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1.

Purpose

This study aimed to present an innovative approach to quantify, visualize, and predict radiation therapy (RT) process reliability using data captured from a voluntary incident learning system, with an overall aim to improve patient safety outcomes.

Methods and Materials

We analyzed 111 reported deviations that were tripped and caught within 159 mapped RT process steps included within 7 major stages of RT delivery, 94 of which were any type of quality assurance (QA) controls. This allowed for us to compute the trip rate and fail-to-catch-rate (FCR) per each QA control with the available data. Next, we used a logistic regression model to identify significant variables predictive of FCRs, predicted FCRs for each QA control without available data, and thus, attempted to quantify RT process reliability expressed as percentage of patients with uncaught deviations after treatment planning, before their first treatment, and during treatment delivery.

Results

Using the predicted FCRs, we computed the upper 95% likelihood that a deviation remains uncaught in a patient's course of treatment at the following RT process stages: immediately after treatment planning at 10.26%; before the first treatment at 0.0052%; and throughout treatment delivery at 0.0276%.

Conclusions

The results suggest that RT process reliability can be predicted and visualized using data from incident learning systems. If implemented and used as a safety metric, this could help RT clinics to proactively maintain their preoccupation with patient safety. RT process reliability may also help guide future work on standardization and continuous improvement of the design of RT QA programs.  相似文献   

2.

Purpose

To assess the pharmacologic costs of second-line treatments for metastatic renal-cell cancer (mRCC).

Methods

The present evaluation was restricted to pivotal phase 3 randomized controlled trials in second-line for mRCC. We calculated the pharmacologic costs necessary to get the benefit in progression-free survival and overall survival (OS) for each trial. The costs of drugs are at the pharmacy of our hospital and are expressed in euros.

Results

Our analysis evaluated 5 phase 3 randomized controlled trials including 3112 patients. The lowest cost per month of progression-free survival and OS gained was associated with the use of cabozantinib (€2006 and €1473, respectively), while everolimus had the highest cost per month of OS gained (€28,590).

Conclusion

Combining pharmacologic costs of drugs with the measure of efficacy represented by OS, cabozantinib is a cost-effective second-line treatments for patients with mRCC.  相似文献   

3.

Background

Cardiovascular events (CVEs) have been observed in patients with chronic myeloid leukemia treated with second-generation tyrosine kinase inhibitors.

Patients and Methods

We retrospectively evaluated the incidence of CVEs on 233 consecutive patients with chronic myeloid leukemia, of which 116 were treated with imatinib, 75 with dasatinib, and 42 with nilotinib. The median follow-up was 2047, 1712, and 1773 days, respectively.

Results

The cumulative incidence of CVEs was 4.29%. Three events occurred during dasatinib treatment, 6 during nilotinib treatment, and none during imatinib treatment (P ≤ .001). Arterial occlusive events occurred in 2 (2.6%) of 75 patients treated with dasatinib and in 6 (14.2%) of 42 patients treated with nilotinib (P ≤ .001). Furthermore, all of them occurred in patients with high-risk (n = 2) and very high-risk (n = 6) cardiovascular risk, contributing to 4.3% of mortality.

Conclusion

CVEs were more frequent in patients treated with second-generation tyrosine kinase inhibitors. Arterial occlusive events were more frequent in patients treated with nilotinib, with high and very high cardiovascular risk.  相似文献   

4.

Background

Colon cancer is the third most frequent cancer diagnosis, and primary payer status has been shown to be associated with treatment modalities and survival in cancer patients. The goal of our study was to determine the between-insurance differences in survival in patients with clinical stage III colon cancer using data from the National Cancer Database (NCDB).

Materials and Methods

We identified 130,998 patients with clinical stage III colon cancer in the NCDB diagnosed from 2004 to 2012. Kaplan-Meier curves and multivariable Cox regression models were used to determine the association between insurance status and survival.

Results

Patients with private insurance plans were 28%, 30%, and 16% less likely to die than were uninsured patients, Medicaid recipients, and Medicare beneficiaries, respectively. Medicare patients were 14% were less likely to die compared with uninsured patients. Patients receiving chemotherapy were, on average, 65% less likely to die compared with the patients not receiving chemotherapy.

Conclusion

Private insurance and a greater socioeconomic status were associated with increased patient survival compared with other insurance plans or the lack of insurance. Future research should continue to unravel how socioeconomic status and insurance status contribute to the quality of care and survival of oncologic patients.  相似文献   

5.

Introduction

Unwanted clinical variation is common across the United States health care system and is particularly vexing in oncology owing to the complexity, morbidity, and high cost of the disease. Efforts to standardize care including guidelines and continuing medical education have had only limited impact. Disease-specific oncology clinical pathways hold the promise of reducing variation but have been hampered by a lack of ownership and accountability among oncology providers.

Materials and Methods

We describe the utility of combining a patient simulation-based clinical variation measurement with the in-house development of multidisciplinary breast cancer pathways at a National Cancer Institute-designated cancer center.

Results

At baseline, we found high variation in care decisions across the multidisciplinary team and within individual specialties in the management of simulated patients. Development and introduction of breast cancer clinical pathways combined with individual and group feedback on pathway adherence led to significant increases in pathway-aligned care decisions and decreases in measured variation. Overall quality scores increased from 47.5% to 61.1% (P < .001), with the largest improvement in diagnostic accuracy (+22.1%). Providers also ordered fewer unnecessary tests, saving an estimated $305 per patient case. Adherence to preferred chemotherapy regimens increased for both medical oncologists (+16%) and other members of the multidisciplinary team (+19%).

Conclusion

Our work shows that a structured process to measure clinical variation and provide personalized feedback to an oncology multidisciplinary team drives adoption of evidence-based pathways, less unneeded spending, and higher quality care for patients.  相似文献   

6.

Purpose

This study aimed to determine the pain response rates after conventional radiation therapy (RT) for painful bone metastases in prospective nonrandomized studies, which better reflect daily practice than randomized controlled trials.

Methods and materials

A literature search was conducted in PubMed and Scopus for articles published between 2002 and 2018. We only included articles in which pain response after RT was assessed using the International Consensus Endpoint initially published in 2002, or the updated version from 2012. In addition, to be included in this review, the study design was required to be prospective or based on prospectively collected data. Our primary outcomes of interest were the overall and complete response rates after conventional RT for bone metastases.

Results

Of the 2863 articles identified in our database search, 12 met the inclusion criteria. Six studies excluded patients with features of complicated bone metastases. Only 2 papers reported exclusion criteria regarding analgesic use. Radiation schedules that were frequently used were 1 × 8 Gy, 5 × 4 Gy, and 10 × 3 Gy. The overall response rate in evaluable patients was 55%, and 754 of the 1379 evaluable patients experienced a complete or partial response. The complete response rate was 15% (196 of 1348 evaluable patients). In the intent-to-treat patient group, the overall response rate was 29% (754 of 2559 enrolled patients), and the complete response rate 8% (196 of 2528 enrolled patients).

Conclusions

We determined the pain response rates after conventional RT for painful bone metastases in prospective nonrandomized studies. The present review may provide benchmarks for future nonrandomized studies that investigate palliative RT for bone metastases.  相似文献   

7.

Purpose

Suppression of respiratory movement of the liver would be desirable for high-precision radiation therapy for liver tumors. We aimed to investigate the effect of our original device-free compressed shell fixation method and breathing instruction on suppression of respiratory movement. The characteristics of liver motion based on the movement of a fiducial marker were also analyzed.

Methods and Materials

First, respiratory amplitudes of the liver with the device-free compressed shell were analyzed from the data of 146 patients. The effect of this shell fixing method on liver movement was evaluated. Second, as another cohort study with 166 patients, interfractional internal motion of the liver for patients fixed in the shell was calculated using the fiducial marker coordinate data of images for position setting before daily irradiation. Third, in another 12 patients, intrafractional internal motion was calculated from the fiducial marker coordinate data using x-ray images before and after irradiation.

Results

The median respiratory movement without the shell, after fixing with the shell, and after instructing on the breathing method with the shell was 14.2 (interquartile range, 10.7-19.8), 11.5 (8.6-17.5), and 10.4 mm (7.3-15.8), respectively. Systematic and random errors of interfractional internal motion were all ≤2 mm in the left-right and anteroposterior directions and 3.7 and 3.0 mm, respectively, in the craniocaudal direction. Systematic and random errors of intrafractional internal motion were all ≤1.3 mm in the left-right and anteroposterior directions and 0.8 and 2.4 mm, respectively, in the craniocaudal direction.

Conclusions

The device-free compressed shell fixation method was effective in suppressing the respiratory movement of the liver. Irradiation position matching using the fiducial marker can correct the interfractional internal motion on each day, which would contribute to the reduction of the margin to be given around the target.  相似文献   

8.

Introduction

Breast cancer (BC) is the most common cancer in women, and the incidence of brain metastasis (BM) from BC ranges from 20% to 30%, with a median survival of 10 to 15 months. Previous reports have shown that the presence of obesity or diabetes negatively impacts survival. The present study investigates the association between obesity or diabetes mellitus (DM) and overall survival of patients with BC with BM.

Materials and Methods

A database from 2 referral centers for the period of July 2014 to February 2018 was analyzed. The inclusion criteria were as follows: patients who had a confirmed diagnosis of BC with BM were followed and treated at these centers. Demographic data, body weight and height, clinical and oncologic history, functional status, prognostic scales, and prognoses were examined.

Results

A total of 228 patients were included. The median age at BM was 50 years; the median survival after diagnosis was 12.1 months; 108 patients had a body mass index (BMI) ≥ 25, and 40 (17%) patients had DM. The association between survival and the presence of BMI > 25 exhibited a P value of 0.3.

Discussion

We found no association between overweight, obesity, or DM and survival in patients with BC with BM. The role of obesity in cancer is a robust research topic, as there are many questions to be answered.

Conclusion

Obesity as a prognostic indicator should be further studied, because we found no association between overall survival and either patients with BM from BC with a BMI > 25 or those with normal weight.  相似文献   

9.

Purpose

In our department, for high dose-per-fraction treatments such as stereotactic body radiation therapy, we require a physician to perform the pretreatment on-board imaging match. The purpose of this study was to determine whether patient-matching positioning performed by radiation therapists (RTTs) is as accurate as that performed by physicians.

Methods and Materials

Sixteen RTTs and 5 physicians participated in this study. Data were collected from 113 patients, totaling 324 measurements. A total of 60 patients were treated for bone lesions and 53 for soft-tissue lesions, such as lung and liver. Matching was performed using kV-kV imaging for bones and cone beam computed tomography for soft tissue. All treatments were delivered on Varian linear accelerators. The initial match was performed by the RTTs, and the shifts were noted. Subsequently, the match was reset, and the physician performed an independent match blinded to the RTT match. Physician shifts were applied for treatment. We used the Wilcoxon rank sum test to determine the statistical significance between RTT and physician shifts.

Results

The differences in patient shifts between physicians and RTTs were calculated in 3 translational 1 one rotational axis. The average vector shift was 0.88 ± 0.57 cm versus 0.91 ± 0.57 cm for RTTs versus physicians, respectively. Neither the average vector nor the individual axis shifts were statistically significantly different (P > .2). There was no significant difference when testing for bony or soft lesion matches separately.

Conclusions

RTT on-board imaging matching is as accurate as physician matching for both bone and soft tissue lesions. On the basis of these results, RTTs are as qualified as physicians to perform a pretreatment match. Thus, it may be feasible for the RTTs to perform the match and the physician to review it offline after treatment without being present at the machine during treatment. Our results show that this approach does not compromise patient safety.  相似文献   

10.

Purpose

Spine stereotactic radiosurgery delivers an ablative dose of radiation therapy (RT) with high conformity relative to standard fractionated RT. This technique is suboptimal for extended targets (>3 vertebral levels) owing to treatment alignment concerns or for patients with marked epidural extension. In these patients, we hypothesized that use of hypofractionated intensity modulated RT/volumetric modulated arc therapy to dose escalate the gross tumor volume (GTV) to 40 Gy as a spinal simultaneous integrated boost (SSIB) would allow for durable local control and palliation.

Methods and Materials

We retrospectively analyzed 15 separate spinal sites (12 patients) that were treated with the SSIB technique between 2012 and 2016. The GTV and clinical target volume were prescribed at 40 Gy and 30 Gy, respectively, in 10 fractions. The spinal cord was allowed a maximum point dose of 34 Gy. The GTV was defined as gross tumor. The clinical target volume encompassed the GTV in addition to the involved vertebral bodies, at-risk paraspinal space, and spinal canal, followed by a planning target volume expansion of 3 to 5 mm.

Results

The median follow-up for patients in our cohort was 17 months. At 1 year, local control was 93%, and overall survival was 58%, with a median time to death after treatment of 7 months. No grade ≥2 neurologic toxicities were reported for any of the patients. Nine of 12 patients had pain at presentation, of which 7 patients (78%) reported improvement and/or complete resolution of their pain after treatment.

Conclusions

Our early experience using a dose of 40 Gy to the GTV delivered via an SSIB technique, in lieu of spine stereotactic radiation surgery but more aggressive than conventional palliative doses, provides durable local control and pain relief. This technique may allow for improved local control and palliation in patients with radioresistant disease compared with conventional 3-dimensional conformal fractionated RT.  相似文献   

11.

Aims

Stereotactic radiosurgery (SRS) alone or upfront whole brain radiation therapy (WBRT) plus SRS are the most commonly used treatment options for one to three brain oligometastases. The most recent randomised clinical trial result comparing SRS alone with upfront WBRT plus SRS (NCCTG N0574) has favoured SRS alone for neurocognitive function, whereas treatment options remain controversial in terms of cognitive decline and local control. The aim of this study was to conduct a cost-effectiveness analysis of these two competing treatments.

Materials and methods

A Markov model was constructed for patients treated with SRS alone or SRS plus upfront WBRT based on largely randomised clinical trials. Costs were based on 2016 Medicare reimbursement. Strategies were compared using the incremental cost-effectiveness ratio (ICER) and effectiveness was measured in quality-adjusted life years (QALYs). One-way and probabilistic sensitivity analyses were carried out. Strategies were evaluated from the healthcare payer's perspective with a willingness-to-pay threshold of $100 000 per QALY gained.

Results

In the base case analysis, the median survival was 9 months for both arms. SRS alone resulted in an ICER of $9917 per QALY gained. In one-way sensitivity analyses, results were most sensitive to variation in cognitive decline rates for both groups and median survival rates, but the SRS alone remained cost-effective for most parameter ranges.

Conclusions

Based on the current available evidence, SRS alone was found to be cost-effective for patients with one to three brain metastases compared with upfront WBRT plus SRS.  相似文献   

12.

Background

Breast cancer is one of the most relevant malignancies among women. Molecular abnormalities in promotor region of survivin gene may account for overexpression of survivin and increased breast cancer risk. This study aimed to explore the potential association between survivin promotor gene -31G/C single nucleotide polymorphism (rs9904341) and its serum level alteration on one hand, and the risk of breast cancer in Egyptian patients on the other hand. It also aimed to assess the usefulness of survivin as an early noninvasive diagnostic biomarker and in breast cancer staging.

Patients and Methods

A total of 135 patients with physically and pathologically confirmed breast cancer and 40 unrelated control subjects as well as 40 patients with benign breast mass were recruited from the early detection unit at National Cancer Institute, Cairo University. Genotyping was performed using allelic discrimination probes by real-time quantitative PCR and serum survivin by enzyme-linked immunosorbent assay.

Results

The minor allele C of -31G/C survivin single nucleotide polymorphism was more frequent in breast cancer patients (19.3%) compared to the control group (7.5%). Furthermore, subjects with the GC + CC genotype were at increased risk of breast cancer compared to the GG genotype of the control group and also the benign group. Moreover, those patients exhibited higher serum levels of survivin compared to GG genotype. There was also significant elevation of serum survivin in different breast cancer stages.

Conclusion

Genetic variation in -31G/C of the survivin gene may contribute to the disposition of breast cancer in the Egyptian population. Serum survivin alteration played a pivotal role in the pathogenesis of breast cancer.  相似文献   

13.

Purpose

BioZorb® (Focal Therapeutics, Aliso Viejo, CA) is an implantable 3-dimensional bioabsorbable marker used for tumor bed volume (TBV) identification during postoperative radiation therapy (RT) planning. We aimed to calculate and compare RT TBVs between two cohorts managed with and without the device.

Methods and Materials

Data from patients with breast cancer who were treated at Rhode Island Hosptial, Providence RI between May 1, 2015 and April 30, 2016 were retrospectively reviewed and grouped based on 3-dimensional bioabsorbable marker placement. Pathology reports were used to calculate tumor excision volume (TEV) after breast conservation. Specifically, the three dimensions provided were multiplied to generate a cubic volume, defined as TEV. TBV was calculated using treatment volumes generated with Philips Pinnacle3 treatment planning software (Andover, MA). Linear regression analyses assessed the relationship between excised TEV and TBV. T tests compared the slopes of the best fit lines for plots of TEV versus TBV.

Results

In this retrospective case-control study, 116 patients undergoing breast RT were identified; of whom 42 received a 3-dimensional bioabsorbable marker and 74 did not. The mean TEVs were 102.7 cm3 with the device and 103.2 cm3 without the device, and the mean TBVs for the same groups were 27.5 cm3 and 40.1 cm3, respectively. The TBV standard errors for patients who did and did not receive 3-dimensional bioabsorbable markers were 23.739 and 38.685, respectively. The t tests found the slopes of the lines of best fit for these cohorts to be statistically significantly different (P = .001), with smaller TBVs achieved with 3-dimensional bioabsorbable marker placement.

Conclusions

When comparing TBVs between patients contemporaneously treated with or without a 3-dimensional bioabsorbable marker, device placement was associated with statistically significantly smaller TBVs in the setting of similar TEVs.  相似文献   

14.
15.

Purpose

We assessed the effect of elective extended field radiation (EFRT) and nodal dose escalation on locoregional control and survival in patients with node-positive cervical cancer treated with definitive chemoradiation at 2 academic institutions.

Methods and Materials

Patients with cervical cancer with pelvic and/or paraortic lymph node (PALN) metastases treated with definitive chemoradiation between 2004 and 2011 were retrospectively reviewed. Patterns of failure were recorded. The impact of tumor and treatment on survival or recurrence were evaluated.

Results

A total of 78 patients were included. Median follow-up in surviving patients was 34 months. The 3-year overall survival (OS) and disease-free survival (DFS) were 65% and 50%, respectively (all patients), 68% and 52% (pelvic lymph nodes), and 59% and 48% (PALN). OS or DFS in pelvic-only versus PALN-positive patients was not significantly different (log-rank P = .24). Recurrences were distant (n = 22), PALN (n = 6), central pelvis (n = 5), pelvic lymph node (n = 3), and suspended ovary (n = 1). Higher nodal prescribed dose (range, 45-60 Gy) and elective EFRT did not affect DFS or OS (Cox proportional hazards P > .05). There was a trend toward decreased regional recurrence with higher nodal dose (hazard ratio, 0.85 per Gy increase; Cox proportional hazards P = .08). Elective EFRT did not affect PALN failure rate, OS, or DFS (Cox proportional hazards P > .05).

Conclusions

Survival of patients with PALN involvement was similar to those with pelvic-only nodes. Higher nodal dose may improve regional control but did not affect survival. Elective extended-field radiation did not affect outcomes in this cohort. Most failures were distant, emphasizing the potential role of systemic therapy to improve outcomes.  相似文献   

16.

Aims

To obtain an overview of the management and outcomes of children aged 18 years or younger diagnosed with differentiated thyroid carcinoma of follicular cell origin across the UK, by collecting and analysing data from the limited number of centres treating these patients. This multicentre data might provide a more realistic perspective than single-institution series.

Materials and methods

Six centres submitted data extracted from historical records on patients aged 18 years or younger, diagnosed between 1964 and 2017. The univariate and multivariable Cox proportional hazard model was used to identify potential predictors of progression-free survival, using national data as a control.

Results

Data on 166 patients were available for analysis. Females (74%) were predominant, and the age ranged from 3 to 19 years at diagnosis, mean 14.1 years. Nodal metastases were present in 51%; 12% had distant metastases. After surgery, 95% received radioactive iodine (39% on more than one occasion) and 4% received external beam radiotherapy. With a median follow-up duration of 5 years, 69% are alive with no evidence of disease; 20% are alive with a raised thyroglobulin level as the only evidence of residual disease; 6% have residual structural disease detectable on imaging; 2% have died, from cerebral metastases.

Conclusion

Despite most patients having advanced disease at presentation, outcomes are very good. A national prospective registry should allow systematic collection of good-quality data and may facilitate research to further improve outcomes.  相似文献   

17.

Background

The study aimed to evaluate the feasibility and reliability of ultrasound-guided vacuum-assisted breast biopsy (US-VABB) for sampling of microcalcifications indicative of cancer when stereotactic vacuum-assisted breast biopsy cannot be performed because of reasons such as thin breast tissue, insufficient thickness at compression, and microcalcification situated close to the chest wall or in breast tissue of the axillary tail.

Patients and Methods

The study population was selected from among 187 patients with microcalcifications detected on mammogram. The findings were classified using the American College of Radiology criteria as Breast Imaging Reporting and Data System 3, 4, or 5. 30 Thirty were not eligible for stereotactic guidance because of reasons such as small breast size, compression thickness <2 cm, or microcalcification located in the axillary tails or close to chest wall. In 23 patients microcalcifications were detected at ultrasound, and US-VABB was performed. The other 7 patients underwent surgical biopsy. In the 23 patients who underwent US-VABB, multiple core samples were taken after a specimen mammography to ensure that microcalcifications were included.

Results

Biopsy was successful in all cases of US-VABB. The procedure was well tolerated, and there were no complications.

Conclusion

US-VABB should be preferred over diagnostic surgical biopsy when microcalcifications are sonographically visible and stereotactic guidance is contraindicated. The procedure appears to be reliable and accurate, with added advantages such as low cost and absence of radiation exposure.  相似文献   

18.

Introduction

Approximately 5% of patients with EGFR-activating mutations acquire EGFR tyrosine kinase inhibitor (TKI) resistance through SCLC transformation. However, the reason for the poor outcome and the molecular basis of EGFR-mutant SCLC that has transformed from adenocarcinoma remain unclear.

Methods

In this study, we established two EGFR-mutant SCLC cell lines from lung adenocarcinoma patients after failed EGFR-TKI treatment to investigate their molecular basis and potential therapeutic strategies in the hope of improving patient outcome.

Results

These two EGFR-mutant SCLC cell lines displayed two different phenotypes: suspensive and adherent. Both phenotypes shared the same genomic alterations analyzed by array-based comparative genomic hybridization assay. Increased expression of EGFR and mesenchymal markers and decreased expression of neuroendocrine markers were observed in adherent cells. Principal component analysis and hierarchical clustering analysis of RNA microarray revealed that these two cell lines displayed a unique gene expression pattern that was distinctly different from that in NSCLC and classical SCLC cells. Combined treatment using an EGFR-TKI and an AKT inhibitor attenuated cell viabilities in our two cell lines. Moreover, the use of a histone deacetylase inhibitor significantly inhibited the cell viabilities of both cell lines in vitro and in vivo.

Conclusion

Our findings suggest that EGFR-mutant SCLC may be a distinct subclass of SCLC that exhibits epithelial-mesenchymal transition phenotypes, and adding an AKT or histone deacetylase inhibitor to pre-existing therapies may be one of the therapeutic choices for transformed EGFR-mutant SCLC.  相似文献   

19.

Background

Implant-based breast reconstruction after nipple-sparing mastectomy has been the most common breast reconstruction procedure performed, for both breast cancer treatment and prophylactically. Subpectoral implant placement with partial detachment of the pectoralis major muscle has been the procedure of choice for staged reconstruction and direct-to-implantation. Prepectoral implant placement has recently increased in popularity among plastic surgeons owing to the high rates of animation deformity, loss of muscle function, and chronic pain observed with submuscular implant placement. Acellular dermal matrices or synthetic meshes have been used for implant coverage and support to avoid capsular contracture and implant visibility. In the present study, we have introduced breast reconstruction actualized in nipple-sparing mastectomy and direct-to-implant with prepectoral polyurethane positioning (BRAND4P).

Patients and Methods

A total of 34 nipple-sparing mastectomies and immediate direct-to-implant breast reconstructions with prepectoral polyurethane-coated implant placement were performed in 21 patients (13 bilateral and 8 unilateral). The implant was placed subcutaneously in the exact place of the excised breast parenchyma with no further coverage.

Results

After a mean follow-up of 4 months, no major complications had been observed. No patient presented with animation deformity or grade III-IV capsular contracture. Patient satisfaction, assessed using the BREAST-Q, was excellent.

Conclusions

The BRAND4P method represents a novel prepectoral approach and a feasible alternative to subpectoral implant placement among the available implant-based breast reconstruction techniques.  相似文献   

20.
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