Abstract Objectives To prospectively identify anxiety and depressive symptoms, and their predictors, during the multiple sclerosis (MS) peridiagnostic period. Methods The Hospital Anxiety and ...Depression Scale (HADS) was administered during diagnostic workup (baseline), and one and six months after diagnosis disclosure, to SIMS-Trial participants (ISRCTN81072971). Results Of 197 screened patients, 120 (61%) were diagnosed with MS. At baseline, median HADS anxiety (HADS-A) score was 7.0 (interquartile range IQR 5.0–9.5), ≥ 8 (anxiety cut-off) in 43% (95% confidence interval CI 34%–52%). Median HADS depression (HADS-D) was 3.0 (IQR 1.0–5.0), ≥ 8 (depression cut-off) in 11% (95% CI 5%–16%). Independent predictors of anxiety were female sex (odds ratio OR 2.8, 95% CI 1.1–7.2) and HADS-D score (OR 20.8, 95% CI 2.5–175.5). The only predictor of depressive symptoms was HADS-A score (OR 20.0, 95% CI 2.8–260.9). Anxiety symptoms had decreased slightly but significantly (p < 0.001) at six months. Depressive symptoms remained low. Conclusions Anxiety was prominent in the period surrounding MS diagnosis disclosure, particularly in women. A slight but significant reduction occurred six months after diagnosis disclosure. Depressive symptoms were less common and stable over time. In addition to sex, depressive symptoms were the only variable independently associated with anxiety.
Purpose
Pre-operative diagnosis and staging of small intestine neuroendocrine tumors (SI-NETs) remain sub-optimal, with open palpation during surgery still considered the gold standard. This limits a ...standardized implementation of minimally invasive surgery (MIS). The aim of this single-center retrospective study was to assess a tailored diagnostic work-up to identify candidates at low risk of undetected disease who may benefit from MIS.
Methods
Patients diagnosed with SI-NETs between 2013 and 2022 who underwent contrast-enhanced computed tomography enterography (CTE) and Ga68-DOTATOC-positron emission tomography-CT (68 Ga DOTATATE PET/CT) preoperatively and subsequently underwent open surgical resection were included. Imaging studies were reassessed by two radiologists. Combined use of CTE and 68 Ga DOTATATE PET/CT in determining primary lesion disease burden (number of lesions) and LN disease stage (distal and proximal relative to superior mesenteric vessels) was assessed, using surgical reports and pathology as gold standard.
Results
Overall, 56 patients were included. Sensitivity of CTE and 68 Ga DOTATATE PET/CT for at least one primary SI-NET was 100% and 94%, respectively. In the presence of concordance between studies, combined use of CTE and 68 Ga DOTATATE PET/CT for detection of single primary tumors improved specificity to 89% (
n
= 25/28) with a positive predictive value of 87.5% (
n
= 21/24). Distal LN disease was identified in 89.2% of cases (
n
= 33/37). The association of single lesion and distal LN disease was found pre-operatively in 32% of patients (
n
= 18).
Conclusion
Combined use of CTE and 68 Ga DOTATATE PET/CT enables identifying low-risk surgical candidates (single SI-NET lesions with distal LN disease).
Introduction:
Aim of this study was to analyze the overall complication and failure rates of Peripherally Inserted Central Catheters (PICCs), in a 1-year consecutive unselected cohort of 482 adult ...patients, affected by non-hematological malignancies undergoing chemotherapy.
Methods:
Adult outpatients (aged 18–75 years), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, bearing solid tumors and candidates for intravenous chemotherapy were eligible for the study. Exclusion criteria were active infections, coagulopathy (defined as platelet count <50,000/μL and/or prothrombin time more than 18 s), life expectancy <6 months, or inability to give written informed consent. Devices were all implanted in an outpatients’ hospital facility, following predefined evidence-based institutional guidelines and protocols by a PICC-dedicated team at the European Institute of Oncology in Milan, Italy, during the 12-month period from January 1 to December 31, 2019.
Results:
Five-hundred PICCs were implanted in a cohort of 482 patients during the time interval of this study. Thirty devices were overall removed (6.2%), 23 as a consequence of a complication occurred, and seven inadvertently. The inserted PICCs accounted for a total of 49,718 catheter days in situ, median duration was 85.5 days interquartile range (IQR): 56–146. Overall there were 42 (8.7%) complications, corresponding to 0.84 catheter-adverse events (CAE)/1000 PICC-days (95% CI: 0.61–1.14). There were N = 13 (2.7%) thromboses, N = 11 (2.3%) irreversible occlusions, N = 7 (1.5%) accidental removals, N = 5 (1.0%) infections two Catheter Related Blood Stream Infection (CRBSI) and three exit site/local infection, N = 3 (0.6%) ruptures and N = 3 (0.6%) primary or secondary malpositions.
Conclusion:
This large prospective study supports the increasing use of PICCs in adult oncology outpatients treated in specialized centers with chemotherapy for non-hematological malignancies. In this clinical setting, PICC failure occurred in 6% only of the inserted devices.
Background:
Previous breast surgery does not represent an absolute contraindication for nipple-sparing mastectomy, although it may negatively interfere with surgical outcomes. The aim of the authors’ ...study was to confirm the feasibility of nipple-sparing mastectomy after previous breast surgery, focusing on skin incisions and risk factors, complications, and oncologic outcomes.
Methods:
The authors retrospectively identified 368 patients who underwent 387 nipple-sparing mastectomies and reconstruction after previous surgery (quadrantectomy, breast resection, augmentation and reduction mammaplasty, mastopexy) at the European Institute of Oncology from January of 2003 to November of 2017. Patterns of skin incisions (i.e., radial, hemiperiareolar, periareolar, vertical pattern, inframammary fold, Wise-pattern, and round-block) for primary surgery and for mastectomy, type of reconstruction, and radiotherapy have been recorded. The authors collected data regarding early and late complications and further operations (implant change, fat grafting) performed within 2 years to improve cosmetic outcomes. Oncologic follow-up has been reported for in-breast recurrences.
Results:
Complete and partial nipple-areola complex necrosis occurred, respectively, in 2.8 percent and in 5.4 percent of cases. The authors recorded 5.4 percent failures resulting in implant removal. The analysis of risk factors for complications or for the need for further operations showed no significant association with skin incision for first surgery and mastectomy, use of the same skin incision, previous radiotherapy, or type of primary surgery. Five-year overall survival and disease-free survival were 99.1 and 93.8 percent, respectively. No nipple recurrence was recorded.
Conclusions:
The authors’ results confirm that nipple-sparing mastectomy can be a safe surgical procedure after previous breast surgery. Surgical planning should be tailored to each patient.
CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, III.
Human papillomavirus (HPV) tests differ for technology, targets, and information on the genotype and viral load. In this study, we evaluated the performance of the Seegene Anyplex II HPV HR (Anyplex) ...assay in the detection of cervical intraepithelial lesions (CIN) and as a test‐of‐cure in the follow‐up after surgical treatment. One hundred and sixty‐seven women referred to the European Institute of Oncology, Milan, for surgical treatment of CIN2+ were enrolled. A cervical sample was taken before treatment and at the first follow‐up visit: on these samples, Qiagen Hybrid Capture 2 (HC2), Roche Linear Array HPV Test (Linear Array), cytology and histology were performed at baseline, HC2, and cytology at follow‐up. Anyplex genotyping HPV test was performed on a post aliquot from liquid‐based cytology specimens when available. The concordance between Anyplex and HC2 was 93.6% at baseline and 76.7% at follow‐up (3–9 months after treatment), respectively. The concordance between Anyplex and Linear Array was evaluable only at baseline (92.9%). No recurrence occurred in women without the persistence of the same genotype at follow‐up. Seven women relapsed: six had persistence of the same genotypes (five HPV16, one HPV33, and one HPV39), while one tested negative not only with Anyplex but also with HC2 for the persistence of low‐risk genotype infection (HPV73 only detected by Linear Array). Anyplex test represents a valid option for HPV detection and genotyping in order to stratify women at risk of high‐grade lesions at baseline and to monitor patients treated for CIN2+ lesions during follow‐up.
Background
Vascular infiltration may jeopardize resection of the primary tumor and mesenteric metastatic masses in small-intestine neuroendocrine tumors (SI-NETs). However, other factors may play a ...role in predicting resectability.
Methods
After computed tomography (CT) scan, three radiological parameters were considered: (1) degree of superior mesenteric artery involvement (SMA) according to a previous classification (2) degree of superior mesenteric venous involvement (SMV) as either absent, peripheral or proximal (3) presence or not of mesenteric fibrosis retraction (MF). Pre-surgical parameters were matched to surgical outcome.
Results
Forty-nine consecutive patients were submitted to laparotomy. Of them, 37 had complete primary tumor and mesenteric masses resection. SMA (
p
= 0.001), SMV (
p
= 0.008), metastasis site (
p
= 0.001) and MF (
p
< 0.001) were all significantly associated with the likelihood to receive resection at univariate analysis. All the five patients with infiltration of SMV proximal to middle colic vein were unresectable. At multivariable analysis excluding SMA stage, the absence of MF (HR 13.1, I.C. 1.44–119;
p
= 0.002) was the only factor associated with the likelihood to receive primary tumor and mesentery radical surgery.
Conclusions
SMA stage 3-up and/or signs of MF, as well as infiltration of SMV proximal to middle colic vein at CT scan are predictive of operative failure in patients with SI-NETs. The assessment of such factors should be always considered in the decision-making process of such patients especially in those with asymptomatic disease with synchronous unresectable liver metastases.
The role of chemotherapy in low-/intermediate-grade neuroendocrine tumors (NETs) is still debated. We present the results of an Italian multicenter retrospective study evaluating activity and ...toxicity of oxaliplatin-based chemotherapy in patients with advanced NETs.
Clinical records from 5 referral centers were reviewed. Disease control rate (DCR) corresponding to PR + SD (partial response + stable disease) at 6 months, progression-free survival (PFS), overall survival (OS) and toxicity were calculated. Ki67 labeling index, grade of differentiation and excision- repair-cross-complementing group 1 (ERCC-1) were analyzed in tissue tumor samples.
Seventy-eight patients entered the study. Primary sites were: pancreas in 46, gastrointestinal in 24, lung in 19 and unknown in 10% of patients. The vast majority were G2 (2010 WHO classification). Eighty-six percent of the patients were metastatic, and 87% were pretreated and progressive to previous therapies. Sixty-five percent of the patients received capecitabine/oxaliplatin (CAPOX), 6% gemcitabine/oxaliplatin (GEMOX), and 29% leucovorin/fluorouracil/oxaliplatin (FOLFOX-6). PR occurred in 26% of the patients, half of them with pancreatic NETs, and SD in 54%. With a median follow-up of 21 months, the median PFS and OS were 8 and 32 months with 70 and 45 events, respectively. The most frequent G3 toxicities were neurological and gastrointestinal. ERCC-1 immunohistochemical overexpression was positive in 4/28 evaluated samples, with no significant correlation with clinical outcome.
This analysis suggests that oxaliplatin-based chemotherapy can be active with a manageable safety profile in advanced NETs irrespective of the primary sites and tumor grade. The 80% DCR and 8-month PFS could justify a prospective study in NETs with intermediate biological characteristics, especially with pancreatic primary tumors.
The purpose of this study is the evaluation of clinical and surgical impact of the Z0011 trial criteria on the management of breast cancer (BC) patients undergoing breast conservative surgery (BCS) ...at the European Institute of Oncology (IEO). We studied 1386 patients who underwent BCS and sentinel lymph node biopsy (SLNB) from July 2016 to July 2018. Clinical evaluation, breast ultrasound, mammogram, and cyto/histological examination were performed for all patients at the time of diagnosis. Frozen sections of the sentinel lymph node (SLN) were not performed for any patient. Patients who underwent neo‐adjuvant therapy were excluded. To evaluate the results before and after the introduction of Z0011 criteria, a group of 1425 patients with the same characteristics who underwent BCS and SLNB from July 2013 to July 2015 were analyzed. We studied the characteristics of the patients by nodal status, and we observed that T stage, tumor grade, and lymphovascular invasion were statistically related with the highest rate of positive SLN. Of the 1386 patients who underwent surgery after the introduction of the Z011 trial, 1156 patients (83.4%) had negative SLN, 230 patients (16.6%) had positive SLN. Subsequent axillary lymph node dissection (ALND) was performed in only 7 cases (3.0%). Of the 1425 patients operated before the introduction of the Z0011 trial, 216 patients had subsequent ALND (15%). The reduction in the number of ALND performed after the introduction of Z0011 is statistically significant, and this could result in a remarkable reduction of the comorbidities of our patients.
BACKGROUND:This study investigated the risk of reconstruction failure after mastectomy, immediate breast reconstruction, and radiotherapy to either a temporary tissue expander or permanent implant.
...METHODS:Records of women treated at a single institution between June of 1997 and December of 2011 were reviewed. Two patient groups were identified based on type of immediate breast reconstructiontissue expander followed by exchange with a permanent implant and permanent implant. The study endpoint was rate of reconstruction failure, defined as a replacement, loss of the implant, or conversion to flap.
RESULTS:The tissue expander/permanent implant and the permanent implant groups consisted of 63 and 75 patients, respectively. The groups were well balanced for clinical and treatment characteristics. With a median follow-up of 116 months, eight implant losses, 50 implant replacements, and four flap conversions were recorded. Reconstruction failure occurred in 22 of 63 patients in the expander/implant group and in 40 of 75 patients in the permanent implant group. A traditional proportional hazards model showed a higher risk of reconstruction failure for the expander/implant group (hazard ratio, 2.01) and a significantly shorter time to reconstruction failure compared with the permanent implant group (109.2 months versus 157.7 months; p = 0.03); however, according to a competing risk model, the between-groups cumulative incidences were not significantly different (hazard ratio, 1.09).
CONCLUSIONS:Radiotherapy to either a tissue expander or a permanent implant presented a fairly large risk of reconstruction failure over time. The expander/implant group was not more likely to develop reconstruction failure compared to permanent implant group, but the timing of onset was shorter. More complex techniques should be investigated to lower the risk of reconstruction failure.
CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.
The role of anti-PD1/PD-L1 therapy (IO) in NSCLC harboring driver mutations is questionable. This study aimed to examine the efficacy of IO in patients with non-small cell lung cancer (NSCLC) with a ...KRAS mutation (KRAS
).
We retrospectively identified NSCLC patients harboring KRAS mutation treated with IO in our Institution. We analyzed the results in comparison to non-KRAS patients.
Among 328 consecutive KRAS
NSCLC patients, 43 (13.1%) received IO in our Institution. In parallel 117 non-KRAS NSCLC patients treated with IO were selected for comparison. The baseline characteristics were similar between the two groups. No significant difference was observed between KRAS
and non-KRAS patients in terms of mPFS (4.6 vs. 3.3 months, p=0.58) or OS (8.1 vs. 13.0 months, p=0.38).
KRAS mutations seem to be irrelevant for selecting patients for IO that could be therefore considered an effective therapy for NSCLC patients, independently of KRAS status.
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