A phase II safety study of bevacizumab in patients with multiple recurrent or progressive malignant gliomas

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2079-2079 ◽  
Author(s):  
J. J. Raizer ◽  
L. Gallot ◽  
R. Cohn ◽  
J. Chandler ◽  
R. Levy ◽  
...  
Keyword(s):  
Karnofsky Performance Status ◽  
Performance Status ◽  
Treatment Options ◽  
Single Agent ◽  
Malignant Gliomas ◽  
Response Rates ◽  
Median Number ◽  
Mcdonald Criteria ◽  
Normal Urine

2079 Introduction: Available treatment options for patients with recurrent MG are few. Recent trends have used target specific agents but none has been effective to date. A single agent trial was designed to determine the safety and efficacy of bevacizumab in patients with recurrent MG. Recently, bevacizumab and CPT-11 in combination have shown response rates of approximately 60%. Patients and Methods: All patients (pts) had to sign an IRB informed consent. All pts had to have at least two relapses. Pts had to be > 18 year of age with Karnofsky performance status of > 60. Adequate bone marrow, liver and renal function was required, as well as normal urine protein and creatinine. Patients were required to be on a non-enzyme inducing anti-convulsants. An MRI with perfusion was done at baseline (if patient consented) and then every 6 weeks. Patients continued on trial as long as they did not have tumor progression. Patients received bevacizumab 15 mg/kg every 3 weeks as a 60–90 minute infusion. Results: To date, 16 pts with recurrent MG have been treated. 14 pts had a glioblastoma (GBM) and 2 had an anaplastic oligodendroglioma (AO). Median number of doses given was 3 (range 1–12). No patient had an intracranial hemorrhage and the only significant toxicity was a DVT in a patient with prior DVT. Best responses per McDonald criteria were: PR in 2 pts, SD in 4 pts, PD in 3 pts and non-evaluable in 7 pts: 4 follow up imaging not done, 1 each with stable MRI after 2 doses but WD for non-compliance, clinical decline and patient’s choice. Results: Bevacizumab as a single agent given every 3 weeks at 15 mg/kg is safe. Partial responses and stable disease were seen in about 30 % of patients with follow up imaging but many patients are early in treatment. Our response rates to date are lower then previous reports of patients treated with CPT-11 and bevacizumab; this maybe due to the increased number of prior therapies, a different schedule of bevacizumab or the omission of CPT-11. Updated response rates, time to progression and overall survival will be presented. [Table: see text] No significant financial relationships to disclose.

scholarly journals P14.120 Phase II study of weekly carboplatin in pretreated adult malignant gliomas

2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii97-iii97
Author(s):  
V Villani ◽  
A Pace ◽  
A Vidiri ◽  
A Tanzilli ◽  
F Sperati ◽  
...  
Keyword(s):  
Malignant Glioma ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Phase Ii Study ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Single Agent ◽  
Malignant Gliomas ◽  
Recurrent Malignant Glioma ◽  
Eligibility Criteria

Abstract BACKGROUND Patients with relapse of recurrent glioma have a poor outcome and limited treatment options. The aim of this study is to investigate the clinical benefit and tolerability of weekly intravenous administration of carboplatin-based monotherapy in adult glioma patients who had progressed from previous chemotherapy lines based on temozolomide and nitrosoureas MATERIAL AND METHODS This was a single arm, Phase II study. Eligibility criteria included progressive or recurrent malignant glioma after radiotherapy and chemotherapy-based treatments and Karnofsky Performance Status (KPS) > 60. RESULTS Thirty-two patients (median age: 43.5 y) were enrolled to receive weekly carboplatin monotherapy in intravenous mode of administration. The median duration of response was 7.3 months with an overall disease control rate of 31.3%. Median progression-free survival (PFS) was 2.3 months while overall survival (OS) was 5.5 months. Patients achieving clinical benefit exhibited a longer PFS (4.6 vs 1.5 months; p>0.001) and OS (7.9 vs 3.2 months; p=0.041) compared to those not achieving clinical benefit. CONCLUSION Our findings show that single agent, weekly, intravenous carboplatin may have a role in the treatment patients with recurrent malignant glioma

FCR-3 as Frontline Therapy for Patients with Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2117-2117 ◽  
Author(s):  
Susan O’Brien ◽  
William G. Wierda ◽  
Stefan Faderl ◽  
Alessandra Ferrajoli ◽  
Carlos E. Bueso-Ramos ◽  
...  
Keyword(s):  
Somatic Hypermutation ◽  
Single Agent ◽  
Response Rates ◽  
Median Number ◽  
Lymphocytic Leukemia ◽  
Combination Regimen ◽  
Consensus Primer ◽  
Dose Dense ◽  
Wbc Count

Abstract The combination regimen of Fludarabine, Cyclophosphamide, and Rituximab (FCR) has produced high overall response (OR) rates and complete remission (CR) rates in patients receiving this as initial treatment for CLL. Earlier studies have shown that dose-dense or dose-intensified regimens of single-agent Rituximab produced higher response rates in patients with CLL. The current regimen, FCR-3, was based on the hypothesis that increasing the amount of Rituximab in the combination might improve response rates and remission duration. Doses of chemotherapy were Fludarabine 25 mg/m2/Dx3, and Cyclophosphamide 250 mg/m2/Dx3 given monthly. Rituximab was given at 375 mg/m2 as the first dose and 500 mg/m2 for all subsequent doses. On each day of the chemotherapy a dose of Rituximab was given so 3 doses were given monthly. With the previous FCR regimen 45% of patients achieved a CR or nPR and had <5% CD19+ 5 positive cells in the marrow at the completion of 3 cycles of therapy (rapid response, RR). The median time to progression (TTP) in that group has not been reached; it was 3 years in patients who did not achieve that endpoint (p<.001). The current protocol aimed to increase that response rate from 45% to 60%. Sixty-five patients were treated. Eighty percent were men. The median age was 59 years (27–82). Rai Stage 3–4 disease was present in 25% of patients. Median WBC count was 92.4 x 103/ul (7.9–363). Median B2-microglobulin was 3.8 (1.6–10.1). Unfavorable FISH abnormalities were present in 35% of 52 evaluable patients. Somatic hypermutation status was available for 44 patients; 61% were unmutated. ZAP-70 expression analysis performed by immunostaining or flow cytometry was positive in 62% of 47 evaluable patients. Results of FCR-3 in comparison to FCR are shown in the table. 3 Cycles 6 Cycles No. RR(%) OR CR Flow<5% FCR 300 45 95 72 82 FCR-3 65 45 94 65 74 PCR negativity using consensus primer PCR was achieved in 49% of patients at the end of therapy. Median number of days between courses ranges from 29–35 per course (overall range 27–95). Eighty-five percent of patients completed 6 cycles. No patient has progressed with a median follow-up of 10 months. With limited follow-up the addition of 3 doses of Rituximab to FC chemotherapy does not appear to provide greater benefit than one dose.

Safety and efficacy study of retifanlimab and epacadostat in combination with radiation and bevacizumab in patients with recurrent glioblastoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS2070-TPS2070
Author(s):  
Jian Li Campian ◽  
Christopher Abraham ◽  
Jingqin Luo ◽  
Grayson Talcott ◽  
Ruth Katumba ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Treatment Options ◽  
Single Agent ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Open Label ◽  
Eligibility Criteria ◽  
Safety And Efficacy

TPS2070 Background: Recurrent glioblastoma (rGBM) after chemoradiotherapy has a dismal outcome with very limited treatment options. Addition of reirradiation to bevacizumab appears to improve progression-free survival (PFS) but does not improve overall survival (OS). Immune checkpoint inhibitors of programmed cell death-1 (PD-1) pathway appear to have limited single-agent activity for rGBM due to its immunesuppressive microenvironment. Indoleamine 2,3 dioxygenase 1 (IDO1) is an inducible and rate-limiting enzyme that catabolizes tryptophan (Trp) into kynurenine (Kyn). IDO1 is over-expressed in 50̃90% of GBM patients, and high IDO1 levels correlate with reduced OS. Epacadostat is a highly potent and selective oral inhibitor of IDO1 and may increase tumor sensitivity to anti-PD-1 blockade. Retifanlimab is a humanized anti-PD-1 monoclonal antibody directed against PD-1. The purpose of this study is to evaluate the safety and efficacy of combining retifanlimab plus or minus epacadostat with reirradiation and bevacizumab for rGBM patients. Methods: This is an open-label nonrandomized phase II study of two sequential cohorts for bevacizumab-naïve adults with rGBM: retifanlimab + bevacizumab+ radiation (cohort A), and retifanlimab + epacadostat + bevacizumab + radiation (cohort B). Each cohort will enroll 24 evaluable patients. Key eligibility criteria include candidates for reirradiation and bevacizumab, age ≥ 18 years, Karnofsky performance status ≥ 60%, and dexamethasone dose ≤ 4 mg/day. The primary endpoint is OS. Secondary endpoints include PFS, neurologic functions, and toxicity. The correlative endpoints include studies assess the anti-glioma immune response, serum Kyn/Trp ratio, and RNA expression of IDO1 and PD-L1 from available tissue. The trial is actively enrolling. At the time of abstract submission, 16 of the planned 24 patients in Cohort A have been enrolled. Clinical trial information: NCT03532295. [Table: see text]

Phase IIa trial of cilengitide (EMD121974) single-agent therapy in patients (pts) with recurrent glioblastoma (GBM): EMD 121974-009

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2002-2002 ◽  
Author(s):  
D. Reardon ◽  
K. Fink ◽  
B. Nabors ◽  
T. Cloughesy ◽  
S. Plotkin ◽  
...  
Keyword(s):  
Karnofsky Performance Status ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Median Number ◽  
Recurrent Glioblastoma ◽  
Tumor Control ◽  
Clinical Activity ◽  
Open Label ◽  
Recurrent Gbm

2002 Background: Our phase IIa study evaluated the safety, toxicity, and clinical activity of the cyclic RGD pentapeptide cilengitide (EMD121974), an inhibitor of integrins avβ3 and avβ5, as a single agent at doses of 500 and 2000 mg in pts with recurrent GBM. Methods: In this multicenter, open-label, randomized, uncontrolled study, pts with GBM and measurable disease that had relapsed after previous temozolomide and radiotherapy were randomized to receive cilengitide at either 500 mg or 2000 mg i.v., 2x/week, until progression. Neurologic exams were performed after every cycle (4 weeks) and MRIs were performed every other cycle. Central, blinded pathology and radiology reviews were performed. The primary endpoint was Progression Free Survival (PFS) at 6 months (6-mth PFS). Secondary endpoints included response, survival, time to disease progression, safety, tolerability and pharmacokinetics (PK). Results: 81 pts accrued (median Karnofsky Performance Status 80%; median age 57 yrs) at 15 sites including 41 at the 500 mg and 40 at the 2000 mg dose levels. Demographic and pretreatment variables were comparable between dose level cohorts. The median number of infusions was 16 [range, 4–179]. PK studies revealed significantly greater exposures among the 2000 mg cohort. Treatment related NCI CTC grade 3 adverse events (AEs) included elevated transaminases (at 500 mg), arthralgia/ myalgia (at 500 mg), and weight increase/ edema (at 2000 mg) in 1 patient, respectively. No grade 4 therapy related AEs were reported. One CTC grade 2 cerebral hemorrhage was reported in a pt at progression. The 6- mth PFS was 16.1% (n=13/81 pts). 10 pts (12.3 %, n=4 with 500 mg, n=6 with 2000 mg) received 12 or more cycles. Six pts (7.4%) remain progression-free and on treatment. Median Overall Survival (mOS) was 6.5 mths [95% CI: 5.2–9.3 mths] in the 500 mg arm and 9.9 mths [95% CI, 6.3–15.7 mths] in the 2000 mg arm. Although not statistically significant, there was a trend towards better tumor control in pts receiving 2000 mg 2x/week. Conclusions: Cilengitide was well tolerated and demonstrated single agent activity in recurrent GBM, with long term disease stabilization in a subset of pts. [Table: see text]

A phase II trial of single-agent bevacizumab given every 3 weeks for recurrent malignant gliomas

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2044-2044
Author(s):  
J. J. Raizer ◽  
S. Grimm ◽  
L. Rice ◽  
K. Muro ◽  
J. Chandler ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Malignant Gliomas ◽  
Median Number ◽  
Inclusion Criteria ◽  
Urine Protein ◽  
Macdonald Criteria ◽  
Grade 3 ◽  
Normal Urine

2044 Background: Increasingly target specific agents are used in the treatment of malignant gliomas (MG). Among targeted agents, bevacizumab appears most promising and when combined with CPT-11. As CPT-11 has limited activity in recurrent MG, a single agent phase II trial of bevacizumab given every 3 weeks in with recurrent MG was performed. Methods: All patients (pts) had to sign an IRB informed consent except six pts who were treated at a different site in a similar fashion. All pts had to have at least one relapse with the first sixteen required to have two relapses before protocol amendment. Inclusion criteria required > 18 year of age, KPS > 60, on a non-enzyme inducing anticonvulsant, adequate bone marrow, liver and renal function, and normal urine protein and creatinine. MRI with perfusion was done at baseline (if patient consented) and then every 6 weeks. Patients were assessed using Macdonald criteria and continued on trial until tumor progression or toxicity. Treatment was bevacizumab 15 mg/kg every 3 weeks. Results: 61 patients (35 male; 26 female; 50 GBM, 5 AA, 6 AO/AOA) with a median age of 51 were treated. Median number of doses given was 4 (range 1–18). PFS-6 was 32% (median PFS was 3.9 m; median OS was 6.6 m). Best radiographic response included 0% CR, 25% PR and 50% SD. Grade 3+ toxicities were non-fatal intracranial hemorrhage (1), fatal GI perforation (1), DVT (1), fatigue (4), rectal bleeding (1), weakness (1), and lack of drive (1). Conclusions: Bevacizumab as a single agent given every 3 weeks at 15 mg/kg is effective and safe for recurrent MG. The observed PFS-6 and OS is lower than reported bevacizumab regimens administered every 2 weeks; this difference may be related to patient selection. [Table: see text]

Nivolumab/pembrolizumab in Child-Pugh grade B/C patients with advanced HCC.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16184-e16184
Author(s):  
Jeffrey Sum Lung Wong ◽  
Gin Wai Kwok ◽  
Vikki Tang ◽  
Bryan Li ◽  
Roland Ching-Yu Leung ◽  
...  
Keyword(s):  
Single Agent ◽  
Objective Response ◽  
Median Number ◽  
Refractory Ascites ◽  
Time To Progression ◽  
Advanced Hcc ◽  
Grade 3 ◽  
Experienced Grade ◽  
Systemic Therapies

e16184 Background: Hepatic derangement commonly accompanies advanced HCC (aHCC) and limits the use of systemic therapies. We aimed to evaluate the use of single agent anti-PD-1 nivolumab or pembrolizumab in Child-Pugh (CP) grade B or C patients with aHCC. Methods: Consecutive aHCC patients with CP grade B (CPB) or C (CPC) liver function who received single agent nivolumab or pembrolizumab were analysed. Objective response rate (ORR), time-to-progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were assessed. Results: Between May 2015 and June 2020, 61 patients were included. The median age was 60 (range 28-82). 81% and 4.8% had hepatitis-B and hepatitis-C related HCCs respectively. 72.1% (n = 44) were of CPB and 27.9% (n = 17) were of CPC. Amongst CPB patients, 19 (31.1% of all patients) had CP score 7 (CP7) and 25 (41.0% of all patients) had CP score 8 or 9. The median follow-up was 2.3 months. The ORR of CPB and CPC patients were 6.8% and 0% respectively (p = 0.553). The TTP of CPB and CPC patients were 2.1 months (95% C.I. 1.4-2.8) and 1.4 months (95% C.I. 0.6-2.1) respectively (p = 0.204). CPB patients had significantly better OS than CPC patients (3.1 months (95% C.I. 1.4-4.7), vs. 1.7 months (95% C.I. 1.0-2.4), p = 0.041). Compared to CP score ≥8 (CP≥8) patients, CP7 patients had significantly better OS (median OS CP7 6.7 months (95% C.I. 4.0-9.3), vs. CP≥8 1.8 months (1.2-2.4), p = 0.002). Patients with diuretic-refractory ascites had significantly worse OS compared to those without (1.7 months (95% C.I. 1.0-2.5) vs. 3.7 months (95% C.I. 0.1-7.3), p = 0.004). Portal vein (PV) thrombosis was also significantly associated with inferior survival, with median OS of patients with any PV thrombosis being 1.8 months (95% C.I. 1.0-2.5), compared to 5.3 months (95% C.I. 2.4-8.1) of those without (p = 0.004). The median number of doses given was 3 (range 1-34). Median treatment duration was 5.0 weeks (range 0-77). Overall, 25.4% of patients experienced TRAEs and 4.8% experienced grade ≥3 TRAEs. The most common TRAEs were skin-related (13.1%) and constitutional symptoms (6.6%). Conclusions: Nivolumab/pembrolizumab had acceptable safety in CPB/C patients with aHCC. CP7, absence of diuretic-refractory ascites and lack of PV thrombosis were associated with better survival.

Phase 1/2 study of cirmtuzumab and ibrutinib in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7556-7556
Author(s):  
Hun Ju Lee ◽  
Michael Y. Choi ◽  
Tanya Siddiqi ◽  
Jacqueline Claudia Barrientos ◽  
William G. Wierda ◽  
...  
Keyword(s):  
Phase 1 ◽  
Single Agent ◽  
Objective Response ◽  
Median Number ◽  
Lymphocytic Leukemia ◽  
Synergistic Activity ◽  
Best Response ◽  
Car T ◽  
Treatment Naïve

7556 Background: Cirmtuzumab (Cirm) is a humanized monoclonal antibody that inhibits the tumor promoting activity of ROR1 and had demonstrated additive/synergistic activity with many anti-cancer agents including ibrutinib (Ibr). Methods: Patients (Pts) with relapsed or refractory (RR) MCL or treatment naïve (TN) or RR CLL were enrolled. In Part 1 (Dose Escalation), doses of Cirm IV q2wks x5 then q4wks of 2-16 mg/kg and 300 or 600 mg were examined. Safety of Cirm alone was assessed during the first 28 days, then Ibr was started at approved doses for each indication. Cirm 600 mg IV q2wks x3 then q4wks in combination with Ibr starting day 0 was chosen as the recommended dosing regimen for use in Part 2 (Expansion) and Part 3 (CLL only, Cirm/Ibr vs. Ibr alone). Results: Twelve evaluable MCL pts were enrolled into Part 1, and 5 into Part 2. Median number of prior regimens was 2 (1-5), including pts relapsing after Ibr (4), auto-SCT (3), auto-SCT/ allo-SCT (1), auto-SCT/CAR-T (1). In CLL, 34 evaluable pts (12 TN and 22 RR) enrolled into Part 1 (18) or Part 2 (16). At least 74% of CLL pts in Parts 1 and 2 were high risk as determined by unmutated IGHV, del17p, and/or del11q. In Part 3, 22 evaluable pts received Cirm/Ibr (15) or Ibr (7). As of the 30OCT2020 safety cut-off for MCL and CLL, common TEAEs (all grades) included diarrhea (41%), contusion (39%), fatigue (39%), URI (31%), hypertension (25%) arthralgia (23%). Grade ≥3 neutropenia was 13% and thrombocytopenia 1%. There were no Cirm dose reductions or discontinuations for toxicity. Overall, Cirm did not appear to negatively impact the safety of Ibr. Efficacy (MCL): As of the 02FEB2021 efficacy cutoff, the best response of 17 evaluable pts in Parts 1 and 2 included an objective response rate (ORR) of 82%, 41% CR/CMR, 41% PR, 12% SD, and 6% PD. CR/CMR remain durable from 8-28+ mos. Most responses occurred rapidly after ̃3 mos of Cirm/Ibr. Notably, responses were achieved in all pts who received prior SCT+/- CAR-T (4CR, 1PR) or prior Ibr (2CR, 2PR). At a median follow-up of 14.6 mos, the median PFS (mPFS) had not been reached (NR) (95% CI: 17.5, NA). Efficacy (CLL): The best response of 34 evaluable pts in Parts 1 and 2 included 91% ORR, 3% CR, 88% PR/PR-L, 9% SD, 0% PD. In Part 3, both arms achieved 100% ORR (all PRs). At a median follow-up of 20.2 mos, the mPFS was NR (95% CI: NA, NA), and the PFS estimate at 24 months was 95% for R/R, and 87% for TN, respectively, for evaluable CLL pts receiving Cirm/Ibr. Conclusions: Cirm/Ibr is a well-tolerated, active regimen in both MCL and CLL. For MCL, the mPFS of NR (95% CI: 17.5, NA) and CRR (41%), with all CRs remaining without PD, compare favorably to mPFS of 12.8 mos (95% CI 8.5-16.6) and CRR (20%) reported for single agent Ibr (Rule 2017). For CLL, the high ORR and PFS are encouraging, particularly for RR CLL. The study is ongoing, with MCL enrollment expanded to study Cirm + Ibr in pts who have had a suboptimal response to an Ibr regimen, or who have failed other approved BTKi agents. Clinical trial information: NCT03088878.

Impact of the Karnofsky Performance Status on Survival and its Dynamics during the Terminal Year of Peritoneal Dialysis Patients

2018 ◽  
Vol 38 (1) ◽  
pp. 24-29 ◽  
Author(s):  
Ana Paula Modesto ◽  
Len Usvyat ◽  
Viviane Calice-Silva ◽  
Dandara Novakowski Spigolon ◽  
Ana Elizabeth Figueiredo ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Family Income ◽  
Independent Predictor ◽  
Karnofsky Performance Status ◽  
Low Cost ◽  
Performance Status ◽  
Multi Center Study ◽  
Complications And Mortality ◽  
First Time

Background Simple and low-cost tools to monitor the risk profile of patients on peritoneal dialysis (PD) at high risk of complications and mortality are scarce. One of the tools available to monitor the variation in vitality and dependence levels is the Karnofsky performance status (KPS). This study analyzed the average trends and variation of KPS during the 12 months before death and its independent value in predicting patients’ survival. Methods The data were compiled from the BRAZPD II multi-center study, performed in Brazil between 2004 and 2011. For the analysis of KPS dynamics, we included patients with at least 12 months of follow-up on PD and who had a fatal event during the follow-up. The following covariables were evaluated: age, gender, ethnicity, educational level, and presence of diabetes. We used the linear regression model to present the results: the log (time) before death was represented by the regression variable and KPS was the response. We also analyzed the independent impact of baseline KPS on patients’ survival. Results From the population of 9,905 patients enrolled in the BRAZPD study, 4,133 survived 12 months on PD and were included in the analysis. There was a gradual decline in the KPS scores, which accelerated in the last 2 months before death. These changes were similar irrespective of age, race, family income, gender, diabetes, PD modality, and education level. We observed 989 fatal events in this population during the observation period, and the KPS score was identified as an independent predictor for mortality in this cohort. Conclusions This study demonstrates for the first time the dynamics of KPS before death in PD patients, indicating a progressive and accelerated decline of KPS in the 12 months before patients died. In addition, KPS was an independent predictor of mortality in this population.

Multicenter Phase II Trial of S-1 Plus Cisplatin in Patients With Untreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

2006 ◽  
Vol 24 (4) ◽  
pp. 663-667 ◽  
Author(s):  
Jaffer A. Ajani ◽  
Fa-Chyi Lee ◽  
Deepti A. Singh ◽  
Daniel G. Haller ◽  
Heinz-Josef Lenz ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Median Number ◽  
Phase Iii ◽  
Highly Active ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Gastric Cancer Patients

Purpose S-1 plus cisplatin is considered highly active in Japanese gastric cancer patients. We conducted a phase II multi-institutional trial, in the West, in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma to evaluate activity and safety of this combination. Methods Patients received cisplatin intravenously at 75 mg/m2 on day 1 and S-1 orally at 25 mg/m2/dose bid (50 mg/m2/d) on days 1 to 21, repeated every 28 days. Patients with histologic proof of gastric or gastroesophageal junction adenocarcinoma with a Karnofsky performance status (KPS) of ≥ 70% and near-normal organ function were eligible. All patients provided a written informed consent. To observe a 45% confirmed overall response rate (ORR), 41 assessable patients were needed. Results All 47 patients were assessed for safety and survival, and 41 patients were assessed for ORR. The median age was 56 years and median KPS was 80%. The median number of chemotherapy cycles was four. The confirmed ORR was 51% (95% CI, 35% to 67%) and it was 49% by an independent review. At the 6-month interval, 71% of patients were alive, with a median survival time of 10.9 months. Frequent grade 3 or 4 toxicities included fatigue (26%), neutropenia (26%), vomiting (17%), diarrhea (15%), and nausea (15%); however, stomatitis (2%) and febrile neutropenia (2%) were uncommon. There was one (2%) treatment-related death. Conclusion S-1 plus cisplatin is active against gastric cancer and has a favorable toxicity profile. A global phase III study of S-1 plus cisplatin versus fluorouracil plus cisplatin currently is accruing patients.

scholarly journals Functional Outcome Following Synthetic Vertebral Body Implantation in the Management of Spinal Disorders

2020 ◽  
Vol 8 (B) ◽  
pp. 76-80
Author(s):  
Moneer K. Faraj ◽  
Bassam Mahmood Flamerz  Arkawazi ◽  
Hazim Moojid Abbas ◽  
Zaid Al-Attar
Keyword(s):  
Functional Outcome ◽  
Vertebral Body ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Spinal Tuberculosis ◽  
Vertebral Body Replacement ◽  
Spinal Tumors ◽  
Karnofsky Performance Status Scale ◽  
Significant Change

OBJECTIVE: Synthetic vertebral body replacement has been widely used recently to treat different spinal conditions affecting the anterior column. They arrange from trauma, infections, and even tumor conditions. In this study, we assess the functional outcome of this modality in different spinal conditions. PATIENTS AND METHODS: Thirty-six cases operated from October 2010 to December 2017. Twelve patients had spinal type A3 fractures, 11 cases with spinal tuberculosis (TB), and 13 cases with spinal tumors. They were followed clinically for a mean period of 2.4 years. RESULTS: All the cases were approached anteriorly. Seven cases had a post-operative infection. No neurological worsening reported. We had dramatic neurological improvement in all spinal TB cases. Mortality recorded in only 4 cases with metastatic spinal tumor during the mean period of follow-up. Karnofsky performance status scale showed statistically significant change for spinal TB, and tumor cases during the follow-up period, but there was no significant change in cases of spinal type A3 fractures. CONCLUSION: The positive outcome of this surgery makes it recommended for properly selected patients, especially with spinal TB and tumors.

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