scholarly journals Neuropathy Severity at the Time of Oxaliplatin Treatment Alteration in Patients with Colon Cancer (Alliance A151912)

Author(s):  
Daniel Hertz ◽  
Travis J Dockter ◽  
Daniel V Satele ◽  
Charles L Loprinzi ◽  
Jennifer G Le-Rademacher

Abstract Background: Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients who are experiencing chemotherapy-induced peripheral neuropathy. There are few data available on the clinical use of treatment alteration including the severity of CIPN at the time of treatment alteration. Methods: This was a retrospective analysis of patients receiving oxaliplatin on the NCCTG N08CB trial. Neuropathy severity was assessed at each cycle by clinicians and patients. Patients were classified as 1) completed treatment without alteration, 2) dose reduction or delay due to neuropathy, 3) discontinuation due to neuropathy, or discontinuation for other toxicity (4), or another reason (5). Comparisons focused primarily on patients with alteration due to neuropathy (groups 2 and/or 3) compared with patients who completed treatment without alteration (group 1). Results: In 350 participants, 135 (39%) completed treatment without alteration, 70 (20%) had a dose reduction or delay due to neuropathy, and 35 (10%) discontinued early due to neuropathy. Clinician-assessed neuropathy severity was greater in patients at the time of dose reduction or delay compared with severity at the end of treatment in patients without alteration (p<0.0001). Patient-reported neuropathy severity at cycle 4 was worse in patients who had an alteration as compared with patients who completed treatment without alteration (p=0.017). Conclusions: Treatment alterations due to neuropathy are common in patients receiving oxaliplatin for colon cancer and are associated with clinician-assessed neuropathy severity. Rapid increases in patient-reported neuropathy severity indicate a potential need for monitoring and intervention.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12090-12090
Author(s):  
Daniel Louis Hertz ◽  
Travis Dockter ◽  
Daniel V. Satele ◽  
Charles L. Loprinzi ◽  
Jennifer Le-Rademacher

12090 Background: Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients (pts) experiencing chemotherapy-induced peripheral neuropathy (CIPN). There are few data available on clinical use of treatment alteration including the severity of CIPN at the time of alteration. Our objective was to investigate the incidence of oxaliplatin treatment alterations and CIPN severity at that time. Methods: This was a retrospective analysis of pts with colon cancer scheduled to receive oxaliplatin-containing combination chemotherapy on the N08CB trial of intravenous calcium and magnesium for prevention of CIPN. Dose alterations were not mandated by the N08CB protocol. Clinicians assessed CIPN using NCI-CTCAE V.4.0; pts used the sensory subscale of the EORTC-QLQ Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN8). Pts were classified as 1) completed oxaliplatin treatment without alteration, 2) dose reduction or delay due to CIPN, 3) discontinuation due to CIPN, 4) discontinuation due to other AE, or 5) discontinuation for another reason. Comparisons focused primarily on pts with alteration due to CIPN (groups 2 and/or 3) compared with pts completing treatment without alteration (group 1) using chi-squared and Kruskal-Wallis tests. Results: In this analysis of 350 N08CB pts, 135 (39%) completed oxaliplatin without treatment alteration, 70 (20%) had a dose reduction (n=66) or delay (n=4) due to CIPN and 35 (10%) discontinued early due to CIPN. Pts who experienced alterations due to CIPN were younger (p=0.0249) and more likely to be female (p=0.008). Clinician-assessed CIPN severity was greater in pts at the time of dose reduction or delay compared with CIPN severity at the end of treatment in pts with no alteration (p<0.0001). Pt-assessed CIPN severity was not different in pts who completed treatment without alteration compared to pts who had a dose reduction or delay (p=0.88) or a discontinuation (p=0.37). CIPN8 scores at cycle 4 were higher (worse) in pts who eventually had any alteration (i.e., reduction, delay, or discontinuation) compared to pts who completed treatment without any alteration (median CIPN8 11.5 vs. 7.7, p=0.023). Conclusions: Treatment alterations due to CIPN are relatively common in pts receiving adjuvant oxaliplatin for colon cancer and are associated with clinician-assessed but not pt-reported CIPN severity. Rapid CIPN8 increases early in treatment are indicative of increased likelihood of a future oxaliplatin treatment alteration, indicating a potential use of early monitoring and intervention. Support: UG1CA189823; https://acknowledgments.alliancefound.org. Clinical trial information: NCT01099449 (NCCTG N08CB).


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 88-88
Author(s):  
Ruoyu Ji ◽  
Guanghua Huang ◽  
Lingshan Liu ◽  
Mengyin Chen ◽  
Xiaoduo Yu ◽  
...  

88 Background: Splenic enlargement has been reported in patients treated with oxaliplatin. However, the characteristics of oxaliplatin-induced splenomegaly were not well studied. Here we evaluated the change of splenic volume and its clinical significance in patients treated by oxaliplatin-based regimen. Methods: Patients with stage II-IV primary colon cancer treated with oxaliplatin and capecitabine in China National Cancer Center from January 2016 to December 2017 were screened for this retrospective study. Those with complete laboratory tests and computed tomographic data before, during and up to 1.5 years after the chemotherapy were selected. The splenic size was measured by AWVolumeshare5. Splenomegaly was defined as an over 30% increase of splenic size from baseline. Recovery of splenomegaly was defined as the splenic size fell back to a 0.9 to1.1-fold range of baseline. Results: Out of a total of 144 patients, 102 (70.8%) had over 30% increase, 72 (50.0%) had over 50% increase, and 22 (15.3%) had over 100% increase in splenic size after oxaliplatin-based regimen. Among the 102 splenomegaly patients, 5 (4.9%) develop splenomegaly within 3 chemotherapy cycles, 53 (53.0%) within 6 cycles, 73 (71.6%) within 9 cycles, and 102 (100.0%) within 3 months after the last administration of oxaliplatin. Compared to the group without splenomegaly, patients with splenomegaly received more cycles of oxaliplatin administrations (median 8 vs 6, p < 0.001) and greater dose intensity (total dose per square meter) (median 822.8mg/m2 vs 629.3mg/m2, p < 0.001). Patients with splenomegaly had higher incidence of thrombocytopenia (61.7% vs 38.1%, p = 0.009) and are more likely to undergo oxaliplatin dose reduction due to thrombocytopenia (21.6% vs 7.1%, p = 0.038). The recovery rates of splenic size within 0.5, 1 and 1.5 years after the end of oxaliplatin treatment were 23.2%, 50.6% and 74.3%, respectively. Conclusions: Splenomegaly are common in patients treated with oxaliplatin-based chemotherapy, and most would recover in 1.5 years after completion of therapy. Patients with splenomegaly are prone to experience thrombocytopenia and oxaliplatin dose reduction. Further studies are needed to reveal the mechanism how oxaliplatin induce splenomegaly.


2006 ◽  
Vol 24 (19) ◽  
pp. 3113-3120 ◽  
Author(s):  
Paul G. Richardson ◽  
Hannah Briemberg ◽  
Sundar Jagannath ◽  
Patrick Y. Wen ◽  
Bart Barlogie ◽  
...  

Purpose To determine the frequency, characteristics, and reversibility of peripheral neuropathy from bortezomib treatment of advanced multiple myeloma. Patients and Methods Peripheral neuropathy was assessed in two phase II studies in 256 patients with relapsed and/or refractory myeloma treated with bortezomib 1.0 or 1.3 mg/m2 intravenous bolus on days 1, 4, 8, and 11, every 21 days, for up to eight cycles. Peripheral neuropathy was evaluated at baseline, during the study, and after the study by patient-reported symptoms using the Functional Assessment of Cancer Therapy Scale/Gynecologic Oncology Group–Neurotoxicity (FACT/GOG-Ntx) questionnaire and neurologic examination. During the study, peripheral neuropathy was also evaluated by investigator assessment. A subset of patients underwent nerve conduction studies (n = 13). Results Before treatment, 194 (81%) of 239 patients had peripheral neuropathy by FACT/GOG-Ntx questionnaire, and 203 (83%) of 244 patients had peripheral neuropathy by neurologic examination. Treatment-emergent neuropathy was reported in 35% of patients, including 37% (84 of 228 patients) receiving bortezomib 1.3 mg/m2 and 21% (six of 28 patients) receiving bortezomib 1.0 mg/m2. Grade 1 or 2, 3, and 4 neuropathy occurred in 22%, 13%, and 0.4% of patients, respectively. The incidence of grade ≥ 3 neuropathy was higher among patients with baseline neuropathy by FACT/GOG-Ntx questionnaire compared with patients without baseline neuropathy (14% v 4%, respectively). In all 256 patients, neuropathy led to dose reduction in 12% and discontinuation in 5%. Of 35 patients with neuropathy ≥ grade 3 and/or requiring discontinuation, resolution to baseline or improvement occurred in 71%. Conclusion Bortezomib-associated peripheral neuropathy seemed reversible in the majority of patients after dose reduction or discontinuation. Although severe neuropathy was more frequent in the presence of baseline neuropathy, the overall occurrence was independent of baseline neuropathy or type of prior therapy.


2021 ◽  
pp. 1-9
Author(s):  
Matthias Zaiss ◽  
Jens Uhlig ◽  
Mark-Oliver Zahn ◽  
Thomas Decker ◽  
Helmar C. Lehmann ◽  
...  

<b><i>Introduction:</i></b> Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect persisting after completion of neurotoxic chemotherapies. This observational study was designed to evaluate the effectiveness of the dietary supplement OnLife® (patented mixture of specific fatty acids and palmitoylethanolamide) in improving symptoms of CIPN in breast and colon cancer patients. <b><i>Methods:</i></b> Improvement of CIPN was evaluated in adult patients, previously treated with (neo)adjuvant paclitaxel- (breast cancer) or oxaliplatin-based (colon cancer) therapies, receiving OnLife® for 3 months after completion of chemotherapy. The primary endpoint was to compare the severity of peripheral sensory neuropathy (PSN) and peripheral motor neuropathy (PMN) before and at the end of OnLife® treatment. Secondary endpoints included the assessment of patient-reported quality of life and CIPN symptoms as assessed by questionnaires. <b><i>Results:</i></b> 146 patients (<i>n</i> = 75 breast cancer patients and <i>n</i> = 71 colon cancer patients) qualified for analysis; 31.1% and 37.5% of breast cancer patients had an improvement of PSN and PMN, respectively. In colon cancer patients, PSN and PMN improved in 16.9% and 20.0% of patients, respectively. According to patient-reported outcomes, 45.9% and 37.5% of patients with paclitaxel-induced PSN and PMN, and 23.9% and 22.0% of patients with oxaliplatin-induced PSN and PMN experienced a reduction of CIPN symptoms, respectively. <b><i>Conclusion:</i></b> OnLife® treatment confirmed to be beneficial in reducing CIPN severity and in limiting the progression of neuropathy, more markedly in paclitaxel-treated patients and also in patients with oxaliplatin-induced CIPN.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23143-e23143
Author(s):  
Matthias R. Zaiss ◽  
Jens Uhlig ◽  
Mark-Oliver Zahn ◽  
Thomas Decker ◽  
Helmar C. Lehmann ◽  
...  

e23143 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, long-term side effect of many antineoplastic agents and has a detrimental impact on patients (pts)’ quality of life and functional activities of daily living. Currently, preventive measures and treatment options for CIPN are quite limited. OnLife is a dietary supplement that contains a patented mixture of fatty acids with anti-inflammatory, neuroprotective and antinociceptive properties. Methods: The STEFANO study – an observational, prospective, two-cohort, multicenter study of dietary supplementation – was designed to evaluate the potential of OnLife to improve CIPN in adult pts with completed neo-/adjuvant chemotherapy and manifest CIPN (grade 1-3) (Cohort A: colon cancer, oxaliplatin-containing therapy; cohort B: breast cancer, paclitaxel therapy). Pts received OnLife for 3 months. The primary objective – assessment of changes in CIPN – was evaluated by comparing the severity of sensory and motor CIPN according to CTCAE v4.03 before, during and after treatment with OnLife. Secondary endpoints included patient-reported experience of symptoms and functional limitations related to CIPN. Descriptive statistics were used to analyze data. Results: In total, 75 breast cancer pts with paclitaxel-induced and 71 colon cancer pts with oxaliplatin-induced peripheral neuropathy, respectively, received OnLife. Based on physician-rated CTCAE grades, 21.3% of breast cancer pts and 12.7% of colon cancer pts had a sustained improvement of sensory CIPN after OnLife treatment. Concerning motor CIPN, the proportions were 12.0% and 9.9%, respectively. According to patient-reported outcomes, 45.3% of breast cancer pts and 23.9% of colon cancer pts had less symptoms and functional limitations related to sensory CIPN after OnLife treatment. Concerning motor CIPN, the proportions were 32.0% and 22.5%, respectively. Conclusions: STEFANO provides indications of the potential of OnLife to reduce severity of objective and subjective CIPN-related symptoms. Therefore, it is a promising agent to meet the unmet medical need of management options for patients with established CIPN. Clinical trial information: NCT03065478.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Robert Knoerl ◽  
Emanuele Mazzola ◽  
Fangxin Hong ◽  
Elahe Salehi ◽  
Nadine McCleary ◽  
...  

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) negatively affects physical function and chemotherapy dosing, yet, clinicians infrequently document CIPN assessment and/or adhere to evidence-based CIPN management in practice. The primary aims of this two-phase, pre-posttest study were to explore the impact of a CIPN clinician decision support algorithm on clinicians’ frequency of CIPN assessment documentation and adherence to evidence-based management. Methods One hundred sixty-two patients receiving neurotoxic chemotherapy (e.g., taxanes, platinums, or bortezomib) answered patient-reported outcome measures on CIPN severity and interference prior to three clinic visits at breast, gastrointestinal, or multiple myeloma outpatient clinics (n = 81 usual care phase [UCP], n = 81 algorithm phase [AP]). During the AP, study staff delivered a copy of the CIPN assessment and management algorithm to clinicians (N = 53) prior to each clinic visit. Changes in clinicians’ CIPN assessment documentation (i.e., index of numbness, tingling, and/or CIPN pain documentation) and adherence to evidence-based management at the third clinic visit were compared between the AP and UCP using Pearson’s chi-squared test. Results Clinicians’ frequency of adherence to evidence-based CIPN management was higher in the AP (29/52 [56%]) than the UCP (20/46 [43%]), but the change was not statistically significant (p = 0.31). There were no improvements in clinicians’ CIPN assessment frequency during the AP (assessment index = 0.5440) in comparison to during the UCP (assessment index = 0.6468). Conclusions Implementation of a clinician-decision support algorithm did not significantly improve clinicians’ CIPN assessment documentation or adherence to evidence-based management. Further research is needed to develop theory-based implementation interventions to bolster the frequency of CIPN assessment and use of evidence-based management strategies in practice. Trial registration ClinicalTrials.Gov, NCT03514680. Registered 21 April 2018.


2020 ◽  
Vol 22 (2) ◽  
pp. 146-150
Author(s):  
Mariana Lima da Costa Valente ◽  
Marcela Silva Costa ◽  
Paulo Marcos Bérgamo ◽  
Denise Tornavoi de Castro

Currently, aesthetics, and especially the smile, adds considerable social value. In this way, patients suffering from dental loss wish that their rehabilitation be performed quickly and safely. The aim of oral rehabilitation is to restore masticatory, phonetic, aesthetic and quality of life to the patient. The diagnostic step is one of the most important and relevant steps in establishing a correct treatment plan and, in this way, it is possible to obtain excellent results. The present study aimed to demonstrate the importance of diagnostic waxing in oral rehabilitation. Patient sought treatment at the Dental Prosthesis Specialization Course at Odonto School, due to complaints associated with aesthetics and function. To improve their quality of life, planning of case was carried out through diagnostic waxing and a prosthetic solution was proposed. At the end of treatment and during the follow-up of the case, the patient reported satisfaction and significant improvement in quality of life. It can be concluded that the diagnostic waxing presents customized solutions offering, through a previous study, an effective clinical resolution to the patient. Keywords: Mouth Rehabilitation. Dental Restoration, Temporary. Dental Restoration, Temporary. Resumo Atualmente, a estética, e em especial o sorriso, agregam um valor social considerável. Dessa forma, ao sofrerem a perda dental, os pacientes desejam que sua reabilitação seja realizada de forma rápida e segura. A reabilitação oral tem como objetivo devolver ao paciente a eficiência mastigatória, fonética, estética e a qualidade de vida. A etapa diagnóstica constitui um dos passos mais importantes e relevantes no estabelecimento de um correto planejamento do tratamento e, desta forma, torna-se possível obter resultados de excelência. O presente estudo teve como objetivo demonstrar a importância do enceramento diagnóstico na reabilitação oral. Paciente procurou tratamento no Curso de Especialização em Prótese Dentária da Odonto School, devido a queixas associadas a estética e função. Para melhorar sua qualidade de vida, foi realizado o planejamento do caso por meio do enceramento diagnóstico e uma solução protética foi proposta. Ao final do tratamento e durante o acompanhamento do caso, a paciente relatou satisfação e melhora significativa na qualidade de vida. Pode-se concluir que o enceramento diagnóstico apresenta soluções personalizadas oferecendo, por meio de estudo prévio, uma resolução clínica efetiva ao paciente. Palavras-chave: Reabilitação Bucal. Restauração Dentária Temporária. Prótese Dentária Temporária.


2020 ◽  
Vol 9 (10) ◽  
pp. e3299108753
Author(s):  
Yuri Barbosa Alves ◽  
Paula Cristina Henriques da Silva ◽  
Gabriel Garcia de Carvalho ◽  
José Manuel Peixoto Caldas ◽  
Heloisa Helena Pinho Veloso

Investigations of the oral function of patients undergoing radiotherapy (RT) to the head and neck region are relevant for the overall quality of life. Considering the possible impact of the side-effects on nutrition, the recovery of these patients might be impaired. This study aimed at investigating the oral condition of patients submitted to RT to the head and neck region. A single-center, cross-sectional mixed analysis assessing the oral conditions of patients before RT (group 1) and after 12-months of RT (group 2) was performed. Following inclusion and exclusion criteria consideration, fifty (n=25) patients were included in this study. A calibrated examiner conducted the oral examination, the following variables were assessed: a) DMF index: decayed, missing and filled teeth; b) xerostomia and dysgeusia, subjective assessment of salivary function and taste; c) simplified oral hygiene index – OHI-S, with plaque disclosing solution; d) unstimulated sialometry, assessment of salivary function. Statistical analysis compared the groups considering a significance level of 5%. The group evaluated after 12 months of RT showed high rate of dry mouth (92%) and dysgeusia complaint (72%) while no patient reported in group 1. Statistically significant difference was observed in the comparison of group 1 and 2 regarding DMF index (> 64%), OHI-S index (>38%), and unstimulated sialometry (<70%). Patients submitted to RT to the head and neck region for the treatment of cancer experience oral complications even at 12 months after the last session of RT.


2020 ◽  
Vol 19 (3) ◽  
pp. 80-91
Author(s):  
S. N. Schaeva ◽  
E. V. Gordeeva ◽  
E. A. Kazantseva

AIM: to evaluate the early and long-term results of emergency two-stage surgical procedures in patients with sigmoid colon cancer complicated by decompensated bowel obstruction.PATIENTS AND METHODS: the cohort study included 112 patients with sigmoid colon cancer complicated by bowel obstruction that underwent emergency two-stage surgical procedures in general surgical and coloproctological units in 2011-2017. The group 1 (n=60) included patients who, at the first stage, underwent Hartmann’s procedure, at the second stage – stoma reversal. The group 2 (n=52) included patients with a loop colostomy at the first stage and radical elective surgery as a second stage. The comparative analysis between the groups was carried out according to the following criteria: the type of surgery, the type of intestinal stoma, the rate and type of postoperative complications, postoperative mortality, resection status (R0/R1), the number of removed lymph nodes, the rate of adjuvant polychemotherapy (PChT).RESULTS: postoperative mortality in the group 1 was 3.33% (n=2) and occurred after the first main stage (Hartmann’s procedure), there were no deaths in group 2 (p=0.28). The procedures in group 2 fully met the criteria of oncological radicalism based on the number of lymph nodes examined and resection status (p<0.0001 and p<0.0001, respectively). Three-year overall survival at stage IIB in group 1 was 44.4% vs 75.2% in group 2 (p<0.0001); with IIIB in the 1st group – 60.3% vs 68.2% in group 2 (p=0.034); at IIIС in the 1st group – 35.7% vs 60.7% in the 2nd group (p=0.009). The 3-year disease – free survival at stage IIB in the 1st group was 41.7% vs 68.8% in the 2nd group (p<0.0001); with IIIB in the 1st group – 53.6% vs 64.5% in group 2 (p=0.036); at IIIС in the 1st group – 33.2% vs 60.8% in the 2nd group (p=0.023).CONCLUSION: for sigmoid colon cancer complicated by decompensated obstruction, in general hospitals the stage treatment with the colostomy at the first stage is preferable.


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