PURPOSE Linifanib, a potent, selective inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) receptors, has single-agent activity in non-small-cell lung cancer (NSCLC). We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC. PATIENTS AND METHODS Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to 3-week cycles of carboplatin (area under the curve 6) and paclitaxel (200 mg/m(2)) with daily placebo (arm A), linifanib 7.5 mg (arm B), or linifanib 12.5 mg (arm C). The primary end point was progression-free survival (PFS); secondary efficacy end points included overall survival (OS) and objective response rate. RESULTS One hundred thirty-eight patients were randomly assigned (median age, 61 years; 57% men; 84% smokers). Median PFS times were 5.4 months (95% CI, 4.2 to 5.7 months) in arm A (n = 47), 8.3 months (95% CI, 4.2 to 10.8 months) in arm B (n = 44), and 7.3 months (95% CI, 4.6 to 10.8 months) in arm C (n = 47). Hazard ratios (HRs) for PFS were 0.51 for arm B versus A (P = .022) and 0.64 for arm C versus A (P = .118). Median OS times were 11.3, 11.4, and 13.0 months in arms A, B, and C, respectively. HRs for OS were 1.08 for arm B versus A (P = .779) and 0.88 for arm C versus A (P = .650). Both linifanib doses were associated with increased toxicity, including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition. Baseline plasma carcinoembryonic antigen/cytokeratin 19 fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib 12.5 mg. CONCLUSION Addition of linifanib to chemotherapy significantly improved PFS (arm B), with a modest trend for survival benefit (arm C) and increased toxicity reflective of known VEGF/PDGF inhibitory effects.

PURPOSE To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer. PATIENTS AND METHODS A 2 × 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided α = .05. Overall survival (OS) was a secondary outcome. RESULTS Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens. After a median follow-up of 6 years, a significant interaction developed between the two randomization factors (DFS P = .024; OS P = .010) in the 2,716 patients randomly assigned in the original design, which precluded interpretation of the two factors separately. Comparing all four arms showed a significant difference in OS (P = .040) but not in DFS (P = .11), with all treatments given once every 2 weeks associated with the highest OS. This difference in OS seemed confined to patients with hormone receptor-negative/human epidermal growth factor receptor 2 (HER2) -negative tumors (P = .067), with no differences seen with hormone receptor-positive/HER2-negative (P = .90) or HER2-positive tumors (P = .40). CONCLUSION Patients achieved a similar DFS with any of these regimens. Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/HER2-negative tumors.

OBJECTIVE To analyze factors influencing survival of patients with stage II colon cancer treated at our cancer center (Sparrow Hospital) from February 1996 through December 2006. PATIENTS AND METHODS Survival analyses on 197 patients' age 71.1±0.9 years (29 to 97) were done using SAS system (V9.3, Cary NC). Analysis included age, gender, stage, surgery type, number of examined lymph nodes, pathological grade, tumor size and the use of adjuvant chemotherapy. RESULTS Mean follow up length was 48.1±2.3 months (0.1-133) and 56±3.3 (0.2-133) for survivors. The average number of removed lymph nodes was 18±13 (1-103). Adjuvant chemotherapy treatment (5-FU± leucovorin) was given to 49 patients, while others (148) were followed expectantly. There were 90 deaths during follow up. Only age exhibits a statistically significant relationship to survival (Hazard Ratio (HR) =1.06, 95% CI=1.03-1.08, p<0.001). Adjuvant chemotherapy possibly reduced the risk of death by 42% approaching a borderline advantage for survival (HR=0.58, CI=0.33-1.03, p=0.06. The number of removed lymph nodes also showed a possible relationship to survival (HR=0.98, CI= 0.62-1.56, p=0.07). Other investigated factors (gender, type of surgery, etc.) were not significant correlates. CONCLUSION In this study we found that the most important factor for survival of patients with Stage II colon cancer is the patient's age. Adjuvant chemotherapy showed a borderline significance while the number of resected lymph nodes seemed to be an important survival factor. However, in our study statistical significance was not achieved.

PURPOSE Increased circulating tumor cells (CTCs; five or more CTCs per 7.5 mL of whole blood) are associated with poor prognosis in metastatic breast cancer (MBC). A randomized trial of patients with persistent increase in CTCs tested whether changing chemotherapy after one cycle of first-line chemotherapy would improve the primary outcome of overall survival (OS). PATIENTS AND METHODS Patients with MBC who did not have increased CTCs at baseline remained on initial therapy until progression (arm A). Patients with initially increased CTCs that decreased after 21 days of therapy remained on initial therapy (arm B). Patients with persistently increased CTCs after 21 days of therapy were randomly assigned to continue initial therapy (arm C1) or change to an alternative chemotherapy (arm C2). RESULTS Of 595 eligible and evaluable patients, 276 (46%) did not have increased CTCs (arm A). Of those with initially increased CTCs, 31 (10%) were not retested, 165 were assigned to arm B, and 123 were randomly assigned to arm C1 or C2. No difference in median OS was observed between arm C1 and C2 (10.7 and 12.5 months, respectively; P = .98). CTCs were strongly prognostic. Median OS for arms A, B, and C (C1 and C2 combined) were 35 months, 23 months, and 13 months, respectively (P < .001). CONCLUSION This study confirms the prognostic significance of CTCs in patients with MBC receiving first-line chemotherapy. For patients with persistently increased CTCs after 21 days of first-line chemotherapy, early switching to an alternate cytotoxic therapy was not effective in prolonging OS. For this population, there is a need for more effective treatment than standard chemotherapy.

The authors assessed the overall response rate, including confirmed complete response (CR) and partial response, in patients with relapsed/refractory multiple myeloma treated with sorafenib. Qualitative and quantitative toxicities associated with this regimen were evaluated. Patients were eligible if they had a confirmed diagnosis of refractory or relapsed (RR) multiple myeloma (MM) with measurable monoclonal protein. Patients had to have adequate renal, hepatic, hematologic, and cardiac function with a Zubrod performance status of 0–2. Patients were given 400 mg sorafenib by mouth twice daily for 28‐day treatment cycles. These patients were followed up for a maximum of 3 years to assess responses and adverse events. Twenty‐three patients were enrolled. Of these, five were found to be ineligible for the following reasons: four had insufficient documentation of the baseline disease and one patient did not have measurable disease. All eighteen eligible patients were evaluable for toxicities. Three patients experienced grade 4 toxicities: one with thrombocytopenia, one with anemia, and one with renal failure. Four of the eighteen eligible patients were not assessable for response due to removal from protocol treatment prior to adequate disease assessment. Specifically, three were removed for either grade 4 toxicity or progression of disease and one was removed per patient choice (due to reasons unrelated to treatment). Of the 18 patients who were assessed for toxicities, 5 (27.8%) received at least one fully dosed cycle, 2 (11.1%) of whom had all cycles fully dosed. No responses were observed on this study of the 14 patients who were assessable for response. All patients have discontinued protocol treatment as of August 2008. Overall survival at 12 months was 50% (95% CI 27–73%) and median progression‐free survival was 1.2 months (95% CI 1.0–5.4). The trial did not exhibit activity by the International Uniform Response Criteria for MM. Further research should focus on combination therapy of sorafenib with standard treatments in selected patients with RR MM.

1016 Background: Assessment of the outcome of minority populations within clinical trials may give insight into important tumor and host factors relevant to those populations. Methods: S0221 is a phase III trial of various dose-schedules of doxorubicin, cyclophosphamide and paclitaxel. S0221 allowed enrollment of male patients, and was sufficiently large to enroll significant numbers of minority populations. Here, we report the outcome of male patients and patients of black race. Results: Among 3236 total patients entered on S0221, 23 (0.7%) were male and 378 (12%) were of self-reported black race. Non-significant differences in male/female patients were seen in HER2 positivity (9%/19%), hormone receptor (HR) positivity (100%/66%), lymph node negativity (17%/26%), and treatment completion rate (70%/74%), but men were more often ≥60 years old (48%/21%, p=0.006). Males had significantly worse disease-free survival (DFS), with 5-year DFS 49%/82%; HR=3.16, Log-Rank p=0.0003. Male sex remained an adverse facto...

A previous interim report of MM‐011, the first study that combined lenalidomide with anthracycline‐based chemotherapy followed by lenalidomide maintenance for relapsed and/or refractory multiple myeloma (RRMM), showed promising safety and activity. We report the long‐term outcomes of all 76 treated patients with follow‐up ≥5 years. This single‐center phase I/II study administered lenalidomide (10 mg on days 1–21 of every 28‐day cycle), intravenous liposomal doxorubicin (40 mg/m2 on day 1), dexamethasone (40 mg on days 1–4), and intravenous vincristine (2 mg on day 1). After 4–6 planned induction cycles, lenalidomide maintenance therapy was given at the last tolerated dose until progression, with or without 50 mg prednisone every other day. The median number of previous therapies was 3 (range, 1–7); 49 (64.5%) patients had refractory disease. Forty‐three (56.6%) patients received maintenance therapy. Grade 3/4 adverse events occurred during induction and maintenance therapy in 48.7% and 25.6% of patients, respectively. Four (5.3%) treatment‐related deaths occurred during induction. Responses were seen in 53.0% (at least partial response) and 71.2% (at least minor response) of patients. Overall, median progression‐free survival and overall survival were 10.5 and 19.0 months, respectively; in patients with refractory disease these values were 7.5 and 11.3 months, respectively. Lenalidomide with anthracycline‐based chemotherapy followed by maintenance lenalidomide provided durable control in patients with RRMM (ClinicalTrials.gov number, NCT00091624). Am. J. Hematol. 89:349–354, 2014. © 2013 Wiley Periodicals, Inc.

Introduction: CTC are detectable in approximately 75% of patients with metastatic breast cancer (MBC), and are elevated (≥5CTC/7.5 ml whole blood (WB)) in about half. Elevated CTC at baseline are associated with a worse prognosis, and a decline in CTC levels suggests response to therapy. We initiated a prospective randomized clinical trial (SWOG S0500) to test whether a change in chemotherapy after failure to clear CTC after one cycle of first line chemotherapy would improve outcomes of patients starting first line cytotoxic chemotherapy for MBC. Methods: Patients initiating first-line chemotherapy for MBC were enrolled. All patients had measurable or evaluable disease that included bone metastases. Patients with elevated CTC at baseline and who continued to have elevated CTC after 21 days of therapy were randomly assigned to either continue initial therapy until progression or to change to a second line chemotherapy (physician choice) immediately at cycle 2. Patients with elevated CTC at baseline, which were not elevated at the 21-day follow-up were maintained on their initial therapy. Patients without elevated CTC at baseline were followed in an observation arm. The primary endpoint was overall survival, and progression-free survival was a secondary endpoint. It was expected that approximately 500-650 patients would have to be screened to enroll 120 patients in the randomized trial. Power was 81% with 2-sided α = 0.05 to detect a 70% increase in median overall survival for patients randomized to change therapy. Three interim analyses were planned during the course of the trial. Results: From 10/1/2006 until 3/15/2012, 624 patients were registered of whom 612 were eligible. A baseline CTC was obtained in 593 (97%) eligible patients of whom 317 (53%) had elevated CTC at baseline. Thirty-one patients (10%) with elevated baseline CTC did not complete the follow-up CTC due to death, progression, withdrawal, or assay failure. Of the 286 remaining patients, 123 patients (43%) continued to have elevated CTCs after the first cycle of chemotherapy and were randomly assigned to either maintain original chemotherapy (n = 64) or switched to new chemotherapy (n = 59). Final outcome results will be analyzed in October 2013 and will be reported if released by the SWOG Data Safety Monitoring Board. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S5-07.

CRA1008 Background: S0221 is a SWOG-coordinated phase III adjuvant chemotherapy intergroup trial in node-positive and high-risk node-negative operable breast cancer which hypothesized that 1) the weekly AC+G regimen is superior to ddAC x 6 and 2) 12 weeks of weekly paclitaxel (wP) is superior to q 2 week paclitaxel x 6 (ddP). METHODS Between December 2003 and November 2010, 2,716 patients were randomized in a 2 x 2 factorial design to 1) AC+G vs ddAC and 2) P 80 mg/m2/week x 12 vs P 175 mg/m2 q 2 weeks x 6. If there was no significant interaction between the factors, the trial was powered to find a disease-free survival hazard ratio (HR) ≤ 0.82 for weekly vs q 2 week for each factor. At the first interim analysis, the AC randomization was halted for futility, and S0221 was closed to accrual 10 November 2010. S0221 reopened 15 December 2010, after which time all patients received 4 cycles of ddAC and randomization to P weekly x 12 and ddP x 6 continued. Accrual halted at a total of 3,294 in January 2012. RESULTS By September 7, 2012, 487 events and 340 deaths had occurred, prompting the third planned interim analysis. The Data Safety and Monitoring Committee recommended reporting the results since the futility boundary was crossed. A Cox model adjusting for the AC arms had a HR = 1.08 (95% CI 0.90-1.28; p=0.42), with the 99.5% CI excluding the original alternative hypothesis that the HR=0.82. There was no significant interaction of the two factors. Estimated 5-year progression-free survivals were 82% for weekly P and 81% for ddP. Toxicity data were available for 1,385 patients treated with ddP and 1,367 treated with weekly P. Grade 5 toxicity occurred in 4 patients on ddP and 2 on weekly P. Percent grade 3-4 toxicity per arm are shown in the Table. CONCLUSIONS Either ddPx6 or weekly P x 12 are acceptable schedules of P administration. The differences in leukopenia likely reflect ascertainment bias against weekly P. If this is accepted, weekly P x 12 produces less overall toxicity than 6 cycles of ddP. Support: NCI grants CA32102, CA38926, CA21115, CA21076, CA77597, CA25224, CA77202, CCSRI15469, and Amgen, Inc. CLINICAL TRIAL INFORMATION NCT00070564. [Table: see text].

PURPOSE This three-phase study was performed to improve the mean relative dose intensity (RDI) of chemotherapy administered to patients in a community-based outpatient cancer center. METHODS Medical records were reviewed for patients who began receiving systemic chemotherapy for lymphoma or cancer of the breast, lung, endometrium, ovary, or colon. During phase 1, records were reviewed and the mean RDI was determined through collection of demographic, diagnostic, chemotherapy, and laboratory data. Phase 2 involved implementation of quality improvement initiatives to improve the RDI: development of a febrile neutropenia risk assessment tool, revision of our dose cancellation policy, and interdisciplinary education. Finally, after implementation of these initiatives, the mean RDI was prospectively determined in phase 3, similar to phase 1. RESULTS The mean RDI was determined to be 83% during phase 1 compared with 91% during phase 3 (P=.0087). For adjuvant chemotherapy, the mean RDI was 85% and 95% for phases 1 and 3, respectively (P=.0035). Likewise, for metastatic disease, the mean RDI was 76% and 82% for phases 1 and 3, respectively (P=.3935). The proportion of regimens that met or exceeded the recommended minimum goal RDI of 85% was 54% for phase 1 and 80% for phase 3. Granulocyte colony-stimulating factor use increased from 69% preintervention to 81% postintervention. CONCLUSION The mean overall RDI improved above the threshold goal of 85%, with the RDI for adjuvant chemotherapy reaching 95%, after implementation of three quality-improvement initiatives. With continued education and following policies already in place, further improvements in RDI could be demonstrated.

7512 Background: Linifanib is a potent and selective inhibitor of VEGF and PDGF receptors with modest single-agent activity in NSCLC. We evaluated the combination of linifanib with carboplatin (C) ...

1004 Background: AC+G (doxorubicin 24 mg/m2/week x 15, cyclophosphamide 60 mg/m2/day po, and filgrastim daily except on the days of doxorubicin administration) produced encouraging results in a SWOG Phase II trial of pre-operative chemotherapy in locally advanced breast cancer. S0221 is a SWOG-coordinated Phase III adjuvant chemotherapy intergroup trial in node-positive and high-risk node-negative operable breast cancer, which hypothesized that the AC+G regimen is superior to ddAC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2 IV and pegfilgrastim q 2 weeks x 6) and that weekly paclitaxel is superior to q 2 week paclitaxel. METHODS Between December 2003 and November 2010, 2716 patients were randomized in a 2x2 factorial design to 1) AC+G vs ddAC and 2) paclitaxel 80 mg/m2/week x 12 vs paclitaxel 175 mg/m2 q 2 weeks x 6. If there was no significant interaction between the factors, the trial was powered to find a disease-free survival hazard ratio (HR) ≤ 0.82 for weekly vs q 2 week for each factor. RESULTS By September 8, 2010, 349 events (161 ddAC, 188 AC+G) had occurred among 2,477 patients with follow-up, prompting the first planned interim analysis at 30% of the expected events. The arms were balanced for standard prognostic factors, and a Cox model adjusting for the paclitaxel arms had a HR = 1.21 (95% CI 0.98-1.50; p=0.071) favoring ddAC. The prescribed boundary for futility was the 99.5% CI (0.90-1.64) excluding the original alternative hypothesis that HR=0.82. No boundary was crossed for the paclitaxel comparison and there was no significant interaction of the two factors. Therefore, the Data Safety and Monitoring Committee recommended stopping randomization to the AC+G arms due to futility. Analyses by nodal-, hormone-receptor-, and HER2 status found no subset in which AC+G appeared superior. S0221 has re-opened and randomizes patients to the two paclitaxel arms after only 4 cycles of ddAC. CONCLUSIONS Accrual will continue to 3,250 patients and ancillary studies remain ongoing. We conclude that AC+G is not superior to ddAC x 6, and do not recommend AC+G for routine use. Support: NCI grants CA32102, CA38926, CA21115, CA21076, CA77597, CA25224, CA77202, CCSRI15469, and Amgen, Inc.

Abstract 1967 Background: An initial report of MM011 described the MTD and promising activity in the first 62 patients (pts) (Baz R et al, Ann Oncol 2006). Here we report complete outcomes of the entire study cohort (n=77) with over four years since the enrollment of the last patient. Methods: Pts with relapsed or refractory myeloma after at least 2 cycles of previous therapy were treated with lenalidomide at increasing dose levels (5mg – 10mg – 15mg, MTD 10mg) d1-21 every 28 days, liposomal doxorubicin 40mg/m 2 d1, dexamethasone 40mg d1-4, and, if no significant neuropathy was present, vincristine 2mg IV for 4–6 cycles (2 cycles beyond best response) followed by lenalidomide maintenance at 10mg d1-21 every 28 days. Prednisone 50 mg every other day was allowed during maintenance, dexamethasone was not. DVT prophylaxis with aspirin 81 mg daily was mandated. All pts were included in PFS and OS analyses. Patient mortality was verified via social security death index as of July 20, 2010. Pts who developed progressive disease after at least one dose of study drug or who had measurable disease and stayed on study for at least 60 days were considered evaluable for response. Results: From 03/2003 to 04/2006 77 pts of median age 62 years (range, 41–81) were enrolled, median follow up on study was 16.4 months (range, 0.2–80.4). Median time from diagnosis to enrollment was 39 months (range, 4–118); 67 pts (87%) had Salmon-Durie stage III at diagnosis; median previous therapies were 3 (range 1–7); 49 pts (64%) were refractory to last induction (46 after previous response, 3 primary refractory). Karyotype analysis at study entry revealed abnormal cytogenetics in 28 (36.4%), with del13 in 13 (17.1%) and del17p in 5 pts (6.6%). Previous therapies included doxorubicin (n=60, 78%), thalidomide (n=56, 73%), bortezomib (n=20, 26%), high dose chemotherapy with ASCT (n=17, 22%), and lenalidomide (n=4, 5%). During induction, grade 3 and 4 adverse events occurred in 37 pts (48.1%), with hematologic AEs, VTEs, and infections observed in 32.5%, 6.5%, and 3.9% of pts, respectively. 43 pts (56%) reached maintenance and 41 of them received prednisone in addition to lenalidomide. During maintenance 11 out of 43 pts (25.6%) experienced grade 3 or 4 AEs, (hematologic: 16.3%, infections: 4.7%, VTEs: 4.7%). One patient experienced heart failure that was attributed to severe aortic stenosis. 64 out of 77 pts (83%) were evaluable for response. According to uniform international response criteria with adapted EBMT criteria for MR, their rates of CR, VGPR, PR, and MR were 5%, 16%, 33%, and 20%, respectively, resulting in a 54% response rate (RR=CR+VGPR+PR) and a 74% clinical benefit response rate (CBRR=RR+MR). Median PFS and OS were 12.1 and 21 months, respectively. In the subgroup of 46 pts with relapsed and refractory myeloma, 37 were evaluable for response and achieved a RR of 49% and a CBRR of 65% (VGPR 14%, PR 35%, MR 16%). Median PFS and OS in pts with relapsed and refractory disease (n=46) were 9.7 and 14 months, respectively. Pts with disease relapsed after or refractory to prior thalidomide or lenalidomide and refractory to or relapsing within 60 days after bortezomib (n=14; median age=62.5 years, median previous therapies=4) experienced median PFS and OS of 7.3 and 9.6 months, respectively, as compared to median EFS of 1 and OS of 6 months in a comparable patient population (Kumar S et al, ASH 2009 #2878). Among 12 pts evaluable for response in this highest risk group, RR and CBRR were 25% and 50%, respectively. Their median duration of response was 5.8 months. Conclusion: DVd-R yielded impressive long-term outcomes in relapsed and refractory myeloma pts, even if their myeloma was refractory to bortezomib. Disclosures: Baz: Celgene: Research Funding. Hussein: Celgene: Employment. Srkalovic: EPIC: Speakers Bureau; Physicians Connect: Speakers Bureau. Dean: Celgene: Research Funding. Knight: Celgene: Employment. Zeldis: Celgene Corp: Employment. Reu: Celgene: Research Funding.

Abstract 5046 Background: Bortezomib (B) is a reversible proteasome inhibitor approved by FDA for relapsed/refractory multiple myeloma (MM) patients (pts) in second and higher lines of therapy. The standard regimen includes i.v. injections of B 1.3 mg/m 2 on days 1, 4, 8 and 11 in a 21-day cycle. The addition of dexamethasone (D) 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 increases responses as well as the toxicity of the treatment. Generally accepted protocol is to give up to 8 cycles of the treatment. In this abstract we describe preliminary results of open-label, Phase II clinical trial employing only 4 cycles of standard B+D regimen in order to improve safety and evaluate efficacy. Methods: Patients with relapsed/refractory MM who had at least one previous therapy qualified for the trial. In the study they were treated with 4 cycles of standard B+D regimen followed by B maintenance. Patients who achieved complete response (CR) by Blade/EBMT criteria within 4 cycles received up to 2 additional cycles of standard B+D and then were followed closely off study. Those who had partial response (PR) or stable disease (SD) were placed on maintenance therapy with B 1.6 mg/m 2 i.v. injections on days 1,8,15,22 on 36-days cycle until progression of the disease (PD), development of unacceptable toxicity or decision to stop treatment. Patients with PD were taken of the study. A bone marrow biopsy and aspirate with cytogenetics evaluation were done at the start of the treatment and at the time of CR, PD or decision to stop treatment. MM disease assessment was done with each 21- or 36-day cycle. Thirty eligible and evaluable pts are planned to participate in the study. Primary objective of the study is to evaluate overall response rate (PR + CR). A two-stage accrual design is used in order to allow study to be terminated early, should preliminary results indicate poor activity of the regimen. Results: Fifteen relapsed/refractory MM pts were evaluable in this first analysis. Mean age was 67.2 years (range 51–84). Eleven pts were males and four females. Sixty percent (9/15) of them were IgG kappa MM, 13.3% (2/15) had IgG lambda and lambda light chain disease, respectively and other 2 had IgA kappa and IgA lambda MM, one each. Mean beta-2-macroglobulin level was 9.3 mg/L (range 2.4–79). Most of the patients (13/15) were stage II (7 pts) and III (6 pts) by International Staging System (ISS, 2005). Cytogenetic studies were available in 13 out of 15 pts. Twelve pts had normal findings and one pt was hyperdiploid. Number of previous lines of treatments was 1.7 (range 1–6). Almost all pts (13/15) had received one of the immunomodulators (thalidomide or lenalidomide), one pt was treated with B and one had autologus peripheral stem cell transplant. After 4 cycles of standard B+D, 9/15 (60%) pts responded to the treatment (20% CR and 40% PR). Three pts (20%) had SD and another 3 (20%) had PD. Eight pts continued maintenance treatment with once-a-week B and received 1–35 cycles. There were no additional responses during the maintenance phase. The most common grade (Gr) 3/4 hematological side effects were thrombocytopenia (40% of pts) and anemia (6.6%). Non-hematological Gr 3/4 toxicities were neuropathy (13.3%), infections (6.6%) and fatigue (6.6 %). Median time to progression and overall survival are presently evaluated. Conclusion: Although results of this Phase II study are very preliminary, treatment with reduced number of standard twice-a-week B+D cycles seem to result in significant overall response rates and very good tolerability in the group of pts with advanced relapsed/refractory MM. It is worth mentioning that 86% of pts were previously treated with immunomodulators. In addition, maintenance with weekly B seems to be very well tolerated and one of the pts is treated for more than 4 years without major complications. Disclosures: Al-Janadi: EPIC: Speakers Bureau; Millenium: Membership on an entity9s Board of Directors or advisory committees. Srkalovic: EPIC: Speakers Bureau; Physicians Connect: Speakers Bureau.

Objective. This study was undertaken to determine the averagerelative dose intensity (RDI) of chemotherapy administeredto patients in a community-based outpatient cancercenter. Methods. A retrospective review of medical recordsin an outpatient cancer center was conducted for patientsinitiating systemic chemotherapy in 2007 for a diagnosis oflymphoma, breast, lung, ovary, or colon cancer. Eighty-fourrecords meeting the inclusion criteria were reviewed for demographicinformation, primary tumor type, chemotherapyregimen, staging at diagnosis, presence of disease progression,and mortality status. Regimen data included: chemotherapeuticagents used, dosages administered, dates of administration,treatment intent (adjuvant vs. metastatic), andgranulocyte colony-stimulating factor (G-CSF) usage percycle. Mean summary statistics were calculated and averageRDI was analyzed. Results. The overall RDI at our institutionwas 83% (n=65). The RDI for those receiving adjuvant chemotherapywas 85% (n=51), whereas for those receiving chemotherapyfor metastatic disease the RDI was 76% (n=14).Fifty-four percent (n=35) of the regimens met or exceededthe recommended minimum goal RDI of > 85%. Conclusions.Overall the average RDI at our institution was 83%,slightly below the goal of ≥ 85%. Patients with potentially curablemalignancies receiving adjuvant chemotherapy reachedthe threshold RDI; however, areas for quality improvementexist at our institution.