The value of tissue protein expression as a predictor of efficacy for first- or second-line therapy (tx) in metastatic ductal pancreas cancer (PDAC) in patients (pts) receiving either gemcitabine (G)-based tx or 5FU (F)-based tx.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 460-460
Author(s):  
Lauren Carcas ◽  
Jessica Macintyre ◽  
Jaime R. Merchan ◽  
Peter Joel Hosein ◽  
Ikechukwu Immanuel Akunyili ◽  
...  
Keyword(s):  
Statistical Power ◽  
Statistical Significance ◽  
Clinical Stage ◽  
Performance Status ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Type I ◽  
Histologic Subtype ◽  
Gastric Type ◽  
And Performance

460 Background: No validated biomarkers exist to direct treatment decisions in PDAC. Decisions regarding tx choices are based on age, organ function, and performance status. Defining predictors of efficacy to F (alone or in combination) or G (alone or in combination) in PDAC are urgently needed. Histologic subtype by immunohistochemistry (IHC); pancreatobiliary type (PB), intestinal type (I), gastric type (Ga) and intestinal/gastric type (I/G); may predict benefit to G or F. Methods: Charts of PDAC pts from 2 institutions from 2007 to 2013 having both pathology specimen and a qualifying tx (FOLFIRINOX, FOLFOX, FOLFIRI, Capecitabine or G or G and nab-paclitaxel) were reviewed. IHC phenotypes were defined by staining >25% CDX2 = I, >25% MUC5 = Ga, >25% CDX2 and MUC5 = I/G, >25% MUC1 = PB. Results: 51 pts were identified. 4 cases had Stage II disease without recurrence after adjuvant tx and were excluded. 5 tumors were PB, 1 I, 3 I/G, 38 Ga. 41 (87%) had Ga or I/G type. Due to lack of statistical power for the other histologic subtypes, response to F or G was only analyzed in the 35 metastatic pts with the Ga subtype. 14 were metastatic at diagnosis. 24 males. Median age 57. 21 Hispanic, 14 Non-Hisp. The PFS for Ga treated with F based tx (>12 m) versus G (~9 m) based tx in the 1st line approached statistical significance (p=0.050). In multivariable analysis with adjustments for clinical stage, ECOG, age at dx, there was a significant lower risk of progression in pts treated with F based tx versus G based tx (HR=0.278, p=0.0315). Conclusions: There was near statistical significance favoring F based tx over G based tx in PDAC Ga subtype (p=0.05). Historically, G has proven superior to F as a single agent but our findings suggest F in combination may be superior to G in combination, at least for the treatment of Ga subtype.

When Studies are in Error: Basic Statistical Vocabulary Needed to Understand Clinical Studies

1996 ◽  
Vol 1 (1) ◽  
pp. 25-28 ◽  
Author(s):  
Martin A. Weinstock
Keyword(s):  
Null Hypothesis ◽  
Statistical Power ◽  
Critical Appraisal ◽  
Type I Error ◽  
Statistical Significance ◽  
P Value ◽  
Type I ◽  
Type Ii ◽  
Type Ii Error ◽  
Error Type

Background: Accurate understanding of certain basic statistical terms and principles is key to critical appraisal of published literature. Objective: This review describes type I error, type II error, null hypothesis, p value, statistical significance, a, two-tailed and one-tailed tests, effect size, alternate hypothesis, statistical power, β, publication bias, confidence interval, standard error, and standard deviation, while including examples from reports of dermatologic studies. Conclusion: The application of the results of published studies to individual patients should be informed by an understanding of certain basic statistical concepts.

A phase II trial of capecitabine (C) in combination with the farnesyltransferase (FT) inhibitor (FTI), tipifarnib (T), in patients (pt) with metastatic breast cancer (MBC): ECOG trial 1103

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1036-1036
Author(s):  
M. Wang ◽  
W. J. Gradishar ◽  
J. A. Sparano ◽  
E. A. Perez ◽  
G. Sledge
Keyword(s):  
Mononuclear Cells ◽  
Performance Status ◽  
Single Agent ◽  
Objective Response ◽  
Human Tumor ◽  
Metastatic Breast ◽  
Type I ◽  
Post Translational Modification ◽  
Ras Genes ◽  
Previously Treated

1036 Background: Approximately 30% of human cancers have mutated Ras genes that produce proteins that remain in an active state causing uncontrolled proliferative signals. Post-translational modification of Ras include farneyslation catalyzed by FT. Tipifarnib (R115777) is an oral FTI active against human tumor cell lines and exhibiting modest single agent activity in pts with previously treated MBC. A previous phase I trial reported that CT inhibited farneyslation in peripheral blood mononuclear cells without affecting the pharmacokinetics of either agent. Objective: To evaluate objective response rate (ORR) of CT in taxane refractory MBC and to secondarily evaluate associated toxicity and progression-free survival (PFS). Methods: Pt with measurable MBC, previously treated (rx) with an anthracycline and relapse on a taxane or within 30 days (d). Study rx: T- 300 mg, po BID × 14 d plus C- 1,000 mg/m2, po BID × 14 d, followed by 7 d rest. Tumor reassessment was repeated q 3 cycles. The study was designed to detect improvement in ORR from 25% with C alone to 40% for the CT combination (90.5% power; type I error rate of 9.9%; 21 responses in 64 eligible pt needed to be promising. Results: 66/71 pt are available for primary analysis. Median age 50 yrs. Performance status: 0–1, 100%. ORR: PR-4.8% (3/62) [95% CI 0.01, 0.13], SD - 21% (13/62) [ 95% CI 0.12, 0.33]. Median survival - 10.6 months. Toxicity (%): anemia - 8(G3/4), neutropenia - 30 (G3/4), thrombocytopenia - 8 (G3/4), HFS-8 (G3), nausea/vomiting - 11(G3), diarrhea - 8 (G3), sensory neuropathy - 5 (G3). Conclusion: CT in taxane -refractory MBC has low antitumor activity without excessive toxicity. More mature data, including PFS, will be presented. No significant financial relationships to disclose.

Treatment patterns and outcomes in “real world” patients (pts) with metastatic urothelial cancer (UC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4525-4525 ◽  
Author(s):  
Matt D. Galsky ◽  
Simon Chowdhury ◽  
Joaquim Bellmunt ◽  
Yu-Ning Wong ◽  
Federica Recine ◽  
...  
Keyword(s):  
Real World ◽  
Smoking Status ◽  
Performance Status ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Perioperative Chemotherapy ◽  
Primary Tumor Site ◽  
Primary Tumors ◽  
Metastatic Urothelial Cancer ◽  
Line Chemotherapy

4525 Background: Most studies reporting outcomes of pts with metastatic UC are derived from clinical trial data, potentially limiting the breadth/generalizability of the findings. To explore patterns of care/outcomes in “real world” pts, we initiated an international retrospective cohort study. Methods: Data were collected via an electronic data capture platform from 23 centers. Eligible pts had UC (at least muscle-invasive) and were initially evaluated from 1/1/2006-1/1/2011. Parameters were subjected to regression analysis to identify prognostic variables. Results: By 12/18/12, 1905 pts were enrolled. Among 1077 with metastatic UC, median age was 67 (IQR 60-75), 80% were male, 87% had bladder primary tumors, and 33% received perioperative chemotherapy. Only 758 (70%) received 1st-line chemotherapy for metastatic UC: cisplatin-based (51%), carboplatin-based (29%), non-platinum single-agent (16%), and non-platinum multi-agent (4%). The median survival from date of diagnosis of metastatic UC was 5.2 months (95% CI 4.4-6.5) and 16.1 months (95% CI 15.1-17.5) for pts who did and did not receive 1st-line chemotherapy, respectively [13.9 months (95% CI 12.78-14.98) from start of chemotherapy for latter group]. Among pts receiving 1st-line chemotherapy, univariable analysis revealed gender, primary tumor site, removal of primary, creatinine clearance, LDH, and hgb were not significantly associated with survival whereas smoking status, performance status, perioperative chemotherapy, metastatic sites, study site and chemotherapy regimen were. The multivariable analysis is shown in the Table. Conclusions: The current analysis identifies previously unrecognized prognostic factors in an international cohort of “real world” pts with metastatic UC treated with 1st-line chemotherapy. A large subset of pts with metastatic UC receives no chemotherapy. [Table: see text]

Predictors of outcome for pemetrexed (Pem) in metastatic NSCLC (mNSCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19025-e19025
Author(s):  
Cortney Vanderbilt Jones ◽  
Lingling Du ◽  
Paul Elson ◽  
Tarek Mekhail ◽  
Nathan A. Pennell ◽  
...  
Keyword(s):  
Survival Data ◽  
Clinical Benefit ◽  
Performance Status ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards Model ◽  
Front Line ◽  
Metastatic Nsclc ◽  
Poorly Differentiated ◽  
Metastatic Sites

e19025 Background: Pemetrexed (Pem) is the first agent showing different efficacy based on histology in the treatment (tx) of NSCLC. Our goal was to identify outcome predictors in patients (pts) with metastatic NSCLC (mNSCLC) treated with pem. Methods: Retrospective data of pts with mNSCLC who received pem were analyzed. Variables included demographics, ECOG performance status (PS), disease sites, pre/post-pem tx, and toxicities. Clinical benefit defined as complete response (CR), partial response (PR), and stable disease (SD) >6 months, progression-free survival (PFS), and overall survival (OS) were analyzed using logistic regression and Cox proportional hazards model. Results: 240 pts were included. 55% male, 84% smokers. 68% adenocarcinomas, 10% squamous/adenosquamous carcinomas. Median age 64 years (range 34-84). Pem was given for a median of 4 cycles (range 1-73), as 1st line in 20% and 2nd line in 50%, given as a single agent in 69%. The most common toxicities were constitutional (50%) and GI related (29%). 31% of pts achieved CR (n=4) or PR, 33% progressed, 36% had SD. Front-line pem use (p=.0003), adenocarcinoma histology (p=.05), and non-pulmonic metastatic sites ≤2 (p=.01) were independent predictors of clinical benefit, with response rate of 71% for pts with all three features, compared to only 7% for pts with none of these features. Multivariable analysis of survival data revealed ECOG PS >1, non-pulmonic metastatic sites>2, and squamous/poorly differentiated histology predicted poor PFS and OS. In addition, interval from diagnosis to start of pem <12 months and male gender predicted poor PFS, while former/current smoker predicted poor OS. Pts with favorable features had a median PFS of 7.7 months, compared to 2.1 months with unfavorable features (p<.0001). A median OS of 16 months was achieved in pts with favorable features, compared to 5.9 months with unfavorable features (p<.0001). Conclusions: Front-line pem use, adenocarcinoma histology, and ≤2 non-pulmonic metastatic sites predict better response to pem. Poor PS, >2 non-pulmonic metastatic sites, squamous/poorly differentiated histology predict poor PFS and OS. An analysis of biomarkers is ongoing.

Effect of adding immunotherapy (IT) to treatment regimen of mantle cell lymphoma (MCL): Analysis of the National Cancer Data Base (NCDB).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19022-e19022
Author(s):  
Alaa Altahan ◽  
Eric Vick ◽  
Upama Giri ◽  
Eric Wiedower ◽  
Michael Gary Martin
Keyword(s):  
Cox Regression ◽  
Statistical Significance ◽  
Clinical Stage ◽  
Single Agent ◽  
National Cancer Data Base ◽  
Cox Regression Analysis ◽  
Cancer Data ◽  
Treatment Regimens ◽  
Significant Difference ◽  
A Prospective Study

e19022 Background: There has been some improvement in overall survival (OS) for patients with MCL over the past years [Gordon 2014]. However, side effects of treatment remain a major concern. With introduction of novel therapies like IT, it is imperative to optimize treatment regimens to improve survival while minimizing toxicity. Methods: MCL patients (pts) who were diagnosed in 2013 or later with information available about chemotherapy (CT) and IT and did not receive transplant were extracted from NCDB. Pts were assigned to age categories and were sorted into six groups based on different combinations of CT (none, single agent (SA), and multi-agent (MA)) with or without IT. Cox regression analysis was used to perform multivariate analysis that included age category, sex, race, clinical stage, Charlson/Deyo score, CT, radiation, and IT for each group. Multivariate p values (p) were used to analyze statistical significance. Kaplan Meier method was utilized to analyze OS. T-test was used to compare means (t-p). Results: 1438 total pts were identified with a mean age of 70 (range 24-90); 71% male; 93% white, 4% black, 3% others; 42% with stage III/IV disease. 667 pts did not receive CT or IT, and 40 received IT alone and both of these groups were excluded from further analysis. 52 pts received SA- (without) IT, 206 received SA+(with) IT and 260 pts received MA-IT and 213 MA+IT. Mean age was 72 and 66 for SA and MA groups, respectively (t-p<0.01). Mean OS for SA+IT was 27 months (m) vs SA-IT 16 m (p < 0.01). MA+IT v MA-IT showed no difference in mean OS (25 vs 26 m, respectively, p =0.49). Although there was a significant difference in OS between SA and MA groups without IT (16 vs 25 months, p < 0.01). SA + IT group showed comparable mean OS time to MA + IT (27 vs 26 m, p =0.145). Conclusions: For MCL pts, MA has superior OS to SA group. However, adding IT significantly improves OS for SA group and makes it comparable to MA. Adding IT to MA did not provide significant difference in OS. These results highlight the possibility of achieving same OS with less toxic regimens. Hence further evaluation in a prospective study to optimize treatment while reducing toxicity is warranted.

scholarly journals Early and Midtreatment Mortality in Palliative Radiotherapy: Emphasizing Patient Selection in High-Quality End-of-Life Care

2021 ◽  
Vol 19 (7) ◽  
pp. 805-813
Author(s):  
Matthew S. Ning ◽  
Prajnan Das ◽  
David I. Rosenthal ◽  
Bouthaina S. Dabaja ◽  
Zhongxing Liao ◽  
...  
Keyword(s):  
Head And Neck ◽  
End Of Life ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Palliative Radiotherapy ◽  
Cancer Center ◽  
Time To Death ◽  
Stereotactic Technique ◽  
Care Consultation ◽  
And Performance

Background: Palliative radiotherapy (RT) is effective, but some patients die during treatment or too soon afterward to experience benefit. This study investigates end-of-life RT patterns to inform shared decision-making and facilitate treatment consistent with palliative goals. Materials and Methods: All patients who died ≤6 months after initiating palliative RT at an academic cancer center between 2015 and 2018 were identified. Associations with time-to-death, early mortality (≤30 days), and midtreatment mortality were analyzed. Results: In total, 1,620 patients died ≤6 months from palliative RT initiation, including 574 (34%) deaths at ≤30 days and 222 (14%) midtreatment. Median survival was 43 days from RT start (95% CI, 41–45) and varied by site (P<.001), ranging from 36 (head and neck) to 53 days (dermal/soft tissue). On multivariable analysis, earlier time-to-death was associated with osseous (hazard ratio [HR], 1.33; P<.001) and head and neck (HR, 1.45; P<.001) sites, multiple RT courses ≤6 months (HR, 1.65; P<.001), and multisite treatments (HR, 1.40; P=.008), whereas stereotactic technique (HR, 0.77; P<.001) and more recent treatment year (HR, 0.82; P<.001) were associated with longer survival. No difference in time to death was noted among patients prescribed conventional RT in 1 to 10 versus >10 fractions (median, 40 vs 47 days; P=.272), although the latter entailed longer courses. The 30-day mortality group included 335 (58%) inpatients, who were 27% more likely to die midtreatment (P=.031). On multivariable analysis, midtreatment mortality among these inpatients was associated with thoracic (odds ratio [OR], 2.95; P=.002) and central nervous system (CNS; OR, 2.44; P=.002) indications, >5-fraction courses (OR, 3.27; P<.001), and performance status of 3 to 4 (OR, 1.63; P=.050). Conversely, palliative/supportive care consultation was associated with decreased midtreatment mortality (OR, 0.60; P=.045). Conclusions: Earlier referrals and hypofractionated courses (≤5–10 treatments) should be routinely considered for palliative RT indications, given the short life expectancies of patients at this stage in their disease course. Providers should exercise caution for emergent thoracic and CNS indications among inpatients with poor prognoses due to high midtreatment mortality.

scholarly journals Nonfollicular small B-cell lymphomas: a heterogeneous group of patients with distinct clinical features and outcome

Blood ◽  
1994 ◽  
Vol 83 (10) ◽  
pp. 2829-2835 ◽  
Author(s):  
F Berger ◽  
P Felman ◽  
A Sonet ◽  
G Salles ◽  
Y Bastion ◽  
...  
Keyword(s):  
Cell Lymphoma ◽  
Clinical Stage ◽  
Performance Status ◽  
Poor Performance ◽  
Large Cell ◽  
Lactic Dehydrogenase ◽  
Small Cell ◽  
Poor Performance Status ◽  
Advanced Clinical Stage ◽  
Histologic Subtype

Abstract Two hundred sixteen patients with a nonfollicular small cell lymphoma followed up in our department over a 5-year period have been reviewed to define the clinical behavior and survival of patients with each histologic subtype. The respective frequencies of major subtypes were: small lymphocytic/lymphoplasmacytoid lymphoma (immunocytoma, SL/LPL), 28%; large cell-rich immunocytoma (LCRI), 7%; mantle cell lymphoma (MCL), 24%; mucosa-associated lymphoid tissue-lymphoma (MALT-L), 20%; other rare subtypes, 6%; and nonclassified or nonreviewed, 14%. The SL/LPL patients and the MALT-L patients had a relatively indolent disease, usually disseminated for SL/LPL and usually localized for MALT- L. Both subtypes have a long time to treatment failure (TTF; median, 48 and 58 months, respectively) and long survival (median, 118 and 98 months, respectively). The LCRI patients or the MCL patients had more aggressive clinical or biologic features and experienced shorter TTF (median, 26 and 14 months, respectively) and shorter survival (median, 55 and 52 months, respectively). None of these histologic subtypes was associated with a significant cure rate. MALT-L patients did relapse regardless of the initial localization or treatment and at a similar rate to the SL/LPL patients. Factors associated with a worse outcome in nonfollicular small cell lymphoma patients are identical to those described in other lymphoma subtypes: advanced clinical stage, poor performance status, high tumor bulk, and high lactic dehydrogenase or beta 2microglobulin levels. For patients with disseminated disease, standard chemotherapy regimens did not allow a long TTF; therefore, new therapeutic strategies must be developed.

scholarly journals Analysis of a prospectively randomized comparison of doxorubicin versus 5-fluorouracil, doxorubicin, and BCNU in advanced gastric cancer: implications for future studies.

1986 ◽  
Vol 4 (9) ◽  
pp. 1348-1355 ◽  
Author(s):  
J A Levi ◽  
R M Fox ◽  
M H Tattersall ◽  
R L Woods ◽  
D Thomson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Measurable Disease ◽  
Duration Of Response ◽  
And Performance

A multi-institutional cooperative study of patients with locally advanced, recurrent, or metastatic gastric adenocarcinoma who had not previously received chemotherapy was conducted, prospectively randomizing patients to receive either doxorubicin or the three-drug combination, 5-fluorouracil (5-FU), doxorubicin (Adriamycin; Adria Laboratories, Columbus, Ohio), and BCNU (FAB). The 187 evaluable patients were initially stratified according to the presence of measurable or evaluable disease and performance status. There was a significantly higher response rate observed for FAB (40%) compared with doxorubicin (13%) among the 145 measurable-disease patients. Duration of response and survival were significantly longer for FAB in the measurable-disease group, but for the total patient population an early advantage for FAB in time to disease progression and survival was lost with continued follow-up. Median survival was 33 weeks for patients receiving FAB and 19 weeks for those receiving doxorubicin. Significant pretreatment factors adversely affecting survival included poor performance status, weight loss of greater than 10%, and more than two sites of metastases. Toxicity was not severe in either treatment arm, and only thrombocytopenia occurred significantly more often with FAB. It is contended that in the treatment of advanced gastric cancer, chemotherapy only exerts a relatively short-term and modest beneficial effect, most apparent in patients with intermediate tumor bulk. 5-FU remains the most active single agent, and combination chemotherapy has not yet proven its overall worth. Further studies are indicated comparing the most active combinations with 5-FU using optimal doses and schedules, and consideration must be given to the incorporation of no-treatment controls.

Randomized phase II trial of single agent erlotinib vs. standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) and performance status (PS) of 2

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7022-7022 ◽  
Author(s):  
R. Lilenbaum ◽  
R. Axerold ◽  
S. Thomas ◽  
A. Dowlati ◽  
L. Seigel ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Single Agent ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Initial Therapy ◽  
Randomized Phase Ii ◽  
Never Smokers ◽  
And Performance

7022 Background: A previous CALGB trial suggested a benefit for carboplatin-paclitaxel (CP) over P alone in pts with PS 2. Erlotinib (E) has activity in previously treated pts with low PS but has not been formally tested in 1st line. Methods: In a multi-center randomized phase II trial, untreated pts with advanced NSCLC and PS 2 were randomized to E 150 mg daily or CP (AUC 6 and 200 mg/m2) for 4 cycles. Pts in CP who progressed, did not tolerate, or refused further therapy were allowed to cross over to E. The primary endpoint was progression-free survival (PFS). QoL analysis was performed in all pts and tumor samples were obtained whenever possible. Results: As of 12/05, 98 of 102 projected pts have been accrued. Results are reported for 88 (46 E; 42 CP). Demographics were balanced except for more females in E (59%) than CP (45%). Most pts had stage IV adenoca histology. Never-smokers comprised 13% and 7% of pts respectively. Response for E: 2% PR and 30% SD; for CP, 10% PR and 45% SD. Gr 2–4 toxicities for E: rash (34%) and diarrhea (11%); for CP: nausea (12%), neuropathy (14%) and fatigue (29%). Median PFS was 2.5 mo for E (95%CI 1.28 - 2.79) and 4.0 mo for CP (95%CI 2.66 - 4.86). Of 42 pts in CP, 21 have crossed over to E. Conclusions: This is the first randomized phase II trial of E in PS 2 patients. Based on preliminary results, PS 2 patients seemed to fare better with standard CP than single agent E as initial therapy. Mature survival and QoL data will be available in June. [Table: see text]

OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA5007-LBA5007 ◽  
Author(s):  
C. Aghajanian ◽  
N. J. Finkler ◽  
T. Rutherford ◽  
D. A. Smith ◽  
J. Yi ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Objective Response ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Type I ◽  
Ecog Performance Status ◽  
Fallopian Tube Cancer ◽  
Phase Iii Trial ◽  
Platinum Sensitive

LBA5007 Background: BEV, a humanized anti-VEGF monoclonal antibody, has shown a progression-free survival (PFS) benefit in 2 frontline phase III trials in patients with EOC, PPC and FTC. The therapeutic impact of BEV in combination with carboplatin (C) and gemcitabine (G) followed by single agent BEV to disease progression (PD) was evaluated in this phase III trial in the platinum-sensitive recurrent setting. Methods: Patients had recurrent, platinum-sensitive EOC, PPC or FTC, 1 prior regimen, no prior BEV, ECOG performance status 0-1, measurable disease. Subjects were randomized to: Arm A: [IV C (AUC 4, Day (D) 1) + G (1,000 mg/m2 D1 and 8) + placebo (PL) D1] q21D x 6 cycles (c) → PL q21D until PD or unacceptable toxicity (tox) Arm B: [CG + BEV (15 mg/kg) D1] q21D x 6 c → BEV q21D until PD or tox primary endpoint was investigator assessed PFS (RECIST). Secondary endpoints included objective response (OR), overall survival (OS), duration of response and safety. The design provided 80% power to detect a 27% reduction in the hazard of progression or death in Arm B vs A, limiting the overall type I error of 5%. Results: OCEANS enrolled 484 patients (242 per arm) from 4/07 - 1/10, median follow up of 24 months. BEV plus CG followed by single agent BEV to PD significantly increased PFS compared to CG alone (HR=0.484, p<0.0001). OR increased by 21% (p<0.0001). OS data is immature with only 29% of patients having had an event. The safety profile was consistent with other BEV trials. Conclusions: Results show a statistically significant and clinically relevant benefit when bevacizumab is added to chemotherapy in patients with recurrent, platinum sensitive EOC, PPC, and FTC. This is the first phase III trial of an antiangiogenic to demonstrate a clinical benefit to these patients. [Table: see text]

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