A randomized controlled trial using surgical gloves to prevent chemotherapy-induced peripheral neuropathy by paclitaxel in breast cancer patients (AIUR trial).

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of taxane treatment and can significantly affect patient quality of life. Currently, there are no effective treatments to alleviate symptoms of CIPN; thus, starting with prevention steps in high-risk patients is considered advantageous. However, for these prevention steps to be applicable to all patients, their side effects or accompanying discomforts should be minimal, and the intervention cost-effective. Compression therapy can be considered a prevention intervention, and using surgical gloves is feasible and cost-effective (approximately $0.6 per pair). Although previous studies on compression therapy using surgical gloves have reported decreased incidence of PN, these studies were non-randomized, limited to nab-paclitaxel treatment, and involved the use of small gloves, which may have caused discomfort. Therefore, this study aimed to assess the preventive effects of compression therapy using normal-sized surgical gloves on CIPN in patients treated with paclitaxel. METHODS: This clinical trial is designed to evaluate the preventive effects of compression therapy using surgical gloves on CIPN in women with stage II-III breast cancer who received paclitaxel chemotherapy for at least 12 weeks. This multicenter, randomized-controlled, open-label study will be conducted in six academic hospitals. Patients with medication or a medical history related to neuropathy or hand disease will be excluded. The primary outcome will be the preventive effect of compression therapy using surgical gloves, measured based on changes in the neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane questionnaire. Furthermore, we will assess the National Cancer Institute's Common Terminology Criteria for Adverse Events grade of CIPN after 6 months. Notably, the estimated sample size, based on a p-value < 0.025 and statistical power of 0.9, will consist of 104 patients (52 per group), accounting for a 10% sample loss. DISCUSSION: This intervention can be easily implemented in clinical practice and may serve as a preventive strategy for CIPNs with strong patient adherence. If successful, this intervention could improve the quality of life and treatment adherence in patients receiving chemotherapy that can induce PN, extending beyond paclitaxel treatment alone. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05771974; Registered on March 16, 2023.

Learning curve analysis using the cumulative summation method for totally extraperitoneal repair of the inguinal hernia.

PURPOSE: The totally extraperitoneal repair (TEP) technique has been widely performed, and compared with open surgery, TEP results in less postoperative pain and similar surgical outcomes in the treatment of inguinal hernias. However, TEP has a longer learning curve than does conventional surgery. METHODS: The data for patients who underwent TEP for inguinal hernias by a single surgeon between April 2017 and July 2019 were analyzed retrospectively. The cumulative summation (CUSUM) method and the following two variables were used to analyze the learning curve: (1) the operation event (OE), including intraoperative complications and conversion to open surgery; and (2) the operation score (OS), as calculated by the operation time, patient body mass index, and disease characteristics. RESULTS: The CUSUM chart showed three phases for both the OE and OS. The former reached a first inflection point after the 85th case and decreased after the 200th case, and the latter reached a plateau after the 101st case and decreased after the 203rd case. The operation time was longer in phases 1 and 2 than in phase 3 (64.2 min versus 47.9 min versus 31.1 min; p < 0.001), and the OS was lower in phase 3 than in the other phases (71.9 points versus 106.4 points versus 142.7 points; p < 0.001). Ten cases of intraoperative complications were observed, all in the first and second phases (p = 0.011). CONCLUSION: At least approximately 100 cases are required for the initial learning period, and an additional 103 cases are required for the accumulation of additional experience. Surgical competency can be gained after 203 TEPs are performed.

A Risk Factor Analysis of Axillary Web Syndrome in Patients After Breast Cancer Surgery: A Single Center Study in Korea.

OBJECTIVE: To investigate the prevalence and risk factors of axillary web syndrome (AWS) in Korean patients. METHODS: This retrospective study included a total of 189 women who underwent breast cancer surgery and received physical therapy between September 2019 and August 2020. We analyzed AWS and the correlation between the patients' demographics, underlying disease, type of surgery and chemotherapy or radiation therapy, and lymphedema. RESULTS: The prevalence of AWS was found to be 30.6%. In the univariable analysis, age, chemotherapy, and hypertension were related to AWS. Finally, the multivariable logistic regression revealed that chemotherapy (odds ratio [OR]=2.84; 95% confidence interval [CI], 1.46-5.53) and HTN (OR=2.72; 95% CI, 1.18-6.30) were the strongest risk factors of AWS. CONCLUSION: To the best of our knowledge, this was the first study that explored the risk factors of AWS in a Korean population after breast cancer surgery. As almost one-third of patients suffer from AWS after breast cancer surgery, it is essential to closely monitor the development of AWS in patients with hypertension or undergoing chemotherapy.

Intensity of metastasis screening and survival outcomes in patients with breast cancer.

Previous randomized trials, performed decades ago, showed no survival benefit of intensive screening for distant metastasis in breast cancer. However, recent improvements in targeted therapies and diagnostic accuracy of imaging have again raised the question of the clinical benefit of screening for distant metastasis. Therefore, we investigated the association between the use of modern imaging and survival of patients with breast cancer who eventually developed distant metastasis. We retrospectively reviewed data of 398 patients who developed distant metastasis after their initial curative treatment between January 2000 and December 2015. Patients in the less-intensive surveillance group (LSG) had significantly longer relapse-free survival than did patients in the intensive surveillance group (ISG) (8.7 vs. 22.8 months; p = 0.002). While the ISG showed worse overall survival than the LSG did (50.2 vs. 59.9 months; p = 0.015), the difference was insignificant after adjusting for other prognostic factors. Among the 225 asymptomatic patients whose metastases were detected on imaging, the intensity of screening did not affect overall survival. A small subgroup of patients showed poor survival outcomes when they underwent intensive screening. Patients with HR-/HER2 + tumors and patients who developed lung metastasis in the LSG had better overall survival than those in the ISG did. Highly intensive screening for distant metastasis in disease-free patients with breast cancer was not associated with significant survival benefits, despite the recent improvements in therapeutic options and diagnostic techniques.

Impact of the COVID-19 Pandemic on the Diagnosis and Surgery of Breast Cancer: A Multi-Institutional Study.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted the rates of screening, case identification, and referral for cancer diagnosis. We investigated the diagnosis and surgery status of breast cancer before and after the COVID-19 pandemic at a multi-institutional level. METHODS: We collected breast cancer data from the clinical data warehouse which contained the medical records of patients from six academic institutions in South Korea. Patients were divided into two groups: February to April (period A) and May to July (period B). The data from the two groups were then compared against the same periods in 2019 and 2020. The primary objective was to investigate the differences in breast cancer stages before and after the COVID-19 pandemic. RESULTS: Among 3,038 patients, there was a 9.9% reduction in the number of diagnoses in 2020. This decrease was more significant during period A than period B. The breast cancer stage was not statistically different in period A (p = 0.115), but it was in period B (p = 0.001). In the subset analysis according to age, there was a statistical difference between 2019 and 2020 in period B for patients under the age of 65 years (p = 0.002), but no difference was observed in the other groups. CONCLUSION: The number of breast cancer cases declined during the pandemic, and the staging distribution has changed after the pandemic peak.

Ruptured splenic peliosis in a patient with no comorbidity: A case report.

BACKGROUND: Splenic peliosis is a disease characterized by widespread blood-filled cystic cavities within the parenchyma. Patients with this disease are usually asymptomatic; therefore, spontaneous or trauma-related rupture of the hemorrhagic cysts can occasionally cause life-threatening hemorrhagic shock. CASE SUMMARY: A 51-year-old male patient with abdominal pain visited our emergency medical center two times with an interval of 2 mo. The patient was discharged from the hospital without treatment at his first visit; however, at the time of second admission, the hemoperitoneum with multiple cystic lesions of the spleen was found incidentally on the abdomen computed tomography scan. Since the patient was stable hemodynamically, a scheduled surgery was performed. The operative findings were consistent with splenic peliosis, and laparoscopic splenectomy was performed to prevent recurrent rupture of the hemorrhagic cysts. CONCLUSION: Splenic peliosis is extremely rare, and we suggest splenectomy is necessarily required as a definite treatment for ruptured splenic peliosis to rescue patients with hemodynamic instability and to prevent recurrent rupture of hemorrhagic cysts in patients with stable hemodynamics.

Cephalic vein approach for the implantable central venous access: A retrospective review of the single institution's experiences; Cohort Study.

Long-term venous access is usually required in patients receiving chemotherapy. We hypothesized that, out of the various central line approach techniques, the cephalic vein cut-down technique can be a safe and simple alternative in terms of surgical safety, feasibility, cost-effectiveness, and functional outcomes.We retrospectively reviewed the medical records of 569 patients who underwent implantable central venous access between January 2012 and December 2014 at our hospital.We classified our cohort according to access routes, as follows: 230 patients underwent subclavian vein access, 134 patients underwent internal jugular vein access, 25 patients underwent external jugular vein access, and 119 patients underwent cephalic vein access. The cephalic vein group had a significantly longer operation time than the subclavian group (P < .01); however, there was no difference in operation time between the internal jugular vein and cephalic vein groups (P = .59). The procedure-related complications and functional outcomes of the implanted venous port during chemotherapy were comparable between the cephalic group and other groups. Additionally, body mass index, operation time, and age did not correlate with catheter dysfunction in the multivariate logistic regression analysis (P = .53; P = .66; P = .19, respectively).We suggest that a cut-down central venous catheter insertion through the cephalic vein can be performed easily and safely with no differences in surgical and clinical outcomes compared to those of conventional percutaneous approaches. Moreover, the cephalic vein approach requires no specialized equipment, including percutaneous vascular kits, tunneling instruments, and intraoperative ultrasonography. Therefore, this technique might incur less medical expenses than conventional approaches and would be helpful for both patients and surgeons.

Prognostic influence of 3-dimensional tumor volume on breast cancer compared to conventional 1-dimensional tumor size.

PURPOSE: The prognostic influence of 3-dimensional tumor volume (Tv) on breast cancer compared to conventional 1-dimensional tumor size (T) was investigated. METHODS: Analysis was performed on a cohort of 8,996 primary breast cancer patients who were initially diagnosed with TNM stage I-III. Tumor size was defined as the maximum tumor dimension, and Tv was calculated by the equation of (4π × r1 × r2 × r3)/3; r1, r2, and r3 were defined as half of the largest, intermediate, and shortest dimension of the tumor, respectively. Tv was classified into Tv1, Tv2, and Tv3 according to the cut off values of 2.056 cm3 and 20.733 cm3. RESULTS: The survival curves according to both the T and Tv categories were clearly differentiated (all P < 0.001), as were those for staging by T and Tv (all P < 0.001). In T1 and T2 tumors, the Tv1 group showed superior survival over the Tv2 group (T1, P < 0.001; T2, P = 0.001). Univariate and multivariate analysis both indicated that Tv was a significant prognostic factor (both P < 0.001). The receiver operating characteristic curve showed that the area under the curves were 0.712 (P < 0.001) for Tv and 0.699 (P < 0.001) for T. Positive correlations were observed between the number of positive nodes and T (coefficient = 0.325; P < 0.001), and between the number of positive nodes and Tv (coefficient = 0.321; P < 0.001). CONCLUSION: Tv classification works well for predicting the prognosis of breast cancer, and it is a better predictor than conventional T classification in several aspects. Further studies are needed to validate the practical usefulness of Tv classification in clinical settings.

Prognostic Influence of Preoperative Fibrinogen to Albumin Ratio for Breast Cancer.

PURPOSE: Elevated serum concentration of fibrinogen and decreased serum concentration of albumin have been reported to be markers of elevated systemic inflammation. We attempted to investigate the prognostic influence of preoperative fibrinogen to albumin ratio (FAR) for breast cancer. METHODS: Data from 793 consecutive primary breast cancer patients were retrospectively analyzed. Serum levels of fibrinogen and albumin were tested before curative surgery. Subjects were grouped into two groups according to the cutoff value determined by performing the receiver operating characteristic curve analysis: the high FAR group (FAR>7.1) and the low FAR group (FAR≤7.1). Overall survival was assessed using the Kaplan-Meier estimator. Independent prognostic significance was analyzed using the Cox proportional hazards model. RESULTS: The high FAR group had a worse prognosis compared to the low FAR group (log-rank test, p<0.001). The prognostic effect of FAR was more significant than that of single markers such as fibrinogen (log-rank test, p=0.001) or albumin (log-rank test, p=0.001). The prognostic effect of FAR was prominent in the stage II/III subgroup (log-rank test, p<0.001) and luminal A-like subtype (log-rank test, p<0.001). FAR was identified as a significant independent factor on both univariate (hazard ratio [HR], 2.722; 95% confidence interval [CI], 1.659-4.468; p<0.001) and multivariate analysis (HR, 2.622; 95% CI, 1.455-4.724; p=0.001). CONCLUSION: Preoperative FAR was a strong independent prognostic factor in breast cancer. Its prognostic effect was more prominent in the stage II/III subgroup and in the luminal A-like subtype. Therefore, preoperative FAR can be utilized as a useful prognosticator for breast cancer patients. Further studies are needed to validate its applications in clinical settings.

The treatment outcomes and the use of adjuvant therapies in breast cancer patients with severe co-morbidities.

PURPOSE: Studies have suggested a potential role of patient's co-morbidity in determining the survival outcomes of breast cancer. In this study, we examined the long-term oncologic outcomes in breast cancer patients who underwent curative surgery according to their pre-existing comorbid conditions and analyzed the association between the co-morbidity and the use of adjuvant therapies. METHODS: The medical records of 2,501 patients who underwent surgery for primary breast cancer from June 2006 to June 2010 were reviewed retrospectively. The patients were classified into three groups according to preoperative ASA status determined by the anesthesiologists. Clinico-pathologic characteristics and survival outcomes of the patients were compared among the different co-morbidity groups. RESULTS: There were 1,792 (71.6%), 665 (26.6%), and 44 (1.8%) patients in ASA I, II, and III, respectively. Total 95 (3.8%) deaths and 269 (10.8%) recurrences (loco-regional and distant) occurred during the median follow-up period of 71 months. Patients with high comorbidity showed significantly higher rate of deaths (51 (2.8%), 38 (5.7%) and 6 (13.6%) deaths in ASA I, II and III group, respectively, p<0.001). The ASA 3 patients also showed significantly higher rate of breast cancer recurrence when compared to other groups (180 (10.0%), 80 (12.0%) and 9 (20.5%) in ASA I, II, and III, respectively, p = 0.041). Significantly fewer patients in the high co-morbidity group received adjuvant therapies (77 (4.3%), 44 (6.6%) and 8 (18.2%) in ASA I, II, and III, respectively, p<0.001). The increased recurrence of breast cancer in the high morbidity group was mostly seen in patients who did not receive adjuvant therapies. The incidence of serious adverse effect during the adjuvant therapy did not differ according to the co-morbidity conditions. CONCLUSIONS: In this study, high comorbidity was related to increased risk of death and recurrence in breast cancer. The increased risk of recurrence in high co-morbidity group was mostly seen in patients who did not receive adjuvant therapies. Considering the relatively low rates of serious adverse effects in high co-morbidity patients who received adjuvant therapies, active use of adjuvant therapies in selected patients may improve survival outcomes in breast cancer patients with severe co-morbidities.