In 149 patients, treated with intermittent continuous infusion of different chemotherapeutic agents, 169 Port-a-Cath®s® were implanted by qualified surgeons and residents in training. The peri- and postoperative complications of implantation of the Port-a-Cath®® system and the complications during treatment were retrospectively analysed. The Port-a-Cath® was in situ for a total of 36247 days (median 181, range 1–1332). Of the 169 catheters, major complications occurred during treatment, with infection in 4 patients (2.4%), occlusion in 3 (1.8%), thrombosis in 8 (4.7%), extravasation in 8 (4.7%) and migration in 3 (1.8%). The peri- and postoperative complication rate was low, although pneumothorax occurred in 6 patients (3.6%). In 25 patients (14.8%) the Port-a-Cath® had to be explanted due to complications. It can be concluded that continuous infusion of chemotherapy via a Port-a-Cath® system is a relatively safe procedure, although major complications do occur. The experience of the surgeon could not be related to the complications.
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Spontaneous catheter migration is rare. The incidence rate of catheter migration within the follow-up period of 5–9 months is 0.9%–1.8%.8,9 The incidence of catheter migration in the current study was 1.2% (21/1716), which is consistent with the previous findings.
This study aimed to explore the incidence of abnormal catheter positioning and the effectiveness and safety of intravascular adjustment or removal of abnormally positioned catheters through percutaneous punctures.
A retrospective analysis was conducted on 58 patients with abnormal catheter positioning, treated between January 2009 and June 2019. Intravascular adjustment of the migrated catheters and removal of the fractured catheters were performed through percutaneous puncture using a pigtail catheter, cobra catheter, and gooseneck snare.
Of the 58 cases, there were 23 cases of catheter migration and 35 cases of catheter fracture. The incidence of abnormal catheter positioning was 3.0%, corresponding to 1.2% migrations and 1.8% fractures. Among the 23 cases of migration, 1 case did not require adjustment and another underwent unsuccessful adjustment. The rate of successful adjustment of migrated catheters was 91.3%, whereas the rate of successful removal of fractured catheters was 100%. No surgery-related complications were observed either immediately or during the 1-month follow-up period.
This study showed that the incidence of abnormal catheter positioning is low. Intravascular techniques used for the adjustment or removal of abnormally placed catheters are safe, efficient, and minimally invasive.
Port-A-Cath systems (PCS) are safe and convenient devices for long-term infusion in patients with malignant tumors. This study retrospectively analyzed the complications from PCS and their management.
Data of 1695 adults (641 males and 1054 females) with malignant tumors who underwent PCS implantation in our center from January 1, 2009 to December 31, 2019 who had complete follow-up records were collected in this study. The early and late complications and corresponding treatments were studied.
A total of 1716 PCSs were implanted; 21 patients underwent 2 implantations each. The success rate was 100% and no severe complications occurred during implantation. The overall occurrence rate of post-implantation complications was 18.5% (318/1716); 5.5% (94/1716) were early complications and 13.0% (224/1716) were late complications. A total of 451 PCSs were removed, of which 398 were removed due to the end of chemotherapy, while 53 were removed because of complications. A total of 4 deaths occurred from these complications.
The incidence of intra- and post-operative complications is low. In most cases, complications can be effectively controlled without the removal of the PCS and regular follow-up and maintenance are critical.
2021, International Journal of Pediatrics and Adolescent Medicine
Gaining vascular access in children is challenging. Ultrasound-guided central line insertion in adults became the standard of care; however, its role in children is not clear. Our objective was to evaluate the ultrasound-guided Port-A-Cath or totally implanted long-term venous access device insertion in pediatric patients compared to the traditional approach.
This single-institution retrospective cohort study included 169 children who had port-A-catheters between May 2016 and Oct 2019. The patients were divided into two groups; group A included patients who had Port-A-Cath insertion using the landmark method (n = 117), and Group B included patients who had ultrasound-guided Port-A-Cath insertion (n = 52). Preoperative, operative, and postoperative data were collected and compared between the two groups. The study outcomes were operative time and catheter insertion-related complications.
There was no significant difference in age or gender between both groups (P = .33 and .71, respectively). Eleven cases in group A and two cases in group B were converted to cut down technique because of difficulty in inserting the guidewire. There was no difference in the indication of the need for the port-A-Cath between both groups. The mean operative time for group A was 47 min and for group B was 41.7 min (P < .042). Two patients had intraoperative bleeding and hemothorax and required blood transfusion and chest tube insertion in group A. No statistically significant difference was found in the reported complications between the groups. However, the insertion-related complications were higher in group A (P = .053). No procedure-related mortality was reported.
Ultrasound-guided insertion of Port-A-Cath is an effective and safe technique with a reduction of failure rate. It should be considered the standard technique for Port-A-Cath insertion in the pediatric population.
The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112).
Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires.
One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5–90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0–50.0 min with SC and 130.0–300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1–3 IV → cycles 4–6 SC: 77.5% → 72.5%; cycles 1–3 SC → cycles 4–6 IV: 77.5% → 63.8%).
Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.
A subcutaneous formulation of pertuzumab and trastuzumab with recombinant human hyaluronidase in one ready-to-use, fixed-dose combination vial (pertuzumab, trastuzumab, and hyaluronidase-zzxf) was approved by the US Food and Drug Administration (FDA) on June 29, 2020. We report the primary analysis of the FeDeriCa study, which was designed to assess the pharmacokinetics, efficacy, and safety of the fixed-dose subcutaneous formulation compared to intravenous pertuzumab plus trastuzumab in patients with HER2-positive early breast cancer in the neoadjuvant–adjuvant setting.
FeDeriCa, a randomised, open-label, international, multicentre, non-inferiority, phase 3 study, was done across 106 sites in 19 countries. Patients aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1, HER2-positive, operable, locally advanced, or inflammatory stage II–IIIC breast cancer, and a left ventricular ejection fraction of 55% or more were randomly assigned (1:1), using a voice-based or web-based response system, to receive intravenous pertuzumab (840 mg loading dose, followed by 420 mg maintenance doses) plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg maintenance doses) or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks with neoadjuvant chemotherapy. Patients were stratified by hormone receptor status, clinical stage, and chemotherapy regimen. The investigator selected one of the two protocol-approved standard chemotherapy regimens before randomisation. Four cycles of HER2-targeted therapy were administered concurrently with the taxane. After surgery, patients continued the HER2-targeted therapy to receive an additional 14 cycles (total of 18). The primary endpoint was non-inferiority of the cycle 7 pertuzumab serum trough concentration (Ctrough; ie, cycle 8 predose pertuzumab concentration) within the fixed-dose combination for subcutaneous injection versus intravenous pertuzumab plus trastuzumab in the per-protocol pharmacokinetic population (all enrolled patients who adhered to prespecified criteria for pharmacokinetic assessment). Non-inferiority was concluded if the lower bound of the 90% CI of the geometric mean ratio was 0·8 or higher. The safety population included all patients who received at least one dose of study medication, including chemotherapy or HER2-targeted therapy. Enrolment, neoadjuvant therapy, and surgery have been completed; adjuvant treatment and follow-up are ongoing. The trial is registered with ClinicalTrials.gov, NCT03493854.
Between June 14, 2018, and Dec 24, 2018, 252 patients were randomly assigned to the intravenous infusion group and 248 to the fixed-dose combination group. The geometric mean ratio of pertuzumab serum Ctrough subcutaneous to serum Ctrough intravenous was 1·22 (90% CI 1·14–1·31). The most common grade 3–4 adverse events occurring during neoadjuvant treatment with HER2-targeted therapy plus chemotherapy in 5% or more of patients were neutropenia (34 [13%] of 252 patients in the intravenous infusion group vs 35 [14%] of 248 patients in the fixed-dose combination group), decreased neutrophil count (31 [12%] vs 27 [11%]), febrile neutropenia (14 [6%] vs 16 [6%]), diarrhoea (12 [5%] vs 17 [7%]), and decreased white blood cell count (18 [7%] vs nine [4%]). At least one treatment-related serious adverse event was reported in 25 (10%) patients in the intravenous infusion group and 26 (10%) patients in the fixed-dose combination group. One patient in each treatment group had an adverse event that led to death (urosepsis in the intravenous infusion group and acute myocardial infarction in the fixed-dose combination group); neither death was related to HER2-targeted therapy.
The study met its primary endpoint: the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection provides non-inferior cycle 7 pertuzumab serum Ctrough concentrations to intravenous pertuzumab plus trastuzumab in the neoadjuvant setting with comparable total pathological complete response rates, supporting the FDA approval. Safety was similar between treatment groups, and in line with other pertuzumab, trastuzumab, and chemotherapy trials. Follow-up is ongoing for long-term outcomes, including efficacy and long-term safety.
