicities. Another trials must be conducted in order to define a group of patients which may benefit of this regimen. No significant financial relationships to disclose.

e20566 Background: Homeopathy used as an adjunct in the treatment of chemotherapy (CT)-induced emesis has rarely been evaluated. Methods: Patients with non-metastatic breast cancer treated with 6 courses of FAC 50, FEC 100 or TAC chemotherapy were randomized to Cocculus/nux vomica/tabacum/petroleum extract (Cocculine, C) or Placebo (P) in a multicentric comparative double-blind phase III study. Anti-emetic treatment was standardized (corticoids + ondansetron). Patients were evaluated after each course. The primary endpoint was nausea measured after the 1st CT course using the FLIE (Functional Living Index for Emesis) with 5-day recall. The planned sample size was 396 evaluable patients based on a minimum expected difference in mean of 0.5 ± 1.6 on a scale from 1 (a lot) to 7 (not at all) with 5% two-sided α error and 85% power. An intent-to-treat analysis was planned. Secondary evaluation criteria were: vomiting measured by the FLIE score, patient self-evaluation (EVA) and investigator recording (NCI-CTC) of nausea and vomiting intensities, and compliance. Results: From September 05 to January 08, 431 patients were randomized (217 to P and 214 to C). Patient characteristics were well balanced between groups. Median age was 53 years, 35% of the patients experienced nausea or vomiting. In total, 403 patients (93.5%) were assessable for the primary endpoint, with few nausea episodes (FLIE nausea scores after the 1st CT course were 6.02 and 6.07 for P and C, respectively) and very good compliance (81% patients complied with the protocol). Adverse events related to nausea occurred in 51% vs. 47% of the patients treated with P and C, respectively (p = 0.48). FLIE and NCI-CTC vomiting scores were similar between the 2 arms (6.91 vs. 6.88, p = 0.47, and 20% vs. 21%, p = 0.73, for P and C, respectively). Grade II-III nausea occurred in 17.6% and 15.7% of patients receiving P and C (p = 0.62). Conclusions: No benefit of homeopathy over standard treatment was noted in this study. But surprisingly we observed lower rates of nausea and vomiting measured by patients and by investigators, than in other studies using identical chemotherapy regimens. The observation and management of emesis could modify the perception and rate of such adverse events. No significant financial relationships to disclose.

10508 Background: We previously demonstrated that imatinib mesylate (IM, Gleevec/Glivec; Novartis Pharma) must not be interrupted after 1 and 3 years (yr) in responding patients (pts) and has to be given continuously until disease progression (PD) or intolerance. The impact of IM re-introduction at progression remains unknown regarding the impact of the interruption on the TSR. Methods: This prospective national multicenter BFR14 study was initiated in June 2002. After 1, 3, and 5 yrs of IM 400mg/day, pts free from progression were randomly offered to continue (C arm) or interrupt (I arm) IM. Pts allocated to the I arm could restart IM (same dose) in case of PD. Primary endpoint was PFS. Pts declining randomization proceed with IM. Results: As of December 2008, 415 pts were included in this trial. Fifty-eight, 50 and 12 (ongoing) non progressive pts at 1, 3 and 5 yrs respectively were randomized in the I and C arm. Pt characteristics were well balanced between the two arms. The median time to progression (TTP) were 7.3 months (m) (rate of relapse: 91% of pts) and 9.4 m (rate of relapse: 84%) in the I arms after 1 and 3 years of treatment. In contrast the median TTP were 31.4 m and not reached in the C arms after 1 and 3 yrs of IM treatment respectively. IM reintroduction in the I arm after a re-progression allowed again a tumor control in 93% (43/46) of pts. The median follow-up from randomization is 56 m and 25 m at 1 and 3 yrs respectively. TSR after randomization to IM (first progression in the C arm, 2nd progression in the I arm) was not significantly different between the two arms (the 2-yrs TSR is similar in both arms 63% and 62% in the I and C arm respectively for the 1-yr randomization, 83.5% and 84.3% for the 3-yr randomization) but the rate of secondary resistance decrease over time in both arms: 40% or relapse in the 2 yrs following the 1 yr randomization vs less than 20% or relapse in the 2 yrs following the 3-yrs randomization. Conclusions: The majority of responding pts relapsed when IM was stopped after 1 and 3 yrs of treatment but response is reinduced in 93% of patients after IM reintroduction. TSR was not significantly affected by treatment interruption in this series of pts. [Table: see text]

6552 Background: Although new chemotherapy agents have been approved during the past decade for the treatment of metastatic breast cancer (MBC), it is unclear whether their use has changed the outcome of patients. This study assessed the clinical and economic impacts of these drugs. Methods: We undertook a retrospective study of women diagnosed with MBC during two periods of time, 1994–1998 and 2003–2006 and compared overall survival data between the two groups. Female patients with MBC were identified from the Centre Léon Bérard (Lyon, France) database. Tumor and treatment characteristics, costs of chemotherapy, and patient outcome were compared using the X2 test, the log rank test, and Cox regression analysis. Overall survival was calculated from the date of MBC diagnosis to the date of death or last follow-up. Chemotherapy-related costs were calculated according to the 2008 pricelist of French cancer centers. Results: A total of 301 MBC cases were identified. The median follow-up of living patients was 3.87 years. No survival difference was observed between the two periods, with a median overall survival of 2.76 years for the 1994–1998 cohort (149 patients) and 2.68 years for the 2003–2006 cohort (152 patients) (HR 1.04, 95%CI 0.70–1.55; p = 0.83). The median number of lines of chemotherapy was similar in the two groups (=3). The median cost of chemotherapy per MBC patient was 3 times higher in 2003–2006 (25,320 €) than in 1994–1998 (8,865 €; p < 0.001). In multivariate analysis, prognostic factors for overall survival were the number of metastatic sites (HR 2.06; p < 0.0001), bone metastases (HR 0.67; p = 0.007), and hormone receptors (HR 0.56; p = 0.002). Survival was identical in HER-2 positive and HER-2 negative patients (HR 0.99; p = 0.99). Conclusions: Despite the implementation of numerous novel chemotherapeutic agents, the overall survival of patients with metastatic breast cancer has not improved over the last decade on the scale of our institution, whereas the costs of chemotherapy have significantly increased. No significant financial relationships to disclose.

10518 Background: We present updated results from a previously reported phase II trial assessing clinical efficacy of imatinib in progressive or recurrent aggressive fibromatosis (Fayette et al. ASCO 2007) Methods: Patients with aggressive fibromatosis not amenable to radiotherapy or non-mutilating surgery were eligible and received imatinib 400mg daily (increased to 800mg daily in case of progression) up to 1 year then stopped. The primary end point was non-progressive disease rate at 3 months. Independent radiological committee reviewed responses. The number of patients was calculated according to a optimal 2-stages design. Results: Forty patients were included between September 2004 and October 2005 in 15 centers. The median follow up is 33 months [95% CI: 32–35]. Toxicity of imatinib is similar to that previously reported. At 3 months, the nonprogression rate was 91% [95% CI: 77–96] with 1 (2%) complete and 3 (8%) partial confirmed responses observed. The non progression rates at 6, 9, and 12 months were 80%, 69% and 66% respectively. The median time to progression was 9.5 months. The 2-year progression-free survival (PFS) was 55%. No plateau was observed. The 2-year-overall survival was 95%. Two patients with mesenteric aggressive fibromatosis died from progressive disease. In multivariate analysis including clinical factors, only previous radiotherapy was associated with reduced progression free survival. None of the biological factors tested using IHC on TMA (PDGFR α, PDGFR β, β catenin, c-kit, E cadherine, MCSFR, cycline D1 and Erk) were found correlated to response, progression free or overall survival. Conclusions: With a 2.8 years median follow up, this is the largest study which confirms the high efficacy of imatinib (400 mg daily) in patients presenting with aggressive fibromatosis failing local treatment and with documented evidence of progressive disease before imatinib treatment. [Table: see text]

10551 Background: The role of surgery in the management of patients with advanced gastrointestinal stromal tumors (GIST) in the era of imatinib mesylate (IM) remains unknown. We sought to assess the outcome of patients with locally advanced primary GIST tumors without metastases treated with IM in the neoadjuvant setting within the prospective BFR14 phase III trial. Methods: The data base of the BFR14 trial was searched for patients with locally advanced disease and no metastases. Patients with recurrent disease were excluded. Results: Twenty five patients (9 females, 16 males) met these criteria. Twenty patients were PS 0 or 1, primary tumor sites were: small intestine (n=7), peritoneum (n=7), rectum (n=4), stomach (n=4), esophagus (n=2), and pelvis (n=1). Nine of the 25 patients underwent surgical resection of the primary tumor after a median of 7.3 (range 3.4–12.1) months of treatment with IM. There was a significant improvement in progression-free survival (PFS) for patient who underwent surgical resection versus those who did not: median PFS: 28.7 month vs 12.9 months respectively (p=0.0463) this benefit did not however translate into a significant benefit in overall survival (OS), although the trend favoured the resected group: median OS median not reached vs 29.4 months (p=0.0677). Conclusions: Surgery may increase progression-free survival in patients with locally advanced GIST who become resectable following treatment with IM. [Table: see text]

9573 Background: Little is known about prognosis of MC pts after first-line treatment failure. Our group has already shown that performance status (PS) ≥ 2 and LDH >600 UI/L were independent progno...

10522 Background: We previously demonstrated that IM must not be interrupted after one year (yr) in responding patients (pts) and has to be given continuously until disease progression (PD) or into...

1049 Background: In MBC, XT improves time to progression and overall survival (OS) vs docetaxel alone (O'Shaughnessy, 2002) and first-line capecitabine + paclitaxel shows similar efficacy to epirubicin + paclitaxel (Luck, 2007). The ERASME-4 and CAPEDOC- EPIDOC trials were designed to assess the efficacy of XT vs ET as first-line therapy for MBC. Methods: Patients (pts) with MBC and no prior chemotherapy (adjuvant therapy permitted) were randomized to 3-weekly cycles of either XT (docetaxel 75 mg/m², d1 + capecitabine 1,000 mg/m² twice daily, d1–14) or ET (docetaxel 75 mg/m², epirubicin 75 mg/m², both d1). In the ET arm, primary prevention of febrile neutropenia with hematopoietic growth factor was recommended; ET pts received capecitabine at progression. The primary endpoint was progression-free rate 6 months after randomization. The planned sample size of 106 pts (Simon 1985), gave 95% power to test a progression-free rate of 75% (XT) vs 60% (ET). Secondary endpoints included progression-free survival (...

16022 Background: Anti-tyrosine kinases (TKI) arenow the standard of care in pts with MRCC; some pts benefit from these treatments (ttt) for long periods of time. However, the prognostic factors fo...

11537 Background: Current management of BC pts with HER2 overexpression includes chemotherapy and trastuzumab treatment. In order to assess the potential individual benefit of this treatment we analyzed outcome data and prognostic factors in a prospectively characterized cohort of HER2 positive BC pts treated before the trastuzumab era. Methods: Medical records from 103 HER2 positive BC pts treated between 1996 and 2005 according to our standard institutional protocols without adjuvant trastuzumab were analyzed. Clinicopathologic variables such as age, menopausal status, clinical stage, pathologic tumor size (pTS), histologic grade (HG), ER and PR status, lymphovascular invasion (LVI) and axillary lymph node (ALN) status were extracted from the institutional database that has been prospectively collected since 1996. Variables with a 0.15 significance level in univariate analysis were entered in a multivariate Cox model. A backward stepwise procedure discriminated non-influential variables at 0.05 level. R...

10005 Background: IM the first-line targeted therapy for advanced GIST, must not be interrupted after one year (yr) in responding patients (pts) and has to be given continuously until disease progression (PD) or intolerance (Blay, Le Cesne et al, ASCO 2004 and 2005). The impact on progression free survival (PFS) of IM discontinuation in long lasting responding pts is unknown. Methods: This prospective national multicenter BFR14 study was initiated in June 2002. After 3 yrs of IM 400mg/day, pts free from progression were randomly offered to continue (C arm) or interrupt (I arm) IM, with the exception of pts initially randomized in the I arm after 1 yr of IM (32 pts). Pts allocated to the I arm could restart IM (same dose) in case of PD. Primary endpoint was PFS. Pts declining randomization proceed with IM. Results: As of december 2006, 286 pts were included in this trial and up to date, 35 non progressive pts at 3 yrs were randomized, 19 and 16 in the I anc C arm respectively. Pt characteristics were well balanced between the two arms. Nine progressions were reported after a median follow-up of 5.3 months (range 0–14) in this cohort of patients. IM reintroduction in the I arm after a re-progression allowed again a tumor control (OR or SD) in all evaluable pts so far. Conclusions: An increase in the rate of PD was observed in patients randomized after 3 years of IM. The final analysis will be performed after the randomization of 50 pts. Updated results including mutational analysis will be presented at the meeting. No significant financial relationships to disclose.

10016 Background: IM the first-line treatment for advanced GIST, must be given continuously until disease progression (PD) or intolerance (Blay et al, ASCO 2004). The impact on long term overall survival (OS) of IM discontinuation in responding patients (pts) and its re-introduction at progression is unknown. Methods: This prospective multicenter BFR14 study was initiated in June 2002. After 1 year of IM 400mg/day, 58 pts free from progression were randomly offered to continue or interrupt IM until PD. Pts allocated to the interruption (I) arm could restart IM (same dose) in case of PD. Primary endpoint was progression-free survival (PFS); secondary endpoints were OS, secondary response after IM re-introduction, identification of molecular determinants of response. Survival data were compared using the log-rank test. Results: Pt characteristics were well balanced between the two arms. Current median follow- up after randomization is 37 months (range 0–42): 29/32 pts (91%) in arm I vs. 16/26 pts (62%) in continuous (C) arm experienced PD. IM interruption was significantly associated with reduced PFS (p-4) with a median of 6 months (95% CI, 3.5–9.5) for arm I. Among the 26 pts of I arm who restarted IM after first progression, 24 (92%) achieved tumor control (OR or SD), one progressed, one died from an unrelated cause. The 2-yr OS rates were 87% and 92% for arms I and C, respectively (P = 0.78). Conclusions: Despite a significant increase of PD in the experimental arm, IM re-introduction is safe and allows a tumor control in the majority of pts. No unfavourable impact of IM interruption on OS was reported. Treatment interruption could be a therapeutic option in advanced GIST pts exhibiting intolerance to IM. Updated results including mutational analysis will be presented at the meeting. No significant financial relationships to disclose.

10053 Background: IM is the first-line treatment for advanced GIST and must be given continuously until disease progression or intolerance. The median progression free survival (PFS) of pts included in consecutive prospective trials is around 2 years. Pt characteristics and the exact mutational status of GIST who benefit the most from IM in term of prolonged response to IM and prolonged PFS are unknown. Methods: two hundred and seventy six pts were included in 2 consecutive prospective trials since 2001 in 2 centers. Pts receiving IM for at least 3 yrs (3 to 5 yrs) who have no exhibited any kind of progression and receiving IM continuously until december 2006 have been retrospectively analyzed both clinically and biologically. KIT and PDGFR mutations were analyzed using DHPLC and direct sequencing of frequently mutated exons (KIT 9, 11, 13, 14, 17, PDGFR 12, 14, 18). Results: after a median follow-up of 4 yrs (3–5yrs), 31 pts are free of progression and received IM continuously. The characteristics of these long term survivors favorable cohort of pts are as following: man (61%), small bowel origin (60%), liver involvement (80%), synchronous metastasis at inclusion (58%), and normal initial hemoglobin level (92%>10 g/dl). As of now, 15 pts are evaluable for mutational analysis. All but one (exon 9) pts had an exon 11 mutation. The most commun genetic alteration was an in frame deletion between 550 to 558. Conclusions: Pts with metastatic GIST arising from small bowel harboring an exon 11 mutation in the vicinity of codon 557–558 may be a very favorable subgroup. No significant financial relationships to disclose.

15124 Background: To determine the maximal tolerated dose (MTD) of daily irinotecan with radiotherapy (RT) in patients (pts) with locally advanced adenocarcinoma of the pancreas. Methods: Between 09/2000 and 05/2006, 30 pts with histologically proved adenocarcinoma of pancreas were included in this prospective phase I/II study. Irinotecan was administrated daily, 1 hour before RT session. Doses were escalated by increment of 2 mg/m2 every 3 patients for an initial dose of 6 mg/m2/day. RT was delivered at 2 Gy per session, 5 fractions per week to a total dose of 50 Gy to the doses tumor volume. Primary endpoint was toxicity; secondary endpoints were tumor objective response (OR) defined as complete or partial response, secondary operability and overall survival (OS). Inoperability was assessed by surgeon. All images were reviewed by a radiologist. OR rates were compared using the Fisher’s exact test. Results: 30 pts were entered over 6 years through 7 dose levels from 6 mg/m2/day. Sex ratio was 1:1, median age was 58 years (range 33–71), Karnofsky score was ≥ 90 in 93%. Current median follow-up is 45 months. No dose limiting toxicity was yet observed (last level 18 mg/m2/day). Three patients experienced grade 3 toxicity at level 1 (ulcer perforation), level 6 (nausea, vomiting and abdominal pain), and level 7 (nausea, vomiting and hypokaliemia), respectively. OR rates were 33% at 4 weeks. 3/13 pts (23%) included within the 3 first levels (= 10 mg/m2/day) experienced an OR at 4 weeks, versus 7/17 (41%) in the levels > 10 mg/m2/day (P = 0.44). 3 pts underwent surgery because of control tumor. Median OS was 13 months (95% CI 11–14) with 24 patient’s death. One patient is in complete remission since 21 months. Conclusions: Maximal tolerated dose is not yet reached. Despite response rate is not the main aim of the study, results suggest that RT combined with a higher daily level of irinotecan could be associated with a better tumor control. No significant financial relationships to disclose.

5044 Background: The French Immunotherapy Group previously showed that circulating interleukin-6 (IL-6) and VEGF correlate with survival in MRCC patients (pts) (Négrier JCO 2004). We aimed to confirm the prognostic value of IL-6 and VEGF, and to test that of macrophage colony-stimulating factor (M-CSF) and macrophage inflammatory protein 3-alpha (MIP-3a) for survival in MRCC pts of good and intermediate prognoses. Patients and Methods: Pre-treatment samples were obtained from 302 MRCC pts enrolled in 2 parallel multicenter randomized cytokine trials. Baseline serum levels of IL-6, M-CSF, VEGF, and MIP3a were determined by immunoassays; their prognostic value for progression-free survival (PFS) and overall survival (OS) was tested. Characteristics of pts with a 0.15 significance level in univariate analysis (ECOG PS, prior therapy, metastatic sites and biological parameters) were entered in a multivariate Cox model. A backward stepwise procedure discriminated non-influential variables at 0.05 level. Results: Median IL6, VEGF, M-CSF and MIP3a levels were respectively 7.3 (range 0–392 pg/mL), 0.5 (0–2.3 ng/mL), 406 (0–4,785 pg/mL) and 0 (0–1,705 ng/mL). IL6 or M-CSF and VEGF (p No significant financial relationships to disclose.