ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a phase II study in Indian women with recurrent/refractory cervical cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5106-5106
Author(s):  
Partha Basu ◽  
Robert G. Petit ◽  
Keyword(s):  
Cervical Cancer ◽  
Adverse Events ◽  
Phase Ii ◽  
Survival Data ◽  
Protein Targeting ◽  
Phase Ii Study ◽  
Tumor Burden ◽  
Residual Vector ◽  
Serious Adverse Events ◽  
Cell Immunity

5106 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized phase II study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients are randomized to either 3 doses of ADXS11-001 at 1 x 109 CFU or 4 doses of ADXS11-001 at 1 x 109 CFU with cisplatin chemotherapy. Naprosyn and oral promethazine are given as premedications and a course of ampicillin is given 72h after infusion thereby clearing any residual vector. Patients receive CT scans at baseline and Days 84, 184, 273, 365 and 545. The primary endpoint is 12 month survival. Results: As of January 26, 2012, 88 patients have received 200 doses of ADXS11-001; with the percentage of patients alive at 6 months at 62% (34/55); at 9 months at 41% (15/37) and at 12 months at 40% (6/15). Tumor responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) by RECIST. One serious (Gr3) adverse event and 77 mild-moderate (Gr 1-2) adverse events possibly related to study treatment have been reported in 35% (31/88) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that responded to symptomatic treatment, or resolved on their own within hours of treatment. Conclusions: This immunotherapy can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Early signs of clinical benefit merit further investigation. Updated findings will be presented at the meeting.

ADXS11-011 immunotherapy: Preliminary safety data from two P2 studies in women with CIN 2/3 and with recurrent/refractory cervical cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15546-e15546
Author(s):  
Robert G. Petit ◽  
Keith A. Aqua ◽  
Partha Basu
Keyword(s):  
Cervical Cancer ◽  
Adverse Events ◽  
Survival Data ◽  
Protein Targeting ◽  
Safety Data ◽  
Symptomatic Treatment ◽  
Tumor Burden ◽  
Residual Vector ◽  
Serious Adverse Events ◽  
Cell Immunity

e15546 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized phase II study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients are randomized to either 3 doses of ADXS11-001 at 1 x 109 CFU or 4 doses of ADXS11-001 at 1 x 109 CFU with cisplatin chemotherapy. Naprosyn and oral promethazine are given as premedications and a course of ampicillin is given 72h after infusion thereby clearing any residual vector. Patients receive CT scans at baseline and Days 84, 184, 273, 365 and 545. The primary endpoint is 12 month survival. Results: As of January 26, 2012, 88 patients have received 200 doses of ADXS11-001; with the percentage of patients alive at 6 months at 62% (34/55); at 9 months at 41% (15/37) and at 12 months at 40% (6/15). Tumor responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) by RECIST. One serious (Gr3) adverse event and 77 mild-moderate (Gr 1-2) adverse events possibly related to study treatment have been reported in 35% (31/88) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that responded to symptomatic treatment, or resolved on their own within hours of treatment. Conclusions: This immunotherapy can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Early signs of clinical benefit merit further investigation. Updated findings will be presented at the meeting.

ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a P2 study in Indian women with recurrent/refractory cervical cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5529-5529
Author(s):  
Robert G. Petit ◽  
Partha Basu
Keyword(s):  
Cervical Cancer ◽  
Adverse Events ◽  
Survival Data ◽  
Protein Targeting ◽  
Symptomatic Treatment ◽  
Serious Adverse Events ◽  
Indian Women ◽  
Cell Immunity ◽  
Class 1 ◽  
High Risk Hpv

5529 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized P2 study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients were randomized to either 3 doses of ADXS11-001 at 1 x 109 cfu or 4 doses of ADXS11-001 at 1 x 109cfu with cisplatin chemotherapy. Naprosyn and oral promethazine were given as premedications and a course of ampicillin was given 72h after infusion. Patients received CT scans at baseline and 3, 6, 9, 12 and 18 months. The primary endpoint is overall survival. Results: As of February 2013, the trial has completed enrollment and 110 patients have received 264 doses of ADXS11-001. The percentage of patients alive at 6 months is 63% (67/107); at 9 months is 46% (49/106); at 12 months is 34% (30/87) and at 18 months is 15% (8/54). Tumor responses have been observed in both treatment arms with 6 CRs and 6 PRs; 36 additional patients had stable disease > 3 months, for a disease control rate of 44% (48/110). Activity against different high risk HPV strains has been observed. Three serious adverse events and 69 mild-moderate adverse events possibly related/related to ADXS11-001 treatment have been reported in 41% (45/110) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that either resolved on their own or responded to symptomatic treatment. Conclusions: ADXS11-001 can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Final 12-month OS, updated safety and translational analyses will be presented at the meeting.

Randomized phase II study of FOLFOX +/- MET inhibitor, onartuzumab (O), in advanced gastroesophageal adenocarcinoma (GEC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
Manish A. Shah ◽  
Jae Yong Cho ◽  
Iain Tan Bee Huat ◽  
Niall C. Tebbutt ◽  
Chia-Jui Yen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Receptor Activation ◽  
Asia Pacific ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Line Setting

2 Background: Aberrant up-regulation of the MET/HGF pathway is associated with poor prognosis in multiple malignancies, including GEC. Onartuzumab (O) is a fully humanized, monovalent anti-MET antibody that inhibits HGF binding and receptor activation. We examined the efficacy and safety of mFOLFOX6 and O in the first-line setting for metastatic, HER2-negative GEC. Methods: This was a double-blind, placebo controlled phase II study in which patients were randomized 1:1 to mFOLFOX6 + O 10 mg/kg. Eligibility included no prior treatment for metastatic disease, age >18, ECOG 0-1, retained organ function, HER2-negative, and evaluable disease. The primary objectives were to detect a meaningful improvement in progression free survival (PFS) in the ITT population or the MET-positive (≥ 50% of tumor with moderate-strong intensity staining by IHC based on central review) subgroup. With 120 patients enrolled and 84 PFS events observed, the target HR was 0.7 in the ITT population, and 0.6 in the MET-positive subgroup (estimated 50% of total). Results: 123 patients (83 Asia/Pacific, 40 US) from 25 sites were from 7/2012-5/2013. The treatment arms were well balanced: median age (57 placebo (P), 58.5 O), male (n=36 (59%) P, n=40 (65%) O), and MET-positive (n=19 (33%) P, n=16 (28%) O). Serious adverse events were more frequent with O (55%) vs placebo (40%). Selected grade 3-5 adverse events observed at least 5% more commonly with O included neutropenia (58% vs 45%), thrombocytopenia (10% vs 3%), peripheral edema (10% vs 0), and pulmonary embolism (7% vs 2%). At data cutoff (29 Jan 2014), 96 patients had PFS events (n=46 (74%) O, n=50 (82%) P), with median PFS of 6.77 and 6.97 months, respectively (HR 1.08, 95% CI 0.71-1.63). In the MET-positive subgroup, median PFS was 5.95 months for O and 6.8 months for placebo (HR 1.38 [0.60-3.20]). No difference in efficacy was noted with alternate MET-positive definitions (50% vs 90% MET staining, and 1, 2, or 3+ intensity). Conclusions: The addition of O to mFOLFOX6 in metastatic GEC did not improve PFS in either an unselected population or in MET-positive patients as defined by IHC. Additional biomarker analyses are ongoing to identify patients that may benefit from MET inhibition. Clinical trial information: NCT01662869.

scholarly journals Phase II Study of Venetoclax in Combination with Obinutuzumab and Bendamustine in Patients with High Tumor Burden Follicular Lymphoma As Front Line Therapy (PrECOG 0403)

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 814-814
Author(s):  
Craig A. Portell ◽  
Opeyemi Jegede ◽  
Nina D. Wagner-Johnston ◽  
Grzegorz S. Nowakowski ◽  
Christopher D. Fletcher ◽  
...  
Keyword(s):  
Adverse Events ◽  
Follicular Lymphoma ◽  
Phase Ii ◽  
Research Funding ◽  
Phase Ii Study ◽  
Single Agent ◽  
Tumor Burden ◽  
Type I ◽  
High Tumor Burden ◽  
Grade 3

Abstract Background: Chemoimmunotherapy is considered standard initial therapy for follicular lymphoma (FL) with high tumor burden (HTB). Obinutuzumab and Bendamustine (OB) with maintenance Obinutuzumab (mO) is considered a standard therapy for the frontline treatment of HTB FL (GALLIUM, Marcus et al, NEJM 2017). Venetoclax (VEN), an oral BCL2 inhibitor, is an attractive target in FL given the high BCL2 expression; though single agent activity has been disappointing (Davids et al. JCO 2017). BCL2 inhibition is thought to be synergistic with chemotherapy. Thus, the PrE0403 study evaluated the OB-VEN combination in frontline HTB FL. Here we present end of induction (EOI) outcomes. Methods: The primary objective of this Phase II study was to estimate the complete remission (CR) rate at EOI. Potential participants must have had a histologically confirmed diagnosis of FL grade 1, 2, or 3a with HTB defined by GELF or high risk defined by FLIPI-1 criteria. They must have had adequate performance status and organ function. Notably, creatinine clearance must have been ≥50 mL/min. Participants must have not had prior treatment for FL. Eligible participants were treated with Bendamustine IV 90 mg/m2 Day (D) 1 & 2, Obinutuzumab IV 100 mg D1, 900 mg D2, 1000 mg D8 and D15 of Cycle (C) 1 then D1 of each cycle, and VEN 800 mg orally daily D1-10 every 28 days for 6 total cycles. Due to a high rate of laboratory tumor lysis syndrome (TLS) during C1 in the first 21 patients, VEN was removed from C1 and given in C2-6 only. Participants with a CR at EOI were treated with mO IV 1000 mg D1 every 8 weeks for 2 years. Those with a partial response (PR) or stable disease (SD) were treated with mO as well as VEN 800 mg orally daily for 2 years. Pneumocystis jiroveci Pneumonia (PJP) and antiviral prophylaxis was required as was G-CSF support. Response was assessed via Lugano Criteria at EOI including PET/CT and bone marrow assessment. Adverse Events (AEs) were evaluated using CTCAE v5.0. To be considered promising, OB-VEN should improve the null hypothesis CR rate of 50% (OB) to 65%. With an 85% power and a one sided 15% type I error, 56 participants would be needed with an estimated 51 eligible. Support for the study was from Genentech, Member of the Roche Group. Results A total of 56 participants were enrolled and treated between 12/2017 and 11/2020; baseline characteristics are listed in Table 1. TLS was closely monitored in C1 and 8/21 participants developed TLS when VEN was administered in C1; 0/35 when it was not. However, monitoring for TLS in C1 became less stringent when VEN was not administered. Treatment related Grade ≥3 toxicities occurred in 47/56 participants (83.9%) with serious adverse events in 31 of 56 (55.5%). Atypical infections were seen; there was one treatment related death on study due to cytomegalovirus (CMV) encephalitis as well as PJP pneumonia which occurred after induction C6. Enrollment was temporarily suspended and CMV monitoring was implemented with no further occurrences. Another participant receiving mO later developed BK virus nephropathy following mO C6 and now requires ongoing hemodialysis. Another was diagnosed with Respiratory Syncytial Virus pneumonia 30 days after C6 and later PJP pneumonia after C2 of mO. Common (incidence >10%) AEs during induction are listed in Table 2. 45 of 56 (80.4%) participants were able to receive all 6 cycles of OB-VEN. CR was seen in 41 of 56 participants (73.2%, 2 sided 95% Confidence Interval (CI) 59.7-84.2%) at the EOI. 30 participants (53.5%) went onto maintenance. With a median follow up of 20.9 months, estimated 2 year Overall Survival (OS) and Progression-Free Survival (PFS) (90% CI) is 94.4% (82.4-98.3%) and 85.8% (68.8-93.9%) respectively. Conclusions This Phase II study of OB-VEN in untreated HTB FL showed high CR rate and met its primary endpoint with early signs of prolonged PFS. Laboratory TLS was identified but it was unclear if attributed solely to VEN, as baseline laboratory TLS rate for OB is unknown. The rate of Grade ≥3 AE of 83.9% (compared to 69% for OB in GALLIUM, Hiddeman JCO 2018) and the observation of opportunistic infections including CMV encephalitis, PJP pneumonia and BK nephropathy, suggests the combination is highly immunosuppressive. Therefore, while the study met its primary outcome, the combination of OB-VEN at 800 mg for 10 days, plus mO, does not have an acceptable risk/benefit profile. Participants will continue to be followed for efficacy and safety during the maintenance phase. Figure 1 Figure 1. Disclosures Portell: Acerta/AstraZeneca: Research Funding; SeaGen: Research Funding; Pharmacyclics: Honoraria; Xencor: Research Funding; Aptitude Health: Honoraria; BeiGene: Honoraria, Research Funding; Abbvie: Research Funding; TG Therapeutics: Honoraria, Research Funding; Kite: Honoraria, Research Funding; Merck: Honoraria, Research Funding; Morphosys: Honoraria; Targeted Oncology: Honoraria; Genentech: Research Funding; VelosBio: Research Funding. Nowakowski: MorphoSys: Consultancy; Incyte: Consultancy; Kymera Therapeutics: Consultancy; TG Therapeutics: Consultancy; Blueprint Medicines: Consultancy; Nanostrings: Research Funding; Roche: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; Celgene/Bristol Myers Squibb: Consultancy, Research Funding; Zai Labolatory: Consultancy; Daiichi Sankyo: Consultancy; Bantham Pharmaceutical: Consultancy; Curis: Consultancy; Karyopharm Therapeutics: Consultancy; Selvita: Consultancy; Ryvu Therapeutics: Consultancy; Kyte Pharma: Consultancy. Cohen: Janssen, Adicet, Astra Zeneca, Genentech, Aptitude Health, Cellectar, Kite/Gilead, Loxo, BeiGene, Adaptive: Consultancy; Genentech, BMS/Celgene, LAM, BioINvent, LOXO, Astra Zeneca, Novartis, M2Gen, Takeda: Research Funding. Kahl: AbbVie, Acerta, ADCT, AstraZeneca, BeiGene, Genentech: Research Funding; AbbVie, Adaptive, ADCT, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Celgene, Genentech, Incyte, Janssen, Karyopharm, Kite, MEI, Pharmacyclics, Roche, TG Therapeutics, and Teva: Consultancy. OffLabel Disclosure: Venetoclax is not approved for follicular lymphoma or in combination with bendamustine and obinutuzumab

scholarly journals Durable Responses Observed with JAK Inhibition in T-Cell Lymphomas

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2922-2922 ◽  
Author(s):  
Alison J. Moskowitz ◽  
Eric Jacobsen ◽  
Jia Ruan ◽  
Jonathan H. Schatz ◽  
Obadi Obadi ◽  
...  
Keyword(s):  
T Cell ◽  
Adverse Events ◽  
Phase Ii ◽  
Research Funding ◽  
Phase Ii Study ◽  
Objective Response ◽  
Response To Therapy ◽  
Serious Adverse Events ◽  
T Cell Lymphomas ◽  
Stat Pathway

Abstract Introduction: The JAK/STAT pathway is frequently activated in peripheral T-cell lymphomas (PTCLs) and cutaneous T cell lymphomas (CTCLs) however the utility of JAK inhibition as a therapeutic strategy in these diseases is not known. We hypothesize that JAK/STAT pathway alteration (defined by elevated phospho-STAT3 (pSTAT3) expression or presence of JAK or STAT mutations) will predict for sensitivity to JAK inhibition in PTCL and CTCL. We are conducting a phase II study of ruxolitinib, a JAK1/2 inhibitor, in which we assess its efficacy in a cohort of patients (pts) with PTCL and CTCL enriched for JAK/STAT pathway alterations. Methods: This is an investigator-initiated multi-center phase II study evaluating the efficacy of ruxolitinib 20mg twice daily in PTCL and CTCL. Pts with relapsed or refractory (rel/ref) PTCL or CTCL following at least 1 systemic therapy are eligible to enroll onto one of three of the following cohorts: Cohort 1: Disease determined to have JAK or STAT mutations. Cohort 2: Disease with functional evidence of JAK/STAT activation (defined as ≥ 30% pSTAT3 expression by immunohistochemistry). Cohort 3: Disease does not meet criteria for cohort 1 or 2. Pts initially enrolled onto cohort 3 and determined to have JAK/STAT mutations or functional JAK/STAT activation after enrollment are moved to cohorts 1 or 2. Cohorts 1, 2, and 3 are enrolling up to 17, 17 and 18 pts respectively by Simon 2-stage design. Pts receive treatment until progression and are assessed for response to therapy after cycles 2, 5 and every three cycles thereafter. Results: The first stage has been completed for cohorts 1 and 3 and 33 out of planned 52 pts enrolled to date. Details regarding histology, mutations, and treatment course appear in the table and figure. For Cohort 1, 10 out of planned 17 pts enrolled. Mutations involved JAK1 (1), JAK3 (3), STAT3 (4), and STAT5B (4). Out of 8 evaluable pts, overall response rate (ORR) was 38% with 3 partial responses (PR). In addition, 3 pts have ongoing stable disease (SD) lasting 8-18 months. Altogether, 75% achieved clinical benefit (objective response or SD >6 months). For Cohort 2, 5 out of planned 17 pts enrolled. Among the 5 evaluable pts, ORR was 40% with 1 complete response (CR) and 1 PR. For Cohort 3, 18 pts out of planned 18 pts enrolled. Out of 14 evaluable pts, ORR was 21% with 3 PRs. Grade 3 or higher drug-related adverse events (AEs) observed among the 33 pts enrolled included anemia (4), neutropenia (7), thrombocytopenia (2), and lymphopenia (7). Treatment related serious adverse events (SAEs) included 1 episode each of HSV-1 stomatitis, spontaneous bacterial peritonitis, febrile neutropenia, and herpes zoster. Conclusion: Responses observed across all three cohorts of pts with PTCL and CTCL with a trend towards higher rates and more durable responses among pts with JAK/STAT alterations. Efficacy of ruxolitinib in PTCL and CTCL provides proof of concept that JAK/STAT activation is a viable target in T-cell lymphomas. Enrollment onto cohorts 1 and 2 and assessment for JAK/STAT alternations among pts in cohort 3 continues. Figure. Figure. Disclosures Moskowitz: Incyte: Research Funding; ADC Therapeutics: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Bristol Myers-Squibb: Consultancy, Research Funding; Merck: Research Funding; Takeda: Honoraria. Jacobsen:Merck: Consultancy; AstraZeneca: Consultancy; Seattle Genetics: Consultancy. Weinstock:Travera: Equity Ownership; Astra Zeneca, JAX, Samumed, Regeneron, Sun Pharma, Prescient: Patents & Royalties; Novartis, Dragonfly, Travera, DxTerity, Travera: Consultancy; Novartis, Astra Zeneca, Abbvie, Aileron, Surface Oncology, Daiichi Sankyo: Research Funding; Novartis: Consultancy, Research Funding; Genentech/Roche, Monsanto: Consultancy. Horwitz:Aileron Therapeutics: Consultancy, Research Funding; Portola: Consultancy; Celgene: Consultancy, Research Funding; ADC Therapeutics: Consultancy, Research Funding; Spectrum: Research Funding; Kyowa-Hakka-Kirin: Consultancy, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Innate Pharma: Consultancy; Trillium: Consultancy; Forty Seven: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Mundipharma: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Corvus: Consultancy.

A phase II study of early up-front red blood cell transfusion followed by maintenance epoetin-alpha subcutaneously support during chemotherapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20719-e20719
Author(s):  
J. W. Nortier ◽  
A. Ogilvie
Keyword(s):  
Adverse Events ◽  
Blood Cell ◽  
Phase Ii ◽  
Red Blood Cell ◽  
Phase Ii Study ◽  
Tumor Oxygenation ◽  
Red Blood Cell Transfusion ◽  
Target Range ◽  
Serious Adverse Events ◽  
Epoetin Alpha

e20719 Background: To determine in patients with cancer related anaemia (Hb<11,3 g/d) starting with their chemotherapy the efficacy and safety of up-front red blood cell transfusion and subsequently maintenance epoetin-alpha (Epo) administration. The study target was the range of low-normal Hb levels of 11,3 to 12,9 g/dL aiming at improving tumor oxygenation. Methods: A multicenter, open label, single-arm phase II study. All eligible patients with metastatic solid cancers received around their first or second chemotherapy cycle a transfusion of 1–3 units of erythrocytes depending on their Hb level. This was followed by Epo subcutaneously weekly at an initial dose of 40,000 IU during the chemotherapy period. Epo was only administered when the Hb level was below the lower margin of the target Hb range. All patients started with pre-emptive oral iron suppletion. Primary objectives were: correction of anemia to the Hb level target range and safety. Secondary objectives were: Quality of Life, Length of Treatment Duration and Time to Treatment Failure. Safety included: blood pressure, thrombo-embolic events, adverse events and serious adverse event. Results: 18 Patients enrolled in this study from March 30, 2006 to November 11, 2008. An intention-to-treatment analysis was performed for the primary objectives in 16 patients (8 with breast-, 4 with colorectal-, 1 with ovarian- and 1 with pancreatic cancer) and reported here. Patients were during a median of 12 weeks (range 1 to 32 weeks) on study. Median Hb increased from 10,2 g/dL to 11,2 g/dL after transfusion and stayed at that level during the first 19 weeks of Epo administration; Hb levels were between 10,0 and 11,5 g/dL. In the following period until the final 32nd studyweek, Hb levels increased slightly, ranging from 10,3 to 11,8 g/dL. Two patients remained during the study in the Hb level target range. The safety of Epo was good. Grade 3/4 adverse events and serious adverse events that occurred were found to be all chemotherapy or progressive disease related. Conclusions: Although this up-front treatment increased Hb to stable levels during chemotherapy, the target Hb levels were not reached in most patients. This was presumably related to the lesser than projected yield of the red blood cell transfusion. [Table: see text]

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