Occurrence of tinnitus and peripheral sensory neuropathy in women during chemotherapy treatment of breast cancer

Objective: To analyze the occurrence of tinnitus and peripheral sensory neuropathy in women during breast cancer chemotherapy. Methods: This is a retrospective analytical study with a quantitative approach, performed in medical records of an oncology outpatient service between February 2014 and February 2015, using the toxicities scores of Common Terminology Criteria for Adverse Events (CTCAE). Results: Considering 181 patients with breast cancer who met the inclusion criteria, 49.2% reported tinnitus at some point of the treatment, while 65.1% peripheral sensory neuropathy. In both conditions, the predominant severity score was grade 1, with frequencies of 23.8% and 33.1%, respectively. A significant, positive and weak correlation was observed between the severity of tinnitus and peripheral sensory neuropathy (ρ = 0.325 and p = 0.001), as well as very weak between the number of complete cycles of chemotherapy and tinnitus (ρ = 0.195 and p = 0.009) and neuropathy peripheral sensory (ρ = 0.237 and p = 0.002). Conclusions: Tinnitus and peripheral sensory neuropathy were frequent toxicities during chemotherapy treatment of breast cancer, and both manifested with low severity/functional impact in most participants.

Download Full-text

Efficacy and Safety of Ixabepilone (BMS-247550) in a Phase II Study of Patients With Advanced Breast Cancer Resistant to an Anthracycline, a Taxane, and Capecitabine

Journal of Clinical Oncology ◽

10.1200/jco.2006.09.3849 ◽

2007 ◽

Vol 25 (23) ◽

pp. 3407-3414 ◽

Cited By ~ 296

Author(s):

Edith A. Perez ◽

Guillermo Lerzo ◽

Xavier Pivot ◽

Eva Thomas ◽

Linda Vahdat ◽

...

Keyword(s):

Breast Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Objective Response ◽

Sensory Neuropathy ◽

Efficacy And Safety ◽

Peripheral Sensory Neuropathy ◽

Metastatic Setting ◽

Grade 3 ◽

Peripheral Sensory

PurposeTo evaluate the efficacy and safety of ixabepilone in patients with metastatic breast cancer (MBC) resistant to anthracycline, taxane, and capecitabine, in this multicenter, phase II study.Patients and MethodsPatients with measurable disease who had tumor progression while receiving prior anthracycline, taxane, and capecitabine were enrolled. Ixabepilone 40 mg/m2monotherapy was administered as a 3-hour intravenous infusion on day 1 of a 21-day cycle. The primary end point was objective response rate (ORR), assessed by an independent radiology facility (IRF).ResultsA total of 126 patients were treated and 113 were assessable for response. Patients were heavily pretreated: 88% had received at least two lines of prior chemotherapy in the metastatic setting. IRF-assessed ORR was 11.5% (95% CI, 6.3% to 18.9%) for response-assessable patients. Investigator-assessed ORR for all treated patients was 18.3% (95% CI, 11.9% to 26.1%). Fifty percent of patients achieved stable disease (SD); 14.3% achieved SD ≥ 6 months. Median duration of response and progression-free survival were 5.7 and 3.1 months, respectively. Median overall survival was 8.6 months. Patients received a median of 4.0 treatment cycles (range, one to 16 cycles), and 25% of patients received ≥ eight cycles. Grade 3/4 treatment-related events included peripheral sensory neuropathy (14%), fatigue/asthenia (13%), myalgia (8%), and stomatitis/mucositis (6%). Resolution of grade 3/4 peripheral sensory neuropathy occurred after a median period of 5.4 weeks.ConclusionIxabepilone demonstrated clear activity and a manageable safety profile in patients with MBC resistant to anthracycline, taxane, and capecitabine. Responses were durable and notable in patients who had not previously responded to multiple prior therapies.

Download Full-text

Is nab-paclitaxel better than conventional taxanes as neoadjuvant therapy for breast cancer? A meta-analysis

Journal of International Medical Research ◽

10.1177/0300060520943473 ◽

2020 ◽

Vol 48 (8) ◽

pp. 030006052094347

Author(s):

Yong Li ◽

Xiaoju Lu ◽

Qimou Lin ◽

Weiwen Li

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Meta Analysis ◽

Sensory Neuropathy ◽

Cochrane Library ◽

Peripheral Sensory Neuropathy ◽

Paclitaxel Group ◽

Peripheral Sensory

Objective This study compared the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) with conventional taxanes as neoadjuvant chemotherapy for breast cancer. Methods We searched the literature using PubMed, the Cochrane Library, and Web of Science from their inception to December 15, 2019 based on predetermined inclusion and exclusion criteria. The relevant studies compared pathologic complete response (pCR) and adverse event rates. Results The meta-analysis included five studies and 2335 patients. Compared with conventional taxanes, neoadjuvant chemotherapy with nab-paclitaxel was associated with a higher pCR rate (odds ratio [OR] = 1.39, 95% confidence interval [CI] = 1.16–1.67), especially among patients with triple-negative breast cancer or Ki67 indices of >20%. Pooled outcomes also revealed better event-free survival in the nab-paclitaxel group (hazard ratio = 0.69, 95% CI = 0.57–0.85). However, all-grade (OR = 2.17, 95% CI = 1.38–3.40) and grade ≥3 peripheral sensory neuropathy (OR = 3.92, 95% CI = 2.44–6.28) were more frequent in the nab-paclitaxel group. Conclusions This meta-analysis implied that nab-paclitaxel more effectively improved pCR than conventional taxanes. Nab-paclitaxel may have greater benefits in patients with triple-negative breast cancer. However, additional attention is required for the early diagnosis and management of peripheral sensory neuropathy.

Download Full-text

A pharmacogenetic analysis of peripheral sensory neuropathy related to administration of taxanes in breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e13133 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e13133-e13133

Author(s):

Alyson Leonard ◽

Vinay K. Gudena

Keyword(s):

Breast Cancer ◽

Sensory Neuropathy ◽

Normal Function ◽

Categorical Variables ◽

Cancer Center ◽

Breast Cancer Patients ◽

Peripheral Sensory Neuropathy ◽

Metabolizing Enzymes ◽

Significant Difference ◽

Peripheral Sensory

e13133 Background: Commonly used in the treatment of breast cancer, the taxane class includes paclitaxel and docetaxel. Both medications are primarily metabolized by cytochrome P450 enzymes and transporters mediate drug membrane influx and efflux. Variability in metabolizing enzymes and drug transporter function can affect drug clearance. This study sought to determine if the presence of pharmacogenetic changes in metabolizing enzymes and transporters resulted in a patient experiencing peripheral sensory neuropathy. Methods: In this case-control study, patients were enrolled between April 13, 2018 and April 30, 2018. Electronic medical records of patients with current appointments at Cone Health Cancer Center- Wesley Long were reviewed to identify patients who completed treatment with taxanes for breast cancer after January 1, 2017 for evaluation for inclusion in the study. Buccal swabs for pharmacogenetics testing were collected. Genes of interest, ABCB1, CYP3A4, CYP3A5, and SLCO1B1, were evaluated and data was categorized by phenotype. Baseline characteristics and phenotype results were compared using Fisher's exact test for categorical variables and Wilcoxon Rank Sum for numeric variables as appropriate. Results: Thirty-three patients were included in the final analysis. The population was mainly white at 72% and all patients in the study were female. The average patient age was 57 years old. Most patients had stage 1 breast cancer. Most patients received docetaxel. Among patients with peripheral sensory neuropathy, nine were grade 1, five were grade 2, and seven were grade 3. Resulting phenotypes: CYP3A5, all patients were normal metabolizers. CYP3A5, 7 normal metabolizer, 4 intermediate, and 22 poor. SLCO1B1, 25 normal function, 8 intermediate, and no low. ABCB1, 13 normal function, 7 intermediate, and 13 low. For all genes, there was no statistically significant difference in phenotype between the neuropathy and no neuropathy study arms, CYP3A5 (p = 0.075) SLCO1B1 (p = 0.106), ABCB1 (p = 0.902). Conclusions: The findings of our study indicate that having pharmacogenetics changes in the genes, ABCB1, CYP3A4, CYP3A5, and SLCO1B1 did not influence the patients experience with peripheral sensory neuropathy.

Download Full-text

Primary analysis of a randomized phase II, multicenter trial: Neoadjuvant weekly nab-paclitaxel 100mg/m2 followed by FE100C compared with docetaxel 75mg/m2 followed by FE100C for early breast cancer in Japan.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.28_suppl.136 ◽

2015 ◽

Vol 33 (28_suppl) ◽

pp. 136-136 ◽

Cited By ~ 1

Author(s):

Takashi Kuwayama ◽

Hideko Yamauchi ◽

Toshimi Takano ◽

Koichiro Tsugawa ◽

Takanobu Sato ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Early Breast Cancer ◽

Phase Ii ◽

Response Rate ◽

Sensory Neuropathy ◽

Operable Breast Cancer ◽

Breast Cancer Patients ◽

Peripheral Sensory Neuropathy ◽

Peripheral Sensory

136 Background: Nanoparticle Albumin-Bound Paclitaxel (nab-PTX) is a new solvent free taxane-based anticancer drug. According to CA024 trial, nab-PTX 100mg/m2 demonstrated superior response to docetaxel (DTX) in patients with metastatic breast cancer. Besides, nab-PTX 100mg/m2 was less toxicity. In operable breast cancer, GeparSepto study was reported that the pCR rate were significantly higher with nab-PTX 125/150 mg/m2 compared to paclitaxel. We planned the randomized parallel design phase II trial to evaluate nab-PTX 100mg/m2in early breast cancer. Methods: Stage II-III HER2-negative breast cancer patients were included in this trial and received either 4 cycles of DTX (75 mg/m2 day1) q 3 w or 4 cycles of nab-PTX (100 mg/m2 day1/8/15) q4w followed by 4 cycles of FE100C. The primary end point is pCR (ypT0/is ypN0) rate, and the secondary end points are response rate, histological effect of treatment, breast conservation rate, and toxicity. Results: Between March 2011 to March 2014, 152 eligible patients were enrolled at 6 centers (75 pts were allocated for nab-PTX). Baseline characteristics were well balanced; median age was 51/49 years (DTX/nab-PTX), 61/61% of the patients with ER positive, 38/36% triple negative breast cancer, 57/65% Ki67 > 20%. Clinically response rate was similar to each drug. (53/57%) The pCR rate was 12/17% (p = 0.323). In TNBC group, the pCR rate was 28/30% (p = 0.866). In Ki67 > 20% group, the pCR rate was significantly higher, 16/48% (p = 0.021) with nab-PTX arm. The most common grade3-4 adverse event was neutropenia, which was observed in 40/36% of cases. Non-hematological adverse events of any grade were; 34/32% myalgia (DTX/nab-PTX), 42/35% arthralgia, 55/65% peripheral sensory neuropathy. No Grade3-4 peripheral sensory neuropathy was observed in nab-PTX arm. Infusion reaction of DTX occurred in 1 patient. Conclusions: In this initial effectively analysis, neoadjuvant weekly nab-paclitaxel 100mg/m2 were promising drug in HER2-negative operable breast cancer patients. Larger studies will be needed to evaluate neoadjuvant weekly nab-paclitaxel compared with DTX. Clinical trial information: 000005388.

Download Full-text

Faculty Opinions recommendation of Evidence of GLP-1-mediated neuroprotection in an animal model of pyridoxine-induced peripheral sensory neuropathy.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1060982.512938 ◽

2007 ◽

Author(s):

Ahmet Hoke

Keyword(s):

Animal Model ◽

Sensory Neuropathy ◽

Peripheral Sensory Neuropathy ◽

Peripheral Sensory

Download Full-text

Risk modifiers for peripheral sensory neuropathy in HIV infection/AIDS

European Journal of Neurology ◽

10.1046/j.1351-5101.2003.00713.x ◽

2004 ◽

Vol 11 (2) ◽

pp. 97-102 ◽

Cited By ~ 27

Author(s):

O. L. Lopez ◽

J. T. Becker ◽

M.-A. Dew ◽

R. Caldararo

Keyword(s):

Hiv Infection ◽

Sensory Neuropathy ◽

Peripheral Sensory Neuropathy ◽

Peripheral Sensory ◽

Risk Modifiers

Download Full-text

Peripheral sensory neuropathy is associated with altered postocclusive reactive hyperemia in the diabetic foot

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2016-000235 ◽

2016 ◽

Vol 4 (1) ◽

pp. e000235 ◽

Cited By ~ 9

Author(s):

Alex L Barwick ◽

John W Tessier ◽

Xanne Janse de Jonge ◽

James R Ivers ◽

Vivienne H Chuter

Keyword(s):

Diabetic Foot ◽

Reactive Hyperemia ◽

Sensory Neuropathy ◽

Peripheral Sensory Neuropathy ◽

Peripheral Sensory ◽

Postocclusive Reactive Hyperemia

Download Full-text

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

Blood ◽

10.1182/blood-2019-123156 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5550-5550 ◽

Cited By ~ 1

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.

Download Full-text