scholarly journals Incidence and evolution of oxaliplatin-induced peripheral sensory neuropathy in diabetic patients with colorectal cancer: a pooled analysis of three phase III studies

2010 ◽  
Vol 21 (4) ◽  
pp. 754-758 ◽  
Author(s):  
R.K. Ramanathan ◽  
M.L. Rothenberg ◽  
A. de Gramont ◽  
C. Tournigand ◽  
R.M. Goldberg ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Sensory Neuropathy ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Diabetic Patients ◽  
Peripheral Sensory Neuropathy ◽  
Three Phase ◽  
Peripheral Sensory ◽  
Phase Iii Studies

scholarly journals Incidence of Second Primary Malignancies and Peripheral Sensory Neuropathy in Patients with Multiple Myeloma Receiving Daratumumab Containing Regimen

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5550-5550 ◽  
Author(s):  
Thura Win Htut ◽  
Donald P. Quick ◽  
Myint Aung Win ◽  
Sriman Swarup ◽  
Anita Sultan ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Sensory Neuropathy ◽  
Phase Iii ◽  
Control Group ◽  
Second Primary ◽  
Peripheral Sensory Neuropathy ◽  
Antitumor Effects ◽  
Refractory Multiple Myeloma ◽  
Second Primary Malignancies ◽  
Peripheral Sensory

Introduction: Proteasome inhibitors-based regimens are the mainstay of initial therapy for most patients with multiple myeloma. Daratumumab is a human IgGκ monoclonal antibody that targets CD38 with direct antitumor effects and has an immunomodulatory component. Recent studies have demonstrated that addition of daratumumab to standard regimens enhance direct cytotoxicity on myeloma cells and have shown survival benefits. Yet, there are notable safety concerns. We performed a combined analysis of randomized controlled trials (RCT) to determine the risk of second primary malignancies (SPM) and peripheral sensory neuropathy (PSN) with newer daratumumab combination regimens. Methods: We systematically conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through June 2019. Phase III RCTs utilizing daratumumab in patients with multiple myeloma that mention SPM and PSN as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q- statistic. Random effects model was applied. Results: A total of 3,547 patients with multiple myeloma from 5 phase III RCTs were eligible. Studies compared daratumumab (D) + bortezomib (V) + melphan (M) + prednisone (P) vs VMP, D + lenalidomide (R) + dexamethasone (d) vs Rd, DVd vs Vd and DVd + thalidomide (T) vs VTd. The randomization ratio was 1:1 in all studies. Daratumumab was utilized in relapsed and refractory multiple myeloma in the POLLUX study (n= 564) and the CASTOR study (n= 480) and as first-line treatment for patients with multiple myeloma in the ALCYONE study (n= 700), the CASSIOPEIA study (n= 1085) and the MAIA study (n= 737). The I2 statistic for heterogeneity was 25, suggesting some heterogeneity among RCT. The SPM incidence was 76 (4.29%) in study group vs 77 (4.34%) in control group. The RR for SPM was 1.12 (95% CI: 0.74 - 1.69; P = 0.58) and RD was 0.01 (95% CI: -0.01 to 0.02; P = 0.34). The RR for SPM was noted at 2.56 (95% CI: 0.26 - 25.46; P = 0.42) in a subset of relapsed and refractory multiple myeloma. Any-grade PSN was reported in 527 (46.84%) in daratumumab arm vs 550 (48.72%) in control arm with the RR of 0.98 (95% CI: 0.80 -1.21; P = 0.88). High-grade PSN was noted in 63 (5.6%) vs 76 (6.73%) in control group with the RR of 0.73 (95% CI: 0.42 -1.27; P = 0.27). Conclusions: Our meta-analysis depicted that there was no significant increase in the risk of second primary malignancies and peripheral sensory neuropathy in patients on daratumumab combination regimen, in newly diagnosed and relapsed refractory multiple myeloma, compared to control arm. However, long-term follow-up of these patients is required to determine the actual relation with second primary malignancies. Disclosures No relevant conflicts of interest to declare.

The effect of bundle of warmth care for patients with advanced colorectal cancer undergoing chemotherapy on reduction of oxaliplatin-related peripheral sensory neuropathy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15031-e15031
Author(s):  
Jin-Xiang Lin ◽  
Zhan-hong Chen ◽  
Xiang-Wei Chen ◽  
Zu-Yan Fan ◽  
Xiu-Yan Huang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Intervention Group ◽  
Sensory Neuropathy ◽  
Warm Water ◽  
Control Group ◽  
Peripheral Sensory Neuropathy ◽  
Exposure To Cold ◽  
Hands And Feet ◽  
Peripheral Sensory

e15031 Background: FOLFOX is the one of the most selected chemotherapy regimens for advanced colorectal carcinoma (aCC) patients, which includes oxaliplatin, 5-fu and leucovorin. However, oxaliplatin often causes chemotherapy-induced peripheral sensory neuropathy (CIPN) which is a common treatment-related adverse effect and affects long- term quality of life. The aim of the study is to observe the effect of warmth intervention on patients with advanced colorectal cancer undergoing chemotherapy. Methods: A total of 60 aCC patients were recruited. They were randomized into an intervention group (30 patients) and a control group (30 patients). The intervention group accepted the bundle of warmth care which included wearing cotton gloves and socks, washing hands and taking a bath with warm water, soaking hands and feet before sleep with warm water, reducing exposure to cold and avoiding cold food. The control group was treated with conventional health education which including how to reduce exposure to cold. CTCAE-4.0 was used to evaluate patient, s peripheral sensory neuropathy at baseline, 3 months, 6 months and 6 months after chemotherapy terminate. Results: At baseline, there was no peripheral sensory neuropathy in two groups. In 3 months, incidence of peripheral sensory neuropathy of intervention group and control group were 26.67%(Ⅰ:20.00%,Ⅱ:6.67%) VS 83.34% (Ⅰ:46.67%,Ⅱ:30.00%,Ⅲ:6.67%)(χ2= 22.289,p = 0.000). In 6 months, incidence of peripheral sensory neuropathy of two group were 36.67% (Ⅰ: 26.67%,Ⅱ: 10.00%) VS 93.34%(Ⅰ:46.67%,Ⅱ:30.00%,Ⅲ:16.67%) (χ2= 23.398,p = 0.000). 6 months after chemotherapy terminate, incidence of peripheral sensory nerve damage of two group were 13.33%(Ⅰ:10.00%,Ⅱ:3.33%) VS 33.34%(Ⅰ:6.67%,Ⅱ:10.00%,Ⅲ:6.67%) (χ2= 4.283,p = 0.233). Conclusions: Bundle of warmth care reduced oxaliplatin-related peripheral sensory neuropathy on patients with advanced colorectal cancer undergoing chemotherapy.

VOICE trial: Final results from multicenter phaseII study of assessment of clinical efficiency and safety in capecitabine plus intermittent oxaliplatin together with bevacizumab as first-line therapy for patients with advanced colorectal cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 740-740 ◽  
Author(s):  
Chihiro Kosugi ◽  
Keiji Koda ◽  
Tadamichi Denda ◽  
Keiichiro Ishibashi ◽  
Hideyuki Ishida ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Peripheral Neuropathy ◽  
Primary Endpoint ◽  
Sensory Neuropathy ◽  
Severe Neutropenia ◽  
First Line ◽  
Peripheral Sensory Neuropathy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Peripheral Sensory

740 Background: The FOLFOX with bevacizumab (B-mab) has been established as a standard first-line therapy for metastatic colorectal cancer (mCRC), and OPTIMOX1 study suggested that stop and go strategy for oxaliplatin reduced peripheral sensory neuropathy. The CapeOx is one of the standard treatments for mCRC that has been proven to be as effective as the FOLFOX regimen. Thus we accessed the efficacy and safety of the combination of intermittent CapeOx + B-mab as a first-line therapy in patients with mCRC in this trial. Methods: Eligibility criteria included ECOG PS: 0–1, No Peripheral neuropathy ( < Grade 1). Patients received CapeOX (oxaliplatin 130mg/m2, capecitabine 2000mg/m2 + B-mab 7.5mg/kg) q3 weeks for 5 cycles, maintenance without oxaliplatin for 5 cycles, and reintroduction CapeOX + B-mab for 5 cycles until progression. Primary endpoint was Progression Free Survival (PFS). Results: Between March 2011 and August 2013, 55 pts were enrolled. Baseline characteristics were median age of 67 years (range, 20–83); PS 0/1 (49/6 pts); male/female (33/22 pts), colon/rectum (28/27pts) and metastatic lesion liver/lung/lymph nodes (32/18/21 pts). A total of 47 pts were evaluated as Par Protocol Set population. 38 pts moved from initial CapeOX to maintenance Capecitabine. 20 pts moved to CapeOx reintroduction. Median PFS was 14.7months (95%CI, 8.6–19.5) and Median TTF was 12.3 months (95%CI, 10.3–14.3). Best overall response rate was 48.0%. Oxaliplatin reintroduction rate was 57.4%. Main grade 3/4 toxicity were: neutropenia (1 pt), anemia (1 pt), peripheral neuropathy (1 pt), allergic reaction of oxaliplatin (1 pt), deep vein thrombosis (1 pt), nausea (1 pt), hand-foot syndrome (1 pt), and hypertension (1 pt). Conclusions: This study met its primary endpoint PFS. CapeOx intermittent oxaliplatin indicated to reduce incidence of severe neutropenia and peripheral sensory neuropathy. The results suggested that our treatment strategy was well tolerate and effective for first line therapy in mCRC, and maintenance duration for 5 cycles, was reasonable. Clinical trial information: UMIN000005732.

scholarly journals Retinal Microcirculation in Type 1 Diabetic Patients With and Without Peripheral Sensory Neuropathy

2014 ◽  
Vol 8 (2) ◽  
pp. 356-361 ◽  
Author(s):  
Thomas Forst ◽  
Matthias M. Weber ◽  
Michael Mitry ◽  
Lena Müller ◽  
Senait Forst ◽  
...  
Keyword(s):  
Sensory Neuropathy ◽  
Diabetic Patients ◽  
Peripheral Sensory Neuropathy ◽  
Retinal Microcirculation ◽  
Type 1 Diabetic Patients ◽  
Peripheral Sensory

The study of efficacy and safety of chemotherapy plus bevacizumab with oxaliplatin stop-and-go strategy in first-line treatment for metastatic colorectal cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 761-761
Author(s):  
Nao Takano ◽  
Goro Nakayama ◽  
Yasuhiro Kodera
Keyword(s):  
Colorectal Cancer ◽  
Maintenance Therapy ◽  
Metastatic Colorectal Cancer ◽  
Dose Intensity ◽  
Sensory Neuropathy ◽  
Efficacy And Safety ◽  
First Line ◽  
Peripheral Sensory Neuropathy ◽  
Stop And Go ◽  
Peripheral Sensory

761 Background: In metastatic colorectal cancer (mCRC), the benefit of the molecular targeted drugs added to chemotherapy has been reported and a combination therapy of capecitabine (CAP) and oxaliplatin (CapeOX) plus bevacizumab (BEV) is an established first-line therapy for mCRC. However, the management of the cumlateve neurotoxicity of oxaliplatin still remains. We evaluated the efficacy and safety of CapeOX plus BEV with oxaliplatin stop and go strategy. Methods: Two prospective clinical trials of previously untreated unresectable mCRC were analyzed. Fifty four patients were treated with CapeOX plus BEV with oxaliplatin stop and go strategy (CCOG-0902). They were treated 4 cycles of CapeOX plus BV therapy followed by maintenance therapy of 8 cycles of Capecitabine plus BV and oxaliplatin reintroduction was scheduled after maintenance therapy or upon tumor progression. On the other group, forty seven patients were treated with mFOLFOX6 plus BEV (CCOG-0801). Progression free survival (PFS), overall survival (OS), response rate (RR), disease control rate (DCR), relative dose intensity (RDI), and frequency of peripheral sensory neuropathy (PSN) were evaluated. Results: Patient characteristics were balanced between the two groups. The median RDI of oxaliplatin in CCOG-0902 group was significantly higher, 92% than in CCOG-0801 group, 80%. RR and DCR were 61.5% and 96.3% respectively, in CCOG-0902 group, compared with 61.7% and 89.4% respectively, in CCOG-0801 group. Median PFS was 13.6 and 30.5 months, respectively, compared with 11.7 and 31.6 months, respectively, in CCOG-0801 group (p=not significant). The frequency of peripheral sensory neuropathy (PSN) was 19.0% (>Grade3: 1.9%) of patients in CCOG-0902 group compared with 72.3% (>grade 3: 17.0%) in CCOG-0801 group. Conclusions: CapeOX plus BV with oxaliplatin stop and go strategy could have same efficacy as continuing oxaliplatin with avoiding PSN. Clinical trial information: UMIN000006478.

scholarly journals Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: A pooled analysis of three phase III studies

Epilepsia ◽  
2013 ◽  
Vol 54 (8) ◽  
pp. 1481-1489 ◽  
Author(s):  
Bernhard J. Steinhoff ◽  
Elinor Ben-Menachem ◽  
Philippe Ryvlin ◽  
Simon Shorvon ◽  
Lynn Kramer ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Partial Seizures ◽  
Three Phase ◽  
Phase Iii Studies
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