Effect of goshajinkigan on peripheral neuropathy in breast cancer patients treated with docetaxel.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11564-e11564
Author(s):  
Hajime Abe ◽  
Tsuyoshi Mori ◽  
Yuki Kawai ◽  
Hirotomi Cho ◽  
Yoshihiro Kubota ◽  
...  

e11564 Background: Although taxanes have become a key chemotherapeutic drug in breast cancer treatment, one of the side effects is peripheral neuropathy. Goshajinkigan (GJG) is a traditional Japanese medicine that is used for the treatment of several neurological symptoms including pain and numbness. Recently, GJG has been reported to prevent anticancer drug-induced peripheral neuropathy in colorectal cancer in the gynecology field. We investigated the efficacy of GJG and mecobalamin (B12) on peripheral neurotoxicity associated with docetaxel (DOC) in breast cancer patients. Methods: Between 2007 and 2011, 60 breast cancer patients were treated with DOC. Thirty-three patients (GJG group) received oral administration of 7.5 g/day GJG every day during DOC therapy and 27 patients (B12 group) received oral administration of 1500 μg/day B12. Peripheral neuropathy was evaluated during every course according to DEB-NTC (Neurotoxicity Criteria of Debiopharm), Common Terminology Criteria for Adverse Events (CTCAE) ver. 3.0, and a visual analogue scale (VAS). Results: The median age of the GJG group was 58 years old (35 to 70 years old), the B12 group was 55 years old (33 to 69 years old), and they were all females. For the regimens, in the GJG group, TC (DOC and cyclophosphamide), DOC only, and XT (capecitabine and DOC) were administered in 19 cases, 13 cases and 1 case, respectively. In the B12 group, they were 15 cases, 11 cases and 12 cases, respectively. The cumulative dose of DOC was 338.5 mg/m2 in the GJG group, and 340 mg/m2 in the B12 group. The completion rate was 100% in both groups. The incidence of peripheral neuropathy was 39.3% in the GJG group, and 88.9% in the B12 group (p < 0.01). In the GJG group, grade 1 DEB-NTC was observed in 2 cases, grade 2 in 5 cases and grade 3 in 5 cases. Grade 1 CTCAE was observed in 7 cases, grade 2 in 6 cases, and VAS was 2.7 ± 2.2. In the B12 group, grades 1, 2 and 3 DEB-NTC were observed in one case, 12 cases and 12 cases, respectively; and grades 1 and 2 CTCAE were observed in 12 cases each, and VAS was 4.9 ± 2.4. Peripheral neuropathy was significantly controlled in the GJG group. Conclusions: Concomitant administration of GJG is useful in preventing peripheral neuropathy in breast cancer patients treated with DOC regimen.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11595-e11595
Author(s):  
A. C. Barochia ◽  
L. Cream ◽  
H. Harvey ◽  
J. Sivik

e11595 Background: Paclitaxel (P) is an important part of chemotherapy regimens for early breast cancer. Breast cancer survivors may be left with iaotrogenic peripheral neuropathy which can affect their quality of life. Methods: We conducted a retrospective, IRB approved, medical chart review to determine the rate of peripheral neuropathy in a tertiary care practice in central Pennsylvania. Patients had biopsy proven, newly diagnosed, high risk breast cancer. Patients were treated with a standard dose dense (DD) regimen where 4 cycles of adriamycin (A) 60 mg/m2/cyclophosphamide (C) 600 mg/m2 were followed by four cycles of paclitaxel (P) 175 mg/m2 every 2 weeks (Citron et al) between 7/2006 to7/2008 at Penn State Cancer Institute. All patients who received dose dense chemotherapy by a single provider were included (n=23). No peripheral neuropathy (PN) was reported before initiating paclitaxel, but 3 of 23 patients had type II diabetes. Electronic medical charts were reviewed and data was abstracted to analyze incidence of peripheral neuropathy. These data were compared to reported published data. Results: 22 pts received dose dense AC followed by P chemotherapy. 100% completed 4 cycles of AC and 87% complete 4 cycles of P. Overall, 82% developed neuropathy (32% with grade 1, 41 % with grade 2, 9 % with grade 3). Almost 30% of patients required gabapentin for control of neuropathic pain. 35% of patients with PN had symptoms persisting >3 months after chemotherapy. Conclusions: A considerable percentage of high risk, early breast cancer patients treated with AC followed by DD paclitaxel developed at least mild neurotoxicity. Rates of Grade 3 neurotoxicity were much higher (9%) than the previous CALGB-9741 study (4%). This may be related to regional pharmacogenomic differences. Although dense dose paclitaxel has been shown to improve disease free survival, PN affects most patients treated with paclitaxel and for some patients can have a prolonged impact on their quality of life. Future studies should attempt identify which patients are at risk for severe peripheral neuropathy. No significant financial relationships to disclose.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Qiaoping Xu ◽  
Li Yuanyuan ◽  
Zhu Jiejing ◽  
Liu Jian ◽  
Li Qingyu ◽  
...  

Abstract Background Breast cancer is the most common cancer among women in China. Amplification of the Human epidermal growth factor receptor type 2 (HER2) gene is present and overexpressed in 18–20% of breast cancers and historically has been associated with inferior disease-related outcomes. There has been increasing interest in de-escalation of therapy for low-risk disease. This study analyzes the cost-effectiveness of Doxorubicin/ Cyclophosphamide/ Paclitaxel/ Trastuzumab (AC-TH) and Docetaxel/Carboplatin/Trastuzumab(TCH) from payer perspective over a 5 year time horizon. Methods A half-cycle corrected Markov model was built to simulate the process of breast cancer events and death occurred in both AC-TH and TCH armed patients. Cost data came from studies based on a Chinese hospital. One-way sensitivity analyses as well as second-order Monte Carlo and probabilistic sensitivity analyses were performed.The transition probabilities and utilities were extracted from published literature, and deterministic sensitivity analyses were conducted. Results We identified 41 breast cancer patients at Hangzhou First People’s Hospital, among whom 15 (60%) had a partial response for AC-TH treatment and 13 (81.25%) had a partial response for TCH treatment.No cardiac toxicity was observed. Hematologic grade 3 or 4 toxicities were observed in 1 of 28 patients.Nonhematologic grade 3 or 4 toxicities with a reverse pattern were observed in 6 of 29 patients. The mean QALY gain per patient compared with TCH was 0.25 with AC-TH, while the incremental costs were $US13,142. The incremental cost-effectiveness ratio (ICER) of AC-TH versus TCH was $US 52,565 per QALY gained. Conclusions This study concluded that TCH neoadjuvant chemotherapy was feasible and active in HER2-overexpressing breast cancer patients in terms of the pathological complete response, complete response, and partial response rates and manageable toxicities.


2021 ◽  
Author(s):  
Parth Sharma ◽  
Josh Thomas Georgy ◽  
Anand George Andrews ◽  
Ajoy Oommen John ◽  
Anjana Joel ◽  
...  

Abstract Purpose: Dose dense chemotherapy improves survival but also increases toxicity and treatment related cost. Here we report the prevalence of anemia, understand the risk factors of chemotherapy related anemia and determine the cost and time-delay associated with transfusion requirement in Indian non-metastatic breast cancer patients on dose dense preoperative chemotherapy.Methods: In this study, 116 triple negative breast cancer (TNBC) patients were treated preoperatively with Docetaxel and Cyclophosphamide alternating with Epirubicin and Cisplatin every 2-weekly. Patients were evaluated for anemia pre- and post-chemotherapy. We examined trends in the cell counts, transfusion requirement, time to transfusion as well as risk factors associated with transfusion during treatment, along with delay in treatment due to anemia and the additional cost incurred.Results: One hundred and sixteen women with high-risk non-metastatic TNBC were treated. Median age was 44.5 years. 56.1% had stage III disease. Delivery of 6/8 planned doses was achieved in 98.3% of patients, and all 8 doses in 86% patients. Anemia was detected at baseline in 54(46.5%) patients with mild(10-12g/dl) anemia in 42(36.2%) patients and moderate(8-10g/dl) in 12(10.3%) patients. Forty-four patients (37.9%) required transfusion during chemotherapy with 55(47.4%) patients having grade 1-2 anemia and 40(34.5%) patients having grade 3 anemia. The factors associated with transfusion were low grade of tumor (OR 2.48 (95% CI 1.08 - 5.68), p = 0.025), hemoglobin post 2 cycles of chemotherapy (OR 1.74 (95% CI 1.21- 2.51), p = 0.003), thrombocytopenia grade 3 or 4 (OR 4.35 (95% CI 1.062-17.827), p = 0.034) and drop in hemoglobin after 2 cycles (OR 1.65 (95% CI 1.09-2.48), p = 0.017). Nearly one fourth of the study population had a delay between two cycles of chemotherapy due to anemia. A median additional cost of Rs 7000 (IQR-Rs 7000 – Rs 14000) was incurred on transfusion.Conclusion: Anemia is a common toxicity associated with dose dense chemotherapy during curative breast cancer treatment leading to delay in treatment and increased cost. Low grade tumor, grade 3 or 4 thrombocytopenia and Grade 2 or higher anemia after 2 cycles of chemotherapy are risk factors for blood transfusions during treatment.


2020 ◽  
Vol 117 (4) ◽  
pp. 2092-2098 ◽  
Author(s):  
Ferdia A. Gallagher ◽  
Ramona Woitek ◽  
Mary A. McLean ◽  
Andrew B. Gill ◽  
Raquel Manzano Garcia ◽  
...  

Our purpose is to investigate the feasibility of imaging tumor metabolism in breast cancer patients using 13C magnetic resonance spectroscopic imaging (MRSI) of hyperpolarized 13C label exchange between injected [1-13C]pyruvate and the endogenous tumor lactate pool. Treatment-naïve breast cancer patients were recruited: four triple-negative grade 3 cancers; two invasive ductal carcinomas that were estrogen and progesterone receptor-positive (ER/PR+) and HER2/neu-negative (HER2−), one grade 2 and one grade 3; and one grade 2 ER/PR+ HER2− invasive lobular carcinoma (ILC). Dynamic 13C MRSI was performed following injection of hyperpolarized [1-13C]pyruvate. Expression of lactate dehydrogenase A (LDHA), which catalyzes 13C label exchange between pyruvate and lactate, hypoxia-inducible factor-1 (HIF1α), and the monocarboxylate transporters MCT1 and MCT4 were quantified using immunohistochemistry and RNA sequencing. We have demonstrated the feasibility and safety of hyperpolarized 13C MRI in early breast cancer. Both intertumoral and intratumoral heterogeneity of the hyperpolarized pyruvate and lactate signals were observed. The lactate-to-pyruvate signal ratio (LAC/PYR) ranged from 0.021 to 0.473 across the tumor subtypes (mean ± SD: 0.145 ± 0.164), and a lactate signal was observed in all of the grade 3 tumors. The LAC/PYR was significantly correlated with tumor volume (R = 0.903, P = 0.005) and MCT 1 (R = 0.85, P = 0.032) and HIF1α expression (R = 0.83, P = 0.043). Imaging of hyperpolarized [1-13C]pyruvate metabolism in breast cancer is feasible and demonstrated significant intertumoral and intratumoral metabolic heterogeneity, where lactate labeling correlated with MCT1 expression and hypoxia.


2020 ◽  
Vol 26 (6) ◽  
pp. 1421-1428
Author(s):  
Ebrahim Salehifar ◽  
Ghasem Janbabaei ◽  
Abbas Alipour ◽  
Nasim Tabrizi ◽  
Razieh Avan

Purpose Taxane-induced peripheral neuropathy (TIPN) is a common and bothersome toxicity. This study aimed to determine the incidence and severity of TIPN in patients with breast cancer and to investigate the relationship between TIPN and quality of life. Methods A total of 82 breast cancer patients with TIPN symptoms were included in this study. The criteria of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03) and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) were used to evaluate grading of sensory neuropathy and quality of life, respectively. Analysis of the data was done by IBM SPSS statistics version 23. Results A total of 346 patients received taxane-based chemotherapy and 82 patients (23.7%) experience TIPN. The mean (SD) global health status/quality of life, physical functioning, role functioning, and pain subscales were 60.63 (5.26), 80.64 (9.05), 81.77 (10.41), and 43.88 (11.27), respectively. There were significant negative correlations between global health status/quality of life, physical functioning, and role functioning subscales with the grade of neuropathy (r = −0.33, −0.80, and −0.61, respectively) and positive correlation between pain subscale and the grade of neuropathy (r = 0.70). Conclusion This study shows a clear association between TIPN and worsened quality of life. These findings emphasize on detecting and management of TIPN in an effort to improve the quality of life of breast cancer patients.


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