Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial

PurposeThis single centre, open labelled, randomised non-inferiority trial compared concurrent chemoradiotherapy with carboplatin versus standard concurrent chemoradiotherapy with cisplatin in patients with locoregionally advanced nasopharyngeal cancer (NPC).Patients and methodsFrom August 1999 to December 2004, 206 patients with locally advanced NPC were randomised with 101 to cisplatin arm and 105 to carboplatin arm. Planned radiotherapy was the same in both groups. All the patients were evaluated for toxicity and survival according to the as-treated principle.ResultsWith a median follow-up of 26.3 months (range 3–74.6 months), 59% of patients in the cisplatin arm completed the planned concurrent chemoradiation treatment, compared to 73% in the carboplatin arm. Forty-two percent of cisplatin patients completed the 3 cycles of adjuvant therapy compared to 70% in the carboplatin group. There were more renal toxicity, leucopenia, and anaemia in the cisplatin group, and more thrombocytopenia in the carboplatin arm. The 3 year disease free survival rates were 63.4% for the cisplatin group and 60.9% for the carboplatin group (p = 0.9613) (HR 0.70, 95% confidence interval (CI): 0.50–0.98). The 3 year overall survival rates were 77.7% and 79.2% for cisplatin and carboplatin groups, respectively (p = 0.9884) (HR 0.83, 95% CI: 0.63–1.010).ConclusionWe concluded that the tolerability of carboplatin based regimen is better than that of the cisplatin regimen. Moreover, the treatment efficacy of carboplatin arm is not different from the standard regimen in the treatment of locoregional advanced stage NPC.     

A comparative study between two central veins for the introduction of totally implantable venous access devices in 1201 cancer patients

Introduction and aims

The Subclavian vein has been traditionally the vein of choice for central venous catheterization by general surgeons. Alternative settings for the introduction of totally implantable venous access devices (TIVAD) and the search for lower rates of morbidity led to the choice of other central veins. This study compares two different venous accesses, the subclavian (SC) versus the internal jugular (IJ), in terms of early and late morbidity.

Patients and methods

This is a prospective, non-randomized, observational, uni-institutional (tertiary cancer centre) study. From March 2003 to March 2006, 1231 TIVADs were placed (1201 patients), in an ambulatory operating room, under vital signs and EKG monitoring, using local anaesthesia and without perioperative radiological control.

Results

Of the 1231 TIVAD, 617 were inserted via the SC and 614 via the IJ vein. The two groups (SC vs. IJ) were comparable as to general patient characteristics. Immediate complications were more frequent in the SC than in the IJ approach (respectively, 5.0% vs. 1.5%; p < 0.001); Catheter malposition occurred in 2.3% when using the SC vein and in 0.2% for the IJ (p = 0.001). Long term morbidity was also more frequent in the SC than in the IJ group (respectively, 15.8%, 87/551, vs. 7.6%, 39/512; p < 0.001). Venous thrombosis developed in 2.0% of patients with an SC TIVAD as compared to 0.6% with an IJ TIVAD (p = 0.044). Catheter malfunction was significantly dependent on the vein used: SC - 9.4% vs. IJ - 4.3% (p = 0.001).

Conclusions

Our results support the preferential use of the Internal Jugular vein for the insertion of TIVAD.     

Classical external indwelling central venous catheter versus totally implanted venous access systems for chemotherapy administration: a randomized trial in 100 patients with solid tumors

A prospective randomized trial was organized at the Institut Gustave-Roussy to assess the reliability of classical external catheters (CE) versus totally implanted access systems (TI) for delivering intravenous chemotherapy for a duration of at least 6 months. The analysis was performed on the 96 patients whose implantation succeeded (CE 46, TI 50). Failure was defined as loss of ability to function (followed by removal) within the 6-month period of the survey. Patients dying with functional catheters were considered as censored (15 cases) at the time of death. Twenty-four access systems were removed. The removal-free curves differ significantly (P < 0.001), favoring the TI access systems. The main reasons for removal were: catheter fall (CE 6, TI 0), migration (CE 1, TI 1), infection (CE 5, TI 1), thrombotic occlusion (CE 1, TI 0) and venous complications (CE 1 thrombosis plus 1 pulmonary embolism, TI 1 thrombosis). In addition, a survey by questionnaire demonstrated a significantly better patient activity rate (P = 0.02) and hygiene (P < 0.001) in the TI group. This prospective randomized study demonstrates that totally implanted access systems are more reliable, safer and better tolerated than classical external catheters for solid tumor patients undergoing intravenous chemotherapy for longer than 6 months.     

Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial

BACKGROUND: The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable. The multicentre COLOR (COlon cancer Laparoscopic or Open Resection) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon. METHODS: 627 patients were randomly assigned to laparoscopic surgery and 621 patients to open surgery. The primary endpoint was cancer-free survival 3 years after surgery. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, metastasis, overall survival, and blood loss during surgery. Analysis was by intention to treat. Here, clinical characteristics, operative findings, and postoperative outcome are reported. FINDINGS: Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection (median 100 mL [range 0-2700] vs 175 mL [0-2000], p<0.0001), although laparoscopic surgery lasted 30 min longer than did open surgery (p<0.0001). Conversion to open surgery was needed for 91 (17%) patients undergoing the laparoscopic procedure. Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups. Laparoscopic colectomy was associated with earlier recovery of bowel function (p<0.0001), need for fewer analgesics, and with a shorter hospital stay (p<0.0001) compared with open colectomy. Morbidity and mortality 28 days after colectomy did not differ between groups. INTERPRETATION: Laparoscopic surgery can be used for safe and radical resection of cancer in the right, left, and sigmoid colon.     

Use of totally implantable central venous access port via the basilic vein in patients with thoracic malignancies

Background  For patients with a thoracic malignancy whose peripheral veins are not suitable for blood access for chemotherapy, we evaluated a totally implantable central venous access port, in which the port is implanted in the ulnar side of the arm and the catheter is introduced via the basilic vein into the superior vena cava (TIAP-BV). Methods  Twenty-five patients (21 with lung cancer, 2 with malignant pleural mesothelioma, and 2 with thymoma) receiving TIAP-BV were included. Indications, surgical complications, and long-term complications were analyzed. Results  Indications for TIAP-BV were: chemotherapy (17 patients) and chemotherapy with parenteral nutrition (8 patients). The following surgical complications occurred: arrhythmia due to misplacement of the tip of catheter (1 patient); intraoperative conversion from the left to right arm (2 patients); and hematoma at the implantation site (1 patient). Short-term problems were: death 1 week after implantation without the use of TIAP-BV (2 patients). Long-term complications were: skin ulcer at the port site (1 patient); early removal of TIAP-BV because of port site infection (1 patient); catheter occlusion (1 patient); and venous thrombosis of basilic vein (2 patients). In the 22 patients who did not die early or have the device withdrawn early, the median duration of TIAP-BV use was 7 months (range, 1 to 20 months) without any break to the port system, leakage of drugs, or catheter-related infections. Conclusion  TIAP-BV can be employed for long-term use for chemotherapy and parenteral nutrition. However, a patient’s expected prognosis and infectious disease status at the time of implantation surgery should be considered before the surgery proceeds.     

Efficacy and safety of ultrasound-guided totally implantable venous access ports via the right innominate vein in adult patients with cancer: Single-centre experience and protocol

BackgroundTotally implantable venous access ports (TIVAPs) are widely used and are an essential tool in the efficient delivery of chemotherapy. This study aimed to evaluate the feasibility and safety of implantation of ultrasound (US)-guided TIVAPs via the right innominate vein (INV) for adult patients with cancer.MethodsThis study retrospectively reviewed the medical records of 283 adult patients with cancer who underwent US-guided INV puncture for TIVAPs between September 2015 and September 2017. It also analysed the technical success rate, operation time, and short-term and long-term surgical complications.ResultsTechnical success was achieved in all patients (100%). The mean operation time was 28.31 ± 7.31 min (range: 23–39 min), and the puncture success rate for the first attempt was 99.30% (281/283). Minor complications included artery puncture during the operation in one patient, but no pneumothorax was encountered. The mean TIVAP time was 304.16 ± 42.54 days (range: 38–502 days). The rate of postoperative complications was 2.83% (8/283), including poor healing of the incision in one patient, catheter-related infections in three patients, port thrombosis in one patient, and fibrin sheath formation in three patients; no catheter malposition, pinch-off syndrome, catheter fracture, or other serious complications were observed.ConclusionsTIVAPs are widely employed for chemotherapy. The present study found that the novel approach of using US-guided INV puncture to implant TIVAPs in adult patients with cancer is both short-termly feasible and safe for long-term central venous access.