Interim results of a phase II study of the mTOR inhibitor everolimus in patients with pretreated metastatic gastric and esophageal adenocarcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 80-80
Author(s):  
Zev A. Wainberg ◽  
Ravi Patel ◽  
Brian DiCarlo ◽  
David J Park ◽  
Frederic C. Kass ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Supportive Care ◽  
Disease Control ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Best Supportive Care ◽  
Disease Control Rate ◽  
Upper Gi ◽  
Grade 3

80 Background: There is increased evidence that cancers of the upper GI tract are comprised of distinct epidemiological and molecular entities that may respond differently to anti-cancer therapy in Asian patients compared to North American patients. Everolimus, an oral inhibitor of the mammalian target of rapamycin (mTOR) showed clinical promise in a phase II study in Japanese patients with pre-treated metastatic gastric cancer with a disease control rate of 56% (Doi et al, JCO, 2010). This study evaluates the efficacy and safety of everolimus in patients with pre-treated metastatic gastric and esophagus cancers in a US population. Methods: Patients with advanced upper GI adenocarcinomas who experienced disease progression despite 1-2 prior regimens were treated with everolimus 10 mg PO daily. The primary endpoint was disease control rate (DCR; CR+PR+SD). Secondary end points included progression free survival (PFS), toxicity, overall survival (OS) and translational correlatives of the mTOR pathway. Results: Of the 40 patients enrolled to date, 19 have gastric, 7 have esophagus and 14 have tumors from the GEJ. 32 patients are evaluable to date: median age of 59 (range 36-79), all patients had an ECOG of 0 or 1; 11 (34%) received 1 prior regimen and 21 (64%) received 2 prior regimens. We observed 0 responses with 44% of evaluable patients having stable disease. Median overall survival was 5.6 months (95% CI: 3.2-7.6) and PFS was 1.8 months (95% CI: 1.6-2.2). 89% of all adverse events were grade 1-2, and 11% were grade 3-4. Grade 3-4 related adverse events include: fatigue (24%), thrombocytopenia (22%), anemia (9%). Updated results of translational correlatives with the mTOR pathway will be presented. Conclusions: We did not achieve the same degree of overall survival or disease control as in the Japanese study which may reflect differences in the locations of the primary tumor or underlying geographic variation. However, OS is significantly better than best supportive care reported in a recent randomized European trial (Thuss-Patience PC et al, Eur J Cancer 2011). Results of the randomized Phase III trial of everolimus vs best supportive care in this patient population are pending.

Phase II–III Study of Gemtuzumab Ozogamicin Monotherapy versus Best Supportive Care in Older Patients with Newly Diagnosed AML Unfit for Intensive Chemotherapy: First Results of the EORTC-GIMEMA AML-19 Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 762-762 ◽  
Author(s):  
Sergio Amadori ◽  
Stefan Suciu ◽  
Dominik Selleslag ◽  
Giuliana Alimena ◽  
Liliana Baila ◽  
...  
Keyword(s):  
Supportive Care ◽  
Phase Ii ◽  
Older Patients ◽  
Phase Ii Study ◽  
Best Supportive Care ◽  
Gemtuzumab Ozogamicin ◽  
Phase Iii ◽  
Intensive Chemotherapy ◽  
Grade 3 ◽  
To Receive

Abstract Treatment of AML in the elderly remains challenging. In particular, few therapeutic options exist for patients (pts) who are not considered medically fit for intensive chemotherapy. Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to calicheamicin, has demonstrated single agent efficacy in older patients with relapsed AML. In a previous trial we reported a complete response rate of 17% when the licensed dose/schedule of GO was used as frontline monotherapy for older unfit pts with AML, but excess hematologic and liver toxicity suggested changes in both dosing and scheduling to improve feasibility. The AML-19 study was designed as a sequential phase II–III trial in pts of age 61 or over with untreated AML, who could not be considered candidates for, or must have declined, conventional intensive chemotherapy. The primary objective of the phase II study was to investigate whether any of two different schedules of lower dose GO monotherapy (total delivered dose 9 mg/m2 in 2 or 3 fractions over one week) is sufficiently effective and tolerable frontline therapy to continue phase III comparison with best supportive care (BSC). Pts had to have adequate renal and hepatic function, and the WBC count had to be less than 30,000/cmm at the time of registration. Two-thirds of the pts were randomly assigned to receive a single induction course of either GO 3 mg/m2 iv on days 1, 3 and 5 (arm A), or GO 6 mg/m2 iv on day 1 and 3 mg/m2 on day 8 (arm B); the remaining third was assigned to the BSC arm. Randomization was stratified by age, performance status (PS), initial WBC, CD33 expression on marrow blasts, and Institution. Pts with no evidence of objective disease progression were eligible to receive continuation treatment with monthly outpatient infusions of GO at 2 mg/m2 for a maximum of 8 months. Primary end-point of the phase II study was clinical benefit rate (CBR) defined as the number of pts either achieving a remission (CR, CRp, PR) or maintaining a stable disease (SD) in each experimental arm. The arm associated with the highest CBR would be selected for phase III assessment, providing that it is at least 48% (Simon design). Between 06/2004 and 12/2006, 56 pts were randomized in the two experimental arms (arm A 29; arm B 27). The two arms were comparable in terms of age (arm A: median 77 yrs; arm B: median 78 yrs), PS >2 (arm A: 7%; arm B: 4%), secondary AML (arm A: 45%; arm B: 37%), and CD33 expression on ≥20% marrow blasts (arm A: 86%; arm B: 85%). In arm A, 6 pts achieved CR, 2 PR, and 3 maintained SD for an overall CBR of 38% (90% CI, 23%–55%); in arm B, 5 pts achieved CR, 1 CRp, and 11 maintained SD for an overall CBR of 63% (90% CI, 45%–78%). Most toxicities were <grade 3 in both arms and included nausea/vomiting, diarrhea, fatigue, stomatitis and transient elevations of serum transaminases and bilirubin. The rate of grade ≥3 infection was slightly higher in arm B (48% vs 31%), as was the incidence of severe bleeding (11% vs 0%). All-cause early mortality (<6 wks) occurred in 17% of pts in arm A (2 infection, 3 AML) and in 11% of pts in arm B (1 infection, 1 AML, 1 infection+AML). In summary, lower dose GO is a tolerable and active primary therapy for older AML pts who are considered unsuitable for intensive chemotherapy. The day 1+8 schedule (arm B) is associated with a more favourable efficacy profile, meeting the statistical criteria to be selected as the preferred regimen for phase III comparison with BSC. Accrual to the phase III trial is ongoing.

Phase II Study of Autologous Monocyte-Derived mRNA Electroporated Dendritic Cells (TriMixDC-MEL) Plus Ipilimumab in Patients With Pretreated Advanced Melanoma

2016 ◽  
Vol 34 (12) ◽  
pp. 1330-1338 ◽  
Author(s):  
Sofie Wilgenhof ◽  
Jurgen Corthals ◽  
Carlo Heirman ◽  
Nicolas van Baren ◽  
Sophie Lucas ◽  
...  
Keyword(s):  
Dendritic Cells ◽  
Adverse Events ◽  
Disease Control ◽  
Phase Ii ◽  
Tumor Response ◽  
Phase Ii Study ◽  
Advanced Melanoma ◽  
Disease Control Rate ◽  
Skin Reactions ◽  
Autologous Monocyte

Purpose Autologous monocyte-derived dendritic cells (DCs) electroporated with synthetic mRNA (TriMixDC-MEL) are immunogenic and have antitumor activity as a monotherapy in patients with pretreated advanced melanoma. Ipilimumab, an immunoglobulin G1 monoclonal antibody directed against the cytotoxic T-lymphocyte-associated protein 4 receptor that counteracts physiologic suppression of T-cell function, improves the overall survival of patients with advanced melanoma. This phase II study investigated the combination of TriMixDC-MEL and ipilimumab in patients with pretreated advanced melanoma. Patients and Methods Thirty-nine patients were treated with TriMixDC-MEL (4 × 106 cells administered intradermally and 20 × 106 cells administered intravenously) plus ipilimumab (10 mg/kg every 3 weeks for a total of four administrations, followed by maintenance therapy every 12 weeks in patients who remained progression free). Six-month disease control rate according to the immune-related response criteria served as the primary end point. Results The 6-month disease control rate was 51% (95% CI, 36% to 67%), and the overall tumor response rate was 38% (including eight complete and seven partial responses). Seven complete responses and one partial tumor response are ongoing after a median follow-up time of 36 months (range, 22 to 43 months). The most common treatment-related adverse events (all grades) consisted of local DC injection site skin reactions (100%), transient post–DC infusion chills (38%) and flu-like symptoms (84%), dermatitis (64%), hepatitis (13%), hypophysitis (15%), and diarrhea/colitis (15%). Grade 3 or 4 immune-related adverse events occurred in 36% of patients. There was no grade 5 adverse event. Conclusion The combination of TriMixDC-MEL and ipilimumab is tolerable and results in an encouraging rate of highly durable tumor responses in patients with pretreated advanced melanoma.

scholarly journals Safety and Efficacy of Blinatumomab As Monotherapy Vs Combination Therapy in the Treatment of Relapsed/Refractory Adult ALL: A Systematic Review

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 7-9
Author(s):  
Usman Ali Akbar ◽  
Anam Khan ◽  
Muhammad Ashar Ali ◽  
Atif Irfan Khan ◽  
Sobia Aamir ◽  
...  
Keyword(s):  
Overall Survival ◽  
Combination Therapy ◽  
Adverse Events ◽  
Phase Ii ◽  
Observational Studies ◽  
Acute Lymphocytic Leukemia ◽  
Phase Ii Study ◽  
Lymphocytic Leukemia ◽  
Adult Patients ◽  
Grade 3

Background: Acute lymphoblastic leukemia (ALL) is rare but aggressive. For refractory and relapsed ALL (R/R ALL), various treatment strategies are adopted, of which the use of blinatumomab has shown promising results in recent decades. Blinatumomab is a CD-19 directed CD3 bispecific T-cell engager antibody that has been approved by the FDA for the treatment of both adults and pediatric ALL. We report the efficacy and toxicity of blinatumomab in relapsed and refractory ALL adult patients. Materials/Methods: Following the PRISMA guideline, we performed a comprehensive literature search PubMed, Embase, Cochrane Library, Web of Science, and Clinicaltrials.gov. We used the following keywords, "acute lymphocytic leukemia" and "Blinatumomab" from the inception of data till 06/17/2020. We screened 1199 articles and included 7 trials and 6 retrospective studies. We excluded all case reports, case series, preclinical trials, review articles, and meta-analysis. We extracted the data for efficacy (complete response, relapse, overall survival, etc.) and safety (≥Grade 3 adverse events). Results: A total of 1393 patients with relapsed/refractory ALL were included. Monotherapy: In phase 3 TOWER trial, a total of 405 patients with heavily pretreated B-cell precursor ALL were randomized in a 2:1 ratio to either receive blinatumomab (n=271) or standard of care (SOC) (N=134). The mean age of both groups was 40.8 years and 41.1, respectively. The dose of blinatumomab (9-28 ug/d) was instituted to the intervention group, whereas the control group received investigator-chosen chemotherapy regimens. The CR/CRi rate for both groups was 95/267 (35.5 %) and 27/134 (31.34%), respectively (p&lt;0.01). The median overall survival was 7.7 (5.6 to 9.6 months) vs. 4.0 (2.9 to 5.3 months); the hazard rate for death: 0.71 (95% CI 0.55-0.93) p=0.01 and MRD negativity was 76 % and 48 %, respectively. The most common grade 3 and 4 adverse events (AEs) were neutropenia 45.7%) vs. 61.94% and cytopenia 67.80% vs. 81.34% respectively. In 6 phase 1b/2 studies (N=469), the starting dose of blinatumomab was 5 µg /m2/d and subsequently increased to 30 µg/m2/d. The pooled CR/CRi for these studies was 180/469 (38.37%). The most common hematological grade ≥3 adverse events were neutropenia 89/448 (19.87%), anemia 45/422 (10.70%), and thrombocytopenia 41/422 (9.7%). A total of 509 patients were included in 5 observational studies. The overall CR/CRi reported was 129/509 (25.34%). Grade ≥3 neutropenia and thrombocytopenia were reported as 14/52(26.92%) in one study.CRS was reported in another study as 5/14 (35 %). Combination regimens: In a phase II trial of Blinatumomab when given with a TKI (Dastanib), CR/CRi achieved was 27/47 (56.3%). Blinatumomab related neurotoxicity was observed in 2/12 (16.67%) patients. A total of 38 patients were included in 3 observational studies involving Blinatumomab and TKIs. The overall CR/CRi reported was 25/30(83.33%). In a multicenter phase I/II trial blinatumomab when given with PD-1 inhibitor pembrolizumab (pembro) achieved a CR/CRi of 2/4 (50%). In a phase II study, Blinatumomab and PD-1 and CTLA-4 inhibitors were used in combination in 8 patients. The CR/CRi achieved was 4/5 (80%). Grade ≥3 non-hematological adverse events (AEs) were observed in 1/5 (20%) patients. Blinatumomab has been used in combination with Hyper-CVAD in a phase II study. The ORR and CR achieved have been 14/14 (100%) and 13/14 (93%) respectively. In a recent study, blinatumomab has been used along with miniHCVD + INO in 17 patients. The CR/CRi achieved was 13/17 (76.47%). Conclusion: Blinatumomab alone and in combination with TKIs, PD-1 inhibitors, CTLA-4 inhibitors,hyper-CVAD and miniHCVD + INO were well tolerated by adult patients with acute lymphocytic leukemia. Blinatumomab in combination therapy has shown superior efficacy in adult ALL patients as compared to blinatumomab monotherapy. Additional multicenter randomized, double-blind clinical trials are needed to confirm these results. Disclosures Anwer: Incyte, Seattle Genetics, Acetylon Pharmaceuticals, AbbVie Pharma, Astellas Pharma, Celegene, Millennium Pharmaceuticals.:Honoraria, Research Funding, Speakers Bureau.

Phase II Study of Pemetrexed Plus Carboplatin in Malignant Pleural Mesothelioma

2006 ◽  
Vol 24 (9) ◽  
pp. 1443-1448 ◽  
Author(s):  
Giovanni L. Ceresoli ◽  
Paolo A. Zucali ◽  
Adolfo G. Favaretto ◽  
Francesco Grossi ◽  
Paolo Bidoli ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Control ◽  
Phase Ii ◽  
Malignant Pleural Mesothelioma ◽  
Objective Response ◽  
Dose Intensity ◽  
Pleural Mesothelioma ◽  
Standard Regimen ◽  
Time Curve ◽  
Grade 3

Purpose This multicenter, phase II clinical study was conducted to evaluate the activity of the combination of pemetrexed and carboplatin in patients with malignant pleural mesothelioma (MPM). Patients and Methods Chemotherapy-naive patients with measurable disease and adequate organ function, who were not eligible for curative surgery, received pemetrexed 500 mg/m2 and carboplatin area under the plasma concentration-time curve of 5 mg/mL/min, administered intravenously every 21 days. All patients received folic acid and vitamin B12 supplementation. Pemetrexed was provided within the Expanded Access Program. Results A total of 102 patients were enrolled. An objective response was achieved in 19 patients (two complete and 17 partial responses), for a response rate of 18.6% (95% CI, 11.6% to 27.5%). Forty-eight patients (47.0%; 95% CI, 37.1% to 57.2%) had stable disease after treatment. Overall, 67 patients (65.7%) achieved disease control (95% CI, 55.6% to 74.8%). Median time to progression was 6.5 months; median overall survival time was 12.7 months. Compliance to treatment was excellent, with a relative dose-intensity of 97% for pemetrexed and 98% for carboplatin. Toxicity was mild, with grade 3 or 4 neutropenia occurring in 9.7% of total cycles and grade 3 or 4 anemia occurring in 3.5% of total cycles. Nonhematologic toxicity was negligible. Conclusion Treatment with pemetrexed and carboplatin was active and well tolerated in patients with MPM. Disease control rate, time to disease progression, and overall survival were similar to the results achieved with the standard regimen of pemetrexed and cisplatin, suggesting that the carboplatin combination could be an alternative option for these patients.

A phase II study of docetaxel (D) plus imatinib (I) in patients with previously treated non-small cell lung cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18200-18200
Author(s):  
L. A. White ◽  
A. M. Schmidt ◽  
N. N. Sjak-Shie ◽  
A. O. Greco ◽  
B. Cronin ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hematologic Toxicity ◽  
Synergistic Activity ◽  
Weekly Schedule ◽  
Study Results ◽  
Previously Treated ◽  
Grade 3 ◽  
Ecog Ps

18200 Background: Docetaxel(D) has been shown to improve overall survival in pts with previously treated NSCLC. Pre-clinical data suggest synergistic activity with the combination of D and I. Paul Matthew; et al demonstrated the safety of this combination in pts with prostate cancer. Methods: This is a Phase II study of the combination of D and I in prev tx NSCLC to determine response rate, toxicity and assess overall survival. Pts must have received at least 1 prior regimen and have an ECOG PS of 2 or less. Prior tx with D was allowed. D was admin at 30 mg/m2 on a weekly schedule for 3 weeks followed by 1 week rest. I was admin at a starting dose of 600 mg/day throughout the study. Results: A total of 10 pts were enrolled. Seven male and 3 female with a median age of 66 years (range 58 - 74). A total of 26 cycles were delivered to 10 pts (mean = 3). Responses included 1 PR/3SD/2PD/4NE. One pt with a PR responded after cycle 4 but progressed after cycle 6. One pt maintained SD for 21 wks then expired due to an unrelated PE (h/o peripheral vascular disease). Grade 4 toxicity included periorbital edema (1 pt), pneumonia (2 pts), diarrhea (1 pt), dehydration (1 pt), dyspnea (1pt), anorexia (1 pt), pleural effusion (1 pt), and neutropenia (2 pts). Grade 3 toxicity included hyponatremia (1 pt), renal failure (1 pt), hypotension (2 pts), mental status changes (1 pt), anorexia (1 pt), azotemia (1 pt), dyspnea (1 pt), herpetic esophageal ulcer (1 pt), pneumonia (1 pt), neutropenia (2 pts), weakness & fatigue (1 pt), and anemia (1 pt). Four of 10 pts received only 1 cycle. (Three of those 4 suffered a fatal adverse event during cycle 1, not felt to be treatment related. The fourth developed herpetic esophageal lesions and was taken off study prior to tumor assessment.) Conclusions: The study was closed before the initial planned pts were enrolled due to low activity and unexpected high tox. Only 1 of 10 pts achieved a PR. Stable disease was observed in 3 pts but was of short duration in 2 of the 3. Despite supportive treatment, nausea, vomiting, diarrhea, and anorexia were difficult to control. Hematologic toxicity was encouragingly infrequent with only 2 pts experiencing Grade 4 neutropenia. Alternative dosing schedules would be recommended before pursuing this combination in NSCLC pts. Study supported by a grant from Novartis. No significant financial relationships to disclose.

Phase II study for the suboptimally debulked advanced ovarian cancer: Intravenous platinum followed by interval debulking surgery and intravenous paclitaxel + intraperitoneal cisplatin (KCOG9812 study)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5576-5576
Author(s):  
H. Tsubamoto ◽  
K. Ito ◽  
Y. Itani ◽  
K. Ito ◽  
T. Iijima ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iiib ◽  
Hematologic Toxicity ◽  
Treatment Schedule ◽  
Debulking Surgery ◽  
Interval Debulking Surgery ◽  
Grade 3

5576 Background: Intraperitoneral administration (IP) of cisplatin is recommended by National Cancer Institute for the patients with optimally debulked epitherial ovarian cancer (EOC). However, the advantage is not determined for the suboptimally debulked EOC after the initial surgery. We conducted a phase II study of cisplatin IP after the interval debulking surgery (IDS) following 3 cycles of intravenous platinum. Methods: The initial planned sample size was 30. Eligible patients had previously untreated, histologically confirmed EOC or primary peritoneal carcinoma (PPC) of FIGO stage IIIB-IV with suboptimal (> 1 cm) residual disease. Carboplatin AUC 4 iv d1 and cisplatin 50 mg/sqm iv d3 q21d for 3 cycles. After IDS, paclitaxel 175 mg/sqm iv d1 (or paclitaxel 60 mg/sqm iv d1,d8,d15) and cisplatin 75mg/m2 IP q21d for 4 cycles. Primary endpoint was progression-free survival (PFS) and secondary endpoints were overall survival (OS) and toxicity. Results: 33 patients were enrolled since 1998 till 2005. The median age was 55 (range 19–77). ECOG PS 0/1/2 = 33%/36%/31%; stage IIIB/IIIC/IV = 6%/64%/30%; 91% serous papillary histology. Optimal interval debulking surgery was possible in 85%: none (61%), < 1 cm (24%). Grade 3 or 4 (CTCAE ver.3) non-hematologic toxicity was seen in one patient of neurotoxicity. Grade 3 or 4 hematologic toxicities include: neutropenia (37%), infection (4%), thrombocytopenia (11%). 55% were completed the treatment schedule. The reasons for discontinuing were drug resistance (12%), subileus (4%), elevation of serum creatinine (12%), G3 neurotoxicity (4%), IP catheter block (12%) and infection (4%). Primary recurrent sites of total 20 patients before the second line chemotherapy or surgery were peritoneal cavity (30%), distant metastasis (45%), retroperitoneal lymph nodes (15%), and elevation of serum CA125 (10%). Median PFS was 24 months; median overall survival was 48 months; median follow-up was 36 months (range 15–100). Conclusions: This treatment including cisplatin IP after IDS for the patients with the initially suboptimally debulked EOC was feasible, and showed good prognosis with the small number of the intraperitoneal recurrence. [Table: see text]

Phase II study of AZD2171 for the treatment of patients with myelodysplastic syndromes.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6570-6570
Author(s):  
Shannon Eileen O'Mahar ◽  
Alcee Jumonville ◽  
Patrick J. Flynn ◽  
Alvaro Moreno-Aspitia ◽  
Charles Erlichman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Prior Therapy ◽  
Starting Dose ◽  
Orally Bioavailable ◽  
Grade 3 ◽  
Endothelial Growth Factor

6570 Background: Inhibition of vascular endothelial growth factor receptors (VEGFR) can block growth and trigger apoptosis in neoplastic cells. AZD2171 (cediranib) is a highly potent, orally bioavailable, VEGFR-1/2 inhibitor. We conducted a phase II study of the efficacy of AZD2171 for the treatment of MDS. Methods: Adults with MDS (IPSS Int-2 or High) were eligible if they exhibited adequate organ function and ECOG 0-2. The primary endpoint was proportion of responses according to the IWG criteria assessed at one and every 3 months. Prior investigation of cediranib at 45 mg daily in patients with acute leukemia demonstrated toxicity concerns and therefore, the starting dose of this study was lowered to 30 mg daily. Results: A total of 16 pts with MDS (median age 73 years) were enrolled at a 30 mg starting dose, and all were evaluable. Median baseline marrow blasts were 12.0 % (range 2-18); 3 pts (18.8 %) had low, 6 (37.5 %) intermediate, and 7 (43.8 %) had high risk cytogenetics. Prior therapy included azacitidine (n=7), decitabine (n=2), cytarabine (n=2), erythropoietin-stimulating agents (ESAs) (n=2), lenalidomide (n=1), or none (n=6). Patients were treated for a median of two 28-day cycles (range 1 to 11). There were no confirmed responses. Patients with baseline blasts > 5% showed no significant reduction in the blast count at 4 and 12 weeks. Median OS was 4.7 mo (95% CI: 2.6 – 11.6). Median TTP was 3.8 mo (95% CI: 1.7 – 10.8). Grade 4 hematological adverse events at least possibly related to cediranib were neutropenia (n=2) and thrombocytopenia (n=4). Grade 3 hematological adverse events at least possibly related to study treatment included: neutropenia (n=3), thrombocytopenia (n=2), and anemia (n=2). Grade 3 non-hematological adverse events included fatigue (n=4), dyspnea (n=3), dehydration (n=2), diarrhea (n=2), nausea (n=2), asthenia (n=1), and hypertension (n=1). Hypertension and proteinuria was uncommon with the 30 mg/day dose. Conclusions: With no confirmed response from 16 patients, cediranib was determined to be ineffective at a dose of 30 mg daily in our patient population. Supported by NCI N01-CM62205, NCI P30-CA014520 and the UW Carbone Comprehensive Cancer Center.

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