Patient Preference for Surgical Methods for Ipsilateral Breast Tumor Recurrence.

BACKGROUND: Mastectomy has been the standard surgical treatment for ipsilateral breast tumor recurrence (IBTR). Recently, there has been growing interest in repeat breast-conserving surgery (rBCS) for IBTR among breast surgeons; however, there is currently little information regarding patient preferences for surgical procedure for IBTR. The purpose of this study was to evaluate preference for surgical procedure (mastectomy vs. rBCS) among breast cancer patients who had undergone salvage surgery for IBTR. METHODS: Overall, 100 breast cancer patients who had undergone salvage surgery for IBTR were asked about their preferred surgical methods for IBTR and the reason. The association of patient preference and the reasons related to various clinical and pathological factors were assessed. RESULTS: Of the 100 respondents, only 11 patients (11%) preferred rBCS. Patients who had undergone rBCS and radiotherapy for IBTR were significantly more likely to prefer to undergo rBCS than other groups (p = 0.030). The most frequent reason for choosing rBCS was the patient's desire to minimize breast deformity and surgical wounds. CONCLUSIONS: Our study revealed that there is a low rate of patients who opt to undergo rBCS among patients who had undergone salvage surgery for IBTR. Discrepancies in perceptions regarding the surgical procedure for IBTR between patients and their surgeons may exist.

Eribulin is an immune potentiator in breast cancer that upregulates human leukocyte antigen class I expression via the induction of NOD-like receptor family CARD domain-containing 5.

Eribulin inhibits microtubule polymerization and improves the overall survival of patients with recurrent metastatic breast cancer. A subgroup analysis revealed a low neutrophil to lymphocyte ratio (NLR) (<3) to be a prognostic factor of eribulin treatment. We thus hypothesized that eribulin might be related to the immune response for breast cancer cells and we analyzed the effects of eribulin on the immune system. Immunohistochemical staining revealed that human leukocyte antigen (HLA) class I expression was increased in clinical samples after eribulin treatment. In vitro assays revealed that eribulin treatment increased HLA class I expression in breast cancer line cells. RNA-sequencing demonstrated that eribulin treatment increased the expression of the NOD-like family CARD domain-containing 5 (NLRC5), a master regulator of HLA class I expression. Eribulin treatment increased the NY-ESO-1-specific T-cell receptor (TCR) transduced T (TCR-T) cell response for New York oesophageal squamous cell carcinoma 1 (NY-ESO-1) overexpressed breast cancer cells. The eribulin and TCR-T combined therapy model revealed that eribulin and immunotherapy using TCR-T cells has a synergistic effect. In summary, eribulin increases the expression of HLA class 1 via HLA class 1 transactivatior NLRC5 and eribulin combination with immunotherapy can be effective for the treatment of breast cancer.

Prevalence and radiological characteristics of the dislocation of the second metatarsophalangeal joint in patients undergoing hallux valgus surgery; a matched control study.

BACKGROUND: Hallux valgus (HV) is occasionally associated with chronic subluxation or dislocation (CS/D) of the second metatarsophalangeal joint (2MTPj). The present study aimed to radiographically investigate the prevalence and characteristics of HV with CS/D of the 2MTPj compared with matched controls. METHODS: Dorsoplantar and lateral weight-bearing radiographs of 79 female patients (79 feet) who had HV with an age of 50 years or more were reviewed. All feet were treated with a proximal supination osteotomy for correction of HV. CS/D of the 2MTPj was evaluated on preoperative dorsoplantar and lateral radiographs. HV and intermetatarsal (IM) angles were measured. Seventy-nine feet were divided into two groups: Group CD (16 feet) had HV with CS/D of the 2MTPj, and Group non-CD had HV without the CS/D of the 2MTPj (63 feet). The severity of HV was divided into two grades according to the HV angle: moderate deformity (Group M, 36 feet, HV angle of less than 40°) and severe deformity (Group S, 43 feet, HV angle of 40° or greater). Group CD and non-CD, and Group M and S were matched by age, gender, and BMI. RESULTS: The prevalence of CS/D of the 2MTPj was 20.3%. Group CD had a significantly higher HV angle (p = 0.0001) and a significantly higher IM angle (p = 0.042) than Group non-CD. The prevalence of CS/D of the 2MTPj in Group S (34.9%) were significantly higher than that in Group M (2.8%) (p < 0.001). CONCLUSIONS: CS/D of the 2MTPj was significantly associated with greater HV and IM angles compared with matched controls. The prevalence of CS/D of the 2MTPj (34.9%) in Group S was significantly higher than that in Group M. Severe HV can be at higher risk of acquiring CS/D of the 2MTPj in middle-aged and older females.

Radiological characteristics of hallux valgus with metatarsus adductus: A matched case-control study.

BACKGROUND: No evidence has been found to support the hypothesis that there is a correlation between hallux valgus (HV) and intermetatarsal (IM) angles in HV with metatarsus adductus (MA) and that IM angle in HV with MA is lower than that in HV without MA. The present study aimed to analyze the radiographic characteristics of HV with MA compared to matched controls and to clarify the differences between HV with MA and without MA. METHODS: Preoperative radiographs of 126 female patients (164 feet) who underwent hallux valgus surgery were reviewed. The HV, IM, and MA angles were measured. The MA was defined as MA angle of 20° or greater. Of all the feet, 37 (22.6%) had HV with MA (MA group). Control A (111 feet) having HV without MA was matched by age, gender, and BMI to MA group; Control B (79 feet) having HV without MA was matched by age, gender, BMI, and HV angle to the sub-MA group (31 feet) having HV with MA. RESULTS: The correlation coefficient between the HV and IM angles in the MA group was considered negligible (r = 0.08, p = 0.63), whereas the correlation coefficient in Control A was considered moderate (r = 0.57, p < 0.00001). The correlation coefficient in the MA group was significantly smaller than in Control A (p < 0.01). There was no significant difference in the HV angle between the sub-MA group and Control B (p = 0.23), but the IM angle was significantly smaller than in Control B (p = 0.002). CONCLUSION: There is no significant correlation between the HV and IM angles in HV with MA, as there is in HV without MA. HV with MA has a significantly smaller IM angle for the HV angle compared to HV without MA.

Morphology of the asymptomatic Αchilles tendon: Measurement of tendon length and shape using magnetic resonance imaging, and investigation of related factors.

BACKGROUND: One of the severe complications of Achilles tendon (AT) rupture is muscle weakness due to tendon lengthening. It is very important to prevent tendon lengthening during treatment; however, data on the length, thickness, and width of normal ATs are scarce. Furthermore, no studies have investigated the factors related to the AT length and shape. We aimed to determine the normal AT length and shape and to investigate any correlating factors. METHODS: We measured the AT length, thickness, and width of 100 asymptomatic patients using magnetic resonance imaging. We also investigated the correlation between the AT length, thickness, and width and factors including age, sex, height, body weight, body mass index, history of sports activities, and the area of Kager's fat pad. RESULTS: The mean AT length was 42.1 ± 12.9 mm. The AT length in 73% of the patients was within the range of 30-55 mm. Individual differences in the tendon length were large, but there was no correlation between the tendon length and patient height (P = 0.505). There was a strong correlation between the AT length and area of Kager's fat pad on magnetic resonance imaging (r = 0.734, P < 0.001). Furthermore, the correlation coefficient between the area of Kager's fat pad on magnetic resonance imaging and the area of Kager's triangle on radiography was extremely high (r = 0.851, P < 0.001). CONCLUSIONS: The AT length can be predicted based on the area of Kager's triangle of the unaffected ankle on radiography. If the AT length is > 55 mm or longer than the length measured directly or calculated from the estimated area of Kager's triangle, tendon lengthening should be suspected. Our findings could provide an important indicator for the evaluation of AT lengthening not only in daily clinical situations but also in clinical studies.

Plantar Pressure Distribution Before and After Surgery for Lesser Metatarsophalangeal Joint Dislocation With Hallux Valgus.

Hallux valgus surgery and open reduction of the lesser metatarsophalangeal joints with metatarsal shortening osteotomy help treat severe hallux valgus concomitant with the lesser metatarsophalangeal joint dislocation; however, pre- and postoperative plantar pressure distribution and its effect on the foot remain unclear. The pre- and postoperative groups comprised 16 patients with moderate-to-severe symptomatic hallux valgus with lesser metatarsophalangeal joint dislocation. All feet underwent open reduction and collateral ligament reconstruction of the second metatarsophalangeal joint and proximal metatarsal shortening osteotomy under the second metatarsal with proximal osteotomy of the first metatarsal. Twenty healthy participants (20 feet) were included in the control group. The plantar pressure distribution was determined by measuring the peak pressure, maximum force, contact area, and force-time integral for 12 regions. Under the second toe, all measurements in the preoperative group were significantly lower than those of the control group. The peak pressure, maximum force, and contact area of the postoperative group were significantly greater than those of the preoperative group. However, no differences were observed between the postoperative and control groups. Under the second metatarsal head, the peak pressure of the preoperative group was significantly higher than that of the control group. The peak pressure of the postoperative group was significantly lower than that of the preoperative group and showed no differences from the control group. Open reduction and collateral ligament reconstruction of the lesser metatarsophalangeal joints and proximal metatarsal shortening osteotomy with proximal osteotomy of the first metatarsal in hallux valgus with lesser metatarsophalangeal joints dislocation cases may improve operative outcomes, including favorable foot function.

Operative outcomes of hallux valgus with painful osteoarthritis of the lesser tarsometatarsal joints.

BACKGROUND: Hallux valgus is sometimes accompanied by osteoarthritis of the lesser tarsometatarsal joint. However, information on the operative procedures and outcomes for the treatment of hallux valgus with osteoarthritis of the lesser tarsometatarsal joint simultaneously is limited. We aimed to describe this operative procedure and evaluate the outcomes of the treatment of hallux valgus with osteoarthritis of the lesser tarsometatarsal joint. METHODS: Fifteen patients (17 feet; average age, 66.9 years; average follow-up, 59.4 months; and minimum follow-up, 24 months) with symptomatic hallux valgus accompanied by painful osteoarthritis of the lesser tarsometatarsal joint were enrolled. All feet showed osteoarthritis of the second and/or third tarsometatarsal joint on dorsoplantar weight-bearing radiograph. The operative procedure included a proximal osteotomy of the first metatarsal and arthrodesis of the lesser tarsometatarsal joint with an autologous bone graft. RESULTS: The mean Japanese Society for Surgery of the Foot hallux metatarsophalangeal-interphalangeal score significantly improved from 54.8 points preoperatively to 91.7 points postoperatively (P <0.001). The mean postoperative visual analog score (15 feet) was 1.0 (0-3.9). Preoperative midtarsal pain disappeared in 14 feet and decreased in one foot postoperatively. Preoperative metatarsalgia was found in five feet, of which, it disappeared in two feet, decreased in two feet, and transferred to another region in one foot at the latest follow-up. The mean hallux valgus and intermetatarsal angles were 42.4° and 18.4° preoperatively, which decreased significantly to 12.5° and 6.9° postoperatively, respectively (P <0.001, all). Recurrence of hallux valgus (hallux valgus angle ≥20°) was observed in two feet (11.8%). Nonunion of the third tarsometatarsal joint was observed in one foot (3.1% among 32 joints). CONCLUSIONS: The clinical and radiographic results indicated that operative treatment for hallux valgus with painful osteoarthritis of the lesser tarsometatarsal joint significantly improves forefoot and midfoot pain and function and has low complication rates. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Joint preserving procedures for painful plantar callosities in patients with flexible cavovarus foot.

BACKGROUND: The outcome of a constant joint preserving procedure for painful plantar callosities with cavovarus foot remains unclear. METHODS: Eleven patients (11 feet) who underwent lateral displacement calcaneal osteotomy (LDCO), dorsiflexion first metatarsal osteotomy (DFMO), and plantar fasciotomy (PF), simultaneously were included. The presence of painful callosities, heel alignment of standing (HA), and the Japanese Society for Surgery of the Foot ankle/hindfoot (JSSF) score were evaluated. Radiographically, the talonavicular coverage angle (TNCA), lateral talo-first metatarsal angle (LTMA), calcaneal pitch angle (CPA), and heel alignment angle (HAA) were measured. RESULTS: Postoperatively, painful plantar callosities disappeared in 10 patients and remained in one patient. The postoperative HA and JSSF score significantly improved. The postoperative TNCA, LTMA, CPA, and HAA significantly improved. CONCLUSIONS: In patients with flexible cavovarus foot, LDCO, DFMO, and PF yielded good outcomes at mid-term follow-up with preservation of the foot and ankle joints.

An Optimal Timing for Removing a Drain After Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: In clinical practice, drains had been routinely used for reducing seroma formation after breast surgery. However, an optimal timing to remove drains does not identify yet. METHODS: This study aimed to compare the clinical outcome, such as seroma formation, surgical site infection (SSI), and a length of hospital stay between early removal and late removal. A systematic review was performed using PubMed, MEDLINE, and the Cochrane Library. Breast cancer patients who received surgery using drains were eligible. Those parameters were compared between early vs late removal. RESULTS: Eleven studies included in this meta-analysis. Seroma formation in the early removal group was significantly higher than the one in the late removal group (RR = 1.58: 95%CI [1.25-2.01], P = 0.0001), meanwhile no significant difference was found among the groups for SSI (RR = 0.82: 95%CI [0.51-1.31], P= 0.40). A length of hospital stay in the early removal group was also significantly shorter than late removal (RR -3.31: 95%CI [-5.13-1.49], P = 0.0004). CONCLUSIONS: Seroma formation was significantly higher in patients who had early drain removal. Conversely, SSI incidence was low, and early removal did not increase SSI incidence. In conclusion, early drain removal has no proved clinical benefit in these settings besides reduction of hospital stays.

Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial.

PURPOSE: The newly introduced erector spinae plane block (ESPB) has given anesthesiologists an alternative regional anesthetic technique for thoracic analgesia. Although ESPB and retrolaminar block (RLB) have similar puncture sites, no clinical study comparing ESPB and RLB has been reported. The aim of this study was to compare ESPB and RLB in terms of analgesic efficacy in the context of multimodal analgesia following breast surgery. METHODS: Fifty female patients undergoing breast surgery under general anesthesia were randomly allocated to receive either ultrasound-guided ESPB or RLB with 20 mL of 0.375% levobupivacaine for postoperative analgesia. The primary outcome was analgesic efficacy in terms of time to first postoperative rescue analgesic after the block procedure. The secondary outcomes were consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of postoperative nausea and vomiting (PONV). RESULTS: After excluding five patients, 45 patients (22 and 23 patients in the ESPB and RLB group, respectively) were analyzed. Median time until the first postoperative rescue analgesic after the block procedure in the ESPB group was not significantly longer than that in the RLB group (8.6 [range 2.7-24] vs. 4.8 [3.0-24] h; P = 0.83). There was no significant difference in the consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of PONV between the two groups. CONCLUSION: ESPB is equivalent, and not superior, to RLB for postoperative analgesia after breast surgery when 20 mL of 0.375% levobupivacaine is injected at the fourth thoracic vertebra.

Plantar pressure distribution in hallux valgus feet after a first metatarsal proximal crescentic osteotomy with a lesser metatarsal proximal shortening osteotomy.

BACKGROUND: Plantar pressure distribution after the first metatarsal proximal crescentic osteotomy (FMPCO) with lesser metatarsal proximal shortening osteotomy (LMPSO) for hallux valgus with metatarsalgia has not been previously described. METHODS: The pre- (Pre) and postoperative (Post) groups comprised of 18 patients who underwent unilateral FMPCO with LMPSO; fifteen healthy volunteers constituted the control (C) group. For each of the 10 regions, peak pressure (Peak-P), maximum force (Max-F), contact time (Con-T), contact area (Con-A), and force-time integral (FTI) were measured. RESULTS: The mean Peak-P of the second metatarsal head was significantly lower in the Post group than the Pre group. The mean Peak-P, Max-F, Con-T, and FTI were not significantly different between the Post and C groups. The mean Con-A was significantly lower in the Post group than the C group. CONCLUSION: FMPCO with LMPSO may improve the plantar pressure of the central forefoot comparable to healthy subjects.

Postural stability impairment in patients with bilateral hallux valgus: A case-control study using a stabilometer.

BACKGROUND: Hallux valgus (HV) is an important risk factor for falls (in older people); however, the detailed relationship is less understood. We aimed to evaluate postural stability in bilateral HV patients. METHODS: Two groups of 20 female patients-an HV group and a C (i.e., non-HV) group-participated in this study. Evaluations were made using the Timed Up and Go (TUG) test, the Berg Balance Scale (BBS), the Falls Efficacy Scale (FES), track length (LNG), velocity (VEL), enveloped area (ENV), and root mean square area (RMS). RESULTS: TUG and FES scores were significantly higher and BBS scores were lower in the HV group than in the C group. LNG was significantly longer, VEL was higher, and ENV and RMS were wider in the HV group than in the C group. CONCLUSIONS: The HV group exhibited impaired walking mobility, balance, and postural stability.

Effect of Toe Type on Static Balance in Ballet Dancers.

OBJECTIVES: Some forefoot shapes are ideal for pointe work in ballet. Egyptian-type, with the hallux being longest and the remaining toes decreasing in size, and Greek-type, with the second toe longer than the hallux, are considered less optimal for pointe work. Square-type, with the second toe the same length as the hallux, is considered optimal. This study compared postural stability in the bipedal stance, demi pointe, and en pointe between ballet dancers with the two toe types using a stabilometer. METHODS: This study included 25 Japanese ballet academy dancers who had received ballet lessons for at least 6 years. Toes were categorized into Egyptian-type (n=14) and square-type (n=11). Bipedal stance, demi pointe, and en pointe were tested. Center of pressure (COP) parameters were calculated from ground-reaction forces using two force plates: total trajectory length (LNG), velocities of anterior-posterior (VAP) and medial-lateral directions (VML), and maximum range displacement in the anterior-posterior (MAXAP) and medial-lateral directions (MAXML). Mann-Whitney U-tests were used to examine differences in COP parameters. RESULTS: There were no differences in parameters during bipedal stance or demi pointe. However, dancers with Egyptian-type toes had significantly greater LNG (p<0.01), VML (p=0.01), MAXML (p<0.01), and MAXAP (p=0.03) during en pointe. CONCLUSIONS: Ballet dancers with Egyptian-type toes demonstrated greater displacement in the medial-lateral and anterior-posterior directions during en pointe. Ballet dancers should be aware of toe types and sway character to optimize ballet training and balance.

Immunohistological analysis of pancreatic carcinoma after vaccination with survivin 2B peptide: Analysis of an autopsy series.

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer by providing new options in addition to existing therapies. However, peptide vaccination therapies still represent an attractive approach, because of the antigen specificity. We identified survivin 2B peptide (SVN-2B), a 9-mer antigenic peptide encoded by survivin, and an SVN-2B peptide vaccine-based phase II randomized clinical trial targeting unresectable and refractory pancreatic carcinoma was undertaken. The SVN-2B peptide vaccine did not have any statistically significant clinical benefits in that study. Therefore, we undertook an autopsy study to analyze the immune status of the pancreatic cancer lesions at the histological level. Autopsies were carried out in 13 patients who had died of pancreatic cancer, including 7 who had received SVN-2B peptide vaccination and 6 who had not, as negative controls. The expression of immune-related molecules was analyzed by immunohistochemical staining. Cytotoxic T lymphocytes were analyzed by tetramer staining and enzyme-linked immunospot assay. Histological analysis revealed dense infiltration of CD8+ T cells in some lesions in patients who had received the SVN-2B peptide vaccine. A high rate of programmed cell death ligand 1 expression in cancer cells was observed in these cases, indicating that CTLs were induced by SVN-2B peptide vaccination and had infiltrated the lesions. The lack of a significant antitumor effect was most likely attributable to the expression of immune checkpoint molecules. These findings suggest that the combination of a tumor-specific peptide vaccine and an ICI might be a promising approach to the treatment of pancreatic carcinoma in the future.

Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA-A24-positive pancreatic adenocarcinoma.

The prognosis of advanced pancreatic adenocarcinoma is still extremely poor. This study sought to determine the efficacy of, and immunological response to, peptide vaccination therapy in patients with this disease. In this multicenter randomized phase II study, patients with advanced pancreatic adenocarcinoma after gemcitabine and/or tegafur/gimeracil/oteracil were randomly assigned to 3 groups that each received a 2-step treatment course. In Step 1, the groups received treatments of: (i) survivin 2B peptide (SVN-2B) plus interferon-ß (IFNß); (ii) SVN-2B only; or (iii) placebo until the patients show progression. In Step 2, all patients who consented to participate received 4 treatments with SVN-2B plus IFNß. The primary endpoint was progression-free survival (PFS) after initiation of Step 1 treatment. Secondary endpoints included immunological effects assessed by analysis of PBMCs after Step 1. Eighty-three patients were randomly assigned to receive SVN-2B plus IFNß (n = 30), SVN-2B (n = 34), or placebo (n = 19). No significant improvement in PFS was observed. Survivin 2B-specific CTLs were found to be increased in the SVN-2B plus IFNß group by tetramer assay. Among patients who participated in Step 2, those who had received SVN-2B plus IFNß in Step 1 showed better overall survival compared with those who had received placebo in Step 1. Patients vaccinated with SVN-2B plus IFNß did not have improved PFS, but showed significant immunological reaction after vaccination. Subgroup analysis suggested that a longer SVN-2B plus IFNß vaccination protocol might confer survival benefit. (Clinical trial registration number: UMIN 000012146).

Case report: Long-term survival of a pancreatic cancer patient immunized with an SVN-2B peptide vaccine.

A 62-year-old woman who underwent surgery to treat pancreatic cancer provided written, informed consent to undergo adjuvant therapy with gemcitabine, tegafur, and uracil. However, this was stopped after only 14 days due to Grade 4 neutropenia. She was then started on vaccine therapy with Survivin 2B peptide (SVN-2B) including IFA and INF-α. Although metastatic lung tumors were identified and resected at 82 months after surgery, the patient has remained free of new or relapsed disease for 12 years thereafter. Tetramer and ELISPOT assays revealed the continuous circulation of SVN-2B-restricted cytotoxic T-lymphocytes (CTLs) in her peripheral blood, and CTL clones had specific activity for SVN-2B at 12 years after surgery. The adverse effects of the peptide vaccination were tolerable and comprised low-grade headache, nausea, and fatigue. A prognosis beyond 10 years in the face of pancreatic cancer with distant metastasis is extremely rare. This experience might indicate the value of cancer vaccination therapy.

Comparison of plantar pressure distribution in patients with hallux valgus and healthy matched controls.

BACKGROUND: Detailed information regarding differences in plantar pressure distribution between hallux valgus and healthy feet is unavailable. The purposes of the present study were to clarify the characteristics of the plantar pressure distribution in patients with hallux valgus compared with healthy matched controls and to determine whether hallux valgus leads to dysfunction of the great toe during walking. METHODS: The study consisted of 25 patients with symptomatic moderate-to-severe hallux valgus (HV group) and 13 healthy matched volunteers (C group) without hallux valgus. All patients and volunteers were women. The HV and C groups did not differ significantly in age, height, weight, and body mass index. Plantar pressure during walking was measured using F-scan. The plantar aspect of the foot was divided into eight regions. The peak pressure (Peak-P), maximum force (Max-F), contact time (Con-T), contact area (Con-A), and force time integral (FTI) were measured in each region. RESULTS: The Peak-P of the great toe did not differ significantly between the HV and C groups. However, all other parameters: Max-F, Con-T, Con-A, and FTI of the great toe in the HV group were significantly lower than in the C group. In the central forefoot, the Peak-P and Max-F in the HV group were significantly higher than in the C group. CONCLUSION: The present study demonstrated that a moderate-to-severe hallux valgus deformity leads to dysfunction of the great toe during walking and may increase mechanical loading on the central forefoot.

Responsiveness of the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) in patients with hallux valgus.

BACKGROUND: In this study, we investigated the responsiveness of the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) for patient's assessment before and after hallux valgus surgery. METHODS: Patient-reported answers on the SAFE-Q and Short Form-36 (SF-36) before and at a mean of 3-4 and 9-12 months after hallux valgus surgery were analyzed. Data of 100 patients (92 women, eight men) from 36 institutions throughout Japan were used for analysis. RESULTS: In all subscales of the SAFE-Q, the trend of increased scores after surgery was statistically significant (P < 0.001). Among the patients with available scores both before and at 9-12 months after surgery (n = 66), the largest effect sizes (ESs) were observed for shoe-related (1.60), pain and pain-related (1.05), and general health and well-being (0.84) scales. In the SF-36 (n = 64), the largest ES was observed for the bodily pain scale (0.86). Less notable changes were observed for the remaining SF-36 domains. CONCLUSION: The SAFE-Q is the first patient-reported outcome measure which includes a quality of life assessment of shoes. In our cohort, the most remarkable responsiveness was observed for the shoe-related subscale. Based on its responsiveness, the SAFE-Q appears to be sufficient for evaluation of foot-related quality of life before and after surgery.

Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis?

Pancreatic tumors are chemoresistant and malignant, and there are very few therapeutic options for pancreatic cancer, as the disease is normally diagnosed at an advanced stage. Although attempts have been made to develop vaccine therapies for pancreatic cancer for a couple of decades, none of the resultant protocols or regimens have succeeded in improving the clinical outcomes of patients. We herein review vaccines tested within the past few years, including peptide, biological and multiple vaccines, and describe the three sets of criteria used to evaluate the therapeutic activity of vaccines in solid tumors.