Peptic ulcer recurrence during maintenance therapy with H 2 -receptor antagonist following first-line therapy with proton pump inhibitor

2000 ◽  
Vol 35 (11) ◽  
pp. 824-831 ◽  
Author(s):  
Eizo Kaneko ◽  
Yoshio Hoshihara ◽  
Nobuhiro Sakaki ◽  
Shigeru Harasawa ◽  
Kiyoshi Ashida ◽  
...  
2014 ◽  
Vol 23 (5) ◽  
pp. 443-455 ◽  
Author(s):  
Chen-Li Ye ◽  
Guo-Ping Liao ◽  
Shuai He ◽  
Yan-Na Pan ◽  
Ying-Bo Kang ◽  
...  

1999 ◽  
Vol 35 (2) ◽  
pp. 214-218 ◽  
Author(s):  
J.F.R Robertson ◽  
P.C Willsher ◽  
L Winterbottom ◽  
R.W Blamey ◽  
S Thorpe

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 501-501 ◽  
Author(s):  
R. A. Wolff ◽  
W. Schepp ◽  
M. DiBartolomeo ◽  
A. Hossain ◽  
C. Stoffregen ◽  
...  

501 Background: Maintenance therapy is designed to maximize progression-free survival (PFS) and minimize toxicity in advanced CRC. ENZ is an oral serine/threonine kinase inhibitor that targets PKC-b and the AKT/PI3K pathway. Preclinical studies demonstrated synergistic antitumor effects when ENZ was combined with BV. In phase I studies, the combination was well tolerated. This phase II study assessed ENZ with 5-FU/LV plus BV as maintenance therapy for mCRC. Methods: Patients had locally advanced or mCRC, and completed 6 cycles of first-line chemotherapy ≤4 wks prior to randomization. Arm A received a loading dose of ENZ 1,125 mg, followed by 500 mg/d subsequent doses. Arm B received placebo. Both groups received 5-FU/LV (LV 400 mg/m2 IV, 5-FU 400 mg/m2 bolus, 5-FU 2,400 mg/m2 IV) plus BV 5 mg/kg IV, every 2 wks. Patients were treated with 5-FU/LV plus BV plus either ENZ or placebo until disease progression or for 1 yr. Primary endpoint was PFS from randomization. Secondary endpoints were overall survival (OS) from randomization, and OS and PFS from start of first-line therapy. Analysis was done after 50 events (objective or clinical progression). Results: 58 patients were randomized to Arm A (57 treated), 59 to Arm B (58 treated). 82 (70.1%) patients discontinued treatment (Arm A, 42 [72.4%]; Arm B, 40 [67.8%]), the majority due to disease progression. Median cycles were 9 in Arm A, 10 in Arm B. Median PFS in months was 5.8 in Arm A and 8.1 in Arm B (hazard ratio [HR]=1.35, 95% CI: 0.84, 2.16; protocol specified one-sided test, p=0.896). Median OS was not calculable due to high censoring (77.6% in Arm A and 91.5% in Arm B). Median PFS in months from start of first-line therapy was 8.9 in Arm A and 11.3 in Arm B (HR=1.39, 95% CI: 0.86, 2.23; one-sided, p=0.913). More patients developed thrombosis or embolism (TE), including pulmonary embolism, on Arm A (5 [8.8%] patients had grade 3 and 5 [8.8%] grade 4 TE) compared with Arm B (no grade 3 and 1 [1.7%] grade 4 TE). Conclusions: ENZ did not demonstrate an advantage in PFS compared to BV-based therapy alone. Further development of maintenance therapy with ENZ is not recommended for mCRC. [Table: see text]


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1788-1788
Author(s):  
Francisco Javier Peñalver Párraga ◽  
José Antonio Márquez Navarro ◽  
Soledad Durán Nieto ◽  
Pilar Giraldo Castellano ◽  
Carlos Montalbán Sanz ◽  
...  

Abstract Objectives: To evaluate the efficacy and toxicity of a response-adapted therapy with rituximab/bendamustine/mitoxantrone/dexamethasone (RBMD), followed by rituximab (R) maintenance therapy in patients with relapsed or refractory follicular lymphoma (R/R FL) to first-line treatment with R-chemotherapy (R-ChemoT). Material and methods: Multicenter phase II trial including 60 patients with R/R FL, after a first R-ChemoT line. Induction therapy: R 375 mg/m2 IV, day 1; bendamustine 90 mg/m2 IV, days 1 and 2; mitoxantrone 6 mg/m2 IV, day 1; dexamethasone 20 mg/day, PO, days 1 to 5. Cycles of 28 days. Evaluation of response after third cycle. If stable (SD) or progression disease (PD): patient withdrawn from the study. If complete response (CR) or unconfirmed complete response (CRu): administration of fourth cycle. If partial response (PR): administration up to 6 cycles. If CR, CRu, or PR after induction: patient received maintenance therapy with R (375 mg/m2/day every 12 weeks for 2 years). Results: N=60 patients: 50% female, age 63 (32-76) years. Ann Arbor stage III-IV 70% (42/60). FLIPI intermediate-high risk: 50% (30/60). Refractory to R-ChemoT: 18% (11/60). Received RCHOP as first line therapy: 77% (43/60). R maintenance after first line therapy: 43% (26/60). Number of administered RBMD cycles: 4 (1-6). Efectiveness: CR/CRu after 3 cycles (CR-3), 27 patients. Response after induction therapy (4-6 cycles): Overall response (OR), 88.5% (53/60); CR, 58.5% (35/60); CRu, 12% (7/60); PR, 18% (11/60); SD, 1.5% (1/60); PD, 10% (6/60). Median follow-up: 24.41 mo. (15.58-30.15). Progression free survival, median not reached (NR) (28.28-NR). Overall survival, median NR (NR-NR). OR after RBMD in patients who received R maintenance after first line therapy, 96% (25/26; CR + CRu, 65%). OR in patients who did not receive R maintenance after first line therapy, 94% (32/34; CR + CRu, 82%). Safety: Grade 3/4 hematologic toxicity: neutropenia, 60% (n=36; 34 patients received G-CSF); anemia, 2% (n=1); thrombopenia, 4% (n=2). Grade 3/4 infections: 8% (n=4); febrile neutropenia 8%, (n=4). Exitus, 2/60 (PD, cycle 1; influenza A, cycle 5). Grade 3/4 non-hematologic toxicity: infusion reaction, 4% (n=2). No skin reactions. Patient withdrawals before R maintenance therapy: no inclusion criteria (NIC), 2/60; protocol delay of over 4 weeks, 7/60. Forty-four patients began R maintenance therapy (CR-3, 24/44). During R maintenance therapy: PD, 8/44 (18%; 5/8 in CR-3 patients); SD, 1/44 (2.5%); NIC, 3/44 (7%, all CR); protocol delay, 1/44 (2.5%); toxicity, 1/44 (2.5%, myelodysplastic syndrome). Response to R maintenance therapy: OR, 68% (30/44); CR, 61% (27/44; in CR-3 patients, 65%, 17/26); CRu, 4.5% (2/44); PR, 2.5% (1/44). Conclusions: RBMD is an effective and safe alternative for patients with R/R FL who have received first line treatment with R-ChemoT and R maintenance therapy. This response-adapted treatment strategy achieved results similar to the scheme with 6 cycles and may allow reduction of the intensity and duration of induction therapy and minimize toxicity. No skin reactions were reported, possibly due to the inclusion of dexamethasone in the treatment scheme. Disclosures No relevant conflicts of interest to declare.


2010 ◽  
Vol 4 (11) ◽  
pp. 712-716 ◽  
Author(s):  
Guilherme Felga ◽  
Fernando Marcuz Silva ◽  
Ricardo Correa Barbuti ◽  
Tomas Navarro-Rodriguez ◽  
Schlioma Zaterka ◽  
...  

Introduction: The scheme proton pump inhibitor/amoxicillin/clarithromycin (PPI/AC) is still the first-line treatment for Helicobacter pylori (H. pylori) infections despite evidence suggesting its failure in up to 20% to 30% of patients. Methodology: This study involved 493 patients who were prescribed omeprazole (20 mg twice a day) or another proton pump inhibitor in equivalent dosage, amoxicillin (1 g twice a day), and clarithromycin (500 mg twice a day) for seven days. Efficacy was determined by negative urease test and absence of H. pylori on gastric biopsy samples twelve weeks after the end of treatment. Safety was defined according to the adverse effects reported. Mean age of the patients was (± SD) 48.96 ± 13, and demographic and clinical data were recorded for correlation with treatment outcomes. Results: Out of 493 patients, 316 (64.1%) presented duodenal ulcer, 111 (22.5%) gastric ulcer, and 66 (14.4%) simultaneous gastric and duodenal ulcers. Additionally, 267 (54.2%) patients had at least one risk factor for peptic ulcer disease, smoking being the most common (99 [36.5%]). Successful eradication was achieved in 408 patients. The eradication rates per protocol, and according to the intention to treat, were 88.8% and 82.7%, respectively.  Of 164 (35.5%) patients who presented adverse effects, 100 (61%) reported them as mild and only six (3.7%) patients had to discontinue treatment. Previous use of tobacco and non-steroid anti-inflammatory drugs was the only risk factor for treatment failure (P 0.00). Conclusion: PPI/AC is still a valuable and remarkably tolerable option for first-line H. pylori eradication in Brazil.


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